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wmj201305<\/a><\/p>\n

COUNTRY
\n\u2022 64rd
\nWMA General Assembly and 195th
\n\/196th
\nCouncil
\nSessions
\n\u2022 Declaration of Helsinki
\nvol. 59
\nMedicalWorld
\nJournal
\nOfficial Journal of the World Medical Association, INC
\nG20438
\nNr. 5, October 2013
\nCover picture from Norway
\nEditor in Chief
\nDr. P\u0113teris Apinis
\nLatvian Medical Association
\nSkolas iela 3, Riga, Latvia
\nPhone +371 67 220 661
\npeteris@arstubiedriba.lv
\neditorin-chief@wma.net
\nCo-Editor
\nProf. Dr. med. Elmar Doppelfeld
\nDeutscher \u00c4rzte-Verlag
\nDieselstr. 2, D-50859 K\u00f6ln, Germany
\nAssistant Editor
\nVelta Poz\u0146aka
\nwmj-editor@wma.net
\nJournal design and
\ncover design by
\nP\u0113teris Gricenko
\nLayout and Artwork
\nThe Latvian Medical Publisher
\n\u201cMedic\u012bnas apg\u0101ds\u201d,
\nPresident Dr. Maija \u0160etlere,
\nKatr\u012bnas iela 2, Riga, Latvia
\nCover painting:
\nThe painters name is: Karl Aspelin (1857\u20131932)
\nThe name of the painting is: L\u00e4karebes\u00f6ket,
\n1880-talet (the doctor appointment, from the
\n1880th
\n). Oil on canvas.
\nPublisher
\nThe World Medical Association, Inc. BP 63
\n01212 Ferney-Voltaire Cedex, France
\nPublishing House
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\nDeutscher-\u00c4rzte Verlag GmbH,
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\nSubscription fee \u20ac 22,80 per annum (incl. 7%
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\nsubscription fee is settled by the membership
\nor associate payment. Details of Associate
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\nMedical Association website
\nwww.wma.net
\nPrinted by
\nDeutscher \u00c4rzte-Verlag
\nCologne, Germany
\nISSN: 0049-8122
\nDr. Margaret MUNGHERERA
\nWMA President
\nUganda Medical Association
\nPlot 8, 41-43 circular rd., P.O. Box
\n29874
\nKampala
\nUganda
\nDr. Leonid EIDELMAN
\nWMA Chairperson of the Finance
\nand Planning Committee
\nIsrael Medical Asociation
\n2 Twin Towers, 35 Jabotinsky St.
\nP.O.Box 3566, Ramat-Gan 52136
\nIsrael
\nDr. Masami ISHII
\nWMA Vice-Chairman of Council
\nJapan Medical Assn
\n2-28-16 Honkomagome
\nBunkyo-ku
\nTokyo 113-8621
\nJapan
\nDr. Cecil B. WILSON
\nWMA Immediate Past-President
\nAmerican Medical Association
\n515 North State Street
\n60654 Chicago, Illinois
\nUnited States
\nSir Michael MARMOT
\nWMA Chairperson of the Socio-
\nMedical-Affairs Committee
\nBritish Medical Association
\nBMA House,Tavistock Square
\nLondon WC1H 9JP
\nUnited Kingdom
\nDr. Guy DUMONT
\nWMA Chairperson of the Associate
\nMembers
\n14 rue des Tiennes
\n1380 Lasne
\nBelgium
\nDr. Xavier DEAU
\nWMA President-Elect
\nConseil National de l\u2019Ordre des
\nM\u00e9decins (CNOM)
\n180, Blvd. Haussmann
\n75389 Paris Cedex 08
\nFrance
\nDr. Heikki P\u00c4LVE
\nWMA Chairperson of the Medical
\nEthics Committee
\nFinnish Medical Association
\nP.O. Box 49
\n00501 Helsinki
\nFinland
\nDr.Frank Ulrich MONTGOMERY
\nWMA Treasurer
\nHerbert-Lewin-Platz 1
\n(Wegelystrasse)
\n10623 Berlin
\nGermany
\nDr. Mukesh HAIKERWAL
\nWMA Chairperson of Council
\n58 Victoria Street
\nWilliamstown, VIC 3016
\nAustralia
\nDr. Otmar KLOIBER
\nWMA Secretary General
\n13 chemin du Levant
\n01212 Ferney-Voltaire
\nFrance
\nWorld Medical Association Officers, Chairpersons and Officials
\nOfficial Journal of the World Medical Association
\nOpinions expressed in this journal\u00a0\u2013 especially those in authored contributions\u00a0\u2013 do not necessarily reflect WMA policy or positions
\nwww.wma.net
\n161
\nMembers of the World Medical General
\nAssembly, colleagues, guests and our hosts
\nthe Brazilian Medical Association:
\nSince my inauguration last year in Bang-
\nkok, it has been my privilege to represent
\nthe World Medical Association (WMA)
\naround the world.
\nI\u2019ve traveled to at a total of five continents,
\ntwelve countries and attended twenty-nine
\nmeetings and conferences.
\nI\u2019ve also reported on my travels and the var-
\nied and important activities of this organi-
\nzation on the WMA website through the
\nPresident\u2019s Blog.
\nThe message I have carried may be summed
\nup as follows:
\n1. The moral imperative of ethics in medicine.
\n2. The challenge of noncommunicable dis-
\nease and the social determinants of health.
\n3. The threat of climate change.
\nFirst, the moral imperative of ethics in
\nmedicine
\nAs you all are aware, the WMA has been
\nvery involved in the process of bringing the
\nDeclaration of Helsinki (DOH) up to date in
\nanticipation of its fiftieth anniversary in 2014.
\nThe Expert Conferences convened in Cape
\nTown, South Africa, Tokyo, Japan and
\nWashington, DC, brought together experts
\nin ethics, members of the medical profes-
\nsion, educators and governmental officials
\nto provide input.
\nThe conferences are part of the multi-year
\neffort by the World Medical Association to
\nexamine the DOH to determine if changes
\nare needed.
\nIn examining the DOH for potential
\nchanges the WMA has focused on trans-
\nparency and on obtaining a diversity of
\nopinions from experts around the world.
\nAt this meeting, we see the culmination of
\nmany hours\u2019 work by the workgroup, and
\nespecially the facilitating group, who had
\nthe unenviable task of taking mountains of
\ncomments and distilling them into a new
\nmore understandable document.
\nIn addition, the transparency of the process
\nthat encouraged involvement by experts in
\nthe field and the public is an affirmation
\nthat the end product will preserve the DOH
\nas the gold standard for ethical principles in
\nresearch involving human subjects.
\nSecond, the challenge of noncommunicable
\ndisease and the social determinants of health
\nThe social determinants of health are the
\nconditions in which people are born, grow,
\nlive, work and age; and the societal influ-
\nences on these conditions.
\nThey are major influences on both quality
\nof life, including good health, and length of
\ndisability-free life expectancy.
\nThe primary responsibility for addressing
\nthe social determinants of health is that of
\ngovernment and society.
\nIn March I attended the Institute of Health
\nEquity (IHE) which makes recommenda-
\ntions for actions and provides analysis in
\ncore areas of work for physicians:
\n1. Workforce education and training as
\nwell as individuals and communities.
\n2. Government organizations and working
\nin partnership and as advocates.
\n3. Challenges and opportunities in the
\nhealth system.
\nThe WMA believes in the importance of
\nhealth care system strengthening, universal
\naccess and emphasizing social determinants
\nof health as the right approach in fighting
\nNCDS.
\nAt all WHO events on this topic, the
\nWMA will advocate for a holistic approach
\nthat puts social determinants of health at
\nthe forefront of thinking about health care.
\nThird, the threat of climate change
\nClimate change due to global warming is
\nreality of life on our planet today.
\nIt has health effects that are significant and
\nalready being felt.
\nFor example extreme heat events are more
\nfrequent, of longer duration and more se-
\nvere, causing increased deaths in the tens of
\nthousands yearly.
\nEarly research suggests that mitigation of
\nthe effects of climate change may have a
\nlink with prevention and might have sig-
\nnificant health benefits for both individuals
\nand populations.
\nIn climate change vernacular, mitigation
\nand adaption are the buzzwords.
\nThe WMA is committed to being involved
\nin the mitigation of climate change \u2013 that is
\nattempting to slow or reverse climate change
\nby decreasing greenhouse gas production
\nthrough implementation of green policies.
\nIncluding for example extremes of weather
\nsuch as heat events and torrential down-
\npours and flooding;
\nChanges in insect disease vector popula-
\ntions, and adverse effects on food sources
\nbrought on by droughts.
\nAs another part of ongoing efforts to sup-
\nport responses to climate change, the
\nAddress of Past President of WMA Cecil B Wilson,
\nOctober,18th
\n2013
\nCecil B. Wilson
\nWMA News
\n162
\nWMA established an environmental caucus
\nwhich meets regularly in conjunction with
\nWMA meetings.
\nLast fall the caucus surveyed WMA mem-
\nbers to assess implementation of WMA\u2019s
\ngreen policies within its membership.
\nThe goal was to evaluate medical associa-
\ntions\u2019 involvement in those areas and get
\nuseful guidance for potential additional ac-
\ntivities.
\nBased on the results of the environmental
\ncaucus survey, WMA members report they
\nare engaged in dealing with climate change
\nand have a variety of suggestions about how
\nfurther progress can be accomplished.
\nIn conclusion, as I stated in my inaugural
\naddress,
\nI still believe that in spite of the constancy
\nof change and the unexpected events of our
\nlives,
\nWe as physicians can open new doors, share
\nnew insights,find new cures,prevent disease
\nWe can help our patients the world over to
\nlive healthier, happier, longer more produc-
\ntive lives.
\nI thank you for the great honor of contrib-
\nuting to these ideals as WMA President
\nover the past year, and I look forward to
\nmore opportunities to create a brighter fu-
\nture of medicine.
\nThe Health Secretary of the State of Ceara,
\nMr. Secretary Ciro Ferreira Gomes, the
\nHon. Minister of Health, Uganda, Dr. Ru-
\nhakana Rugunda, the outgoing President of
\nthe World Medical Association Dr. Cecil
\nWilson, the Chair of WMA Council, Dr.
\nMukesh Haikerwal, the WMA Secretary
\nGeneral, Dr. Otmer Kloiber, the Presi-
\ndent of the Brazilian Medical Association,
\nDr. Florentino Cardoso, members of the
\nWMA, ladies and gentlemen.
\nIt is my honour and privilege to express my
\nsincere appreciation to the President of the
\nBrazilian Medical Association,Dr.Florentino
\nCardoso and his team for hosting the WMA
\nmeeting and their warm hospitality and for
\nthe choice for such an auspicious venue for
\nthe meeting.Please join me in acknowledging
\nthe hard work put in by the Secretariat (Sun-
\nny, Lamine, Anna and others) ably led by the
\nWMA Secretary General,Dr.Otmar Kloiber
\nin organizing the meeting.
\nIn a special way, I would like to thank Dr.
\nCecil Wilson for having graciously men-
\ntored me a lot over the last 12 months about
\nwhat it means to be passionate and dedicat-
\ned to getting things done and he has indeed
\nachieved things done. Thank you, Cecil and
\nI wish you all the best.
\nSome of you might be asking yourselves but
\nwho I am and where I come from.
\nI come from Uganda, a small country in
\nthe eastern part of Africa named which Sir
\nWinston Churchill in 1903 described as the
\n\u201cthe pearl of Africa\u201d The weather, the cli-
\nmate, the evergreen scenery, the source of
\nthe River Nile and the world\u2019s largest popu-
\nlation of mountain gorillas make Uganda an
\nexquisitely beautiful country and you are all
\ninvited to visit it.
\nThis country which at one time had the
\nbest medical school in Eastern, Central and
\nSouthern Africa is just beginning to recover
\nfrom more than 25 years of state inspired
\nviolence and civil conflict. It is now heart-
\nening to note that it is making progress and
\nwe are on the right track.
\nI have lived in that country all my life not
\nbecause I had no choice but because I made
\na conscious decision to stay and make my
\nown contribution to making things right
\nespecially in the medical profession.
\nWhen I qualified from the medical
\nschool, I continued to witness the dete-
\nrioration in health services. I had spent
\nthe whole of my third and fourth years
\nin abject fear for my life and that of my
\nfamily and friends. For 2 whole years,
\nreading at night was difficult because that
\nwas when the gun shots and bombing was
\nworst. Getting to the teaching hospital in
\nthe mornings for lectures to find that yet
\nanother doctor had been killed on his way
\nfrom the hospital became the order of the
\nday. I still remember the helplessness I
\nfelt as I saw many of my lecturers flee the
\ncountry and into exile.
\nThe question on our minds as students
\nwas, would we be able to complete
\nmedical school. By the time, our final
\nyear ended, Idi Amin, the former presi-
\ndent, had fled the country but leaving
\nInaugural Address of Dr. Margaret Mungherera,
\nPresident of the WMA, October, 18th
\n2013
\nMargaret Mungherera
\nWMA News
\n163
\nthe country in disarray. Internship was
\neven worse. The scarcity of resources was
\ngross. I\u00a0 spent the whole of my intern-
\nship putting up IV lines without gloves
\nand draining abcesses of fully conscious
\npatients without a local anaesthetic.
\nAnd this is when I promised myself that
\nI\u00a0would do everything I could to be part
\nof the change and I am glad to say that
\nI have been part of it and continue to be.
\nAs we completed our internship in 1983,
\nout of a class of almost 100, more than
\n60 of my classmates left the country in
\nsearch of greener pastures. But despite
\npleas from parents, I\u00a0chose to stay.
\nThis resolve and determination enabled me
\nto be one of the founder members of the
\nAssociation of Uganda Women Medical
\nDoctors who embarked on speaking out on
\nthe need for rural women to be able to ac-
\ncess reproductive health services. It is this
\nresolve and determination that led me ac-
\ncept to stand for the post of President of the
\nUganda Medical Association and become
\nthe first woman to hold that position since
\nits formation in 1964. I would like to thank
\nRichard, my husband, for being there for
\nme all the time.
\nIn a country of 36 million people, I am
\none of 5000 medical doctors, one of the
\n36 psychiatrists and one of the only 2 fo-
\nrensic psychiatrists the country has. But
\nthings are slowly getting better \u2013 One of
\nthe highlights of my time as President of
\nUganda Medical Association was when I
\nreluctantly took up that position again in
\n2010 to fight for better pay for doctors and
\nfinally convinced Government to accept
\nour proposal to increase the pay of doc-
\ntors working in rural areas by 300 percent.
\nIt showed me that the decision I made 30
\nyears ago to stay in Uganda was indeed a
\ngood decision.
\nIt has been a long journey but it has been
\nworth it. I have tried to take the knowl-
\nedge and skills I acquired during my train-
\ning as a doctor and psychiatrist beyond the
\nhospitals and use it to reduce the suffering
\nof poor communities, I have sat in a grass
\nthatched hut with mud and wattle walls
\nwith no lunch for days running mental
\nhealth clinics for Sudanese refugees and
\ninternally displaced persons in Northern
\nUganda, in the scorching heat with bomb-
\ning and sporadic gun shots as the back-
\nground music.
\nI have demonstrated on the streets for psy-
\nchosocial support for survivors of gender
\nbased violence and I have had heated argu-
\nments with the tobacco industry on nation-
\nal radios. I am a human rights advocate and
\na women\u2019s rights advocate. It is this passion
\nand determination to fight for social justice
\nfor all that I bring to the leadership of the
\nWMA.
\nIt gives me great pride to note that despite
\nthe differing environments and circum-
\nstances of its members, the WMA remains
\ncommitted to providing guidance to na-
\ntional medical association as regards pro-
\nmoting their professional freedom, high
\nmedical ethical standards and professional
\nconduct, and advocacy for access to quality
\nhealth care for all.
\nDuring my term as President of the World
\nMedical Association, I will advocate for
\nthe health of the poor and vulnerable com-
\nmunities. Almost half of the world lives
\non less than a dollar a day. Therefore we,
\nthe Physicians of the world, through our
\nnational medical associations have a duty
\nto advocate on behalf of the poor among
\nus \u2013 because as the famous adage goes
\n\u201cIf you miss the poor, you\u2019ve missed the
\npoint\u201d. And there is no part of the globe
\nthat does not have poor people who for one
\nreason or another cannot enjoy their ba-
\nsic human rights- the people who cannot
\naccess health care, mentally ill people who
\nare discriminated against, and survivors
\nof torture and other forms of violence. As
\nphysicians, we have been given the privi-
\nlege to do something about it. We can do
\nmuch as individual physicians, but we can
\nhave wider and more sustainable impact
\nwithin our NMAs, under the umbrella of
\nthe World Medical Association.
\nNMAs can ensure poor people have ac-
\ncess to health care by ensuring that health
\nsystems in their countries are functional.
\nUniversal health care or the Millennium
\nDevelopment Goals cannot be achieved
\nwhere there is for example a gross shortage
\nof health workers or a lack of essential med-
\nicines. What the various stakeholders in the
\nHealth Sector need is effective leadership
\nand guidance and who better suited than
\nNMAs to provide this leadership? However,
\nNMAs must ensure they have the necessary
\ncapacity to be effective and this is where the
\nWMA comes in.
\nI salute you all, who strive, sometimes
\nrisking your lives to minimize the suf-
\nfering of your communities, working in
\nthe aftermath of natural and man-made
\ndisasters, in places where the health facili-
\nties are less than adequate. Your dedica-
\ntion to maintain the highest standards
\nin the practice of human medicine has
\nhelped save and transform the quality of
\nlife of individuals and whole communities
\naround the world.
\nAs I conclude I would like to thank my
\nMinister of Health, Hon. Dr. Ruhakana
\nRugunda for travelling all the way to wit-
\nness my installation as president.
\nThrough him I would like to express my
\ngratitude and that of Uganda Medical As-
\nsociation to the President of Uganda for his
\nsupport and interest in the health profes-
\nsion and the health sector.
\nOnce again I would like to thank all of you
\nfor having entrusted me with the respon-
\nsibility of heading this august body for the
\nnext 12 months.
\nWMA News
\n164
\nHuman rights, patients\u2019 rights, professional
\nindependence, informed consent: the fun-
\ndamental principles of medical ethics are
\nuniversal and know no boundaries.
\nIn 1947, doctors from 27 countries united
\nto set up the World Medical Association.
\nTheir aim was to serve mankind by estab-
\nlishing the highest standards of ethics in
\nteaching, medical treatment and preven-
\ntion for all peoples. They did not speak the
\nsame language, nor share the same culture
\nbut they all had the same ideal, the same
\ncommitment to their patients, regardless of
\ntheir religion, their social standing or their
\npolitical opinions.
\nThe WMA has shown these past sixty years
\nthat our will to defend the independence of
\nNational Medical Associations and the in-
\ndependence of each doctor requires nowa-
\ndays political advocacy at all levels, both
\nnational and international.
\nI wish to strongly collaborate with you
\nall during the next three years with a
\nview to further cooperation in the longer
\nterm.
\nIt is an ethical principle that unites us:
\nbringing together physicians in the interests
\nof patients.
\nDr. Xavier Deau
\nCurrent positions
\n\u2022 President of the European and Interna-
\ntional Delegation of the French Medical
\nCouncil since June 2013.
\n\u2022 President of the Departmental Council
\nof Medical Order of Vosges since 1993.
\n\u2022 General Secretary of the European
\nCouncil of Medical Orders (CEOM)
\nsince 2011.
\n\u2022 General Secretary of the Conference of
\nMedical Councils from French-speaking
\ncountries (CFOM) since 2011.
\nFormer positions
\n\u2022 Council Member of the WMA since
\n2012.
\n\u2022 Vice-president of the French Medical
\nCouncil in charge of international rela-
\ntions from 2011 to 2013.
\n\u2022 Vice-president of the French Medical
\nCouncil in charge of relations with Uni-
\nversity from 2009 to 2013.
\n\u2022 President of the Medical Training
\nand Qualifications Department of the
\nFrench Medical Council from 2005 to
\n2009.
\n\u2022 Vice-president of the Professional Prac-
\ntice Department of the French Medical
\nCouncil from 2003 to 2005.
\nWMA President \u2013 Elect Dr. Xavier DEAU
\nXavier Deau
\nWMA News
\n165
\nWMA News
\nThe General Assembly meeting in For-
\ntaleza, Brazil will be remembered for many
\nthings. But chief among them will be that it
\nwas the meeting where the revised Declara-
\ntion of Helsinki was adopted after a pro-
\ncess lasting two years. But it was also the
\nAssembly where Dr. Margaret Mungherera
\nwas installed as the first African woman to
\nbecome WMA President.
\nThe meeting, held at Villa Gal\u00e9 Cumbuco,
\nFortaleza, Brazil, held from October 16th
\nto
\n20th
\n, was attended by more than 250 del-
\negates and observers from more than 45
\nnational medical associations (NMAs) and
\nother organisations. As usual the proceed-
\nings opened on the first day with a meeting
\nof the Council.
\nCouncil
\nDr. Mukesh Haikerwal, Chair of the WMA,
\nreported briefly on the activities of theWMA
\nin helping doctors around the world who get
\ninto difficulties. The latest example was the
\ncase of a Canadian doctor, arrested and im-
\nprisoned in Egypt during the recent riots,
\nwho had just been released with the help of
\nthe WMA and others. He also referred to
\nthe multiple global meetings that were held
\naround the world, such as the G8 and the
\nG21. What he found very concerning was
\nthat often the place of health care and health
\nwas missing.\u2018Our role and that of the WMA
\nand its members is to bring to people\u2019s notice
\nthat it is very important to have good clinical
\ncare, to have good healthy subjects to make
\nsure the agenda for economic development is
\nactually achieved\u2019, he said.
\nThe Secretary General, Dr. Otmar Kloiber,
\nadded to an extensive written report on ac-
\ntivities during the year, by highlighting the
\nEuropean Union directive on clinical trials,
\nwhich related to the Declaration of Hel-
\nsinki. This was now being converted into
\na regulation and it would have a direct ef-
\nfect as a law on all European countries. He
\nsaid the WMA was disappointed that in
\nthe new regulations there was no longer a
\nrequirement to have the approval of ethics
\ncommittees before a clinical trial could start.
\nThe requirement to have ethics commit-
\ntees involved had now been put back into
\nthe proposal as the WMA had requested,
\nbut not in a way it would like to have seen.
\nHowever he was hopeful that there would
\nbe further changes so that any proposal for a
\ntrial would have to be positively considered
\nby an ethics committee.
\nA second issue in the regulation, which was
\nof global importance, related to the dual use
\nof samples and data in clinical studies. He
\nsaid the WMA was convinced that for all the
\nresearch carried out the informed consent of
\nparticipants was needed.However a problem
\nmight occur when there was a second use
\nfor the samples from the study and patients
\nmight not be able to be reached for a second
\ninformed consent. If that was not possible,
\nthe Declaration of Helsinki now said that an
\nethics committee had to give permission to
\nuse that data. But major research groups had
\nbeen lobbying the European Parliament to
\ncome to a different conclusion,by saying that
\nthere should be a broad consent for the sec-
\nondary use of samples or data in bio banks or
\nfrom research projects. The WMA believed
\nthat would undermine informed consent
\ncompletely because it would not allow for
\nthe subjects in a study to exercise their self-
\ndetermination correctly. He said the WMA
\nwould like to see a solution closer to that
\nsuggested in the Declaration of Helsinki.
\nDiscussions were continuing and the WMA
\nwould continue to monitor the situation.
\nEmergency Motions
\nNotice was given to the Council of three
\nemergency motions \u2013 on the Prohibition of
\nChemical Weapons, Chemical Riot Con-
\ntrol Agents and Health Care in Syria.It was
\nagreed that all three should be considered as
\na matter of urgency.
\nFinance and Planning
\nCommittee
\nThe committee met under the Chairman-
\nship of Dr. Leonid Eidelman (Israel Medi-
\ncal Association).
\nFinancial Reports
\nThe Treasurer, Dr. Frank-Ulrich Montgom-
\nery, introduced the audited financial state-
\nment for 2012, and the Budget for 2014.
\nMr Adolf H\u00e4llmayr, the Financial Advisor,
\nhighlighted some of the main points of the
\nexpenditure and income figures for 2012
\nand went through the Budget for 2014.
\nHe said that due to the on-going negative
\neffects of inflation on the expenses an ade-
\nquate increase in income would be necessary
\nto obtain balanced results and to guarantee
\nfinancial stability. To this end discussions
\nhad already started. It was agreed that the
\nreports be forwarded to Council and then
\n64rd
\nWMA General Assembly and 195th
\n\/196th
\nCouncil Sessions
\nNigel Duncan
\n166
\nDeclaration of Helsinki COUNTRYWMA News
\nto the Assembly for adoption. Mr H\u00e4llmayr
\nalso reported on the situation on member-
\nship dues and categories. A brief debate fol-
\nlowed on a proposed new dues structure. It
\nwas agreed to recommend that the Council
\nshould establish a workgroup to review the
\nproposal for new structure of membership
\ndues and report back
\nStrategic Plan
\nDr. Kloiber mentioned the current difficulty
\nwith raising sponsorship money, although
\nthere were still sponsored projects running.In
\nthe areas of ethics and advocacy, the WMA,
\nin collaboration with the World Health Pro-
\nfessions Alliance,would be hosting the World
\nHealth Professions Regulation Conference
\nin May 2014. There was a global trend for
\nregulation to be taken over by governments
\nand this was a critical issue that required the
\nWMA\u2019s attention. He also recognized that
\nthe Junior Doctors Network had become very
\nactive in the WMA and this was a benefit in
\nterms of new ideas as well as increasing the
\nvisibility of the Association.
\nBusiness Development Group
\nProfessor Vivienne Nathanson (British
\nMedical Association) reported on the first
\nmeeting of the business development round
\ntable recently held in London. Six of the
\n12 organisations that had agreed to join
\nthe group had attended and it was agreed
\nto meet again. A paper was being prepared
\nabout other ideas for producing non dues
\nrevenue. The Group was planning its next
\nround table in Tokyo in conjunction with
\nthe Council session.
\nFuture WMA Meetings
\nAn oral report was given about the Council
\nmeeting due to be held in Tokyo from April
\n8\u201312. It also agreed that at the next General
\nAssembly in Durban,South Africa in Octo-
\nber 2014 the theme of the scientific session
\nwould be \u2018Universal Access to Health Care
\nafter MDGs\u2019. The committee agreed that
\nthe invitation from the Norwegian Medical
\nAssociation to host the 200th
\nCouncil Ses-
\nsion in 2015 in Oslo be accepted.It was also
\nagreed that the Council recommend to the
\nAssembly that the theme of scientific ses-
\nsion for General Assembly in Moscow 2015
\nbe medical education.
\nDeclaration of Helsinki \u2013 50th
\nAnniversary
\nDr. Eidelman gave an oral report about
\nplans for an event in Helsinki to celebrate
\nthe 50th
\nanniversary of the Declaration of
\nHelsinki in May or June 2014. Dr. Heikke
\nP\u00e4lve (Finish Medical Association) ex-
\nplained that the event would begin with a
\nscientific session in the morning followed
\nby a celebration attended by the President
\nof Finland. He said that suitable dates and
\nvenues were still being considered
\nNew Members
\nThe Committee considered applications for
\nmembership from the Medical Chamber of
\nMontenegro, the Ordre National des M\u00e9-
\ndecins du Cameroun,the Sudanese Medical
\nAssociation and the Federazione Nazionale
\ndegli Ordini dei Medici Chirurghi e degli
\nOdontoiatri, Italy. It was agreed that these
\nbe forwarded to Council for adoption by
\nthe Assembly. Dr. Kloiber reported that the
\nAssociation of Hungarian Medical Societ-
\nies (MOTESZ) had agreed to be replaced
\nby the Hungarian Medical Chamber in
\nWMA membership and this matter would
\nbe considered by Council.
\nSocio-Medical Affairs
\nCommittee
\nThe committee met under the Chairman-
\nship of Sir Michael Marmot (British Medi-
\ncal Association).
\nHealth Care in Danger
\nProf. Nathanson, Chair of the workgroup
\non Health Care in Danger, reported on the
\nactivities of the group. She said the British
\nMedical Association had agreed to work
\nwith the International Committee of the
\nRed Cross on a toolkit looking at the ethical
\ndilemmas faced by doctors in situations of
\narmed conflicts and other situations of vio-
\nlence. She also reported on the workgroup\u2019s
\ndecision to work on the subject of psychia-
\ntry and quality of care, and in particular
\nissues related to whether some psychiatric
\ntreatment without the consent of the indi-
\nvidual amounted to torture or ill treatment.
\nViolence Against Women and Girls
\nThe Chair of the Committee put forward
\nproposals for implementing the proposed
\nresolution on violence against women and
\ngirls. He suggested exploring opportuni-
\nties to collaborate with global organisations
\nworking in this area, such as the Global
\nFoundation to End Domestic Violence,
\ninitiated by Baroness Scotland. The Ameri-
\ncan Medical Association referred to the US
\norganisation, Futures without Violence, and
\nsaid they would make contact with them. It
\nwas also suggested that the WMA might
\norganise a side-event on this issue at the
\nWorld Health Assembly 2014, possibly in
\ncooperation with the International Federa-
\ntion of Medical Students Association and
\nthe International Federation of Gynaecolo-
\ngy and Obstetrics.A third idea was to invite
\nnational medical association members to
\nreport to the secretariat on their initiatives
\nin relation to violence against women in or-
\nder to acquire an overview of their involve-
\nment in this area.The Indian and Australian
\nMedical Associations also reported on their
\nactivities on this issue.
\nRight to Reparation of Victims of Torture
\nThe Committee considered a proposed
\nStatement on the Right to Reparation of
\nVictims of Torture proposed by the Danish
\nMedical Association. The statement urged
\nnational medical associations to work with
\nother organisations to ensure the reparation
\nof victims of torture in view of concern at the
\n167
\nWMA News
\ncontinued use of torture in many countries
\nthroughout the world. It was proposed and
\nagreed that the title of the Statement should
\nbe amended to use the word \u2018rehabilitation\u2019
\nrather than \u2018reparation\u2019and it was agreed that
\nthe document should be forwarded to Coun-
\ncil for adoption by the Assembly.
\nHuman Papillomavirus Vaccination
\nThe Committee considered a proposed
\nStatement on Human Papillomavirus Vac-
\ncination.Dr.Ardis Hoven (American Med-
\nical Association) said the Statement had
\nbeen circulated for comments and these had
\nbeen taken into account. The safety, efficacy
\nand value of a vaccine were well known.
\nEach nation would have its own health pri-
\norities and the unique opportunity to pre-
\nvent HPV associated cancers merited con-
\nsideration. A brief debate followed, when it
\nwas argued that the WMA should be very
\ncautious about getting involved in specific
\nmedical issues. However Dr. Hoven replied
\nthat a stand-alone Statement was needed
\nbecause there was little common knowl-
\nedge, even among physicians, about what
\nthis vaccine could do and what it could pre-
\nvent. A motion to defer the document was
\ndefeated and it was agreed that the State-
\nment be approved by the Council with the
\nrecommendation that it be forwarded to the
\nGeneral Assembly for adoption.
\nFungal Disease Diagnosis and Management
\nDr. Jos\u00e9 Luiz Gomes do Amaral (Brazil
\nMedical Association) proposed a State-
\nment on Fungal Disease and Management.
\nHe said its purpose was to raise the atten-
\ntion of national medical associations to the
\nproblem of fungal disease, which was often
\nconsidered not as important as tuberculo-
\nsis, malaria or AIDs. But from the data the
\nglobal burden of fungal disease compared to
\nthese other diseases. In a brief debate, it was
\ndecided to remove the statistics from the
\ndocument because they would quickly go
\nout of date and undermine the fundamental
\nmessage of the Statement.It was agreed that
\nthe proposed Statement be revised and be
\nsubmitted to the Council for consideration.
\nEthical Guidelines for Recruitment of Physi-
\ncians
\nThe Committee considered a proposed revi-
\nsion to the WMA statement on the Ethical
\nGuidelines for Recruitment of Physicians.
\nProf. Nathanson said none of the principles
\nhad been changed but it had merely been
\nupdated. It was agreed that the document
\nbe circulated to NMAs for comments.
\nNon-Commercialization of Human Repro-
\nductive Material
\nA proposed revision of the WMA Resolu-
\ntion on the Non-Commercialization of Hu-
\nman Reproductive Material was put forward
\nby Dr. Eidelman. In view of the fact that the
\nrevisions introduced substantial changes, it
\nwas agreed that the document should be cir-
\nculated to NMAs for comment.
\nEthical Implications of Reality TV for Physi-
\ncians
\nA proposed Statement on the Ethical Im-
\nplications of Reality TV for Physicians
\nwas presented by the Israel Medical As-
\nsociation. It argued that these programmes
\nwere a form of experimentation on human
\nbeings, putting enormous pressure on par-
\nticipants in the drive to win audiences.Such
\nshows were now popular around the world,
\nand the WMA should have some ethi-
\ncal policy for physicians involved in these
\nprogrammes. This led to a lengthy debate
\nin which a number of speakers argued that
\nthis was not an appropriate subject for the
\nWMA to consider.On a vote it was decided
\nthat the document should be circulated to
\nNMAs for comment.
\nThe Role of Physicians in Preventing the Traf-
\nficking with Minors and Illegal Adoptions
\nThe Committee considered a proposed
\nStatement on the Role of Physicians in Pre-
\nventing the Trafficking with Minors and Il-
\nlegal Adoptions. Introducing the document,
\nDr.Fernando Rivas Navarro (Spanish Medi-
\ncal Association) said the problem of chil-
\ndren trafficking and illegal adoptions was an
\noverwhelming one. It was estimated by the
\nUnited Nations Office for Drugs and Crime
\nthat an average of 1.2 million children were
\ntrafficked every year.A good number of them
\nwould need\u00a0genetic identification to find out
\nwho they are and where their families were,
\nor even which were their countries of\u00a0origin.
\nIn 2006 a pilot program, DNA-Prokids, was
\nstarted in Guatemala, and extended to Mex-
\nico. In 2009 the University of North Texas
\nHealth Sciences Center joined with the Uni-
\nversity of Granada to launch the program in
\nas many countries as possible, basically Latin
\nAmerica and Asia.Since the program started
\na total of 9330 samples had been analyzed.
\nAmong these, 697 positive associations had
\nbeen made and most of these children had
\nbeen returned to their families or were in the
\nlegal process of doing so.In addition 221 ille-
\ngal adoptions had been detected and avoided.
\nThe intention of the proposed document was
\nto establish a\u00a0professional\u00a0observatory within
\nthe WMA and, led by the Organizaci\u00f3n
\nM\u00e9dica Colegial de Espa\u00f1a,to learn in detail
\nabout the role of physicians in the medical
\nattention of\u00a0unidentified\u00a0children\u00a0and adop-
\ntion.Such a move would also help to find out
\nhow physicians could play a preventive role
\nby warning adopting\u00a0families\u00a0and\u00a0by\u00a0collab-
\norating\u00a0with\u00a0their\u00a0own\u00a0national\u00a0authorities.
\nAesthetic Procedures
\nTwo papers were received by the committee,
\nthe first a proposed Statement on Aesthetic
\nProcedures for Minors presented by the
\nIsrael Medical Association and a second,
\na proposed Statement on Aesthetic Treat-
\nment in general proposed by the Swedish
\nMedical Association. Proposing the general
\npaper, Tomas Hedmark (Swedish Medical
\nAssociation) said that aesthetic treatments
\nhad become more common in recent years
\nand were performed by practitioners with
\nwidely different backgrounds. Some were
\n168
\nWMA News
\nphysicians, but many were not. In Sweden
\nthe view seemed to be that aesthetic treat-
\nments without medical indication should
\nnot be considered as health care. He be-
\nlieved that the WMA should develop policy
\napplying to all practitioners, physicians and
\nothers, who performed these treatments.
\nOne reason for this was that the negative
\neffects of aesthetic treatments would end
\nup in regular health care where they would
\nbe handled by physicians. The committee
\nagreed that the Israel and Swedish Medical
\nAssociations should get together to consid-
\ner if the two documents could be combined
\nand then circulated for comment to NMAs.
\nStatement on Variations of Human Sexuality
\nA proposed Statement on Normal Varia-
\ntions of Human Sexuality was proposed
\njointly by the German Medical Association,
\nthe Conseil National de l\u2019Ordre des M\u00e9de-
\ncins, and the British Medical Association.
\nAfter the paper had been proposed by Dr.
\nXavier Deau there was a lengthy and pas-
\nsionate debate about a proposal to delete
\nthe word \u2019normal\u2019 from the document and
\nsubstitute it with the word \u2018natural\u2019. Some
\nspeakers questioned whether the subject of
\nthe Statement was an urgent matter and said
\nthat in several countries being homosexual
\nwas illegal. But supporters of the Statement
\nargued that widespread concern had been
\nexpressed by professional medical societies
\nabout the use of conversion procedures, as
\nwell as the fact that in many regions being
\nhomosexual was still a reason for torture,
\njail or execution. It was eventually decided
\nthat the proposed Statement be amended as
\nproposed and sent to the Council with the
\nrecommendation that it be forwarded to the
\nGeneral Assembly for adoption.
\nThe Role of Physicians and NMAs, Social De-
\nterminants of Health and Health Equity
\nThe Committee considered a proposal from
\nthe Canadian Medical Association to orga-
\nnise a symposium of interested constituent
\nmembers in to develop plans to address the
\nsocial determinants of health and health
\nequity. NMAs were invited to provide their
\nviews on the proposal to the Canadian
\nMedical Association or to WMA secretari-
\nat in the coming weeks and a more detailed
\nproposal would be brought to the Council
\nat its next session in Tokyo, April 2014.
\nBrazilian Medical Association
\nThe Committee considered a proposed Res-
\nolution in Support of the Brazilian Medi-
\ncal Association introduced by Dr. Miguel
\nJorge. He explained that the Brazilian
\nGovernment had introduced a programme,
\n\u201cMais M\u00e9dicos\u201d, to give recognition to Bra-
\nzilian citizens who had studied in Cuban
\nmedical schools. They received diplomas
\nthat were not valid even in Cuba. The pro-
\ngramme was created by the Government in
\norder to recognise those diplomas and put
\nthese people to work in remote areas of the
\ncountry. There were some places where no
\nphysicians were working because of a lack
\nof health infrastructure. In response to the
\nreaction of the Brazilian Medical Asso-
\nciation, the Government had changed the
\nmain purpose of the programme and aban-
\ndoned the idea of using its programme to
\ngive validity to these Brazilian physicians
\nwho gained their diplomas outside Brazil
\nand changed the focus to import physicians.
\nIt was expected that there would be around
\n12,000 Cuban physicians working in Brazil.
\nFrom these 12,000 physicians some hun-
\ndreds had arrived and were starting to work.
\nThe problem was that these physicians and
\nothers covered by the programme were not
\nbeing employed by the Government re-
\nspecting the labour laws. They would just
\nreceive pocket money and some support to
\nwork in the cities. Those from Cuba would
\nnot receive the same amount of money as
\nothers. Their payments would be sent from
\nthe Brazilian Government to the Cuban
\nGovernment. These physicians were not al-
\nlowed to bring their families to Brazil.Most
\nof the physicians that had been imported
\nwere not working in remote areas but had
\ngone to work in the big cities and there was
\nsome concern about their prescribing com-
\npetence.The committee approved the Reso-
\nlution and agreed to send it to Council with
\nthe recommendation that it be forwarded to
\nthe General Assembly for adoption.
\nAdvocacy
\nDr. Jeff Blackmer (Canadian Medical As-
\nsociation) reported on the activities of the
\nAdvocacy Committee, which had met the
\nday before and discussed two main items.
\nThe first related to a media event to be
\nscheduled in conjunction with the celebra-
\ntion of the 50th
\nanniversary of the Declara-
\ntion of Helsinki in 2014.The second referred
\nto plans for an advocacy training session
\nduring the scientific session to be held in
\nDurban, South Africa in October 2014. It
\nwas agreed that the Committee would pro-
\nvide its support to the South African Medi-
\ncal Association with a view to including an
\nadvocacy component in the session.
\nEmergency Resolutions
\nProhibition of Chemical Weapons
\nA proposed Resolution on the Prohibition
\nof Chemical Weapons was introduced by
\nthe Turkish Medical Association. After a
\nbrief debate it was decided that the Reso-
\nlution be revised, in particular by removing
\nthe references to countries in the text. The
\nBritish Medical Association volunteered to
\nlead the revision and submit the result to
\nthe Council for consideration. It was agreed
\nthat a workgroup be set up with a man-
\ndate to develop a comprehensive policy on
\nchemical weapons and riot control agents,
\nas referred to in the second emergency reso-
\nlution.
\nChemical Riot Control Agents
\nThe second emergency Resolution call-
\ning for the Prohibition of Chemical Riot
\nControl Agents was also introduced by the
\n169
\nWMA News
\nTurkish Medical Association with reference
\nto the recent disturbances in Turkey. How-
\never, the Resolution failed to gain support.
\nInstead it was agreed that it would be con-
\nsidered by the workgroup.
\nHealth Care in Syria
\nThe Committee considered the proposed
\nEmergency Resolution on the Healthcare
\nSituation in Syria. Prof. Nathanson said
\nthat attacks on civilians and on hospitals,
\nclinics and those attempting to provide care
\nseemed to be getting worse every day. This
\nwas now a crisis situation. Not only were
\nhuge numbers of the Syrian population
\nfleeing the country, but those remaining
\nand who were ill were not getting access to
\nhealthcare and doctors and others looking
\nafter them were at serious risk.The commit-
\ntee agreed that the proposed Resolution be
\napproved by the Council with the recom-
\nmendation that it be forwarded to the Gen-
\neral Assembly for adoption.
\nMedical Ethics Committee
\nThe committee met under the Chairman-
\nship of Dr. Heikke P\u00e4lve (Finland Medical
\nAssociation).
\nDeclaration of Helsinki
\nThe first of several lengthy debates then took
\nplace about revisions to the Declaration of
\nHelsinki. Dr. Parsa-Parsi (German Medi-
\ncal Association), Chair of the workgroup,
\nthanked the members of the working group,
\nincluding ethics advisors,for their hard work
\ntoward the shared goal of revising the docu-
\nment to promote the highest standards in
\nmedical ethics.The revised document repre-
\nsented input from many expert stakeholders
\nand organizations throughout the interna-
\ntional community, provided over a two year
\nperiod, in an open and collaborative process.
\nAll comments and suggestions had been
\ncarefully and systematically considered by
\nthe workgroup in the drafting process. Prof.
\nUrban Wiesing, ethics adviser to the work-
\ngroup, gave an overview of the changes be-
\ning proposed. He reported on the revision
\nprocess and the 150 comments received. It
\nhad been the most intensive public debate
\non the revision of the Declaration that had
\never taken place.The workgroup had decided
\nat the outset that the character of the Decla-
\nration should remain, that its length should
\nstay about the same and that it should re-
\nmain distinct from other guidelines. He said
\nthe main changes were to introduce more
\nprecise wording, a more readable structure,
\nrevised paragraphs on vulnerable groups,
\npost study arrangements and research ethics
\ncommittees and for the first time to mention
\nthe issue of compensation. The workgroup
\nhad decided to give the Declaration a new
\nstructure with a new order and some merg-
\ning of paragraphs. He explained why the
\nrevisions contained no list of specific vul-
\nnerable groups. Referring to changes to the
\npost study arrangements, he said that in the
\n2008 version of the Declaration the wording
\nwas vague.The workgroup was now propos-
\ning more precise wording and in particular
\nto state clearly the responsible institutions \u2013
\nsponsors, researchers and host country gov-
\nernments. For the first time norms had been
\nset out for members of research ethics com-
\nmittees, that they should be duly qualified.
\nThe introduction of compensation was a big
\nstep in the history of the Declaration. Until
\nnow compensation had not been mentioned
\nfor people who were harmed during clini-
\ncal trials. Now compensation and treatment
\nfor subjects who were harmed was being de-
\nmanded and this improved the protection of
\nparticipants, in particular in poor countries.
\nHe explained the reference for the first time
\nto biobanks. The general principles of in-
\nformed consent complied for the collection,
\nstorage and reuse of samples.Turning to the
\nissue of placebos, he said there had been no
\nethical change compared to the 2008 Dec-
\nlaration. But a more systematic approach
\nhad been proposed. Now a proposal that any
\ncontrol less than the best proven interven-
\ntion was addressed. He accepted that the is-
\nsue of placebos was controversial. Another
\nbig step was the proposal for every research
\nstudy to be registered, not only clinical stud-
\nies.
\nDr. Jeff Blackmer, the WMA\u2019s ethics ad-
\nviser, explained in more detail the proposed
\nchanges, going through the document para-
\ngraph by paragraph.The Chair then opened
\nthe meeting to invite discussion and pro-
\nposed amendments.The Royal Dutch Med-
\nical Association asked for clarification about
\nwhy participants in medical research were
\n\u2018encouraged\u2019in parts of the Declaration and
\nnot imposed. Dr. Blackmer explained that
\nthe WMA could not impose things on oth-
\ners involved in research. Dr. Kloiber added
\nthat the WMA should refrain from making
\nrules for other groups. Concern about the
\nissue of compensation and the possibility of
\nabuse was raised by the Ugandan Medical
\nAssociation. Professor Weising explained
\nthe scope and intent of the paragraph and
\nfurther clarification was provided from two
\nmembers of the workgroup.
\nThe main discussion took place on para-
\ngraph 20 concerning medical research with
\na vulnerable group and the issue of benefits.
\nThe South African Medical Association
\nexpressed concern about the subject of \u2018ad-
\nditional benefits\u2019 in the paragraph, espe-
\ncially with respect to developing countries,
\nand the possibility of coercion and undue
\ninducement. The Indian Medical Associa-
\ntion supported this concern. Prof. Wiesing
\nexplained the rational of the workgroup in
\nincluding this language. Dr. Blackmer also
\ndescribed the advantages and disadvantages
\nof this language. Medical research with a
\nvulnerable group was only justified if the
\nresearch was responsive to the health needs
\nor priorities of this group and the research
\ncould not be carried out in a non-vulnerable
\ngroup. In addition, this group should stand
\nto benefit from the knowledge, practices
\nor interventions that resulted from the re-
\nsearch. A proposal was made to delete the
\nfinal two sentences in paragraph 20 relating
\nto a group receiving a fair level of additional
\nbenefits if certain conditions were met and
\n170
\nWMA News
\non a vote it was agreed that the two sen-
\ntences should be deleted.
\nOn paragraph 25, relating to informed
\nconsent, the French and Uruguay Medical
\nAssociations expressed concern about how
\nthis paragraph might relate to the use of
\nplacebo. Prof. Wiesing reviewed the history
\nof debate on informed consent over the past
\ntwo revision processes and the reasons be-
\nhind the way the current text was written. A
\nmotion to amend paragraph 25 by addition
\nwas not accepted.
\nFurther debates took place about the re-
\nquirement to obtain informed consent for
\nthe reuse of human material or data and
\non the issue of use of placebos, but without
\nany further amendments being agreed. At
\nthe end of the debate, the proposed revised
\nDeclaration, as amended by the committee,
\nwas approved for forwarding to Council
\nand the General Assembly with the recom-
\nmendation that it be adopted.
\nHealth Databases
\nThe Committee received the oral report of
\nthe workgroup on Health Databases from
\nDr. Jon Snaedel (Iceland Medical Associa-
\ntion). He noted that there were several op-
\ntions for defining the scope of the WMA
\nwork in this area. The committee recom-
\nmended that the workgroup be instructed
\nto continue its work on the broad concept
\nof health databases.
\nAssociate Members
\nJunior Doctors Network
\nDr. Thorsten Hornung, immediate past
\nChair of the Network, gave an oral report
\non behalf of the Junior Doctors Network,re-
\nporting on its activities during the past year.
\nA new team of officers had been elected at
\nthe Network\u2019s meeting on Tuesday. In par-
\nticular he spoke about the JDN\u2019s work on a
\npolicy paper about physician well-being. He
\ntalked about junior doctors having to live in
\nplaces with no running water and being on
\ncall all the time and not going home for 30
\ndays in a row. He said there was much stress
\namong physicians and yet they were a group
\nwho should practice what they preached.
\nHe said support structures were needed.
\nDr. Daniel Johnson, past President of the
\nWMA, referred to the system in most US
\nstates where impaired physicians \u2013 physi-
\ncians with alcohol or drug problems \u2013 were
\nhelped to return to practice. The intent was
\nnot to keep these physicians from being able
\nto practice, but to correct the impairment
\nand restore them to practice. There was a
\nshortage of physicians and this was the best
\napproach, both from the physicians\u2019 point of
\nview and the patients. He suggested that the
\nJDN consider introducing such a suggestion
\ninto their paper.
\nChair
\nDr. Guy Dumont, Chair of the Associ-
\nate Members since 1993, said he would be
\nretiring as a physician next year and would
\nbe stepping down as Chair of the Associate
\nMembers. He was thanked for his work and
\nreceived a standing ovation.
\nScientific Session
\nThe theme of the session was \u2018Life styles
\nand non communicable chronic diseases\u2019.
\nOpening the session, Dr. Margaret Mungh-
\nerera,President elect of the WMA,said that
\nthe adoption of abnormal lifestyles among
\npopulations had had immeasurable adverse
\nimpact on the health and survival of peoples
\nof the world,much greater than that created
\nby the epidemics of communicable diseases
\nsuch as the plague of the middle ages,tuber-
\nculosis and syphilis.
\n\u2018The insidious onset of NCDs is elusive\u2019,she
\nsaid. \u2018They spread silently through the pop-
\nulations and they kill or maim quick when
\nthey emerge. The behavioural contributory
\nfactors are known and include inadequate
\nphysical activity, cigarette smoking, un-
\nhealthy eating habits and excessive alcohol
\ningestion\u2019.
\nShe said that NCDs were cheaper and eas-
\nier to prevent and that was where most of
\nthe focus and therefore the resources should
\ngo. And the targets should include children.
\n\u2018Rather than focus on a few NCDs, the ap-
\nproach needs to be holistic and therefore
\nstrengthening health systems, universal
\nhealth care and addressing social deter-
\nminants is where the emphasis should be
\nplaced. For instance, effective preventive
\nand health promotion programmes require
\nadequate numbers of motivated and skilled
\nhealth workers\u2019.
\nSpeakers during the day talked about diet,
\nphysical activity, tobacco and alcohol. The
\nopening presentation on the social deter-
\nminants of health was given by Sir Michael
\nMarmot (British Medical Association),who
\nspoke about health data around the world
\ncompared to social gradients. He talked
\nabout data from Brazil about cardiovascular
\ndisease showing that the more deprived the
\ndistrict the higher the mortality.He referred
\nto data on diabetes based on social gradients
\nand talked about the data on obese children
\nin England and its relationship to the social
\ndeterminants of health. The challenge was
\nto deal with the social determinants of the
\nrisk factors involved.He looked at how Bra-
\nzil had tackled social inequality and found
\nthat they had made progress. And he posed
\nthe question about what doctors could do
\nabout these problems. Among the areas
\nwhere they could get involved were educa-
\ntion and training, working with individuals
\nin communities, the health service as an
\nemployer, working in partnership with oth-
\ners, and working with the health system.
\nDr. Howard Bauchner, editor in chief of
\nthe Journal of the American Medical As-
\nsociation, spoke about controversies over
\ndiet and health in the United States and
\n171
\nWMA News
\nthe worldwide epidemic of obesity. He said
\nthere had been a seismic shift from organic
\nto processed food. But he said there were
\nvery few clinical trials that could help them
\nunderstand what their public health recom-
\nmendation should be. Tremendous strides
\nhad been made in the US on cardiovascular
\ndisease. But as people have lived longer Al-
\nzheimer\u2019s Disease and cancer had become
\nmore important. He spoke of the progress
\nmade in dealing with HIV Aids, but said
\nthat chronic renal disease had skyrocketed,
\nas had drug abuse. He talked about the con-
\ntroversy over salt and the amount of salt that
\nanyone should consume. And he said that
\nthe only common factor that made a diet
\nsuccessful was adherence. On the politics
\nof public health, he said that every country
\nstruggled with how much they should dic-
\ntate to its citizens about lifestyle.
\nDr. Luiz Claudio Castro (Brazilian Medi-
\ncal Association), a professor of paediatrics,
\nspoke about childhood obesity. He said that
\nthey had to promote health and well-being
\nat childhood in order to assure quality of life
\nin future stages. Obesity disrupted three in-
\nstances of well-being, physical, mental and
\nsocial. It had to be managed as a disease and
\nnot just a situation.Yet with childhood obe-
\nsity they had lots of questions but still few
\nanswers. There were some certainties \u2013 that
\nchildhood obesity had reached epidemic
\nlevels. But they had to believe that this
\ncould be reversed.
\nDr. Jeremy Lazarus (American Medical
\nAssociation) spoke about physicians as role
\nmodels for physical activity.He said physical
\nactivity was both enjoyable and rewarding.
\nHe spoke about competing in marathons
\nand said he had completed 13 of them. He
\nand his wife rode a tandem and this was
\ngood for relieving stress. He said it was im-
\nportant for physicians to act as role models
\nnot only for their patients, but also for their
\nfamilies and their communities. He enjoyed
\nthe challenge of pushing himself and said
\nit was important that physicians thought
\nabout their own physical and mental health.
\nDr.Carlos Serrano Jr.(Brazilian Medical As-
\nsociation),a cardiologist,spoke about cardio-
\nvascular risk reduction as a result of physical
\nactivity and health promotion. The concept
\nof taking exercise for heath was centuries old.
\nHe said physicians should recommend their
\npatients to take exercise. But to educate their
\npatients about health and well-being and for
\nphysicians to convince their patients about
\nthe benefits of well-being it was important
\nfor physicians themselves to exercise.
\nThe session on Tobacco and Public Health
\nopened with Dr. Heikki P\u00e4lve (Finish
\nMedical Association) talking about the
\nFinish Tobacco Policy. He stressed the
\nneed for co-operation to achieve any re-
\nsults. Finland\u2019s battle against tobacco began
\nin the 1960s when the medical association
\nput forward proposals. But it had to persist
\nbefore its policies began to take effect with
\nlegislation introduced in the 1970s. But it
\nwas rather the intense discussion leading up
\nto the legislation which caused many people
\nto quit smoking rather than the legislation
\nitself. He said there must be no compro-
\nmises with the tobacco industry. The aim
\nnow was a tobacco-free Finland by 2040.
\nWas this possible, he asked. After their ex-
\nperiences of already achieving things people
\ndid not think were possible, he thought the
\nanswer was a definite yes.This was followed
\nby Alberto Araujo (Brazilian Medical As-
\nsociation) talking about The Role of Health
\nProfessionals on Tobacco Control Policies.
\nThe final session on alcohol began with
\nDr.\u00a0 Mervi Kattelus (Finish Medical As-
\nsociation) talking about European Union
\nPolicies Against Alcohol Related Harm
\nand the session concluded with Dr. S\u00e9rgio
\nde Paula Ramos (Brazilian Medical As-
\nsociation) talking about Alcohol Abuse by
\nAdolescents.Dr.Ramos said that there were
\n2.5\u00a0million deaths a year as a result of al-
\ncohol. For young people it was the number
\none risk factor. He talked about the adver-
\ntising of alcohol in Brazil and said that the
\nalcohol industry was not concerned with
\nethics or public health.
\nCouncil
\nCouncil reconvened on the third day of the
\nmeeting to consider reports from the com-
\nmittees held on the first day.
\nMedical Ethics Committee
\nDeclaration of Helsinki
\nThe Council considered the revised Dec-
\nlaration of Helsinki as amended by the
\nMedical Ethics Committee. This led to a
\nfurther brief debate on the document, but
\nno further amendments were made and the
\nCouncil approved the revised Declaration
\nfor sending to the Assembly for adoption.
\nHealth Databases
\nThe Council agreed that the membership
\nand mandate of the workgroup on health
\ndatabases be extended to include the issue
\nof biobanks.
\nPerson Centred Medicine
\nIt was agreed to recommend to the As-
\nsembly that a proposed Statement on
\nPerson Centred Medicine be circulated to
\nNMAs for consideration. The paper, from
\nthe Iceland Medical Association, calls for
\na shift in the focus of health care from the
\nproviders and healthcare system to the in-
\ndividual.
\nWomen\u2019s Rights to Healthcare and How that
\nRelates to Mother and Child HIV Infection
\nThe Council agreed that a proposed Resolu-
\ntion submitted by the South African Medi-
\ncal Association should be sent to the As-
\nsembly for adoption.
\nForensic Investigations of The Missing
\nThe Council agreed that a revised Statement
\non Forensic Investigations of The Missing
\nbe sent to the Assembly for adoption.
\n172
\nWMA News
\nFinance and Planning Committee
\nMembership
\nDr. Kloiber said that since 1988 the As-
\nsociation of Hungarian Medical Societies
\n(MOTESZ) had been a member of the
\nWMA. However the Association had ex-
\nperienced problems in maintaining mem-
\nbership and the WMA had now received a
\nrequest from the Hungarian Chamber,open
\nto all physicians in Hungary, to become the
\nWMA member.The Council recommended
\nto the Assembly that the Hungarian Medi-
\ncal Chamber should be accepted as a mem-
\nber of the WMA.
\nWorld Medical Journal
\nDr. Peteris Apinis, the editor of the Journal,
\nsaid next year would be the 60th
\nanniversary
\nof the Journal. He talked about the possibil-
\nity of changing the journal to an electronic
\njournal and indicated that it was time for a
\nyounger person to take over as editor.
\nPast Presidents and Chairs Network
\nDr. Kloiber reported on the newly-set up
\nNetwork of Past Presidents and Chairs. It
\nhad met for the first time the previous day
\nwhen terms and reference were discussed on
\nthe basis of the network acting as a sound-
\ning board for the Council. In an election
\nDr. Dana Hanson (Canada) was elected
\nChair, Dr. Kgosi Letlape (South Africa)
\nVice Chair and Dr. Jon Snaedal (Iceland)
\nSecretary.
\nSocio-Medical Affairs Committee
\nHuman Papillomavirus Vaccination
\nDr.Heikke P\u00e4lve referred to the document\u2019s
\nrecommendation that there should be \u2018HPV
\nvaccination for all children starting at age
\n11 or 12, for all females age 13 through 26,
\nfor all males age 13 through 21 (any male
\nmay be vaccinated through age 26), for all
\nimmunocompromised patients who are
\nage 22 through 26, and for men who have
\nsex with men who are age 22 through 26\u2019.
\nHe suggested that this was far too detailed
\nand should be deleted from the paper. The
\nCouncil agreed to delete the sentence and
\nsubstitute it with the sentence \u2018Recommend
\nHPV vaccination for all appropriate popu-
\nlations\u2019and to forward the Statement to the
\nAssembly for adoption.
\nFungal Disease Diagnosis and Management
\nThe Council agreed that the proposed
\nStatement should be forwarded to the As-
\nsembly for adoption.
\nBrazilian Medical Association
\nThe proposed Resolution in Support of the
\nBrazilian Medical Association was agreed
\nand it was recommended that it be forward-
\ned to the Assembly for adoption.
\nProhibition of Chemical Weapons
\nProf.Nathanson said that the two papers on
\nthe Prohibition of Chemical Weapons and
\nthe Prohibition of Chemical Riot Control
\nAgents had now been combined into one
\ndocument. Reference to specific countries
\nhad been deleted and a final recommenda-
\ntion had been added, urging urges states
\nusing chemical agents in riot control situa-
\ntions to carefully consider and minimise the
\nrisks and to, wherever possible, refrain from
\nsuch use.\u00a0The Council approved the Resolu-
\ntion and it was agreed to forward it to the
\nAssembly for adoption.
\nHealth Care in Syria
\nThe Council approved the Resolution and
\nagreed to forward it to the Assembly for
\nadoption.
\nVariations of Human Sexuality
\nA further debate took place on the pro-
\nposed Statement after Dr.Leonid Mikhay-
\nlov (Russian Medical Society) proposed
\nthat the word \u2018natural\u2019 be deleted from the
\ndocument. However several speakers sup-
\nported keeping the word \u2019natural\u2019. Prof.
\nNathanson said it was completely unac-
\nceptable to argue that in most of the world
\nthis was a question for debate as a scien-
\ntific issue. It would be unacceptable for the
\nWMA to have a document on homosexu-
\nality that did not make it quite clear that
\nthis is a natural variation of sexuality. Af-
\nter the proposal to delete the word\u2019 natu-
\nral\u2019 failed to find a seconder, the Council
\nagreed the Statement and recommended
\nthat it should be forwarded to the Assem-
\nbly for adoption.
\nPresidency
\nDr.Haikerwal, Chair of Council, report-
\ned that a letter had been received from
\nthe Indian Medical Association request-
\ning that the 2010 suspension imposed on
\nDr.\u00a0 Ketan Desai\u2019s inauguration as Presi-
\ndent should be lifted. He said the Indian
\nMedical Association had submitted a mo-
\ntion calling for a date to be set for Dr. De-
\nsai\u2019s Presidency. He explained to Council
\nthe background to the case, arising from
\nDr.\u00a0 Desai\u2019s arrest and imprisonment in
\n2010 which prevented him from attending
\nthe Vancouver Assembly. Dr. Haikerwal
\nsaid that the charges against Dr. Desai had
\nsince been withdrawn and he was asking
\nCouncil to recommend to the Assembly
\nthat the suspended inauguration be lifted
\nand to recommend a date when Dr. De-
\nsai should take up his Presidency. Dr. Ajay
\nKumar (Indian Medical Association) said
\nthat Dr. Desai\u2019s arrest was a result of him
\nbecoming too powerful a medical leader
\nfor the Indian Government. After a further
\ndebate, the Council decided to recommend
\nto the Assembly that the suspension of
\nDr.\u00a0 Desai\u2019s inauguration should be lifted
\nand that the question of when this should
\ntake place should be considered at the
\nCouncil meeting in Tokyo in April 2014 to
\nbe confirmed at the next Assembly meet-
\ning in Durban in October 2014.
\n173
\nWMA News
\nGeneral Assembly
\nCeremonial Session
\nThe Assembly was called to order by the
\nChair,Dr.Mukesh Haikerwal and a roll call
\nand introduction of delegates and observers
\nwas carried out by the Secretary General,
\nDr. Kloiber.
\nWelcome addresses were given by Secretary
\nCiro Ferreira Gomes,Health Secretary of the
\nState of Cear\u00e1,and Dr.Florentino de Ara\u00fajo
\nCardoso Filho, President of the Brazilian
\nMedical Association, before Dr. Haikerwal
\npaid a tribute to the outgoing WMA Presi-
\ndent, Dr. Cecil Wilson as a thoughtful, hon-
\nourable and diligent man. Dr. Wilson then
\ndelivered his valedictory address. (p. 161)
\nDr. Margaret Mungherera, President of the
\nUganda Medical Association, was then in-
\nstalled as the 64th
\nPresident of the WMA,
\nand gave her inaugural address. (p. 162)
\nGeneral Assembly
\nPlenary Session
\nElection of President for 2014\/15
\nDr. Xavier Deau, President of the European
\nand International Delegation of the French
\nMedical Council, was elected unopposed as
\nPresident of the WMA for 2014\/15. Thank-
\ning the meeting for his election,Dr.Deau said
\nthat for several decades the French Council
\nhad built up close links with its European in-
\nternational counterparts. Nowadays this in-
\nternational commitment was more important
\nthan ever. National and global health were
\nbecoming more and more political issues and
\nthe French Council wanted the WMA to
\nbe the leader in anticipating the changes in
\nmedical practice while preserving the quality
\nof doctors and access to health care.
\nUse of the Death Penalty
\nThe proposed Statement on support for
\nthe United Nations Resolution for a Mor-
\natorium on the Use of the Death Penalty
\nwas put forward for adoption. Dr. Jeremy
\nLazarus (American Medical Association)
\nsaid the AMA delegates would be voting
\nagainst this Statement. Although they re-
\nspected the views of all their colleagues,
\nthe AMA did not take a position for or
\nagainst the death penalty or on the issue
\nof a moratorium. They believed these were
\nissues for the individual moral decision of
\nphysicians, and physicians in the US were
\ndeeply divided on this matter. The Chair
\nexplained that the Statement would re-
\nquire 93 votes, a three-quarters majority,
\nfor adoption. On a vote, the Statement was
\ncarried by 94 votes to 25 with four absten-
\ntions. (p. 179)
\nDeclaration of Helsinki
\nThe revised Declaration of Helsinki was
\nthen introduced and Dr. Parsa-Parsi, Chair
\nof the workgroup, Professor Wiesing and
\nDr. Blackmer explained to the Assembly
\nthe revision process that had been under-
\ntaken for the past two years and the de-
\ntailed changes that were being proposed.
\nProf. Wiesing explained the details of the
\nnew compensation proposals included in
\nthe Declaration and the revised paragraph
\non the use of placebos, which he said would
\nalways be controversial. Dr. Blackmer talk-
\ned about the issue of research on vulner-
\nable groups. The only discussion that fol-
\nlowed concerned paragraph 33 on the use
\nof placebos. Several delegates spoke against
\nthe paragraph and said they could not ac-
\ncept the revised wording. But on a vote the
\nparagraph was approved by 110 votes to
\n10. On a further vote, the revised Declara-
\ntion of Helsinki was adopted with a strong
\nthree-quarters majority as required. (p. 199)
\nMembers of the workgroup were applauded
\nfor their work.
\nWomen\u2019s Rights to Healthcare and How that
\nRelates to Mother and Child HIV Infection
\nThe Resolution on Women\u2019s Rights to
\nHealthcare and How that Relates to Moth-
\ner and Child HIV Infection was adopted
\nwith one small amendment to add the word
\n\u2018unwanted\u2019 to the following recommen-
\ndation for campaigns to \u2018eradicate myths,
\nstigma and stereotypes that might degrade
\nor dehumanise women.\u00a0This must include
\ncampaigns against genital mutilation and
\nforced adolescent marriages and unwanted
\npregnancies.\u2019 (p. 183)
\nForensic Investigations of The Missing
\nThe revised Statement on Forensic Inves-
\ntigations of The Missing was adopted as
\nWMA policy. (p. 180)
\nStandardisation in Medical Practice and Pa-
\ntient Safety
\nThe Resolution on Standardisation in Med-
\nical Practice and Patient Safety was adopt-
\ned. (p. 181)
\nCriminalisation of Medical Practice
\nThe Resolution on Criminalisation of Med-
\nical Practice was adopted. (p. 178)
\nRight to Rehabilitation of Victims of Torture
\nThe Statement on the Right to Rehabili-
\ntation of Victims of Torture was adopted.
\n(p.\u00a0182)
\nVariations of Human Sexuality
\nThe Statement on Variations of Human
\nSexuality was introduced and it was pro-
\nposed that the word \u2018natural\u2019 should be
\nincluded in the title to be consistent with
\nthe rest of the document. Several speakers
\nopposed this suggestion, but the proposal
\nwas accepted for the document to be called
\n\u2018Natural Variations of Human Sexuality\u2019.
\nIt was then proposed by the Russian Medi-
\ncal Association that the document should
\nbe sent back for further discussion and
\ncomment. This led to a passionate debate
\nwith speakers on both sides. The Russian
\nproposal received support from the Ugan-
\n174
\nWMA News
\nda delegation. But Prof. Nathanson argued
\nthat this was an emergency. In at least 50
\ncountries people were being criminalised,
\ndiscriminated against and in some places
\nimprisoned, and threatened with execution
\nbecause they had a natural normal varia-
\ntion of human sexuality. She added: \u2018It is
\ncompletely unacceptable because this is
\nbeing legitimised by bad medicine and
\nwhat we are trying to condemn here is
\nbad medicine, medicine which is trying to
\nforce a change on people when they are in
\nfact entirely expressing a natural or normal
\nvariation of human sexuality.\u2019 Dr. Lazarus
\n(American Medical Association) said it
\nwas important that the WMA voted on
\nthis issue today because they were deal-
\ning with an opportunity for homosexuals
\nto live a decent life. He was supported by
\ndelegates from Canada and South Af-
\nrica. Dr.\u00a0Torunn Janbu (Norway) said the
\nWMA should have adopted such a State-
\nment years ago. The motion to refer the
\nStatement back to NMAs for further con-
\nsideration was defeated. It was then pro-
\nposed that the word \u2018normal\u2019 should be put
\nback into the document, but on a vote this
\nwas defeated. The Statement, as retitled
\n\u2018Natural Variations of Human Sexuality\u2019,
\nwas adopted as WMA policy. (p. 177)
\nHuman Papillomavirus Vaccination
\nThe proposed Statement on Human Papil-
\nlomavirus Vaccination was adopted. (p. 183)
\nBrazilian Medical Association
\nThe Resolution in Support of the Brazilian
\nMedical Association was adopted. (p. 177)
\nHealth Care in Syria
\nThe emergency Resolution on the Health-
\ncare Situation in Syria was adopted. (p. 181)
\nProhibition of Chemical Weapons
\nThe Resolution on the Prohibition of
\nChemical Weapons was adopted. (p. 178)
\nFungal Disease and Management
\nThe Statement on Fungal Disease and
\nManagement was adopted. (p. 179)
\nFinancial Statement and Budget
\nThe Treasurer, Dr. Frank-Ulrich Mont-
\ngomery, introduced the audited financial
\nstatement for 2012, and explained the de-
\ntails to the Assembly. He thanked the Sec-
\nretary General for exercising very efficient
\ncost control, a risk-free investment policy
\nand a thrifty use of the budget. The finan-
\ncial statement was adopted. He then talked
\nabout the budget plans for 2014 which were
\napproved.
\nDurban Assembly 2014
\nThe Assembly agreed that at the next Gen-
\neral Assembly in Durban, South Africa the
\ntheme of the scientific session would be
\n\u2018Universal Access to Health Care after Mil-
\nlennium Development Goals\u2019.
\nFuture Meetings
\nIt was agreed that the venue for the 2016
\nGeneral Assembly be Taipei,Taiwan.
\nMembership
\nApplications for membership from the
\nMedical Chamber of Montenegro, the Or-
\ndre National des M\u00e9decins du Cameroun,
\nthe Sudanese Medical Association and the
\nFederazione Nazionale degli Ordini dei
\nMedici Chirurghi e degli Odontoiatri, It-
\naly were agreed. It was also agreed that the
\nHungarian Medical Chamber be accepted
\nas a member, replacing the Association of
\nHungarian Medical Societies.
\nPresidency
\nDr. Haikerwal updated the Assembly on
\nthe situation relating to Dr. Ketan Desai,
\nwhose inauguration as President was sus-
\npended in 2010 when he was unable to at-
\ntend the Assembly in Vancouver following
\nhis arrest and imprisonment. The charges
\nagainst him had now been withdrawn and
\nthe Indian Medical Association had re-
\nquested that Dr. Desai be inaugurated as
\nPresident. Dr. Haikerwal said Dr. Desai
\nhad been badly maligned by the Indian
\ncourt system. The Council of the WMA
\nwere recommending that the suspension
\nbe lifted and that further consideration be
\ngiven to the timing of Dr. Desai\u2019s Presi-
\ndency at the Council meeting in Tokyo
\nin April 2014 to be approved by the As-
\nsembly in Durban in October 2014. The
\nAssembly agreed to lift the suspension on
\nDr.\u00a0 Desai\u2019s inauguration. A debate then
\ntook place on when a decision should be
\ntaken about the timing of Dr. Desai\u2019s inau-
\nguration. Dr. Ajay Kumar (Indian Medical
\nAssociation) explained the background to
\nDr. Desai\u2019s imprisonment and said it was
\nup to the Assembly to decide when his in-
\nauguration should take place. Dr. Mzukisi
\nGrootboom (South Africa Medical As-
\nsociation) said that a decision about when
\nDr. Desai should take up the Presidency
\nshould be decided straight away to send
\na strong message to the Indian Govern-
\nment. He proposed that there be no elec-
\ntion for President held at the 2014 Assem-
\nbly for the 2015 term and that Dr. Desai
\nbe inaugurated as President in 2015. But
\nDr. Lazarus said that this was a compli-
\ncated matter and should be discussed at
\nthe meeting in Tokyo in April. A motion
\nto discuss the matter immediately was de-
\nfeated and the Assembly agreed to defer
\nthe matter for further consideration until
\nthe Council meeting in Tokyo in 2014.
\nReport of Associate Members Meeting
\nDr. Thorsten Hornung, Past Chair of the
\nJunior Doctors Network, introduced the
\nJDN\u2019s policy paper on Physicians Well-
\nbeing. He said JDN members from all
\nover the world had shared their experi-
\nences and the data was shocking. He gave
\ntwo examples \u2013 there were at least 40 per
\ncent more suicides among physicians com-
\n175
\nWMA News
\npared to the general population and one in
\neight physicians had admitted relying on
\nalcohol or drugs for stress relief. He said
\nthe medical profession needed to practice
\nwhat it preached. In many places physi-
\ncians experienced extreme working hours
\nin excess of 100 hours per week, often with
\na lack of support structures, bullying and
\nharassment. \u2018Many times we are taught
\nto deny our own needs and weaknesses,
\nsadly illustrated by physicians having late
\nstage psychiatric disease when finally seek-
\ning help\u2019, he said. The JDN presented this
\npaper hoping to collaborate with NMAs
\nworldwide to make this an important piece
\nin the WMA\u2019s mission of endeavouring to
\nachieve the highest international standards
\nin healthcare for all people in the world.
\nThe Assembly decided to refer the paper to
\nthe Council for consideration.
\nHealth Care in Danger
\nDr. Bruce Eshaya-Chauvin, medical ad-
\nviser on the Health Care in Danger proj-
\nect of the International Committee of the
\nRed Cross, gave a presentation following
\nthe recent Memorandum of Understand-
\ning between the WMA and the ICRC. He
\nsaid that medical ethics would constitute a
\nmajor area of co-operation between the two
\norganisations. The Health Care in Danger
\nproject encouraged initiatives with NMAs.
\nHe said that violence against patients and
\nhealth care workers was one of the most
\ncrucial yet overlooked humanitarian issues
\ntoday.He presented data about the numbers
\nof health care providers and facilities affect-
\ned by violent incidents and updated the As-
\nsembly on the progress of the Health Care
\nin Danger project. The ICRC alone would
\nnot be able to solve the problem. It would
\nrequire global co-operation.
\nPlain Packaging
\nDr. Andrew Pesce (Australian Medical As-
\nsociation) updated the meeting about the
\nlegal situation relating to the plain ciga-
\nrette packaging legislation in his country.
\nThe tobacco industry had challenged the
\nlegislation but the courts had found in the
\nGovernment\u2019s favour. This should encour-
\nage politicians not to be too intimidated by
\nthreats of legal action. Complaints had also
\nbeen made to the World Trade Organisa-
\ntion. He also reported on the roll out phase
\nof introducing the new plain packs. Re-
\nsearch had shown there was a measurable
\nlowering of the appeal of smoking and an
\nincrease in the urgency among smokers to
\ngive up smoking. He said that all NMAs
\nshould increase their efforts to introduce
\nplain packaging.
\nTurkey
\nProf. Dr. G\u00fclriz Erisgen, Vice President
\nof the Turkish Medical Association, spoke
\nabout threats to the medical profession in
\nTurkey. These followed the peaceful dem-
\nonstrations in Turkey earlier in the year
\nwhen extreme violence was used by the
\npolice against legitimate demonstrators.
\nDuring this period the Turkish Medical
\nAssociation had regularly collected infor-
\nmation from physicians about the num-
\nbers of wounded and fatalities. They had
\nalso surveyed injuries caused by the police
\nuse of chemical agents, tear gas, rubber
\nbullets and water cannons. The Ministry
\nof Health had now started an investiga-
\ntion into the Medical Association and
\nthe Chamber of Medicine, asking for the
\nnames of volunteer physicians during the
\ndemonstrations and the names of the in-
\njured demonstrators. She said it was im-
\npossible to give such information. She
\nthanked the WMA for its support during
\nthis difficult period.
\nOpen Session
\nDuring the \u2018open session\u2019, held to give del-
\negates an opportunity to present to the As-
\nsembly any profession-specific problem,
\npolicy or project that they believed the
\nWMA should know about or help address,
\ndelegates from America, Romania, Bahrain
\nand Nigeria spoke about activities in their
\ncountries. Dr. Ardis Hoven (American
\nMedical Association) said her Association
\nhad recently undertaken a project to iden-
\ntify the factors that influenced physicians\u2019
\nprofessional satisfaction. This was of in-
\ncreasing importance as health reforms were
\nchanging the practice of medicine. Early
\nresearch results suggested that the factors
\ncontributing to physicians\u2019 dissatisfaction
\ncould serve as an early warning to deeper
\nquality problems developing in the health-
\ncare system. A common theme was physi-
\ncians describing stress when they saw barri-
\ners preventing them from providing quality
\ncare. Solving these problems would be good
\nfor both patients and physicians. Specific
\nconcerns that had been identified were
\nhow electronic record technology interfered
\nwith face to face discussions with patients,
\nspending too much time on clerical work,
\nexcessive productivity quotas and limita-
\ntion on the time spent with patients. This
\nwas especially true of primary care physi-
\ncians. Researchers reported that physicians
\nreported being more satisfied when their
\npractice gave them more autonomy, with
\nthe ability to employ more staff members
\nto take care of clerical work. By identifying
\nfactors that positively influenced physicians\u2019
\nsatisfaction, the AMA was committed to
\nsupporting physicians and also improving
\npatient satisfaction as well.
\nCouncil
\nA final meeting of the Council was held to
\ndiscuss business arising from the Assembly.
\nIt was agreed that the paper from the Junior
\nDoctors Network on physicians\u2019 well-being
\nshould be circulated to NMAs before being
\nconsidered by the Socio-Medical Affairs
\nCommittee.
\nIt was also agreed that the Executive Com-
\nmittee should consider whether a policy
\npaper should be developed on weapons of
\nmass destruction, as suggested by a delegate
\nfrom the Bahrain Medical Society.
\n176
\nWMA General Assembly Fortaleza, Brazil, October 2013
\nWMA News
\n177
\nWMA Statement on Natural
\nVariations of Human Sexuality
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil, October 2013
\nPreamble\u00a0
\nHealthcare professionals encounter many aspects of human diver-
\nsity when providing care, including different variations of human
\nsexuality.
\nA large body of scientific research indicates that homosexuality is a
\nnatural variation of human sexuality without any intrinsically harm-
\nful health effects.
\nAs a consequence homosexuality was removed from the American
\nPsychiatric Association\u2019s official diagnostic manual in 1973. The
\nWorld Health Organisation (WHO) removed it from the ICD in
\n1990 following a similar process of scientific review.The Pan Amer-
\nican Health Organization (WHO) states:\u00a0\u201cIn none of its individual
\nmanifestations does homosexuality constitute a disorder or an illness, and
\ntherefore it requires no cure.\u201d
\nDirect and indirect discrimination, stigmatisation, peer rejection,
\nand bullying continue to have a serious impact upon the psy-
\nchological and physical health of people with a homosexual or
\nbisexual orientation.\u00a0 These negative experiences lead to higher
\nprevalence rates of depression, anxiety disorders, substance mis-
\nuse, and suicidal ideations and attempts.\u00a0The suicide rate among
\nadolescents and young adults with a homosexual or bisexual ori-
\nentation is, consequently, three times higher than that of their
\npeers.
\nThis can be exacerbated by so-called \u201cconversion\u201d or \u201creparative\u201d
\nprocedures, which claim to be able to convert homosexuality into
\nasexual or heterosexual behaviour\u00a0and give the impression that ho-
\nmosexuality is a disease.These methods have been rejected by many
\nprofessional organisations due to a lack of evidence of their effec-
\ntiveness. They have no medical indication and represent a serious
\nthreat to the health and human rights of those so treated.
\nRecommendations
\nThe WMA strongly asserts that homosexuality does not represent
\na disease, but rather a natural variation within the range of human
\nsexuality.
\nThe WMA condemns all forms of stigmatisation, criminalisation
\nand discrimination of people based on their sexual orientation.
\nThe WMA calls upon all physicians to classify physical and psy-
\nchological diseases on the basis of clinically relevant symptoms ac-
\ncording to ICD-10 criteria regardless of sexual orientation, and to
\nprovide therapy in accordance with internationally recognised treat-
\nments and protocols.
\nThe WMA asserts that psychiatric or psychotherapeutic approaches
\nto treatment must not focus upon homosexuality itself, but rather
\nupon conflicts, which arise between homosexuality, and religious,
\nsocial and internalised norms and prejudices.
\nThe WMA condemns so-called \u201cconversion\u201d or \u201creparative\u201d meth-
\nods. These constitute violations of human rights and are unjustifi-
\nable practices that should be denounced and subject to sanctions
\nand penalties. It is unethical for physicians to participate during any
\nstep of such procedures.
\nWMA Resolution in Support of
\nthe Brazilian Medical Association
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil, October\u00a02013
\nThere are credible reports that the Brazilian Government pro-
\ngram \u201cMais M\u00e9dicos\u201d to create more medical schools, extend
\nthe duration of the medical course, compulsorily place last years
\nmedical students to work in public services and attract foreign
\nphysicians to work in remote areas of the country and in the poor-
\nest outskirts of big cities, was proposed without the appropriate
\nconsultation to the medical community and medical schools, and
\ndeparts from a wrong diagnosis about the causes of the insuf-
\nficient health care provided to the Brazilian population. The pro-
\ngram as proposed bypass systems established to verify physicians\u2019
\ncredentials, medical competence and language skills in order to
\nprotect patients.
\nThe World Medical Association is concerned that patients are put at
\nrisk by unregulated medical license,inadequate medical competence
\nand potential misunderstanding of patient communication and of
\ndrugs and medical supplies labels.
\nTherefore, the WMA:
\n\u2022 Condemns any policy and practice that disrupt the accepted stan-
\ndards of medical credentialing and medical care;
\n\u2022 Calls upon the Brazilian government to work with the medical
\ncommunity and medical schools on all matters related to medical
\nWMA News
\n178
\neducation, physician certification and the practice of medicine,
\nand to respect the role of the Brazilian Medical Association on
\nbehalf of the Brazilian physicians and population;\u00a0
\n\u2022 Urges, as a matter of utmost concern, that the Brazilian gov-
\nernment respect the WMA International Code of Medical
\nEthics that guides the medical practice of physicians all over
\nthe world.
\nWMA Resolution on
\nthe Prohibition of Chemical
\nWeapons
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil,\u00a0October 2013
\nPreamble
\nIt has been recognised for centuries that certain chemical agents
\ncan affect consciousness, or other factors influencing the ability of
\nan individual to take part in fighting,predominantly during warfare.\u00a0
\nMore recently some agents have been used to temporarily disable
\nparticipants in civil unrest, protests or riots.\u00a0 In warfare such agents
\nhave, historically, had a significant morbidity and mortality and in-
\ncluded nerve gases and related agents.
\nDespite widespread condemnation such weapons were extensively
\nused in the early 20th
\ncentury. A global movement to outlaw the use
\nof such weapons led to the development of the Chemical Weapons
\nConvention (CWC), which entered into force in 1997 having been
\nopened to signature in 1993.\u00a0 Currently only six countries have not
\nratified or acceded to the CWC.
\nThe production, stockpiling and use of CW is prohibited.\u00a0 Despite
\nthis, such weapons have been used by state forces and by non-state
\nactors in a number of countries. By their nature such weapons are
\nindiscriminate.\u00a0 This use has led to deaths, injuries and human suf-
\nfering in those countries.
\nChemical agents used in policing actions, including by the military
\nacting in a policing role, are allowed under the CWC.\u00a0 There is
\na significant international dialogue underway on the definition of
\nsuch agents and the situations in which they can be used. It should
\nbe noted that the CWC appears to assume such agents will not
\nbe lethal, but the use of any agent might have fatal consequences.\u00a0
\nThose using them, or authorising their use, must seek to ensure that
\nthey are not used in a manner which risks death or serious injury to
\ntargeted persons.
\nRecommendations
\n\u00a0The WMA notes that the development,production,stockpiling and
\nuse of Chemical Weapons is banned under the CWC, and that use
\nof such weapons is regarded by some to be a crime against humanity,
\nregardless of whether the target populations are civilian or military.
\nThe WMA urges all relevant parties to make active efforts to abide
\nby the CWC ban on the development, production, stockpiling and
\nuse of Chemical Weapons.
\nThe WMA urges support from all states party to the CWC for the
\nsafe destruction of all stockpiles of Chemical weapons.
\nThe WMA supports UN initiatives to identify anyone who is re-
\nsponsible for the use of Chemical Weapons and to bring them to
\njustice.
\nThe WMA urges states using chemical agents in riot control and
\nrelated situations to carefully consider and minimise the risks and
\nto, wherever possible, refrain from such use.\u00a0 Any use must follow
\nthe establishment of the necessary procedures to reduce the risk of
\ndeath or serious injury. They should not be used in a manner, which
\ndeliberately increases the risk of injury,harm or death to their targets.
\nWMA Resolution on
\nCriminalisation of Medical
\nPractice
\nAdopted as a Council Reolution by the 194th
\nWMA Council Session, Bali,
\nApril 2013 and adopted by the 64th
\n\u00a0WMA General Assembly, Fortaleza,
\nBrazil, October 2013
\nPreamble
\nDoctors who commit criminal acts which are not part of patient
\ncare must remain as liable to sanctions as all other members of soci-
\nety. Serious abuses of medical practice must be subject to sanctions,
\nusually through professional regulatory processes.
\nNumerous attempts are made by governments to control physicians\u2019
\npractice of medicine at local,regional and national levels worldwide.\u00a0
\nPhysicians have seen attempts to:
\n\u2022 Prevent medically indicated procedures;
\n\u2022 Mandate medical procedures that are not indicated; and
\n\u2022 Mandate certain drug prescribing practices.
\nWMA News
\n179
\nCriminal penalties have been imposed on physicians for various
\naspects of medical practice, including medical errors, despite the
\navailability of adequate non-criminal redress. Criminalizing medi-
\ncal decision making is a disservice to patients.
\nIn times of war and civil strife, there have also been attempts to
\ncriminalize compassionate medical care to those injured as a result
\nof these conflicts.
\nRecommendations
\nTherefore, the WMA recommends that its members:
\n1. Oppose government intrusions into the practice of medicine
\nand in healthcare decision making, including the government\u2019s
\nability to define appropriate medical practice through imposi-
\ntion of criminal penalties.
\n2. Oppose criminalizing medical judgment.
\n3. Oppose criminalizing healthcare decisions, including physician
\nvariance from guidelines and standards.
\n4. Oppose criminalizing medical care provided to patients injured
\nin civil conflicts.
\n5. Implement action plans to alert opinion leaders, elected officials
\nand the media about the detrimental effects on healthcare that
\nresult from criminalizing healthcare decision making.
\n6. Support the principles set forth in the WMA\u2019s Declaration of
\nMadrid on Professional Autonomy and Self-Regulation.
\n7. Support the guidance set forth in the WMA\u2019s Regulations in
\nTimes of Armed Conflict and Other Situations of Violence.
\nWMA Statement
\non the United Nations
\nResolution for a Moratorium
\non the Use of the Death
\nPenalty
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil, October 2013
\nPreamble
\nThe WMA Resolution on Physician Participation in Capital Pun-
\nishment states that it is unethical for physicians to take part in
\ncapital punishment, and the WMA Declaration of Geneva obliges
\nphysicians to maintain the utmost respect for human life.
\nThe WMA acknowledges that the views prevalent in the countries
\nof some of its members prevent all members unconditionally oppos-
\ning the death penalty.
\nThe WMA therefore supports the suspension of the use of the death
\npenalty through a global moratorium.\u00a0
\nThe WMA has long recognized that it cannot hold its national
\nmedical association members responsible for the actions and poli-
\ncies of their respective governments.
\nRecommandations
\nThe World Medical Association supports United Nations General
\nAssembly Resolution 65\/206 calling for a moratorium on the use of
\nthe death penalty.
\nWMA Statement on Fungal
\nDisease Diagnosis and
\nManagement
\nAdopted by the 64th
\n\u00a0WMA General Assembly, Fortaleza, Brazil, October
\n2013
\nAnnual WHO Global Burden of Disease estimates recognize
\nthat fungal diseases account for a significant proportion of health
\nproblems worldwide.\u00a0 These include cutaneous fungal infections
\nwhich affect up to a billion persons and vulvovaginal candidiasis
\nwhich affects tens of millions of women, often multiple times an-
\nnually.\u00a0
\nEven more serious are invasive and chronic fungal diseases that lead
\nto\u00a0 estimated annual morbidity rates that are similar to those caused
\nby commonly recognized global health concerns such as malaria and
\ntuberculosis. In addition to death, these fungal diseases commonly
\nlead to chronic ill health, including blindness with keratitis,\u00a0 respi-
\nratory distress\u00a0with\u00a0allergic\u00a0bronchopulmonary\u00a0aspergillosis (ABPA),
\nsevere asthma with fungal sensitisation (SAFS) and chronic pulmu-
\nnary aspergillosis (CPA),weight loss and nutritional deficiency with
\noesophageal candidiasis and CPA,and inability to engage in healthy
\nsexual activity with vulvovaginal candidiasis.
\nSerious fungal diseases are often opportunistic, occurring as a con-
\nsequence of other conditions that suppress the immune system,\u00a0such
\nas asthma, AIDS, cancer, post-transplant immunosuppressive drugs
\nand corticosteroid therapies. Some occur in critically ill patients.
\nWMA News
\n180
\nDespite the fact that many fungal diseases can be treated relatively
\nsimply,in many cases,these diseases go untreated.\u00a0Fungal infections
\nalone are often not distinctive enough to allow a clinical diagnosis,
\nand as cultures are frequently falsely negative, missed diagnosis is
\ncommon. In addition, a relatively narrow diagnostic window to cure
\nthe patient is frequently missed, resulting in prolonged expensive
\nhospital stays, often with a fatal outcome.\u00a0 Despite the existence
\nof effective medicine to treat fungal infections, these are often not
\navailable when and where they are needed.
\nStatement
\nThe WMA stresses the need to support the diagnosis and man-
\nagement of fungal diseases and urges national governments to
\nensure that both diagnostic tests and antifungal therapies are
\navailable for their populations. Depending on the prevalence of
\nfungal diseases and their underlying conditions, specific antigen
\ntesting or microscopy and culture are essential. These tests, and
\npersonnel trained to administer and interpret the tests, should
\nbe available in all countries where systemic fungal infections\u00a0oc-
\ncur.\u00a0 This will likely include developing at least one diagnostic
\ncentre of excellence with a sufficient staff of trained diagnostic
\npersonnel. Monitoring for antifungal toxicities should be avail-
\nable.\u00a0
\nPhysicians will be the first point of contact for most patients with a
\nfungal infection and should be sufficiently educated about the topic
\nin order to ensure an effective diagnostic approach.\u00a0
\nThe WMA encourages its\u00a0members to undertake and support epi-
\ndemiologic studies on the burden of fungal disease in their country
\nand to inform the national government of the results.
\nWMA Statement on Forensic
\nInvestigations of the Missing
\nAdopted by the 54th
\n\u00a0WMA General Assembly, Helsinki, Finland, Sep-
\ntember 2003 and amended by the 64th
\n\u00a0WMA General Assembly, For-
\ntaleza, Brazil, October 2013
\nPreamble
\nOver the last three decades, forensic investigations into the where-
\nabouts and fate of people killed and missing as a result of armed
\nconflict, other situations of violence and catastrophes, have made an
\nimportant contribution to humanitarian action on behalf of victims,
\nincluding [the deceased and] bereaved families.\u00a0 Forensic investiga-
\ntions have also helped in achieving justice and reparations for vic-
\ntims.
\nIn 2003 the International Conference on The Missing and their
\nFamilies, organized by the International Committee of the Red
\nCross (ICRC), adopted a set of recommendations to help prevent
\npeople going missing, and resolve the cases of those already miss-
\ning, as a result of armed conflicts\u00a0and other situations of violence.\u00a0
\nThe recommendations include ethical,\u00a0scientific and legal principles
\nthat must apply to forensic investigations in the search, recovery,
\nmanagement and identification of human remains.These principles
\nhave since been further developed by the ICRC\u203as forensic services
\nand they provide a framework for humanitarian forensic action in
\nsituations of armed conflicts, other situations of violence and catas-
\ntrophes1
\n. The principles also ensure the proper and dignified man-
\nagement and identification of the dead, and help provide answers to
\nthe bereaved.
\nNational Medical Associations have a role in promoting these
\nprinciples and encouraging compliance with them, \u00a0and for en-
\nsuring the highest possible ethical, scientific and legal\u00a0standards
\nin forensic investigations aimed at addressing the humanitarian
\nconsequences of armed conflicts, other situations of violence and
\ncatastrophes.
\nIn many countries NMAs will not have a role in certifying the qual-
\nifications and experience of forensic medical practitioners. NMAs
\nshould draw the attention of practitioners to the best practice
\nguidelines produced by the ICRC,the United Nations and Interpol,
\nand recommend or, where possible, require compliance with those
\nstandards.
\nRecommendations
\nThe WMA calls upon all NMAs to help ensure that,when its mem-
\nbers take part in forensic investigations for humanitarian and hu-
\nman rights purposes, such investigations are established with a clear
\nmandate based upon the highest ethical, scientific and legal stan-
\ndards,and conform with the principles and practice of humanitarian
\nforensic action developed by the ICRC.
\nThe WMA calls upon NMAs to develop expertise in the principles
\ncollated by the different authorities on forensic investigations for
\n1 The ICRC defines catastrophes as disasters beyond expectations. See: M.Tid-
\nball-Binz,\u00a0Managing the dead in catastrophes: guiding principles and practical
\nrecommendations for first responders.International review of the Red Cross,Vol
\n89 Number 866 June 2007 p.p. 421-442
\nWMA News
\n181
\nhumanitarian and human rights purposes, including those devel-
\noped by the ICRC to prevent new cases and resolve those of exist-
\ning missing persons, and to assist their members in applying these
\nprinciples to forensic investigations worldwide.
\nThe WMA calls upon NMAs to disseminate the principles that
\nshould apply to such investigations, including those developed
\nby the ICRC, and to attempt to ensure that physicians refuse to
\ntake part in investigations that are ethically or otherwise unac-
\nceptable.
\nThe WMA calls upon NMAs to help ensure compliance by forensic
\nmedical practitioners with the principles enshrined in international
\nhumanitarian law for the dignified and proper management, docu-
\nmentation and identification of the dead, and, where possible, pro-
\nviding answers to the bereaved.
\nThe WMA invites NMAs to be mindful of academic qualifications
\nand ethical understanding, ensuring that forensic doctors practice
\nwith competence and independence.
\nWMA Council Resolution
\non Standardisation
\nin Medical Practice and
\nPatient Safety
\nAdopted as a Council Resolution by the\u00a0194th
\n\u00a0WMA Council Session,
\nBali, Indonesia, April 2013 and acopted by the 64th
\nWMA General As-
\nsembly, Fortaleza, Brazil, October 2013\u00a0
\nEnsuring patient safety and quality of care is at the core of medical
\npractice. For patients, a high level of performance can be a matter of
\nlife or death. Therefore, guidance and standardisation in healthcare
\nmust be based on solid medical evidence and has to take ethical
\nconsiderations into account.
\nCurrently, trends in the European Union can be observed to
\nintroduce standards in clinical, medical care developed by non-
\nmedical standardisation bodies, which neither have the neces-
\nsary professional ethical and technical competencies nor a public
\nmandate.
\nThe WMA has major concerns about such tendencies which are
\nlikely to reduce the quality of care offered, and calls upon govern-
\nments and other institutions not to leave standardisation of medical
\ncare up to non-medical self selected bodies.
\nWMA Resolution
\non the Healthcare Situation
\nin Syria
\nAdopted by the 64th
\n\u00a0 General Assembly, Fortaleza, Brazil, October
\n2013
\nPreamble
\nDuring wars and armed conflicts, hospitals and other medical fa-
\ncilities have often been attacked and misused and patients and
\nmedical personnel have been killed or wounded. Such attacks are
\na violation of the Geneva Conventions (1949), Additional Pro-
\ntocols to the Geneva Conventions (1977) and WMA policies, in
\nparticular, the WMA Statement on the Protection and Integrity
\nof Medical Personnel in Armed Conflicts and Other Situations
\nof Violence (Montevideo 2011) as well as WMA Regulations
\nin Times of Armed Conflicts and Other Situations of Violence
\n(Bangkok 2012).
\nThe World Medical Association (WMA) has been active in con-
\ndemning documented attacks on medical personnel and facilities in
\narmed conflicts, including civil wars.
\nThe Geneva Conventions and their Additional Protocols are de-
\nsigned to protect medical personnel, medical facilities and their pa-
\ntients in international and non-international armed conflicts.
\nThe parties on both sides of the conflict have legal and moral duties
\nnot to interfere with medical care for wounded or sick combatants
\nand civilians, and to not attack, threaten or impede medical func-
\ntions. Physicians and other health care personnel must act as and be
\nconsidered neutral and must not be prevented from fulfilling their
\nduties.
\nRecommendations
\n\u2022 The WMA calls upon all parties in the Syrian conflict to ensure
\nthe safety of healthcare personnel and their patients, as well as
\nmedical facilities and medical transport.
\n\u2022 The WMA calls upon its members to approach local governments
\nin order to facilitate international cooperation in the United Na-
\ntions, the European Union or other international body with the
\naim of ensuring the safe provision of health care to the Syrian
\npeople.
\nWMA News
\n182
\nWMA News
\nWMA Statement on the Right
\nof Rehabilitation of Victims
\nof Torture
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil, October 2013
\nPreamble
\nThe World Medical Association notes with grave concern the con-
\ntinued use of torture in many countries throughout the world.
\nThe WMA reaffirms its total condemnation of all form of tor-
\nture, and other cruel, inhuman or degrading treatment or pun-
\nishment, as defined by the UN Convention Against Torture
\n(CAT, 1984).
\nTorture is one of the gravest violations of international human
\nrights law and has devastating consequences for victims, their
\nfamilies and society as a whole.
\nTorture causes severe physical and mental injuries and is a crime
\nabsolutely prohibited under international law.
\nThe WMA reaffirms its policies adopted previously, namely:
\n\u2022 The Declaration of Tokyo laying down Guidelines for Physicians
\nConcerning Torture and other Cruel, Inhuman or Degrading
\nTreatment or Punishment in Relation to Detention and Impris-
\nonment\u00a0 (1975)
\n\u2022 The Declaration of Hamburg concerning Support for Medical
\nDoctors Refusing to Participate in, or to Condone, the Use of
\nTorture or Other Forms of Cruel, Inhuman or Degrading Treat-
\nment (1997)
\n\u2022 The Resolution on the Responsibility of Physicians in the Docu-
\nmentation and Denunciation of Acts of Torture or Cruel or Inhu-
\nman or Degrading Treatment (2003).
\nThe medical evaluation is an essential factor in pursuing the docu-
\nmentation of torture and the reparation of victims of torture. Phy-
\nsicians have a critical role to play in gathering information about
\ntorture, documenting evidence of torture for legal purposes, as well
\nas supporting and rehabilitating victims.
\nThe WMA recognizes the adoption, in December 2012, by the UN
\nCommittee Against Torture of the General Comment on the Im-
\nplementation of article 14 of Convention against Torture relating to
\nthe right to reparation of victims of torture.
\nThe General Comment outlines the right of rehabilitation as an
\nobligation on States and specifies the scope of these services. The
\nWMA welcomes in particular:
\n\u2022 The obligation of State parties to adopt a \u201clong-term and in-
\ntegrated approach and ensure that specialized services for the
\nvictim of torture or ill treatment are available, appropriate and
\npromptly accessible\u201d (paragraph 13), without making access to
\nthese services dependent on the victim pursuing judicial rem-
\nedies.
\n\u2022 The recognition of the right of victims to choose a rehabilitation
\nservice provider, be it a State institution, or a non-State service
\nprovider, which is funded by the State.
\n\u2022 The recognition that State parties should provide torture victims
\nwith access to rehabilitation programs as soon as possible follow-
\ning an assessment by qualified independent healthcare profes-
\nsionals.
\n\u2022 The references in paragraph 18 to measures aimed at protecting
\nhealth and legal professionals who assist torture victims, develop-
\ning specific training on the Istanbul Protocol for health profes-
\nsionals, and promoting the observance of international standards
\nand codes of conduct by public servants, including medical, psy-
\nchological and social service personnel.\u00a0
\nRecommendations
\nThe WMA emphasizes the vital function of reparation for vic-
\ntims of torture and their families in rebuilding their lives and
\nachieve redress and the important role of physicians in rehabili-
\ntation.
\nThe WMA encourages its member associations to work with rel-
\nevant agencies \u2013 governmental and non-governmental – acting for
\nthe reparation of victims of torture, in particular in the areas of doc-
\numentation and rehabilitation, as well as prevention.
\nThe WMA encourages its members to support agencies that are
\nunder threat of – or subjected to – reprisals from state parties due
\nto their involvement in the documentation of torture, rehabilitation
\nand reparation of torture victims.
\nThe WMA calls on its members to use their medical experience
\nto support torture victims in accordance with article 14 of the UN
\nConvention against Torture.
\nThe WMA calls on its member associations to support and facili-
\ntate data collection at the national level in order to monitor the
\nimplementation of the State\u2019s obligation to provide rehabilitation
\nservices.
\n183
\nWMA News
\nWMA Statement on Human
\nPapillomavirus Vaccination
\nAdopted by the 64th
\n\u00a0General Assembly, Fortaleza, Brazil, October 2013
\nPreamble
\nHuman papillomavirus (HPV) vaccination presents a unique and
\nvaluable opportunity for physicians to substantially prevent mor-
\nbidity and mortality from certain cancers in all populations, and to
\nimprove maternal health. The HPV vaccine therefore merits con-
\nsideration by the World Medical Association (WMA) separately
\nfrom other vaccines.
\nHPV is a sexually transmitted virus and is so common that most
\nsexually active adults become infected at some point in their lives.
\nMost infections are asymptomatic and resolve without medical in-
\ntervention. However, some of the 40 types of HPV can cause cervi-
\ncal cancer. HPV is the cause of nearly 100% of cervical cancer cases
\nand may also cause cancer of the vagina, vulva, anus, penis and the
\nhead and neck. Cervical cancer accounts for more than 10% of all
\nfemale cancers, and the majority of cervical cancer deaths are in
\ndeveloping countries.
\nVaccines can protect against infection by the most common HPV
\ntypes and afford protection against cancer. The U.S. Advisory Com-
\nmittee on Immunization Practices recommends HPV vaccination for
\nboth females and males starting at age 11 years up to age 26 years.
\nBenefits of vaccinating young men include protection against genital
\nwarts and cancer in addition to preventing transmission of HPV to
\nsexual partners. The additional protection afforded by the quadriva-
\nlent vaccine against genital warts as well as cervical and other cancers
\nshould be taken into consideration when developing HPV vaccina-
\ntion programmes. The HPV vaccines are effective; post-marketing
\nstudies have shown decreases in\u00a0HPV prevalence and\u00a0HPV related
\ndisorders such as genital warts and abnormal cervical cytology.\u00a0Stud-
\nies concerning the safety of\u00a0HPV vaccines have been reassuring.\u00a0
\nThese vaccines should be made widely available and should be pro-
\nmoted by physicians as a matter of individual patient wellbeing and
\npublic health.\u00a0
\nRecommendations
\nThe WMA urges physicians to educate themselves and their pa-
\ntients about HPV and associated diseases, HPV vaccination and
\nroutine cervical cancer screening; and encourages the development
\nand funding of programs to make HPV vaccine available and to
\nprovide cervical cancer screening in countries without organized
\ncervical cancer screening programs.
\nNational medical associations (NMAs) are encouraged to carry out
\nintensive education of and advocacy efforts toward their members
\nto:
\n\u2022 Improve awareness and understanding of HPV and associated
\ndiseases;
\n\u2022 Understand the availability and efficacy of HPV vaccines;
\n\u2022 Understand the desirability of including HPV vaccines in nation-
\nal immunization programs;
\n\u2022 Understand the need for routine cervical cancer screening; and
\n\u2022 Integrate HPV cancer prevention methods, early detection and
\nscreening, diagnosis, treatment and palliative care into existing
\ncontinuing professional development programs and pre-service
\ntraining. Such training will leverage existing support for HPV
\nprograms and help in capacity building and quality assurance ef-
\nforts.
\nNMAs are also encouraged to:
\n\u2022 Integrate HPV vaccination for all adolescents and routine cervi-
\ncal cancer screening for young women into all appropriate health
\ncare settings and visits;
\n\u2022 Support the availability of the HPV vaccine and routine cervi-
\ncal cancer screening for appropriate populations that benefit most
\nfrom preventive measures, including but not limited to at-risk
\npatients such as low-income, disadvantaged and populations that
\nare not yet sexually active;
\n\u2022 Recommend HPV vaccination for all appropriate populations;
\n\u2022 Promote member advocacy for HPV prevention, care and treat-
\nment; and
\n\u2022 Create a network of physicians and practitioners who are will-
\ning and able to mentor and support one another and establish
\nlinkages to existing HPV vaccine and cancer prevention net-
\nworks.
\nWMA Resolution on Women\u2019s
\nRights to Health Care and How
\nThat Relates to the Prevention of
\nMother-to-Child HIV Infection
\nAdopted by the 53rd
\n\u00a0 WMA General Assembly, Washington, DC,
\nUSA,\u00a0October 2002 and amended by the 64th
\nWMA General Assembly,
\nFortaleza, Brazil, October 2013\u00a0
\n184
\nWMA News
\nPreamble
\nIn many parts of the world the prevalence of HIV infection con-
\ntinues to increase. One of the Millennium Development Goals
\n(MDG 6), specifically targets combating HIV\/AIDS, malaria and
\nother diseases, with 2015 being its target year to halt HIV\/AIDS
\ninfection and to begin reversing the spread of HIV\/AIDS. In ad-
\ndition, it was hoped that by 2010 universal access to treatment
\nfor HIV\/AIDS for all those requiring it would be achieved. A
\nDecember 2012 UN resolution declared that countries must de-
\nvelop programmes for Universal Health Access after 2015 when
\nthe MDGs end.
\nHIV\/AIDS is a disease that disproportionately affects people in
\ntheir reproductive years although today, due to better management
\nof the condition, there are also many older people who are infected.
\nIn addition, many who were infected as infants are now reaching
\nreproductive maturity.
\nIn developed countries men who have sex with men and injection
\ndrug users constitute significant risk groups for contracting HIV.
\nIn many developing countries, women are at risk due to hetero-
\nsexual contact with HIV infected partners. In 2011 approximately
\n58 percent of people living with HIV in sub-Saharan Africa were
\nwomen,equating to about 13.6 million women living with HIV and
\nAIDS, compared to about 9.9 million men(UNAIDS\u00a0 \u2018Global Fact
\nSheet 2012: World AIDS Day 2012).
\nIn the absence of HIV, maternal mortality worldwide would be sig-
\nnificantly (20% ) lower (Murray et al. Maternal mortality for 181
\ncountries, 1980\u20132008:\u00a0 a systematic analysis of progress towards
\nMillennium Development Goal 5).
\nHIV infection increases the risk of invasive cervical cancer 2 to 22
\nfold. Some evidence exists that the use of antiretroviral therapy may
\ndecrease this\u00a0risk. Hence,\u00a0the appropriate management of patients
\ninfected with HIV may have a long-term impact on other aspects
\nof women\u2019s health.
\nThe WMA believes that access to healthcare, including both thera-
\npeutic and preventative strategies, is a fundamental\u00a0human right.
\nThis imposes an obligation on government to ensure that these hu-
\nman rights are fully respected and protected.\u00a0 Gender inequalities
\nmust be addressed and eradicated.\u00a0 This should impact every aspect
\nof healthcare.
\nThe promotion and protection of the reproductive rights of women
\nare critical to the ultimate success of confronting and resolving the
\nHIV\/AIDS pandemic.
\nMany of the MDGs address\u00a0empowering women and promot-
\ning their role in society and specifically in healthcare. MDG 5B,
\nin particular, promotes universal access to reproductive health in-
\ncluding contraceptive access, reduction in adolescent birth rate,
\nantenatal care coverage and addressing unmet needs for family
\nplanning.\u00a0 In addition, MDG 3 which promotes gender equality
\nand empowers women,\u00a0\u00a0and MDGs 1 and 2 will influence wom-
\nen\u2019s status in society and therefore their access to healthcare and
\nhealth promotion.\u00a0
\nRecommendations
\nThe WMA requests all national member associations to encour-
\nage their governments to undertake and promote the following
\nactions:\u00a0
\n\u2022 Develop empowerment programs for women of all ages to en-
\nsure that women are free from discrimination and enjoy uni-
\nversal and free access to reproductive health education and life
\nskills training. It is recommended that campaigns be\u00a0initiated
\nand activated in the media, including social media and popu-
\nlar programmes on radio and television in order to eradicate
\nmyths, stigma and stereotypes that might degrade or dehuma-
\nnise women.\u00a0 This must include campaigns against genital mu-
\ntilation and forced adolescent marriages and unwanted preg-
\nnancies.\u00a0 In addition, promoting the availability and choice of
\ncontraception for women, without necessarily having to get in-
\nput from their partners, and promoting the availability of HIV
\ntesting and treatment are essential for reproductive health. It is
\nalso important to provide for the economic \u00a0means for the in-
\nfected populations in terms of prevention, treatment and medi-
\ncal follow-up.
\n\u2022 Women must have the same access as men, without discrimina-
\ntion to education, employment, economic independence, infor-
\nmation about healthcare and health services.
\n\u2022 Laws, policies and practices that facilitate the full recognition
\nand respect of human rights and the fundamental freedom of
\nwomen should be initiated or reviewed and revised where ap-
\npropriate. It is essential that women are empowered to make de-
\ncisions regarding their children, their financial status and their
\nfuture.
\n\u2022 All governments should develop programmes to provide pro-
\nphylactic treatment in the form of antiretrovirals to women who
\nhave been raped or sexually assaulted. \u00a0Universal and free access
\nto antiretroviral therapy must also be provided to all HIV infected
\nwomen.
\n\u2022 HIV infected women who are pregnant should receive counsel-
\nling and access to anti-retroviral prophylaxis or treatment in order
\nto prevent mother to child transmission of HIV.
\n185
\nDeclaration of Helsinki
\nIntroduction
\n\u201cLe mieux est l\u2019ennemi du bien.\u201d (The perfect is
\nthe enemy of the good.)\u201d
\nThe Philosophical Dictionary attributes this
\nfamiliar quote to the French philosopher
\nVoltaire, and more specifically to his poem
\nLa Bequeule which begins: \u201cDans ses \u00e9crits,
\nun sage Italien, it que le mieux est l\u203aennemi du
\nbien\u201c (which translates as: \u2018In his writings, a
\nwise Italian says that the best is the enemy
\nof the good\u2019). The translation of \u201cmieux\u201d
\nas \u2018best\u2019 or \u2018perfect\u2019 is a matter of minor
\ntranslational dispute, but this has become a
\ncommon aphorism, so common in fact that
\ninserting \u201cthe perfect is the enemy of the
\ngood\u201dinto the Google search engine returns
\n71,800,000 results (in 0.34 seconds). Like
\nall pieces of good advice, the point being
\nmade is clear: sometimes it is preferable to
\nmake things better rather than striving for
\nperfection. Presumably the thinking is part-
\nly pragmatic: to achieve perfection may take
\nmore time or resources than are available
\nand hence the pragmatic solution of achiev-
\ning something (rather than nothing) is con-
\nsidered a wise strategy. It is also likely that
\nadvice about pursuing perfection is an epis-
\ntemic asymptote in that one can constantly
\ntry to seek perfection and can move closer,
\nbut the effort will ultimately fail given that
\nan accepted definition and understanding
\nof the perfect is either beyond our knowl-
\nedge or at least beyond political consensus.
\nAchieving perfection is hard. The Oxford
\nEnglish Dictionary defines it as: \u201cIn a state
\nof complete excellence; free from any im-
\nperfection or defect of quality; that cannot
\nbe improved upon; flawless, faultless\u201d. This
\nis why debates persist in Olympic scoring,
\nphysical attributes, the cut of a diamond, or
\nin a written document.
\nNo one is (or should be) arguing that the
\nDeclaration of Helsinki is a perfect docu-
\nment. But after five decades, six revisions
\nand two Notes of Clarification it is an ap-
\npropriate occasion to look backwards at the
\nevolution of some of its more controversial
\nsections and ponder how much further it
\nstill needs to go to get closer to a document
\nworthy of its status as one of the most au-
\nthoritative statements on ethical standards
\nfor human research in the world [1].
\nAmong the Most Controversial
\nPrinciples: Placebos and
\nProvision of Care
\nPlacebos and Standard of Care. Few topics
\nhave occupied the attention of regulators,
\ngovernments, sponsors, or academic com-
\nmentators as much as the Declaration\u2019s
\nefforts to provide principled advice on the
\njustification for using placebos in biomedi-
\ncal research. I recall vividly the debates over
\nthis topic in the late 1990s when the US
\nNational Bioethics Advisory Commission
\nwas undertaking work on a report on the
\nethics of international clinical trials [2,3].
\nIt was during the course these deliberations,
\nand subsequent discussions by other groups
\nsuch as the Nuffield Council for Bioethics
\n[4] that sides were taken on the ethical ac-
\nceptability of placebos. Stimulated in part
\nby the published responses to the ACTG-
\n076 maternal-fetal HIV transmission trials
\n[5-7], the WMA weighed in on this topic
\nin the 2000 revision and then in a clarifying
\nnote in 2002 which, arguably, did little to
\nsettle the issues. Indeed, one commentator
\nhas referred to the placebo principle (then
\nPrinciple 29) in a prior version of the Dec-
\nlaration as one of the two \u201cmost controver-
\nsial elements of the whole Declaration\u201d (the
\nother being principle 30 relating to post
\nstudy obligations [8].
\nAt stake was whether the ethical and sci-
\nentific justification for including a placebo
\nwould meet an agreed standard of care,
\nwhich itself has been the subject of ongo-
\ning deliberation [9]. The choice of whether
\na new intervention could be tested against
\na placebo (or no treatment) only when no
\nestablished effective, no proven, no current
\nproven, no best available treatment existed
\npreoccupied much of the debate over the
\npast decade. Wording changes in Principle
\n33 such as where \u201cmethods\u201d replaces \u201ctreat-
\nments\u201d, provide some conceptual clarifica-
\ntion, but any gains in clarity may still be lost
\nwhen considering that the Declaration is
\ntranslated into the three official languages
\nof the WMA, presenting certain interpreta-
\ntion problems [10].
\nThis has had the effect of creating a policy
\n\u2018valley of death\u2019, which has been described
\nas an environment in which policy advice
\nIf Perfect Isn\u2019t Possible, Is The Good \u201cGood Enough?\u201d
\nPlacebos, Post-Trial Provisions and the Politics of Helsinki
\nEric M. Meslin
\n186
\nDeclaration of Helsinki
\n(including guidelines) may actually im-
\npede scientific progress if not presented in
\nan implementable way [11]. Little progress
\nwas made to traverse what has become a
\npolicy valley of death on this issue; that is
\nthe 2013 draft revision maintains the status
\nquo with only minor grammatical changes
\nfor terminological consistency, such as re-
\nplacing \u201ctreatment\u201d with \u201cintervention\u201d and
\ndeleting \u201ccurrent\u201d as a qualifier for \u201cproven\u201d.
\nThis may be as good as it gets so long as
\nthe Helsinki reflects the considered judg-
\nment of the WMA members on the ethics
\nof placebo controls a position that has not
\nchanged in almost 15 years.
\nLanguage notwithstanding, this principle
\nhas been, and one suspects will continue to
\nbe controversial as it relates to the question
\non when is it acceptable to design a study
\nwith a placebo (or no treatment). Regret-
\ntably, the debate has been mired in a set of
\nepistemic problems including whether the
\nstandard of care is determined locally or
\nglobally. Such issues are further influenced
\nby the economics of drug development and
\npricing. Arguably, one of the objections to
\nthe ACTG-076 trials, namely that it would
\nbe unethical to test a drug regimen that
\nwould be too expensive for implementation
\nin Low and Middle Income Countries [6],
\nwould carry less weight if the price of medi-
\ncines can be reduced in those countries.
\nGiven the tremendous progress that has
\nbeen made to lower drug prices by many or-
\nganizations, as well as innovative approach-
\nes for negotiating price [12], the way should
\nbe cleared somewhat for continued discus-
\nsion about the scientific and ethical merit of
\nusing placebos.
\nProvision of care at the End of a Study.
\nSlightly less controversial than the placebo
\nprinciple is the laudable effort in the Dec-
\nlaration to provide guidance in Principle 34
\non the issue of what, if anything, is owed at
\nthe end of a study, to whom, and on whose
\nshoulders any obligation may rest. Like the
\nplacebo principle, the history of this provi-
\nsion can be traced back to the debate at the
\nend of the last century to recognize and try
\nto encourage implementation of a moral in-
\ntuition about the ethical obligation to pro-
\nvide some type of care or treatment to those
\nwho participate in studies and would ben-
\nefit from continued access to a beneficial
\ntreatment [3]. Unlike the placebo principle,
\nthe controversy about which is focused on
\nwhether one can set firm conditions on
\nwhen it should be used at all, the post-trial
\nprovision principle is controversial because
\nit does not set firm limits on the scope of
\nthe ethical expectations created. Accepting
\nfor the moment that the provision is unique
\nin that (even if not explicitly stated) it is
\non research undertaken in LMICs since no
\nsuch provision is found in national guide-
\nlines for economically developed countries,
\nit is still a provision that is challenging to
\nimplement consistently. Consider the diffi-
\nculty in identifying those who still need an
\nintervention identified as beneficial, given
\nfactors such as symptom improvement,
\nsafety monitoring, or other requirements
\nfor ongoing care. These and other concerns
\nwere partly responsible for the need to
\nproduce a further Note of Clarification in
\n2004 at the Tokyo meeting of the WMA
\nreaffirming the need \u201cduring the planning
\nprocess to identify post trial access by study
\nparticipants to prophylactic, diagnostic
\nand therapeutic procedures identified as
\nbeneficial in the study or access to other
\nappropriate care\u201d [13]. This provision may
\nbe as good as Helsinki can get so long as
\nthe WMA, like many other organizations,
\ncontinues to support the idea that among
\nthe best ways to respect the best interests of
\npatients involved in studies is by encourag-
\ning protocols to include provisions for on-
\ngoing care, to empower ethics committees
\nto review these aspects of protocols, and
\nfor prospective research participants to be
\nmade aware of such provisions during the
\nconsent process. However, it is also likely
\nthat as more collaborative research occurs
\ninvolving participants from many different
\ncountries \u2013 some of whom will not have
\ndomestic provisions in their own gover-
\nnance documents that accept this provision
\nin Helsinki \u2013 there will be conflicts about
\nthe best way to satisfy this provision.
\nThe Politics and Ethics
\nof the Declaration as a
\nPolicy Instrument
\nOne of the great strengths of the Declara-
\ntion is the impact that its widespread use
\nhas on the policy positions of countries
\nthroughout the world. Many countries who
\nhave not developed their own national eth-
\nics guidelines have adopted Helsinki as
\ntheir national standard. It is, therefore, first
\nand foremost, a governance document in-
\ntended to guide the conduct of domestic
\nresearch in a global environment. In this
\nway it is different from the hundreds of do-
\nmestic guidelines each of which were writ-
\nten to provide substantive direction for the
\nconduct of research in those countries [14].
\nIn becoming a global document, inevitably
\nit also has become a political document,
\nwhich should come as no surprise as it is
\nreflects the consensus view of the world\u2019s
\nmedical associations. As such, there is no
\ndenying that among the challenges that this
\nincreasingly popular document faces is the
\n\u201cpoliticization\u201d of its content [8]. Five and
\nhalf years ago, the Declaration found itself
\nthe object of a political dispute when the
\nU.S.Food and Drug Administration (FDA)
\nannounced that it would be substituting its
\nhistoric reliance on the Declaration as the
\nstandard for judging the ethical acceptabil-
\nity of international clinical trials with those
\nstandards adopted by the International
\nConference on Harmonization\u2019s (ICH)
\nGuideline for Good Clinical Practice [15].
\nSome of us speculated about the possible
\nreasons that the FDA under then U.S.
\nPresident George W. Bush used to justify
\nthis policy maneuver [1]. Just as the plural
\nof anecdote is not data, neither is it appro-
\npriate to elevate speculation about political
\nmotives to the level of confirmed intention.
\nStill one does not have to be a conspiracy
\ntheorist to appreciate the mutual benefits
\n187
\nDeclaration of Helsinki
\nof adopting a standard that enjoys consen-
\nsus among those parties whose interactions
\nrequire a common standard or benchmark.
\nIn the case of licensing and marketing new
\nmedicines, there is a decided advantage for
\nthe pharmaceutical industry in the U.S.,
\nEurope and Japan to abide by the ICH
\nstandard \u2013 having developed it jointly \u2013 as
\ncontrasted with adopting the Helsinki stan-
\ndard which was developed by the WMA.
\nThese maneuverings should not, however,
\ndiminish the confidence that the public
\nmight be expected to have in the integrity
\nof research undertaken in compliance with
\nHelsinki. The WMA should be congratu-
\nlated for its efforts to democratize the revi-
\nsion process by taking many steps to con-
\nvene working groups and expert panels in
\ndifferent countries over many months, and
\nto solicit public comments on the revision
\nonline. The final draft received fewer than
\n130 comments from around the world but
\nwhile this seems an unusually small number
\nfor a document of such importance, the ex-
\nplanation may be found in the lessons from
\nother efforts to engage the public in policy
\nmaking [16\u201317]. most notably that public
\ncommentary is a labor intensive and some-
\ntimes technology dependent activity.
\nConclusion
\nThe Declaration of Helsinki is not a per-
\nfect document and perhaps it can never be.
\nIt has enjoyed a unique status that has im-
\nproved over time, as each subsequent revi-
\nsion has attempted to be responsive to new
\ndevelopments in science and deeper ethical
\nand policy reflections. No sooner will the
\ncurrent revision be finalized and dissemi-
\nnated then the process will start again as
\none would expect of a living document in
\nresearch ethics.
\nDisclaimer:This paper is based in part on com-
\nments provided at the \u201cStakeholders Meeting
\non the Revision of the Declaration of Helsinki\u201d,
\nAugust 26, 2013, Washington, DC.
\nReferences
\n1. Kimmelman J, Weijer C, Meslin EM, The Hel-
\nsinki Discords: FDA, Ethics, and International
\nDrug Trials, The Lancet 373(9657): 13-14, Janu-
\nary 2009 doi:10.1016\/S0140-6736(08)61936-4
\n2. National Bioethics Advisory Commission.Ethi-
\ncal and Policy Issues in International Research:
\nClinical Trials in Developing Countries (2001).
\nNBAC. Rockville, MD, http:\/\/bioethics.george-
\ntown.edu\/nbac\/clinical\/Vol1.pdf
\n3. Shapiro HT and Meslin, EM. Ethical Issues in
\nthe Design and Conduct of Clinical Trials in
\nDeveloping Countries. New England Journal of
\nMedicine 2001;345:139-141
\n4. Nuffield Council on Bioethics. The ethics of re-
\nsearch related to healthcare in developing coun-
\ntries. Nuffield Council (2002). www.nuffieldbio-
\nethics.org\/research-developing-countries
\n5. Varmus H, Satcher D, Ethical complexities of
\nconducting research in developing countries. N
\nEng J Med 1997;337: 1003-1005
\n6. Lurie P, Wolf SM. Unethical trials of interven-
\ntion to reduce perinatal transmission of the hu-
\nman immunodeficiency virus. N Eng J Med,
\n1997;337; 853-855
\n7. Angell, M. The ethics of clinical research in the
\nthird world. N Eng J Med. 1997; 337: 847-9
\n8. Ashcroft, RE. The Declaration of Helsinki. In
\nEmanuel EJ, Grady C, Crouch RA, Lie RK,
\nMiller FG, Wendler D. eds. The Oxford Textbook
\nof Clinical Research Ethics. Oxford University
\nPress (2008): 146.
\n9. Macklin, R. Double Standards in Medical Re-
\nsearch in Developing Countries. Cambridge
\nUniversity Press, 2004.
\n10. Carlson RV, van Ginneken NH, Pettigrew LM,
\nBoyd KM, Webb DJ, The three official lan-
\nguage versions of the Declaration of Helsinki:
\nwhat\u2019s lost in translation? J Med Ethics. 2007
\nSeptember; 33(9): 545\u2013548. doi:\u00a0 10.1136\/
\njme.2006.018168
\n11. Meslin EM, Blasimme A, Cambon-Thomsen
\nA, Mapping the Science Policy \u2018Valley of Death\u2019
\nClinical and Translational Medicine. 2013, 2:14.
\nDOI: 10.1186\/10.1186\/2001-1326-2-14
\n12. Lucchini S, Cisse B, Duran S, de Cenival M,
\nComiti C, Gaudry M , Moatti JP Decrease in
\nPrices of Antiretroviral Drugs for Develop-
\ning Countries: from Political \u201cPhilanthropy\u201d to
\nRegulated Markets? http:\/\/apps.who.int\/medi-
\ncinedocs\/documents\/s18253en\/s18253en.pdf
\n13. World Medical Association. Declaration of
\nHelsinki: Ethical Principles for Medical Re-
\nsearch Involving Human Subjects.Tokyo, Japan.
\nWMA: October 2004 [Online]. http:\/\/www.
\nwma.net\/en\/40news\/20archives\/2004\/2004_24\/
\n(Accessed October 16, 2013)
\n14. Office of Human Research Protections. 2013
\nEdition of the International Compilation of
\nHuman Research Standards. http:\/\/www.hhs.
\ngov\/ohrp\/international\/index.html (Accessed
\nOctober 16, 2013)
\n15. Department of Health and Human Services,
\nFood and Drug Administration. Human sub-
\nject protection; foreign clinical studies not
\nconducted under an investigational new drug
\napplication. Fed Reg April 28, 2008. 22800-16.
\nhttp:\/\/www.fda.gov\/cber\/rules\/forclinstud.pdf
\n(accessed Nov 9, 2008).
\n16. Meslin EM. When Policy Analysis is Carried
\nOut in Public: Some Lessons for Bioethics from
\nNBAC\u2019s Experience. In: James Humber and
\nRobert Almeder, eds. The Nature and Prospect of
\nBioethics: Interdisciplinary Perspectives. Humana
\nPress: Totowa, NJ. 2003: pp. 87-111.
\n17. Singer PA, Taylor AD, Daar AS, Upshur REG,
\nSingh JA, et al. (2007) Grand Challenges in
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\njournal.pmed.0040265
\nFunding
\nSupport from Grant # 2R25TW006070-05,
\nFogarty International Center, NIH; Grant #
\nUL1RR025761-01, NCATS, NIH. Meslin is
\na consultant to the Ethical, Social and Cultural
\nProgram of the Grand Challenges in Global
\nHealth (GCGH) initiative funded by the Bill
\n& Melinda Gates Foundation.
\nEric M. Meslin, Ph.D.
\nDirector, Indiana University
\nCenter for Bioethics
\nProfessor of Bioethics
\nAssociate Dean for Bioethics
\nIndiana University School of Medicine
\nIndianapolis, USA 46202
\nE-mail: emeslin@iu.edu
\n188
\nDeclaration of Helsinki
\nSince the first version of the Declara-
\ntion of Helsinki (DoH) was adopted in
\n1964, it has been revised nine times and
\nnumerous other bodies have promulgated
\nethics guidance documents. During this
\nsame period, scientific research with hu-
\nman subjects has dramatically increased in
\nsize, scope, and importance. If the DoH
\nis to continue to play a significant role in
\nregulating the research enterprise, it must
\nconvincingly convey a coherent, if highly
\ngeneral, view of the research enterprise
\nand the basic normative requirements nec-
\nessary to preserve its integrity and protect
\nthe rights and welfare of participants. In
\nwhat follows, I argue that the emphasis in
\nthe DoH on detailed prescriptive require-
\nments untethered from general justifica-
\ntory grounds means that it is particularly
\ndependent on readers to supply underlying
\nnormative justifications. Without these
\nnormative grounds, its provisions might
\nappear inconsistent, unfounded, or arbi-
\ntrary.
\nTo make this argument, I provide a read-
\ning of several revised passages in the 2013
\nDoH. This reading draws on a normative
\nframework that emphasizes a particular
\nview of the proper division of labor be-
\ntween research and medical and public
\nhealth systems and the threat that biased
\nor poor quality research poses to those
\nsystems. It also treats various provisions
\nof the DoH as helping to provide a pub-
\nlic assurance to stakeholders that the re-
\nsearch enterprise functions as a system of
\nmutually beneficial social cooperation in
\nwhich all parties are respected as free and
\nequal contributors [1]. Although these
\ncommitments are not expressed within
\nthe DoH itself, this reading illustrates
\nstrengths and weakness of the new docu-
\nment and highlights areas for improve-
\nment.
\nIntegrity of Scientific
\nInformation
\nThe 2013 version of the DoH contains
\nseveral changes that significantly expand
\nthe scope of requirements relating to the
\nregistration of research and the disclosure
\nof findings. For example, the requirement
\nfor trial registration has been expanded
\nfrom \u201cevery clinical trial\u201d in the 2008 ver-
\nsion to \u201cevery research study involving hu-
\nman subjects\u201d (par. 35). With this expanded
\nscope, this requirement now covers a wider
\nrange of research activities. For example,
\nthe 2008 wording would not cover sub-
\nstudies carried out within larger trials, such
\nas biomarker studies, because these are not
\nseparate clinical trials. Such sub-studies are
\ncovered under the new language because
\nthey are research studies involving human
\nsubjects.
\nThis expanded requirement also highlights
\na tension with the DoH. On the one hand,
\nit claims to explicitly address only physi-
\ncians. But to the extent that its require-
\nments apply to every study involving hu-
\nman subjects, they would apply to research
\ncovered by non-physicians as well. Limiting
\nthe scope of the provisions to only research
\nwith human subjects that is conducted by
\nphysicians seems arbitrary, at best. More-
\nover, the requirement that research results
\nbe published has been expanded to include
\n\u201cpublication and dissemination\u201d and this
\nobligation is now ascribed to sponsors as
\nwell as researchers, authors and editors (par.
\n36).The language of this paragraph has also
\nbeen strengthened from \u201cshould\u201d to \u201cmust\u201d
\nin several places, including the obligation to
\npublish negative and inconclusive findings
\nand to report conflicts of interest.
\nThese concrete prescriptions assign poten-
\ntially costly duties to a range of stakeholders
\nand their requirements are not limited by
\ndisciplinary orientation or by the degree of
\nrisk posed to study participants. It is some-
\nwhat surprising, therefore, that the DoH
\ndoes not contain an explicit statement of
\ntheir normative grounding or justification.
\nIn particular, there have been a number of
\nproposals recently to titrate the level of re-
\nsearch oversight to risk as a way of reign-
\ning in what is criticized as costly regulatory
\noverreach [2, 3]. The only explicit discus-
\nsion of the \u201cimportance\u201d of a \u201cresearch ob-
\njective\u201d in the DoH is to state that it must
\noutweigh the risks and burdens imposed on
\nparticipants (par. 16, 2013). If a study poses
\nlittle to no risk to participants, there is no
\nindependent ground stated in the DoH to
\njustify requiring uniformly high oversight
\nfor it and risker or more burdensome stud-
\nies.
\nThe DoH would benefit, therefore, from
\nan explicit statement that these require-
\nments are justified because registration of
\nstudies and comprehensive reporting of all
\nstudy data, including negative and incon-
\nclusive results, are necessary to ensure the
\nJustification, Coherence and Consistency
\nof Provisions in the Revised Declaration
\nof Helsinki
\nAlex John London
\n189
\nDeclaration of Helsinki
\nreliability, relevance, and validity of scien-
\ntific information. As the DoH states, the
\nprimary purpose of research involving hu-
\nman subjects is \u201cto understand the causes,
\ndevelopment and effects of diseases and
\nimprove preventive, diagnostic and thera-
\npeutic interventions (methods, procedures
\nand treatments)\u201d (par.\u00a0 6). Reliable, rel-
\nevant, and valid data are essential to the
\nability of the research enterprise to fulfill
\nthis purpose.
\nIn modern health systems and health pol-
\nicy, many forms of research with human
\nsubjects contribute data on which clini-
\ncians, patients, researchers, institutions,
\npolicy makers, and others rely in making
\ndecisions that affect the health and wel-
\nfare of individuals and groups and the al-
\nlocation of scarce resources [4]. Because
\nresearch data are the bedrock of evidence-
\nbased health systems and social policy, the
\nquality and reliability of that information
\naffects the health, welfare, and rights of the
\nindividuals who rely on those health sys-
\ntems to address their health needs. Even
\nresearch that imposes little or no risk to
\nstudy participants can generate data that is
\nbiased or of poor quality. Concerns about
\nthe quality of low risk studies have sur-
\nfaced frequently in the context of postmar-
\nketing research, where decreased oversight
\nremoves incentives and safeguards against
\nusing biased evidence to advance market-
\ning objectives, sometimes at the expense of
\npatient health [5,6]. Similar concerns have
\nemerged recently in biomarker studies as
\nwell [7,8].
\nStrengthening registration, publication
\nand reporting requirements is justified by
\ntheir contribution to ensuring the quality
\nand reliability of research data. Ascribing
\nobligations for registration, reporting, and
\ndissemination of study findings to a broad
\nrange of stakeholders is also warranted
\nbecause responsibility for ensuring the in-
\ntegrity of the research enterprise must be
\nshared by all of the parities that assert some
\ncontrol over critical aspects of that process.
\nThe WMA may be uncomfortable stating
\nmoral requirements for stakeholders beyond
\nphysicians, but omitting the obligations of
\nothers would either cripple the document\u2019s
\nability to provide comprehensive ethical
\nguidance across the lifecycle of research or
\nit would lead to unfairly attributing to phy-
\nsicians responsibilities that vest in and must
\nbe discharged by other parties.
\nResponsiveness and Benefits
\nIn several places, the 2008 DoH states that
\npopulations in which research is carried out
\nshould stand to benefit from the results of
\nresearch. Paragraph 17 of the 2008 ver-
\nsion reads, \u201cMedical research involving a
\ndisadvantaged or vulnerable population or
\ncommunity is only justified if the research
\nis responsive to the health needs and pri-
\norities of this population or community and
\nif there is a reasonable likelihood that this
\npopulation or community stands to benefit
\nfrom the results of the research.\u201d Paragraph
\n33 of the 2008 version uses even broader
\nlanguage, \u201cAt the conclusion of the study,
\npatients entered into the study are entitled
\nto be informed about the outcome of the
\nstudy and to share any benefits that result
\nfrom it, for example, access to interventions
\nidentified as beneficial in the study or to
\nother appropriate care or benefits.\u201d
\nAlthough the most direct result of research
\nis new information and knowledge, re-
\nsearch can also produce new interventions,
\nimproved infrastructure, and potentially
\nlucrative financial rewards. If the core re-
\nquirement for research in disadvantaged
\npopulations is that those populations ben-
\nefit from participation, and if there are
\nmyriad benefits that can flow from research,
\nthen critics might wonder why research
\nshould be required to meet the responsive-
\nness requirement at all [9].
\nThe current revision of the DoH retains
\nresponsiveness as a requirement and elimi-
\nnates this ambiguity:
\nMedical research with a vulnerable group is
\nonly justified if the research is responsive to the
\nhealth needs or priorities of this group and the
\nresearch cannot be carried out in a non-vul-
\nnerable group. In addition, this group should
\nstand to benefit from the knowledge, practices
\nor interventions that result from the research
\n(par 20).
\nAlthough the responsiveness requirement
\nwill undoubtedly be subject to further criti-
\ncism for vagueness, this language makes it
\nclear that the primary consideration in eval-
\nuating research in vulnerable groups should
\nbe the relationship of the questions being
\ninvestigated, and the knowledge that is ex-
\npected to be generated, to the health needs
\nor health priorities of that group.
\nThe current version of the DoH does not
\ncontain a justification for this requirement,
\nand some changes to the text obscure one
\npotential justificatory ground. That is, in
\nthe 2008 version, the statement \u201cMedical
\nprogress is based on research that ultimate-
\nly must include studies involving human
\nsubjects\u201d is followed immediately by the
\nclaim that \u201cPopulations that are underrep-
\nresented in medical research should be pro-
\nvided appropriate access to participation
\nin research,\u201d (par 5, 2008). Although both
\nclaims are retained in the 2013 revision,
\nthe second now appears as an independent
\nstatement (par. 13), eight paragraphs after
\nthe former claim (par. 5). Separating these
\nclaims severs the natural justificatory link
\nthat was at least implied in the previous
\nversion.
\nThe link that is more clearly implied in the
\n2008 version is that inclusion in research
\nis necessary for vulnerable groups to share
\nin medical progress. Excluding vulner-
\nable groups from research stifles what is,
\nif not the only, then the most efficient, av-
\nenue through which their distinctive health
\nneeds can be understood and addressed. If
\nthe fundamental purpose of research with
\nhuman subjects is to produce the evidence
\nnecessary to improve standards of care and
\n190
\nDeclaration of Helsinki
\nprevention, then exclusion from research
\ncreates or perpetuates evidence gaps. This
\nmeans that health systems have fewer effec-
\ntive interventions for the distinctive health
\nneeds of excluded groups and that patients
\nfrom these groups are exposed to elevated
\nrisk when they access those health systems
\n[10].
\nAlthough the DoH is not explicit about the
\nrelationship between the requirements that
\nhave been discussed so far, there is a read-
\ning on which they can be seen as playing
\na crucial role in the social justification of
\nresearch. On this view, the purpose of re-
\nsearch is to produce a unique social good,
\nnamely, the information necessary to en-
\nable health systems to better understand
\nand address the health needs of the people
\nthey serve [1, 4, 6]. This good is unique,
\nbecause unlike other benefits that stake-
\nholders seek from research participation,
\nit often cannot be produced in any other
\nway. Promoting access to research among
\nunderrepresented groups is thus necessary
\nto promote equity in the capacity of health
\nsystems to meet the needs of the diverse
\ncommunities that they serve. The respon-
\nsiveness requirement, and the requirements
\nrelating to registration and publication are
\nnecessary to ensure that when individuals
\nand groups participate in research, they
\nhave public assurance that they are help-
\ning to generate information that is likely to
\nstrengthen and improve the health systems
\non which they depend.
\nThis kind of social justification is impor-
\ntant because it legitimates social and indi-
\nvidual support for the research enterprise
\nas a collaborative undertaking [1]. In par-
\nticular, medical and public health research
\nrequire the support of diverse stakeholders,
\nfrom researchers and institutions of scien-
\ntific advancement, to public and private
\nsponsors, participants, policy makers, and
\nthe community in whose name research
\nis often conducted and whose interests
\nit is supposed to advance. Many of these
\nparties may contribute to the research en-
\ndeavor for a variety of reasons. Some may
\nseek profit, career advancement, access to
\nmedical care, prestige, or some mixture of
\nthese and other motives. These parochial
\nmotives alone cannot justify social sup-
\nport for the research enterprise, since not
\nall parties seek the same parochial goals,
\nthere are often other means of advancing
\nthese ends, and because pursuit of these
\ngoals can sometimes come at the expense
\nof other parties.
\nIn contrast, research is often the only way
\nto produce the evidence base necessary
\nfor health systems to effectively and ef-
\nficiently meet the diverse health needs of
\nthe individuals that they serve. Because
\ncommunity members must rely on medical
\nand public health services to address their
\nbasic health needs, ensuring equity in their
\ncapacity to fulfill this mission can be seen
\nas a legitimate focus for social support and
\nthe use of social resources. When there is
\ncredible public assurance that the research
\nsystem is designed to advance this goal,
\nall of the necessary stakeholders can par-
\nticipate with the warranted belief that even
\nif they each contribute in order to pursue
\nsome parochial interest, the system will not
\nbe coopted so as to siphon social support
\nand social resources simply to advance the
\nparochial interests of some at the expense
\nof the others.
\nI am suggesting that it is useful to view the
\nprovisions discussed so far as helping to
\nprovide a public assurance to stakeholders
\nthat the research enterprise functions as a
\nsystem of mutually beneficial social coop-
\neration in which all parties are respected
\nas free and equal contributors [1]. Because
\nstudy participants are the most at risk of
\nhaving their status as free and equal per-
\nsons compromised in research participation,
\nthey require special assurance that their
\nrights and welfare will be respected. Ethi-
\ncal principles that are traditionally viewed
\nas forming the moral core of research ethics
\n(such as informed consent, the minimiza-
\ntion and justification of risk, and protec-
\ntions for confidentiality) can then be seen
\nas special requirements necessary to ensure
\nproper respect for study participants as free
\nand equal.
\nThe 2013 DoH contains a new provision
\nthat can be read as trying to ensure that
\nparticipant interests are not compromised
\nthrough research participation.It holds that,
\n\u201cAppropriate compensation and treatment
\nfor subjects who are harmed as a result of
\nparticipating in research must be ensured\u201d
\n(par. 15). If the legitimate social purpose of
\nresearch is to generate a public good \u2013 the
\nevidence base for effective and equitable
\nhealth systems \u2013 then compensation for
\nstudy-induced harms can be grounded in
\nreciprocity. The DoH does not specify who
\nbears this obligation and it would seem un-
\nreasonable to saddle researchers alone with
\nit since other stakeholders who contribute
\nto and benefit from the enterprise are better
\nsituated to effectuate it.
\nSimilarly, the new paragraph 34 holds that,
\n\u201cIn advance of a clinical trial, sponsors, re-
\nsearchers and host country governments
\nshould make provisions for post-trial access
\nfor all participants who still need an inter-
\nvention identified as beneficial in the trial.
\nThis information must also be disclosed to
\nparticipants during the informed consent
\nprocess.\u201d This duty is ascribed to multiple
\nstakeholders and the more general language
\nof benefit sharing from the 2008 version
\nhas been replaced with specific emphasis on
\nparticipants who need access to study inter-
\nventions.
\nOn the reading I have been proposing,
\nthis provision fits into a larger view of the
\nproper division of labor between research
\nand medical and public health systems. The
\nsocial function of research is to generate the
\nevidence necessary to improve the standard
\nof care and prevention and it falls to medi-
\ncal and public health systems to provide ac-
\ncess to this improved care on a large-scale
\nbasis. When research is contemplated in
\nplaces where this division of labor may not
\n191
\nDeclaration of Helsinki
\ntake place, requiring strong assurance that
\nresearch is relevant to health needs or pri-
\norities of the less-advantaged increases the
\nlikelihood that information and interven-
\ntions will later be integrated into the health
\nsystems that serve those populations. How-
\never, the time horizon for the process of
\nintegrating new findings or interventions
\ninto health systems can be protracted. The
\nrequirement in paragraph 34 ensures that
\nthere is some meaningful continuity in the
\ncare that is provided to participants whose
\nhealth depends on access to study interven-
\ntions until the responsibility for providing
\naccess to an improved standard of care can
\nbe effectively discharged within the regular
\nhealth system.
\nCritics may counter that even if these con-
\nditions are met, there is no guarantee that
\nhost communities will receive a fair level
\nof benefit from hosting research. After all,
\nmost studies do not vindicate successful
\ninterventions. Three brief points about this
\nobjection are worth considering. First, it
\nis not at all clear what a fair level of ben-
\nefit is for hosting a research study and the
\nmost prominent accounts of this matter
\nare underdeveloped, at best, and internally
\ninconsistent at worst [11]. Second, rigor-
\nously designed and well-executed trials that
\nproduce negative findings do contribute
\nto the evidence base necessary to improve
\nthe standard of care \u2013 if they are published.
\nGranted, this is not an immediate benefit
\nto communities. But compliance with the
\nrequirements discussed above increases
\nthe prospect that host communities will
\nhave access to the long-term benefits that
\ncome from increased understanding and the
\neventual development of interventions that
\ncan bridge health gaps.
\nThird, there is a genuine concern that stud-
\nies might be carried out in ways that divert
\nlocal resources from other health priorities,
\nconsume scarce resources, or otherwise bur-
\nden members of communities that already
\nsuffer from problems rooted in poverty and
\ndeprivation. These are legitimate concerns
\nand it would strengthen the DoH if it con-
\ntained a statement to the effect that research
\nconducted in resource scarce environments
\nmust mitigate the prospect of these delete-
\nrious effects and should make positive con-
\ntributions to strengthen the capacity of local
\nhealth systems.
\nReasonable Risk
\nIn the previous section I suggested that
\nstandard research ethics requirements re-
\ngarding informed consent and the reason-
\nableness of risk can be seen as helping to
\nprovide public assurance to potential par-
\nticipants that their moral status and their
\ninterests will be respected in the course of
\nresearch participation. The 2013 revision of
\nthe DoH includes a new provision in para-
\ngraph 17 that adds to this assurance,namely,
\nthat \u201cMeasures to minimise the risks must
\nbe implemented.The risks must be continu-
\nously monitored, assessed and documented
\nby the researcher.\u201d However, other revisions
\nare somewhat puzzling.
\nThe 2013 DoH retains language from the
\n2008 version to the effect that physicians
\nmust not be involved in research unless
\nthey are confident that the risks have been
\n\u201cadequately assessed and can be properly
\nmanaged.\u201d The 2008 version then states
\nthat, \u201cPhysicians must immediately stop
\na study when the risks are found to out-
\nweigh the potential benefits or when there
\nis conclusive proof of positive and benefi-
\ncial results\u201d (par. 20, 2008). The claim that
\nstudies must be stopped when findings
\nof benefit or lack thereof are conclusive
\nseems to follow directly from the scien-
\ntific purpose of research and from concern
\nfor the welfare of study participants. Once
\nthere is conclusive proof that risks of an
\nintervention outweigh its benefits, or its
\nbeneficial effects have been confirmed,
\nthe study question has been answered and
\nthere is no longer a social purpose that
\njustifies exposing participants to study-
\nrelated risks.
\nThe language form the 2008 version may
\nstrike readers as too simplistic since, for
\nexample, it may be difficult in practice to
\nknow when the results of a single study
\nrepresent \u201cconclusive proof.\u201d The new ver-
\nsion retains this language, however, and
\nreads, \u201cWhen the risks are found to out-
\nweigh the potential benefits or when there
\nis conclusive proof of definitive outcomes,
\nphysicians must assess whether to contin-
\nue, modify or immediately stop the study\u201d
\n(par. 18, 2013). If the risks of participation
\nare found to outweigh potential benefits
\nor there is conclusive proof of definitive
\noutcomes, on what basis would a trial be
\ncontinued? Where the 2008 version states
\na condition for stopping studies based on
\nconfirmation of risks and benefits, the pro-
\nposed revision opens the possibility that
\nstudies could continue after these issues
\nhave been conclusively established with-
\nout providing substantive guidance about
\nhow clinicians should make such decisions.
\nMoreover, continuing a study once \u201crisks
\nare fond to outweigh the potential ben-
\nefits\u201dseems to undermine any public assur-
\nance to participants that their interests will
\nnot be knowingly compromised through
\nstudy participation.
\nTo avoid inconsistency, either the old lan-
\nguage should have been retained or the new
\nlanguage should have been be clarified. For
\nexample, it might be revised to say that as
\nevidence mounts to indicate that poten-
\ntial benefits do not outweigh risks or that
\nconfirms beneficial results, physicians must
\nassess whether to continue, modify or im-
\nmediately stop the study.
\nConclusion
\nI have tried to provide a reading of the
\n2013 DoH that integrates some of its key
\nprovisions within a coherent, general view
\nof the research enterprise and the central
\nethical challenges that it has to address.
\nAlthough this analysis draws heavily on
\nnormative foundations not explicitly stated
\n192
\nDeclaration of Helsinki
\nin the DoH, it is clear that those concerns
\nare not alien to the document. This analysis
\nhighlights ways in which many proposed
\nchanges increase the coherence and com-
\nprehensives of the document while indicat-
\ning particular areas where difficulties and
\ninconsistencies remain. Because the DoH is
\nnot explicit about these foundational issues,
\nhowever,it is vulnerable to appearing incon-
\nsistent, unfounded, or arbitrary to readers
\nwho approach it with different interpretive
\nstarting points.
\nReferences
\n1. London AJ. 2012. A Non-Paternalistic Model
\nof Research Ethics and Oversight: Assessing the
\nBenefits of Prospective Review. Journal of Law,
\nMedicine, and Ethics 40(4):930-944.
\n2. U.S. Department of Health and Human Ser-
\nvices, Fed. Regist. 76, 44512 (2011).
\n3. Federman DD, Hanna KE, Rodriguez LL, eds,
\nResponsible Research: A Systems Approach to Pro-
\ntecting Research Participants. (National Academ-
\nics Press, Washington, DC, 2002).
\n4. A. J. London, J. Kimmelman, M. E. Emborg,
\nResearch ethics. Beyond access vs. protection
\nin trials of innovative therapies. Science 328, 829
\n(May 14, 2010).
\n5. J. Hasford, T. Lamprecht, . Company observa-
\ntional post-marketing studies: drug risk assess-
\nment and drug research in special populations-
\n-a study-based analysis. Eur J Clin Pharmacol
\n53, 369 (Jan, 1998).
\n6. London AJ, Kimmelman J, Carlisle B. 2012.
\nRethinking Research Ethics: The Case of Post-
\nmarketing Trials. Science 336 (May 4):544-545.
\n7. Tzoulaki I, Siontis KC, Evangelou E, Ioannidis
\nJA. Bias in Associations of Emerging Biomark-
\ners With Cardiovascular Disease. JAMA Intern
\nMed. 2013;173(8):664-671. doi:10.1001\/ja-
\nmainternmed.2013.3018.
\n8. Nissen SE. Biomarkers in Cardiovascular Medi-
\ncine: The Shame of Publication Bias Comment
\non \u201cBias in Associations of Emerging Biomark-
\ners With Cardiovascular Disease\u201d. JAMA In-
\ntern Med. 2013;173(8):671-672. doi:10.1001\/
\njamainternmed.2013.4074.
\n9. Rebecca Wolitz, Ezekiel Emanuel, Seema Shah.
\n2009. Rethinking the responsiveness require-
\nment for international research. Lancet 374:
\n847\u201349
\n10. Jeffrey P. Kahn, Anna C. Mastroianni, and Jer-
\nemy Sugarman eds. Beyond Consent: Seeking
\nJustice in Research New York: Oxford Univer-
\nsity Press, 1998.
\n11. London AJ, Zollman KJS. 2010. Research at
\nthe Auction Block: Some Problems for the Fair
\nBenefits Approach to International Research.
\nThe Hastings Center Report 40(4):34-45.
\nInterest Disclosure: I was an invited speaker at
\nthree WMA consultations regarding proposed
\nrevisions to the Declaration of Helsinki.
\nAcknowledgement: I thank Jonathan Kimmel-
\nman and Danielle Wenner for their feedback on
\na draft of this manuscript.
\nAlex John London, PhD
\nProfessor of Philosophy and Director,
\nCenter for Ethics and Policy,
\nCarnegie Mellon University.
\n5000 Forbes Avenue
\nPittsburgh,
\nE-mail: ajlondon@andrew.cmu.edu
\nSince the 2000s, international ethical guide-
\nlines for human subjects research increas-
\ningly emphasize that exclusion from research
\nparticipation must be justified. Despite
\nincreased use of inclusive selection require-
\nments for the choice of study populations, it
\nhas so far not been evaluated what the moral
\nstrength of these requirements is and who
\nshould ensure that study populations are in-
\nclusively selected.
\nMethods
\nWe analysed inclusive selection require-
\nments or statements on justifying the exclu-
\nsion of study populations in ethical guide-
\nlines on human subjects research.
\nResults
\nWe found that most ethical guidelines fo-
\ncus on inclusive selection requirements
\nFrom Justifying Inclusion to Justifying Exclusion of Study
\nPopulations: Strengths and Limitations
\nRieke van der Graaf Rolf HH Groenwold Shona Kalkman Diederick E Grobbee Johannes JM van Delden
\n193
\nDeclaration of Helsinki
\nfor reasons of justice, in particular correc-
\ntive justice for underrepresented groups in
\nresearch. A few guidelines mention scien-
\ntific reasons. We found that scientific rea-
\nsons may outweigh the concern for justice
\nas fair inclusion in some cases. In order to
\nyield generalizable health knowledge it may
\nsometimes be necessary to set up different
\ntrials, or to deliberately exclude subgroups.
\nMoreover, if it is unknown whether inter-
\nvention effects differ between subgroups,
\nthe inclusion of these subgroups should be
\nsubstantial and proportional. We also found
\nthat most guidelines leave out who should
\nbe responsible.
\nConclusions
\nSome ethical guidelines seem to have gone
\nfrom the one extreme into the other: from
\njustifying inclusion to justifying exclusion.
\nHowever, a sole focus on corrective justice
\ndoes not necessarily render the choice of
\nstudy populations more ethically acceptable.
\nFurthermore, guidelines should consider
\nwhose responsibility it is and determine
\nreasonable actions for those responsible to
\nensure inclusive selection.
\nSince the 2000s, international ethical
\nguidelines for human subjects research in-
\ncreasingly emphasize that exclusion from
\nresearch participation must be justified.
\nFor instance, the International Guide-
\nlines for Biomedical Research Involv-
\ning Human Subjects of the Council for
\nInternational Organizations for Medical
\nSciences (CIOMS) state that \u201cthe exclu-
\nsion of groups or communities that might
\nbenefit from study participation must be
\njustified\u201d [1]. Likewise, the Canadian Tri
\nCouncil Policy Statement (TCPS) states that
\n\u201cresearchers should be inclusive in select-
\ning participants\u201d and have a duty \u201cnot to
\nexclude individuals or groups from par-
\nticipation for reasons that are unrelated to
\nthe research\u201d [2]. The World Medical As-
\nsociation (WMA) has a similar paragraph
\nin its Declaration of Helsinki. Although
\nthe WMA has never strongly required of
\nresearchers to justify exclusion of popula-
\ntions that might benefit, nor to be inclusive
\nin their selection of study populations, it
\nhas acknowledged that \u201cpopulations that
\nare underrepresented in research should be
\nprovided appropriate access to participa-
\ntion in research\u201d in the 2008 version of the
\nDeclaration [3].
\nIncorporation of requirements on inclu-
\nsive selection of study participants in ethi-
\ncal guidance documents may be explained
\nfrom an altered way of thinking about fair
\ninclusion of research participants during
\nthe 80s and 90s. Until then, ethical guide-
\nlines on human subjects research focused
\non justifying the use and inclusion of hu-
\nman beings solely for research purposes.
\nFor instance the Belmont Report empha-
\nsizes that populations cannot be chosen
\nfor study purposes only because they are
\nreadily available\u00a0[4]. But in the past three
\ndecades research participation became to
\nbe considered as a good that is not only
\nburdensome but also potentially beneficial
\nand hence should be distributed equally
\n[5]. Therefore, current thinking on fair in-
\nclusion not only implies that inclusion of
\nstudy populations has to be justified but
\nalso their exclusion.
\nAlthough there may be an historical expla-
\nnation for incorporation of the idea of in-
\nclusive selection in ethical guidelines, sever-
\nal issues are unclear. First, what is the moral
\nstrength of this requirement and what are
\nits limitations? Second, who is responsible
\nfor fulfilling this requirement? These ques-
\ntions will be studied in this paper.Therefore,
\nwe will analyze paragraphs on inclusive se-
\nlection in main international ethical guide-
\nlines on human subjects research and study
\nthe rationales that underlie the inclusive se-
\nlection claims. Accordingly, we will evaluate
\nthese rationales. We will also study which
\nactors are mentioned in the guidelines. Fur-
\nthermore,we will provide recommendations
\nfor future use of inclusive selection require-
\nments in international requirements.
\nJustice
\nIn the last decades, main ethical guidance
\ndocuments have grounded the idea of jus-
\ntification of exclusion of subgroups in both
\nformal and material notions of justice (see
\ntable).
\nAccording to formal justice, people are in
\nprinciple to be regarded as equal and hence
\nhave to be treated equally. For instance, the
\nCanadian TCPS claims that \u201cresearchers
\nshall not exclude individuals from the op-
\nportunity to participate in research on the
\nbasis of attributes such as culture, language,
\nreligion, race, disability, sexual orientation,
\nethnicity, linguistic proficiency, gender or
\nage\u201d [2].
\nInclusive selection requirements in ethical
\nguidance documents are also incorporated
\nin guidance documents on of corrective jus-
\ntice. In the introduction we mentioned that
\nthe WMA emphasizes appropriate access
\nfor underrepresented groups [3]. Likewise,
\nthe CIOMS guidelines set out that: \u201cas a
\nconsequence of exclusions [in the past], in-
\nformation about diagnosis, prevention and
\ntreatment of diseases in [these] groups of
\npersons is limited. This has resulted in a se-
\nrious class injustice\u201d[1].Thus, in these para-
\ngraphs justifying exclusion is a means to re-
\nstore differences between trial populations.
\nScientific reasons
\nScientific reasons for selective inclusion
\nor exclusion follow from the need, or lack
\nthereof,to study effect modification by pop-
\nulation characteristics of the benefits or risks
\nof interventions [6]. For instance, the NIH
\nguideline on The Inclusion of Women and Mi-
\nnorities as Subjects in Clinical Research is a
\nproponent of inclusive selection of women
\nand minorities for certain types of studies
\nto be able to perform valid analyses [7].This
\nrationale for inclusive selection is unique
\nand not present in the other guidelines.Fur-
\nthermore, few guidelines that present more
\n194
\nDeclaration of Helsinki
\nTable. Ethical guidance documents on inclusive selection of study populations
\nContent Rationale: Justice
\nCIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), guideline 12
\n\u201cGroups or communities to be invited to be
\nsubjects of research should be selected in
\nsuch a way that the burdens and benefits of
\nthe research will be equitably distributed.
\nThe exclusion of groups or communities that
\nmight benefit from study participation must
\nbe justified.\u201d
\n\u201cEquity requires that no group or class of persons should bear more than its fair share of the
\nburdens of participation in research. Similarly, no group should be deprived of its fair share of
\nthe benefits of research, short-term or long-term.\u201d
\n\u201cSubjects should be drawn from the qualifying population in the general geographic area of
\nthe trial without regard to race, ethnicity, economic status or gender unless there is sound
\nscientific reason to do otherwise.\u201d
\n\u201cIn the past, groups of persons were excluded form participation in research for what were then
\nconsidered good reasons. As a consequence of such exclusions, information about the diagnosis,
\nprevention and treatment of diseases in such groups is limited.This has resulted in a serious
\nclass injustice.\u201d
\nWMA, Declaration of Helsinki (2008), paragraph 5
\n\u201cPopulations that are underrepresented
\nin medical research should be provided
\nappropriate access to participation in
\nresearch.\u201d
\n\u201cAppropriate access\u201d
\nCanadian Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (2010), chapter 4
\n\u201cTaking into account the scope and
\nobjectives of their research, researchers
\nshould be inclusive in selecting participants.
\nResearchers shall not exclude individuals
\nfrom the opportunity to participate in
\nresearch on the basis of attributes such as
\nculture, language, religion, race, disability,
\nsexual orientation, ethnicity, linguistic
\nproficiency, gender or age, unless there is a
\nvalid reason for the exclusion.\u201d
\n\u201cAppropriate inclusion\u201d is \u201cbased on the principle of justice\u201d, meaning that \u201cresearchers shall
\nnot exclude individuals from the opportunity to participate in research on the basis of attributes
\nsuch as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic
\nproficiency, gender or age, unless there is a valid reason for exclusion\u201d.
\n\u201cNot to exclude individuals or groups from participation for reasons that are unrelated to the
\nresearch\u201d (..) \u201cis explicitly stated because groups have been inappropriately excluded from
\nparticipation in research on the basis of attributes such as gender, race, ethnicity, age and
\ndisability\u201d.
\n\u201c[Inappropriate] exclusion of women [in the past], where unwarranted, has delayed the
\nadvancement of knowledge, denied potential benefits to women, and exposed women to
\nharm when research findings from male-only research projects were generalized inappropriately
\nto women\u201d.
\n\u201cAs is the case with women, the inclusion of children in research advances commitment to
\njustice in research by improving our knowledge of, and ability to respond to, the unique needs
\nof children throughout their development.\u201d
\nUNAIDS Ethical Considerations in Biomedical HIV Prevention Trials (2007), guidance point 7, 9 and 10
\n\u201cIndividuals should not be excluded from the
\nopportunity to participate without a good
\nscientific reason or a susceptibility to risk
\nthat justifies their exclusion.\u201d
\n\u201cIn order to conduct biomedical HIV prevention trials in an ethically acceptable manner, (\u2026)
\nthe selection of participating communities and individuals must be fair and justified in terms of
\nthe scientific goals of the research. \u201c
\n\u201cWomen, including pregnant women, potentially pregnant women and breast-feeding women,
\nshould be eligible for enrolment in HIV preventive vaccine trials, both as a matter of equity
\nand because in many communities throughout the world women are at high risk of HIV
\nprevention.\u201d
\n\u201cChildren, including infants and adolescents, should be eligible for enrolment in HIV
\npreventive vaccine trials, both as a matter of equity and because in many communities
\nthroughout the world children are at high risk of HIV infection.\u201d
\n195
\nDeclaration of Helsinki
\njustice-oriented reasons for having to justify
\nexclusion of study populations acknowledge
\nscientific limitations for excluding certain
\npopulations. The UNAIDS\/WHO guide-
\nline on Ethical Considerations in Biomedical
\nHIV Prevention Trials emphasizes that in-
\nclusion of study populations must not only
\nbe fair but also \u201cjustified in terms of the sci-
\nentific goals of the research\u201d [8]. The NIH
\nguideline also point at scientific limitations
\nof inclusive selection.
\nIt distinguishes three situations in the selec-
\ntion of study populations: 1) prior studies
\nsupport the existence of significant differ-
\nences in intervention effect between groups
\nof subjects; 2) prior studies support no sig-
\nnificant differences in intervention effect;
\nand 3) prior studies neither support nor
\nnegate significant differences in interven-
\ntion effect. Regarding the first situation the
\nguideline states that \u201c\u2026 if men and women
\nare thought to respond differently to an in-
\ntervention, then the Phase III clinical trial
\nmust be designed to answer two separate
\nprimary questions, one for men and the
\nother for women\u2026 \u201d. The opposite situa-
\ntion (situation 2) occurs when there is no
\nevidence for a differential intervention ef-
\nfect: \u201cIf the data from prior studies strongly
\nsupport no significant differences in inter-
\nvention effect based on sex, then gender
\nwill not be required as subject selection
\ncriteria. However, the inclusion and analysis
\nof gender subgroups is still strongly encour-
\naged.\u201d The third situation is most common
\nin practice. \u201cIf the data from prior studies
\nneither strongly support nor strongly negate
\nthe existence of significant differences in in-
\ntervention effect based on gender subpopu-
\nlation comparisons, then the NIH-defined
\nPhase III clinical trial will be required to
\ninclude sufficient and appropriate entry
\nof gender participants, so that valid analy-
\nsis of the intervention effects can be per-
\nformed\u201d\u00a0[7].
\nActors
\nMost guidelines are silent on the responsi-
\nble person for inclusive selection.The Cana-
\ndian TCPS [2] bestows researchers with this
\nobligation, and the NIH has determined
\nthat its Director shall ensure inclusive se-
\nlection [7].
\nDiscussion
\nIn this paper we studied two issues: 1. the
\nmoral strength of the inclusive selection
\nrequirement and 2. who should be respon-
\nsible for inclusive selection. As regards the
\nfirst issue, we have seen that inclusive selec-
\ntion requirements have their basis in prin-
\nciples of justice which determine the moral
\nstrength of these claims. Justice as equity
\nand as corrective justice is put forward with
\nregard to the selection of study populations.
\nThe function of equity is to assure that peo-
\nple are not excluded for arbitrary reasons
\nwhen they meet the inclusion criteria. Cor-
\nrective justice has a different function. It as-
\nsures that groups that have been underrep-
\nresented in research are not systematically
\nexcluded as a class.
\nIncreased attention for inclusion of under-
\nrepresented groups is to a certain extent
\nessential since it may render interventions
\nfor these groups more evidence-based. For
\ninstance, pharmacokinetics and pharmaco-
\ndynamics of drugs during pregnancy have
\nbeen poorly studied, which may adversely
\nimpact the health of both pregnant women
\nand their fetuses [9].
\nHowever, fair inclusion of underrepresent-
\ned study groups should not be considered
\nas being as inclusive as possible, as some
\nguidelines seem to suggest. There are scien-
\ntific limitations to justice-based reasons for
\njustifying exclusion. We have seen that the
\nNIH does not always promote the inclusion
\nof women and minorities and sets out that
\nfrom a scientific perspective three situations
\nshould be distinguished.
\nIn the following, we will discuss these three
\nsituations indicated by the NIH guideline.
\nWe focus on inclusion and exclusion of men
\nand women, though these gender groups
\ncould be substituted for other subgroups
\n(mutatis mutandis).
\nSituation 1
\nFrom a scientific perspective, the NIH
\nguideline seems obvious. The overall ob-
\nserved intervention effect in a population of
\nContent Rationale: Justice
\nNIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (2001)
\n\u201cIt is the policy of NIH that women and
\nmembers of minority groups and their
\nsubpopulations must be included in all
\nNIH-funded clinical research, unless a clear
\nand compelling rationale and justification
\nestablishes (\u2026) that inclusion is inappropriate
\nwith respect to the health of the subjects or
\nthe purpose of the research.\u201d
\n\u201cSince a primary aim of research is to provide scientific evidence leading to a change in health
\npolicy or standard of care, it is imperative to determine whether the intervention or therapy
\nbeing studied affects women or men or members of minority groups and their subpopulations
\ndifferently.\u201d
\n196
\nDeclaration of Helsinki
\nmen and women is a (weighted) average of
\nthe effect among men and the effect among
\nwomen. If the intervention effect differs
\nbetween men and women, the overall effect
\nneither applies to men,nor to women; it will
\nonly apply to a population with a similar dis-
\ntribution of men and women as in the trial.
\nRandomized trials are typically designed to
\nprovide evidence on the overall effective-
\nness of treatment in the trial population.
\nTo identify differential intervention effects
\nrequires much more study participants.10
\nHence, in case of strong prior evidence of a
\ndifferential intervention effect conducting a
\ntrial in a population that is a mixture of sub-
\ngroups is unreasonable, because it provides
\nan estimate of the intervention effect that is
\nlittle informative and the study is probably
\ntoo small to demonstrate differential inter-
\nvention effects. From an ethical perspective,
\nit is essential that guidelines that focus pri-
\nmarily on justification of exclusion for rea-
\nsons of justice acknowledge that in case of
\ndifferential intervention effects, it is scien-
\ntifically preferable to set up different trials
\ninstead of being as inclusive as possible in
\na single trial. The value of knowledge gen-
\nerated from a study with a heterogeneous
\nstudy population may then be limited com-
\npared to multiple studies each conducted in
\nhomogenous populations.
\nSituation 2
\nAlso when strong prior evidence against
\ndifferential intervention effects, the NIH
\nguideline seems rational. In such situations,
\na trial can be conducted in either men only,
\nwomen only, or any combination of the two
\ngroups. Actually, results from trials in which
\nnot a single woman was included can still
\nbe generalized to women as long as the as-
\nsumption of no differential intervention ef-
\nfects holds.For example,even if trials on the
\neffect of antibiotics in children with acute
\notitis media are conducted in boys only, one
\nwill probably assume antibiotics are equally
\neffective in girls, because the mechanism
\nthrough which the intervention acts is the
\nsame for boys and girls\u00a0[11]. Thus, in the
\nabsence of differential intervention effects,
\nthe exclusion of any such subgroup will not
\naffect generalizability.
\nFrom both a scientific and ethical perspec-
\ntive, it may even be sensible to deliberately
\nexclude particular subgroups. For example,
\nin a trial on the prevention of cardiovascular
\ndisease the exclusion of women will likely
\ndecrease sample size requirements or dura-
\ntion of the trial, since women have a lower
\nrisk of cardiovascular morbidity than men.
\nHence, in case of equal intervention effects
\namong men and women, including only
\nmen in a trial would require less study par-
\nticipants compared to a trial including both
\nmen and women and thus reduce the bur-
\nden for study participants, without hamper-
\ning generalizability of results.Therefore, the
\ndisclaimer in the NIH guideline in situation
\n2 (i.e., to include gender subgroups even if
\nprior studies have shown no difference be-
\ntween these subgroups) is remarkable. The
\nethical value of this disclaimer is question-
\nable since it may increase the required sam-
\nple size, as indicated above, and hence may
\nextra burden participants as a group. There-
\nfore, the rationale for this disclaimer needs
\nto be explained.
\nSituation 3
\nIf it is unknown whether the intervention
\neffect differs between men and women, as
\nwill often be the case, the NIH guideline
\nindicates that both men and women should
\nbe included. However the phrase \u201csufficient
\nand appropriate\u201d inclusion of participants
\nfrom both genders in the guideline is un-
\nclear. If it turns out that the intervention
\neffect differs between men and women, the
\nobserved effect is a (weighted) average of
\nthe effect among men and the effect among
\nwomen. In that case, it could be invalid to
\ngeneralize findings from a study in which
\nsay only three out of a thousand study par-
\nticipants were women to a population of
\nwhom 40% are women. Hence, if the possi-
\nbility of a differential intervention effect by
\ngender cannot be excluded, the proportion
\nof women enrolled in a trial should be simi-
\nlar to the proportion of women among typi-
\ncal users. If a random subset of those typi-
\ncal users (e.g., subjects with hypertension,
\nwho constitute the typical antihypertensive
\ndrug users) is included in a trial, inclusion
\nis proportional and results will generalize
\nto populations with a similar proportion of
\nwomen. However, physician treat individu-
\nals rather than groups and they may thus
\nrequire more evidence regarding specific
\nsubgroups. For example, if 1% of the typi-
\ncal users is female, one may nevertheless re-
\nquire e.g. 10% inclusion of women in a trial
\nin order to generalize results from that trial
\nto an individual female patient. In other
\nwords, fair inclusion means that in those
\ncases where it is unknown whether the in-
\ntervention effect differs between men and
\nwomen, researchers should clarify whether
\nparticipation of subgroups is either propor-
\ntional or substantial.
\nWe note that a trial on the efficacy of an in-
\ntervention is typically designed to detect an
\noverall intervention effect and will not pro-
\nvide evidence of the presence (or absence) of
\ndifferential effects [10].This is acknowledged
\nin the NIH guideline, which states that \u201cthe
\ntrial will not be required to provide high sta-
\ntistical power for these comparisons\u201d. The
\nanalysis to assess whether the intervention
\neffect differs between subgroups seems to be
\n(only) secondary and often impossible.
\nIf the question is not what the overall inter-
\nvention effect is, but whether the interven-
\ntion effect differs between men and women,
\none would typically design a study in which
\nthe ratio between men and women is not
\nproportional to that ratio among future us-
\ners. In fact, a design with equal numbers of
\nmen and women may be more efficient to
\ndetect a differential intervention effect. We
\nnote that such a trial is designed to answer
\na different research question (namely that
\nof differences in the intervention effect be-
\ntween men and women) than the trial that
\n197
\nDeclaration of Helsinki
\nis aimed to show an overall intervention ef-
\nfect, on which the NIH guideline focuses.
\nIn summary, although the NIH guideline
\non women and minorities demonstrates that
\nscientific considerations are essential for fair
\ninclusion, the guideline should be further
\nsharpened. If there are no differential inter-
\nvention effects it remains unclear why the
\nguideline suggests inclusion of both gender
\ngroups. Furthermore, when it is unknown
\nwhether the intervention effect differs be-
\ntween men and women the inclusion should
\neither be proportional or substantial.
\nThe second question was who should be
\nresponsible for inclusive selection. Most
\nguidelines are very brief at this point. The
\nCanadian TCPS sets out that the obligation
\nfalls on the shoulders of the researcher. It is
\nhowever questionable whether the research-
\ner should be solely responsible now we have
\nseen that corrective justices underlies in-
\nclusive selection claims. Although the re-
\nsearcher is directly involved in the inclusion
\nprocess, there should also be an authority or
\n(inter)national organization which is in the
\nposition to ensure that a given study popula-
\ntion has appropriate access to participation.
\nIn theory, there will also be a moment that
\ninclusive selection requirements for reasons
\nof corrective justice are no longer needed.
\nIf researchers are imposed with this obliga-
\ntion, they should have access to information
\non fair inclusion of study populations on
\na global level. Currently, empirical data on
\nequitable distribution of burdens and ben-
\nefits among trial populations is lacking.
\nConclusions and
\nrecommendations
\nMany ethical guidelines on human subjects
\nresearch emphasize inclusive selection of
\nstudy populations in order to prevent arbi-
\ntrary exclusion or to prioritize groups that
\nhave been underrepresented in research.
\nHowever, in order to yield generalizable
\nknowledge it may sometimes be necessary
\nto set up different trials, or to deliberately
\nexclude subgroups. Moreover, if it is un-
\nknown whether intervention effects differ
\nbetween subgroups, the inclusion of these
\nsubgroups should be either proportional or
\nsubstantial. We caution that a sole focus on
\njustice as equity and corrective justice does
\nnot necessarily render the choice of study
\npopulations more ethically acceptable.
\nFurthermore, we emphasize that guidelines
\nshould clarify who is responsible for inclu-
\nsive selection and what actions are required
\nof this person or organization. The Decla-
\nration of Helsinki and the CIOMS guidelines
\nare unclear at this point. In the (next) revi-
\nsion process the guideline makers may want
\nto consider whether and how the actors of
\nthis obligation may be able to fulfil the idea
\nthat exclusion of study populations must be
\njustified.
\nReferences
\n1. Council for International Organizations of
\nMedical Sciences. International Ethical Guide-
\nlines for Biomedical Research Involving Human
\nSubjects. Geneva, Switzerland: CIOMS; 2002.
\n2. Canadian Institutes of Health Research, Natu-
\nral Sciences and Engineering Research Coun-
\ncil of Canada, Social Sciences and Humanities
\nResearch Council Canada. Tri-Council Policy
\nStatement. Ethical conduct for research involving
\nhumans, December 2010.
\n3. World Medical Association. Declaration of Hel-
\nsinki: Ethical Principles for Medical Research In-
\nvolving Human Subjects. Seoul: 2008.
\n4. Office of the Secretary. Ethical Principles and
\nGuidelines for the Protection of Human Sub-
\njects of Research. The National Commission for
\nthe Protection of Human Subject of Biomedical
\nand Behavioral Research. The Belmont Report.
\nApril 18, 1979
\n5. Emanuel E, Grady C. Four paradigms of clinical
\nresearch and research oversight. Camb Q Healthc
\nEthic 2006;16:82-96.
\n6. Grobbee DE, Hoes AW. Clinical epidemiology.
\nBoston: Jones and Bartlett 2009, pp 38.
\n7. National Institutes of Health, NIH Policy and
\nGuidelines on The Inclusion of Women and Minori-
\nties as Subjects in Clinical Research \u2013 Amended,
\nOctober, 2001.
\n8. UNAIDS\/WHO. Ethical considerations in
\nbiomedical HIV prevention trials. Geneva,
\n2007\/2012.
\n9. Haas DM, Gallauresi B, Shields K, Zeitlin D,
\nClark SM, Hebert MF, et al. Pharmacotherapy
\nand Pregnancy: Highlights from the Third
\nInternational Conference for Individualized
\nPharmacotherapy in Pregnancy. Clin Transl Sci
\n2011;4:204-9.
\n10. Brookes ST, Whitely E, Egger M, Smith GD,
\nMulheran PA, Peters TH. Subgroup analyses
\nin randomized trials: risks of subgroup-specific
\nanalyses; power and sample size for the interac-
\ntion test. J Clin Epidemiol 2004;57:229-236.
\n11. Rovers MM, Glasziou P, Appelman CL, Burke
\nP, McCormick DP, Damoiseaux RA, Gaboury
\nI, Little P, Hoes AW, Antibiotics for acute otitis
\nmedia: a meta-analysis with individual patient
\ndata. Lancet 2006;368:1429-1435.
\nRieke van der Graaf,
\nUniversity Medical Center Utrecht, Julius
\nCenter for Health Sciences and Primary Care
\nE-mail: r.vandergraaf@umcutrecht.nl
\nRolf HH Groenwold,
\nUniversity Medical Center Utrecht, Julius
\nCenter for Health Sciences and Primary Care
\nShona Kalkman,
\nUniversity Medical Center Utrecht, Julius
\nCenter for Health Sciences and Primary Care
\nDiederick E Grobbee,
\nUniversity Medical Center Utrecht, Julius
\nCenter for Health Sciences and Primary Care,
\nUniversity Professor International
\nHealth Sciences and Global Health
\nJohannes JM van Delden
\nUniversity Medical Center Utrecht, Julius
\nCenter for Health Sciences and Primary Care
\nUtrecht, Netherlands
\nJohannes JM van Delden and Rieke van der
\nGraaf are members of the Working Group
\nof the Revision of the CIOMS guidelines.
\nThe ideas on improvement of the respon-
\nsiveness requirement in the CIOMS guide-
\nlines are the authors\u2019 own and do not reflect
\nthe position of CIOMS.
\n198
\nDeclaration of Helsinki
\nIncreased protection for people taking part
\nin medical research has been proposed by
\nthe World Medical Association in changes
\nto its Declaration of Helsinki.
\nAfter a revision process lasting two years,
\nthe WMA today adopted and published a
\nrevised version of the Declaration on medi-
\ncal research, which next year celebrates its
\n50th
\nanniversary.
\nDelegates at the WMA\u2019s annual Assembly
\nin Fortaleza, Brazil, voted overwhelmingly
\nto support changes to the Declaration,which
\nnot only provide for increased protection for
\nvulnerable groups involved in research, but
\nalso include a new provision for compensat-
\ning people harmed as a result of participating
\nin research. In addition there are expanded
\nrequirements for post-study arrangements to
\nensure that participants involved in research
\nare informed of the results and have access to
\nany beneficial treatments that emerge.
\nDr. Margaret Mungherera, President of the
\nWMA, said: \u2018The changes agreed today are
\nall about providing a greater degree of pro-
\ntection for those involved in research. We
\nhave spent two years consulting our na-
\ntional medical association members, outside
\nexperts and the public and we are satisfied
\nthat today we have a Declaration that re-
\nquires greater transparency about medical
\nresearch, greater accountability and in-
\ncreased patient safety.
\n\u2018The changes also place more obligations on
\nthe sponsors of research, on the research-
\ners themselves and on host governments to
\nprotect research subjects.\u2019
\nThis is the seventh time the Declaration of
\nHelsinki has been revised since its incep-
\ntion, with notes of clarification being added
\nin 2002 and 2004. It is one of the most
\nimportant international ethical regulations
\nin biomedical research and is a core docu-
\nment of the WMA. It was adopted by the
\n18th
\nGeneral Assembly of the WMA in
\nHelsinki, Finland in 1964 and consists of
\na collection of ethical principles which set
\nout clear and easily readable guidelines for
\nmedical research involving human subjects.
\nThemes and Soundbites
\nFacts
\n\u2022 Next year (2014) is the 50th
\nanniversary of
\nthe Declaration
\n\u2022 The Declaration has been revised six
\ntimes with two notes of clarification
\n\u2022 Previous revisions in 1975, 1983, 1989,
\n1996, 2000 and 2008
\n\u2022 Sixth version was adopted in Edinburgh
\nin 2000.The process lasted three years
\n\u2022 In 2002 there was a note of clarification
\n\u2022 The original version was adopted in 1964
\nafter a 12-year debate
\n\u2022 Originally the Declaration comprised 11
\narticles and 713 words
\n\u2022 The most recent revision was completed
\nin 2008
\n\u2022 It was the first significant effort of the
\nmedical community to regulate research
\nitself, and forms the basis of most subse-
\nquent documents
\n\u2022 The Declaration is incorporated into
\nmany laws and regulations
\nPhrases
\n\u2022 WMA came into being because of the
\nlack of research ethics
\n\u2022 Declaration grew out of the horrific re-
\nsearch during WWII carried out by phy-
\nsicians
\n\u2022 Prominent status
\n\u2022 Unique standing of Declaration
\n\u2022 One of the most important international
\nethical documents
\n\u2022 It is the cornerstone of contemporary re-
\nsearch ethics
\n\u2022 Public trust
\n\u2022 Doctors acting in patients\u2019 best interests
\n\u2022 The duty of physicians to safeguard the
\nhealth of patients
\n\u2022 Recognised internationally as the stan-
\ndard guidance on medical research ethics
\n\u2022 Medical progress is dependent on re-
\nsearch on human subjects
\n\u2022 Advances in medicines used today to save
\nlives and relieve suffering would not be
\npossible without research involving hu-
\nman subjects
\n\u2022 Millions of people have benefited from
\nresearch carried out under DoH guide-
\nlines
\n\u2022 The Declaration must be responsive to
\nthe fast changing world of medicine
\n\u2022 Declaration lays out the roadmap for
\ntrust and ethics
\n\u2022 Medical research is about understanding
\nthe causes, development and effects of
\ndiseases and improving preventive, diag-
\nnostic and therapeutic interventions
\n\u2022 One of the principles of the DoH is that
\nmedical research involving the vulnerable
\nor disadvantaged population can only be
\njustified if the research is responsive to
\nthe health needs and priorities of this
\ncommunity and if there is a reasonable
\nlikelihood that this population or com-
\nmunity stands to benefit from the results
\nof the research
\nRevision Process
\n\u2022 Latest workgroup was formed in 2011
\n\u2022 Four expert conferences have been held
\n\u2022 The core principles remain unchanged
\n\u2022 Increased protection for vulnerable
\ngroups
\n\u2022 More protection for participants
\n\u2022 DOH requires that research only be con-
\nducted if the importance of the objective
\noutweighs the inherent risks and burdens
\nto the research subjects
\n\u2022 New provision for compensation
\n\u2022 Expanded requirements for post study ar-
\nrangements
\n\u2022 A more systematic approach to use of
\nplacebos
\n\u2022 Improved readability
\n\u2022 Clarification of the role of research ethics
\ncommittees
\n\u2022 The April-June public consultation re-
\nsulted in 129 submissions
\nWMA Publishes its Revised Declaration
\nof Helsinki
\n199
\nDeclaration of Helsinki
\nWMA Declaration of Helsinki\u00a0\u2013
\nEthical Principles for Medical
\nResearch Involving Human
\nSubjects
\nAdopted by the 18th
\nWMA General Assembly, Helsinki, Finland, June
\n1964 and amended by the: 29th
\nWMA General Assembly, Tokyo, Ja-
\npan, October 1975 35th
\nWMA General Assembly, Venice, Italy, October
\n1983 41st
\nWMA General Assembly, Hong Kong, September 1989 48th
\nWMA General Assembly, Somerset West, Republic of South Africa, Oc-
\ntober 1996 52nd
\nWMA General Assembly, Edinburgh, Scotland, Octo-
\nber 2000 53rd
\nWMA General Assembly, Washington DC, USA, October
\n2002 (Note of Clarification added) 55th
\nWMA General Assembly,Tokyo,
\nJapan, October 2004 (Note of Clarification added) 59th
\nWMA General
\nAssembly, Seoul, Republic of Korea, October 2008 64th
\nWMA General
\nAssembly, Fortaleza, Brazil, October 2013
\nPreamble
\n1. The World Medical Association (WMA) has developed the Dec-
\nlaration of Helsinki as a statement of ethical principles for medical
\nresearch involving human subjects, including research on identifi-
\nable human material and data.
\nThe Declaration is intended to be read as a whole and each of its
\nconstituent paragraphs should be applied with consideration of all
\nother relevant paragraphs.
\n2. Consistent with the mandate of the WMA, the Declaration is
\naddressed primarily to physicians. The WMA encourages others
\nwho are involved in medical research involving human subjects to
\nadopt these principles.\u00a0
\nGeneral Principles
\n3. The Declaration of Geneva of the WMA binds the physician
\nwith the words,\u201cThe health of my patient will be my first consider-
\nation,\u201d and the International Code of Medical Ethics declares that,
\n\u201cA physician shall act in the patient\u2019s best interest when providing
\nmedical care.\u201d
\n4. It is the duty of the physician to promote and safeguard the
\nhealth, well-being and rights of patients, including those who are
\ninvolved in medical research. The physician\u2019s knowledge and con-
\nscience are dedicated to the fulfilment of this duty.
\n5. Medical progress is based on research that ultimately must in-
\nclude studies involving human subjects.
\n6. The primary purpose of medical research involving human sub-
\njects is to understand the causes,development and effects of diseases
\nand improve preventive, diagnostic and therapeutic interventions
\n(methods, procedures and treatments). Even the best proven inter-
\nventions must be evaluated continually through research for their
\nsafety, effectiveness, efficiency, accessibility and quality.
\n7. Medical research is subject to ethical standards that promote and en-
\nsure respect for all human subjects and protect their health and rights.
\n8. While the primary purpose of medical research is to generate
\nnew knowledge, this goal can never take precedence over the rights
\nand interests of individual research subjects.
\n9. It is the duty of physicians who are involved in medical research
\nto protect the life, health, dignity, integrity, right to self-determina-
\ntion, privacy, and confidentiality of personal information of research
\nsubjects. The responsibility for the protection of research subjects
\nmust always rest with the physician or other health care profes-
\nsionals and never with the research subjects, even though they have
\ngiven consent.
\n10. Physicians must consider the ethical, legal and regulatory norms
\nand standards for research involving human subjects in their own
\ncountries as well as applicable international norms and standards.
\nNo national or international ethical, legal or regulatory requirement
\nshould reduce or eliminate any of the protections for research sub-
\njects set forth in this Declaration.
\n11. Medical research should be conducted in a manner that mini-
\nmises possible harm to the environment.
\n12. Medical research involving human subjects must be conducted
\nonly by individuals with the appropriate ethics and scientific edu-
\ncation, training and qualifications. Research on patients or healthy
\nvolunteers requires the supervision of a competent and appropri-
\nately qualified physician or other health care professional.
\n13. Groups that are underrepresented in medical research should be
\nprovided appropriate access to participation in research.
\n14. Physicians who combine medical research with medical care
\nshould involve their patients in research only to the extent that this
\nis justified by its potential preventive,diagnostic or therapeutic value
\nand if the physician has good reason to believe that participation in
\nthe research study will not adversely affect the health of the patients
\nwho serve as research subjects.
\n200
\nDeclaration of Helsinki
\n15. Appropriate compensation and treatment for subjects who are
\nharmed as a result of participating in research must be ensured.
\nRisks, Burdens and Benefits\u00a0
\n16. In medical practice and in medical research, most interventions
\ninvolve risks and burdens.
\nMedical research involving human subjects may only be conducted
\nif the importance of the objective outweighs the risks and burdens
\nto the research subjects.
\n17. All medical research involving human subjects must be pre-
\nceded by careful assessment of predictable risks and burdens to the
\nindividuals and groups involved in the research in comparison with
\nforeseeable benefits to them and to other individuals or groups af-
\nfected by the condition under investigation.
\nMeasures to minimise the risks must be implemented. The risks
\nmust be continuously monitored, assessed and documented by the
\nresearcher.\u00a0
\n18. Physicians may not be involved in a research study involving
\nhuman subjects unless they are confident that the risks have been
\nadequately assessed and can be satisfactorily managed.
\nWhen the risks are found to outweigh the potential benefits or
\nwhen there is conclusive proof of definitive outcomes, physicians
\nmust assess whether to continue, modify or immediately stop the
\nstudy.
\nVulnerable Groups and Individuals
\n19. Some groups and individuals are particularly vulnerable and
\nmay have an increased likelihood of being wronged or of incurring
\nadditional harm.
\nAll vulnerable groups and individuals should receive specifically
\nconsidered protection.
\n20. Medical research with a vulnerable group is only justified if the
\nresearch is responsive to the health needs or priorities of this group
\nand the research cannot be carried out in a non-vulnerable group.
\nIn addition, this group should stand to benefit from the knowledge,
\npractices or interventions that result from the research.
\nScientific Requirements and Research Protocols\u00a0
\n21. Medical research involving human subjects must conform to
\ngenerally accepted scientific principles, be based on a thorough
\nknowledge of the scientific literature, other relevant sources of
\ninformation, and adequate laboratory and, as appropriate, animal
\nexperimentation. The welfare of animals used for research must be
\nrespected.
\n22. The design and performance of each research study involving
\nhuman subjects must be clearly described and justified in a research
\nprotocol.
\nThe protocol should contain a statement of the ethical consider-
\nations involved and should indicate how the principles in this Dec-
\nlaration have been addressed.The protocol should include informa-
\ntion regarding funding, sponsors, institutional affiliations, potential
\nconflicts of interest, incentives for subjects and information regard-
\ning provisions for treating and\/or compensating subjects who are
\nharmed as a consequence of participation in the research study.
\nIn clinical trials, the protocol must also describe appropriate ar-
\nrangements for post-trial provisions.
\nResearch Ethics Committees
\n23. The research protocol must be submitted for consideration,
\ncomment, guidance and approval to the concerned research ethics
\ncommittee before the study begins. This committee must be trans-
\nparent in its functioning, must be independent of the researcher,
\nthe sponsor and any other undue influence and must be duly quali-
\nfied. It must take into consideration the laws and regulations of the
\ncountry or countries in which the research is to be performed as well
\nas applicable international norms and standards but these must not
\nbe allowed to reduce or eliminate any of the protections for research
\nsubjects set forth in this Declaration.\u00a0
\nThe committee must have the right to monitor ongoing studies.The
\nresearcher must provide monitoring information to the committee,
\nespecially information about any serious adverse events. No amend-
\nment to the protocol may be made without consideration and ap-
\nproval by the committee. After the end of the study, the researchers
\nmust submit a final report to the committee containing a summary
\nof the study\u2019s findings and conclusions.\u00a0
\nPrivacy and Confidentiality\u00a0
\n24. Every precaution must be taken to protect the privacy of re-
\nsearch subjects and the confidentiality of their personal information.
\nInformed Consent\u00a0
\n25. Participation by individuals capable of giving informed consent
\nas subjects in medical research must be voluntary. Although it may
\nbe appropriate to consult family members or community leaders, no
\nDeclaration of Helsinki
\nindividual capable of giving informed consent may be enrolled in a
\nresearch study unless he or she freely agrees.
\n26. In medical research involving human subjects capable of giv-
\ning informed consent, each potential subject must be adequately
\ninformed of the aims, methods, sources of funding, any possible
\nconflicts of interest, institutional affiliations of the researcher, the
\nanticipated benefits and potential risks of the study and the dis-
\ncomfort it may entail, post-study provisions and any other rel-
\nevant aspects of the study.The potential subject must be informed
\nof the right to refuse to participate in the study or to withdraw
\nconsent to participate at any time without reprisal. Special atten-
\ntion should be given to the specific information needs of indi-
\nvidual potential subjects as well as to the methods used to deliver
\nthe information.
\nAfter ensuring that the potential subject has understood the infor-
\nmation, the physician or another appropriately qualified individual
\nmust then seek the potential subject\u2019s freely-given informed con-
\nsent, preferably in writing. If the consent cannot be expressed in
\nwriting, the non-written consent must be formally documented and
\nwitnessed.
\nAll medical research subjects should be given the option of being
\ninformed about the general outcome and results of the study.
\n27. When seeking informed consent for participation in a research
\nstudy the physician must be particularly cautious if the potential
\nsubject is in a dependent relationship with the physician or may
\nconsent under duress. In such situations the informed consent must
\nbe sought by an appropriately qualified individual who is completely
\nindependent of this relationship.
\n28. For a potential research subject who is incapable of giving in-
\nformed consent,the physician must seek informed consent from the
\nlegally authorised representative. These individuals must not be in-
\ncluded in a research study that has no likelihood of benefit for them
\nunless it is intended to promote the health of the group represented
\nby the potential subject, the research cannot instead be performed
\nwith persons capable of providing informed consent, and the re-
\nsearch entails only minimal risk and minimal burden.
\n29. When a potential research subject who is deemed incapable of
\ngiving informed consent is able to give assent to decisions about
\nparticipation in research, the physician must seek that assent in ad-
\ndition to the consent of the legally authorised representative. The
\npotential subject\u2019s dissent should be respected.
\n30. Research involving subjects who are physically or mentally inca-
\npable of giving consent, for example, unconscious patients, may be
\ndone only if the physical or mental condition that prevents giving
\ninformed consent is a necessary characteristic of the research group.
\nIn such circumstances the physician must seek informed consent
\nfrom the legally authorised representative. If no such representative
\nis available and if the research cannot be delayed,the study may pro-
\nceed without informed consent provided that the specific reasons
\nfor involving subjects with a condition that renders them unable to
\ngive informed consent have been stated in the research protocol and
\nthe study has been approved by a research ethics committee. Con-
\nsent to remain in the research must be obtained as soon as possible
\nfrom the subject or a legally authorised representative.
\n31. The physician must fully inform the patient which aspects of
\ntheir care are related to the research. The refusal of a patient to
\nparticipate in a study or the patient\u2019s decision to withdraw from
\nthe study must never adversely affect the patient-physician rela-
\ntionship.
\n32. For medical research using identifiable human material or data,
\nsuch as research on material or data contained in biobanks or simi-
\nlar repositories, physicians must seek informed consent for its col-
\nlection, storage and\/or reuse. There may be exceptional situations
\nwhere consent would be impossible or impracticable to obtain for
\nsuch research.In such situations the research may be done only after
\nconsideration and approval of a research ethics committee.
\nUse of Placebo
\n33. The benefits, risks, burdens and effectiveness of a new interven-
\ntion must be tested against those of the best proven intervention(s),
\nexcept in the following circumstances:
\nWhere no proven intervention exists, the use of placebo, or no in-
\ntervention, is acceptable; or
\nWhere for compelling and scientifically sound methodological rea-
\nsons the use of any intervention less effective than the best proven
\none, the use of placebo, or no intervention is necessary to determine
\nthe efficacy or safety of an intervention and the patients who receive
\nany intervention less effective than the best proven one, placebo, or
\nno intervention will not be subject to additional risks of serious or
\nirreversible harm as a result of not receiving the best proven inter-
\nvention.\u00a0
\nExtreme care must be taken to avoid abuse of this option.
\nPost-Trial Provisions
\n34. In advance of a clinical trial, sponsors, researchers and host
\ncountry governments should make provisions for post-trial access
\nfor all participants who still need an intervention identified as ben-
\neficial in the trial.This information must also be disclosed to partici-
\npants during the informed consent process.
\nIV
\nContents
\nResearch Registration and Publication
\nand Dissemination of Results
\n35. Every research study involving human subjects must be reg-
\nistered in a publicly accessible database before recruitment of the
\nfirst subject.
\n36. Researchers, authors, sponsors, editors and publishers all have
\nethical obligations with regard to the publication and dissemination
\nof the results of research. Researchers have a duty to make pub-
\nlicly available the results of their research on human subjects and
\nare accountable for the completeness and accuracy of their reports.
\nAll parties should adhere to accepted guidelines for ethical report-
\ning. Negative and inconclusive as well as positive results must be
\npublished or otherwise made publicly available. Sources of funding,
\ninstitutional affiliations and conflicts of interest must be declared
\nin the publication. Reports of research not in accordance with the
\nprinciples of this Declaration should not be accepted for publication.
\nUnproven Interventions in Clinical Practice
\n37. In the treatment of an individual patient, where proven inter-
\nventions do not exist or other known interventions have been in-
\neffective, the physician, after seeking expert advice, with informed
\nconsent from the patient or a legally authorised representative,
\nmay use an unproven intervention if in the physician\u2019s judgement
\nit offers hope of saving life, re-establishing health or alleviating
\nsuffering. This intervention should subsequently be made the ob-
\nject of research, designed to evaluate its safety and efficacy. In all
\ncases, new information must be recorded and, where appropriate,
\nmade publicly available.
\nDisclaimer: \u00a9 2013 World Medical Association, Inc. All Rights Reserved. All intellectual property rights in the Declaration of Helsinki are vested
\nin the World Medical Association. Previous permissions granted to publish or reproduce otherwise WMA policy don\u2019t apply to this version of the
\nDeclaration of Helsinki until January 1st
\n, 2014. For further questions, please contact the WMA secretariat at\u00a0secretariat@wma.net
\nAddress of Past President of WMA Cecil B Wilson . . . . . 161
\nInaugural Address of Dr. Margaret Mungherera . . . . . . . . 162
\nWMA President \u2013 Elect Dr. Xavier DEAU . . . . . . . . . . . . 164
\n64rd
\nWMA General Assembly and 195th
\n\/196th
\nCouncil Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
\nWMA Statement on Natural Variations of Human
\nSexuality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
\nWMA Resolution in Support of the Brazilian
\nMedical Association . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
\nWMA Resolution on the Prohibition of Chemical
\nWeapons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
\nWMA Resolution on Criminalisation of Medical Practice . . . 178
\nWMA Statement on the United Nations Resolution
\nfor a Moratorium on the Use of the Death Penalty . . . . . . 179
\nWMA Statement on Fungal Disease Diagnosis
\nand Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
\nWMA Statement on Forensic Investigations
\nof the Missing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
\nWMA Council Resolution on Standardisation
\nin Medical Practice and Patient Safety . . . . . . . . . . . . . . . . 181
\nWMA Resolution on the Healthcare Situation in Syria . . 181
\nWMA Statement on the Right of Rehabilitation
\nof Victims of Torture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
\nWMA Statement on Human Papillomavirus Vaccination . . . 183
\nWMA Resolution on Women\u2019s Rights to Health Care and
\nHow That Relates to the Prevention of Mother-to-Child
\nHIV Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
\nIf Perfect Isn\u2019t Possible, Is The Good \u201cGood Enough?\u201d
\nPlacebos,Post-Trial Provisions and the Politics of Helsinki . . . 185
\nJustification, Coherence and Consistency of Provisions
\nin the Revised Declaration of Helsinki . . . . . . . . . . . . . . . . 188
\nFrom Justifying Inclusion to Justifying Exclusion
\nof Study Populations: Strengths and Limitations . . . . . . . . 192
\nWMA Publishes its Revised Declaration of Helsinki . . . . . . 198
\nWMA Declaration of Helsinki\u00a0\u2013 Ethical Principles
\nfor Medical Research Involving Human Subjects . . . . . . . 199<\/p>\n"},"caption":{"rendered":"

wmj201305 COUNTRY \u2022 64rd WMA General Assembly and 195th \/196th Council Sessions \u2022 Declaration of Helsinki vol. 59 MedicalWorld Journal Official Journal of the World Medical Association, INC G20438 Nr. 5, October 2013 Cover picture from Norway Editor in Chief Dr. P\u0113teris Apinis Latvian Medical Association Skolas iela 3, Riga, Latvia Phone +371 67 220 […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":940,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj201305.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3657"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3657"}]}}