{"id":3842,"date":"2017-01-20T12:27:01","date_gmt":"2017-01-20T12:27:01","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/WMA_Cape_town-_Feinholz.pdf"},"modified":"2017-01-20T12:27:01","modified_gmt":"2017-01-20T12:27:01","slug":"wma_cape_town-_feinholz-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/wma_cape_town-_feinholz-2\/","title":{"rendered":"WMA_Cape_town-_Feinholz"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

WMA_Cape_town-_Feinholz<\/a><\/p>\n

EXPERT CONFERENCE ON THE
\nREVISION OF THE DECLARATION OF
\nHELSINKI
\nCAPE TOWN, SOUTH AFRICA.
\n06\/12\/2012
\nDAFNA FEINHOLZ
\nCHIEF OF BIOETHICS SECTION
\nUNESCO AND DoH
\nDeclaration of Helsinki
\nRecognized by UNESCO as one of the leading
\ninternational guidelines.
\nImportant for UNESCO to participate in the debates
\nto collaborate in the efforts to ensure DoH remains
\nrelevant and with a prominent role.
\nFor Whom?
\n\uf097 From and for Physicians, yes but\u2026.
\n\uf097 Aspiration: should be good to anybody!
\n\uf097 The principles are relevant for other researchers and
\nother actors (funders, publishers)
\n\uf097 DoH in fact, invites others.
\n\uf097 De facto, it is a reference for non physicians and for
\nmany engage in research with human research.
\n\uf097 Its a responsibility also to assume the relevance it
\nhas gained. Integrated in some countries
\nlegislation.
\nSome of the challenges
\n\uf097 Maintaining the specificity, and readable in 15
\nminutes, should not exclude to keep relevant in a the
\nwider (including dissemination of knowledge),
\nchanging and increasingly complex context in
\nwhich research takes place.
\n\uf097 I will refer basically to post trial
\narrangements\/benefit sharing and ethics
\ncommittees.
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n15. Sharing of benefits
\nRelated to Articles 4: Benefit and harm: In applying
\nand advancing scientific knowledge, medical
\npractice and associated technologies, direct and
\nindirect benefits to patients, research participants
\nand other affected individuals should be
\nmaximized\u2026.\u201d
\nArt 13 Solidarity and Cooperation
\nArt 21: \u201c Transnational health research Research
\nshould be responsive to the needs of host
\ncountries\u2026.\u201d
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\nArt. 10: Equality, justice and Equity
\nHuman rights framework of UN and the Declaration:
\nInternational Covenant on Economic, Social and
\nCultural Rights:
\n\u201cEnjoy the benefits of science and technology and its
\napplications.\u201d
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n15. Sharing of benefits
\n1. Benefits resulting from any scientific research and
\nits applications should be shared with society as a
\nwhole and within the international community, in
\nparticular with developing countries.
\nIn given effect to this principle, benefits may take any
\nof the following forms:
\na) Provision of new diagnostic and therapeutic modalities or
\nproducts steaming from research
\nb) Access to quality health care
\nc) Access to scientific and technological knowledge
\nd) Support for health services
\ne) Capacity-building facilities for research purposes.
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\nArt 14. \u2026..\u201dDescription of arrangements for post-study
\naccess by study subjects to interventions identified
\nas beneficial in the study or access to other
\nappropriate care of benefit.\u201d
\nPositive:
\nCall for a description in the protocol, which should
\nimply prior negotiation
\nCaution:
\nPost study (access to successfully tested ..) and other
\nbenefits (health care during the research, etc)
\ntogether. Does not mean choosing, but differently as
\nappropriate.
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\nNegative:
\nNo specification of whose obligation it is to discharge post study obligations.
\nHow will ethics committees will evaluate and promote compliance with
\nthese obligations?
\nArticle: 33. \u201cAt the conclusion of the study, patients entered into the study
\nare entitled to be informed about the outcome of the study and to
\nshare any benefits that result from it, for example access to
\ninterventions identified as beneficial or to other appropriate care or
\nbenefit.
\nBut\u2026..
\n\u2022 What about other benefits during the research? Access to health care,
\netc.
\n\u2022 Of course it could elicit the problem of undue inducement, but that
\nwould also need to be sorted out.
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n\u2022 Compared to : \u2026..\u201devery patient entered into the study
\nshould be assured of access\u201d
\n\u2022 \u201care entitled\u201d vs. should be assured\u2026. and not clearly by
\nwhom\u2026\u2026.
\n\u2022 Different stakeholders, different type of research,
\nparticipants (not only patients), but there is a need to:
\n\u2022 define who will be responsible particularly in ensuring
\naccess to successful outcome or other benefits,
\n\u2022 When this will be decided (before the trial starts)
\n\u2022 What are the benefits
\n\u2022 Who are the beneficiaries
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n\u2022 As different stakeholders are involved and had
\ndifferent obligations, there is a need to identify
\npotential responsible and indicate the need for a
\nmechanism to agree.
\n\u2022 Some countries like Brazil have local legislation in
\norder to assure \u201caccess to medicine being tested\u201d\u2026
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n21. Transnational Practices
\n2. When a research is undertaken or otherwise
\npursued in one or more States (the hosts State(s)
\nand funded by a source in another State, such
\nresearch should be the object of an appropriate
\nlevel of ethical review in the host State(s) and the
\nState in which the funder is located. (Dual review)
\n4.When negotiating a research agreement, terms for
\ncollaboration and agreements on the benefits of
\nresearch should be established with equal
\nparticipation by those party to the negotiation
\n(taking into account power and minimum basis)
\nRelevant principles of Universal Declaration
\nof Bioethics and Human Rights
\n\uf097 Indicate the role of ethics committee in reviewing
\nand ensuring appropriate post study access and
\nbenefit sharing arrangements and who will be
\nresponsible.
\n\uf097 Indicate the need for host country committee to
\nfully participate in the review of the protocol in
\ninternational research.
\n\uf097 Previous version included reporting sources of
\nfunding, sponsors and other sources of conflict of
\ninterest to Ethics Committees, and is lacking here,
\n\u2026..they are mentioned in the information to the
\nresearch participant.<\/p>\n"},"caption":{"rendered":"

WMA_Cape_town-_Feinholz EXPERT CONFERENCE ON THE REVISION OF THE DECLARATION OF HELSINKI CAPE TOWN, SOUTH AFRICA. 06\/12\/2012 DAFNA FEINHOLZ CHIEF OF BIOETHICS SECTION UNESCO AND DoH Declaration of Helsinki Recognized by UNESCO as one of the leading international guidelines. Important for UNESCO to participate in the debates to collaborate in the efforts to ensure DoH remains […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/WMA_Cape_town-_Feinholz.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3842"}],"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=3842"}]}}