{"id":3939,"date":"2017-01-20T13:45:34","date_gmt":"2017-01-20T13:45:34","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Wiesing-DoH-Helsinki-20141111.pdf"},"modified":"2017-01-20T13:45:34","modified_gmt":"2017-01-20T13:45:34","slug":"wiesing-doh-helsinki-20141111-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/wiesing-doh-helsinki-20141111-2\/","title":{"rendered":"Wiesing-DoH-Helsinki-20141111"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"<p class=\"attachment\"><a href='https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Wiesing-DoH-Helsinki-20141111.pdf'>Wiesing-DoH-Helsinki-20141111<\/a><\/p>\n<p>\n \u00a0<\/p>\n<p> \u00a0<br \/>\n1<br \/>\n \u00a0<\/p>\n<p> \u00a0<br \/>\nThe Declaration of Helsinki \u2013 its history and its future<br \/>\nUrban Wiesing<br \/>\nHelsinki, 11.11.2014<br \/>\nFifty years ago, in June 1964, the delegates of the national medical associations<br \/>\ncame from all over the world to Helsinki to attend the 18th<br \/>\nGeneral Assembly of the<br \/>\nWorld Medical Association. The Finnish president of the WMA, Dr. Urpo Siirala,<br \/>\ninvited the delegates. The Finnish medical association was responsible for organizing<br \/>\nthe assembly. The delegates might have thought to attend one of numerous<br \/>\nmeetings, as many others before. They might have thought to be involved in<br \/>\nbusiness as usual. Those who thought this were wrong. But the delegates could have<br \/>\nhardly imagined the historical significance that would later be gained by this general<br \/>\nassembly and by their decision to adopt a certain document. The document they<br \/>\nadopted without a dissentient vote would serve for generations of researchers as a<br \/>\npoint of reference. The document on \u201cRecommendations guiding doctors in clinical<br \/>\nresearch\u201d came to be known as the \u201cDeclaration of Helsinki\u201d. It was the first<br \/>\ninternational set of ethical principles for research involving human subjects. In the<br \/>\nfollowing years this guideline became the most influential one and still is. One tiny<br \/>\nstep had been taken by the delegates that would later turn out to be a giant leap. As I<br \/>\nsaid: This happened 50 years ago.<br \/>\n\u201cBut the road to the Helsinki declaration was neither straight nor smooth.\u201d1<br \/>\nThe work<br \/>\ntook more than a decade. The discussion started shortly after the founding of the<br \/>\nWorld Medical Association in 1947, two years after the war, and still in the wake of<br \/>\nthe crimes committed by German doctors in the concentration camps. In the same<br \/>\nyear, the Nuremberg Code as a guideline for medical research on human subjects<br \/>\nresulted from the \u201cDoctors\u2019 Trial\u201d at the Nuremberg Trials.<br \/>\nWhat was the Nuremberg Code? And what was its role in history? The Nuremberg<br \/>\ncode was meant to prevent crimes like those committed by Nazi doctors in the<br \/>\nconcentration camps. Therefore it demanded to obtain participants\u2019 voluntary consent<br \/>\nwithout any exception. In addition, the code set a limit on reasonable risks and<br \/>\ndemanded that subjects have the right to leave the experiment at any time. However,<br \/>\nthe code attracted little interest at first. How could it? It served to justify the judgment<br \/>\nof an American military court. It was a secret document in some countries. What<br \/>\nauthority could such a Code claim to have? This was a difficult question to answer.<br \/>\nThe Nuremberg Code was an important document, but it did not serve as an<br \/>\ninfluential answer to the demanding situation in medical research. Another answer<br \/>\nwas needed.<br \/>\nIn 1953 a first proposal for a position paper was submitted to the Medical Ethics<br \/>\nCommittee of the WMA. It was published a year later as the \u201cResolution on Human<br \/>\nExperimentation\u201d. In contrast to the Nuremberg Code, participants\u2019 informed consent<br \/>\nwas not an absolute condition. It gives researchers a little leeway when it comes to<\/p>\n<p> \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n \u00a0<br \/>\n1<\/p>\n<p> \u00a0Susanne Lederer (2007): Research without Borders: The Origin of the Declaration<br \/>\nof Helsinki. In: Schmidt\/Frewer: A History and Theory of Human Experimentation.<br \/>\nStuttgart, Franz Steiner Verlag, p. 145-167, p. 145.<br \/>\n \u00a0<\/p>\n<p> \u00a0<\/p>\n<p> \u00a0<br \/>\n2<br \/>\n \u00a0<\/p>\n<p> \u00a0<br \/>\nresearch on those incapable of giving informed consent. These patients could be<br \/>\nincluded in experiments if their legally authorized representatives provided consent<br \/>\non their behalf. Even though this first document was vague, very short and somewhat<br \/>\npoorly phrased, it shows important characteristics of the subsequent declaration: first<br \/>\nof all the resolution stresses the respect for the individual. Furthermore, it<br \/>\ndifferentiates between research on healthy volunteers and research performed on<br \/>\npatients for whom medical treatments are considered. This is not mentioned in the<br \/>\nNuremberg Code. And the declaration makes research possible on those incapable<br \/>\nof giving informed consent under strict regulations.<br \/>\nSeven years later, in 1961, the Medical Ethics Committee presented the first draft of<br \/>\nthe declaration. Three additional years of intense and controversial debates had to<br \/>\npass until it was adopted. Many suggestions have been made and discussed &#8211;<br \/>\namong them the suggestion to implement an article on astronauts, which has not<br \/>\nbeen done. Highly controversial were the questions on research with prisoners and<br \/>\nwith children. The discussion continued up to the General assembly in Helsinki, and<br \/>\ncorrections were made until the day before. Finally the declaration was adopted in a<br \/>\nversion that represents the character of the further versions: A compromise,<br \/>\nbalanced, far away from unrealistic demands, but clear in central norms for the<br \/>\nprotection of participants. Research with children was not totally prohibited, but<br \/>\nregulated, and the same goes for prisoners. Realism is one of the characteristics that<br \/>\nmakes and has made the declaration acceptable for 50 years.<br \/>\nMedicine and human subject research: a dilemma<br \/>\nThe declaration is the most imported document of ethical principles for the regulation<br \/>\nof research involving human subjects. But why did it gain such an importance? The<br \/>\ndeclaration is what it is because it gives an answer: an answer to a question that is<br \/>\ndesperately needed to be answered in modern medicine; an answer to the<br \/>\nfundamental ethical question of research involving human subjects, an answer to a<br \/>\ndilemma.<br \/>\nWhat is the dilemma modern medicine is confronted with? On the one hand, modern<br \/>\nmedicine knows that precise knowledge concerning the efficacy and safety of<br \/>\ninterventions can only be gained from research involving human subjects. Animal or<br \/>\nlaboratory experimentation is necessary and a prerequisite to clinical research. But<br \/>\nthey cannot provide the knowledge relevant for medical practice. On the other hand,<br \/>\nresearch involving human subjects is fraught with ethical conflicts that cannot be<br \/>\ncompletely prevented. If one conducts research on human subjects, there will always<br \/>\nbe the risk of harming them. Exposing the patients to such risks is inconsistent with<br \/>\nthe medical professional\u2019s obligations, especially with the old Hippocratic principle<br \/>\nprimum nil nocere, do no harm. However, harmful effects are inevitable in research. If<br \/>\nthe researcher knows beforehand that the patient will not be exposed to any risks<br \/>\nbecause the intervention is effective and does not inflict any harm, then no further<br \/>\nresearch is needed.<br \/>\nResearch involving human subjects is controversial because of the risks. Therefore<br \/>\none might think that it is morally preferable to abstain from research involving human<br \/>\nsubjects. But this idea is fundamentally wrong. Abstaining from conducting this<br \/>\nresearch to avoid ethical conflicts would mean treating future patients with previously<br \/>\nuntested drugs. This would significantly lessen the quality of medical practice. And<br \/>\nnow we are arriving at one of the central dilemmas of modern medicine: The<\/p>\n<p> \u00a0<\/p>\n<p> \u00a0<br \/>\n3<br \/>\n \u00a0<\/p>\n<p> \u00a0<br \/>\nunsolvable problem lies in the fact that physicians are not permitted to use<br \/>\nempirically untested interventions but are simultaneously not supposed to empirically<br \/>\ntest them. The ethical principle \u201cdo no harm\u201d cannot be realized in therapy without<br \/>\nclinical research. But clinical research is ethically critical because it violates the<br \/>\nprinciple \u201cdo no harm\u201d.<br \/>\nThis ethical dilemma is much older than the Declaration of Helsinki. The ethical<br \/>\ndilemma arose when medicine wanted to become a science based discipline. And<br \/>\nthe declaration is by no means the first regulatory response to this conflict. Some<br \/>\nnational institutions had been aware of this problem since the end of the 19th<br \/>\ncentury.<br \/>\nThey adopted regulations and continued to do so in 20th<br \/>\ncentury. These national<br \/>\nregulations emphasized, among other things, the patient\u2019s informed consent as a<br \/>\nrequirement for research. But they had little influence. They failed to prevent the<br \/>\nunspeakably cruel experiments performed on inmates of the Nazi concentration<br \/>\ncamps. That means: The fundamental problems of research involving human<br \/>\nsubjects were known, but the response thereto was insufficient.<br \/>\nThese ethical problems grew larger with the increase in complexity and power of<br \/>\nmedicine. It grew larger with scientific progress. In addition the problem grew larger<br \/>\nwith the altered self-conception of the people. They did not want put themselves at<br \/>\nthe disposal of medical science without being asked. They simply did not want to<br \/>\nbecome guinea pigs. An increased awareness of the ethical issues called for new<br \/>\nsolutions. Moreover, the Nazi crimes and other scandals in medical research<br \/>\nthreatened to undermine the public\u2019s faith in the entire medical community. The<br \/>\nNuremberg Code was one answer but more or less unknown. The Declaration of<br \/>\nHelsinki gave the most important answer to the dilemma associated with research<br \/>\ninvolving human subjects.<br \/>\nThis is the historical achievement of the declaration. It gives an answer to an<br \/>\nunavoidable dilemma of modern medicine, to an unavoidable conflict between the<br \/>\nrole of a physician and the role of a researcher. The declaration regulates an<br \/>\nunavoidable tension between exposing current patients to risks for the benefit of<br \/>\nfuture patients. Therefore the declaration stresses the protection of the participants<br \/>\non the one hand and medicine\u2019s need for research on the other.<br \/>\nFinal part<br \/>\nAfter the adoption of the declaration the inevitable happened: the declaration was<br \/>\ndebated. It was classified from the very beginning as too permissive by some<br \/>\ncommentators and as too restrictive by others. The debate on whether the<br \/>\nDeclaration of Helsinki is too \u201cresearch-friendly\u201d or too restrictive persists up to the<br \/>\npresent day. But if a document is criticized to be too liberal and also criticized to be<br \/>\ntoo restrictive it may very well be a balanced compromise.<br \/>\nIn an open society, in the modern world the Declaration of Helsinki is the object of<br \/>\ncontroversial discussions. This is unavoidable; it is a sign of an open society. It has to<br \/>\nbe welcomed; it is nothing but necessary. It can only serve to improve the document.<br \/>\nThere is no doubt: The international literature on the declaration was extremely<br \/>\nhelpful for the last revision process and I am sure for the others as well. And \u2013 I<br \/>\nassure you by my own experience \u2013 the WMA is willing to lead such a discussion.<br \/>\nThe WMA \u2013 the proud owner of the declaration, as they call themselves \u2013 does not<\/p>\n<p> \u00a0<\/p>\n<p> \u00a0<br \/>\n4<br \/>\n \u00a0<\/p>\n<p> \u00a0<br \/>\nshy away from any debate. The declaration is a living document that is adapted to a<br \/>\nchanging environment and improved.<br \/>\nHowever, regardless of the debate on certain revisions and paragraphs, the<br \/>\ndeclaration as a historical document is uncontroversial. For with the adoption, much<br \/>\nmore has been accomplished in terms of implicit judgments than visible at first<br \/>\nglance. What does this mean? Allow me to explain.<br \/>\nFirst of all the Declaration of Helsinki embodies the acceptance that research<br \/>\ninvolving human subjects not only has scientific and technical but also ethical<br \/>\ndimensions. It underlines that the ethical aspects can by no means be answered by<br \/>\nscience alone. More than science is needed, what is needed is ethics. In this respect,<br \/>\nthe declaration is also based on the acknowledgment of the limits of science. It is a<br \/>\ndocument of scientific prudence. Science can say how the world is, yes, and better<br \/>\nthan ever before. But science cannot say how the world should be. Science can say<br \/>\nhow one is supposed to go about researching something, but not whether it should<br \/>\nbe researched at all. The declaration is based on the acceptance of these<br \/>\nfundamental theoretical distinctions and argumentative integrity. Therefore it is a<br \/>\ndocument of argumentative transparency. In this sense the declaration is simply<br \/>\nmodern.<br \/>\nThe declaration also secures trust. Thanks to the declaration and others this<br \/>\nresearch no longer has an exclusively negative image. The declaration not only limits<br \/>\nresearch on human beings, but it also legitimizes it. The declaration not only protects<br \/>\nthe participants but the researchers as well. This not only stabilizes the medical<br \/>\nprofession but gives the system of research hope that the people will accept it. The<br \/>\nacceptance and trust in research is essential in modern, open societies.<br \/>\nThe declaration expresses a profession\u2019s will and capability of self-control. I have to<br \/>\nremind you that other institutions, organizations etc. could have adopted a<br \/>\ncomparable regulation. But that is not what happened. The declaration was created<br \/>\nand adopted by an organization of physicians for physicians, thus creating a close<br \/>\nrelationship to the profession and the professionals. The declaration remains an<br \/>\nexpression of professional self-reflection. It is living proof that a profession can<br \/>\nregulate not only scientific but also ethical aspects responsibly.<br \/>\nThe adoption and the successful efforts of the World Medical Association for self-<br \/>\nimposed regulations confirm the fundamental willingness and ability to learn as a<br \/>\nprofessional self-organization. Thus, the declaration is an expression of<br \/>\nresponsibility: The medical profession and its world organization are aware of the<br \/>\nethical challenges in conducting research on human subjects. They feel responsible<br \/>\nfor responding appropriately. The profession has not been forced to do so. The<br \/>\nDeclaration is an expression of a voluntary assumption of responsibility. It is an<br \/>\nexpression of the free will of the profession and of practical reason.<br \/>\nIf the declaration didn\u2019t exist it would have to be invented. There is no substitute for<br \/>\nthe declaration. And there is no declaration 2.0. No, there is only one. And today we<br \/>\nare celebrating its 50th<br \/>\nbirthday.<br \/>\nWhat will happen in the future with declaration? Some things are for sure: The<br \/>\nscientific and technological development of modern medicine will go on. They will<br \/>\nconfront us with new challenges. I only have to remind you of some of the latest<\/p>\n<p> \u00a0<\/p>\n<p> \u00a0<br \/>\n5<br \/>\n \u00a0<\/p>\n<p> \u00a0<br \/>\nmedical projects like individualized medicine, system medicine, new developments in<br \/>\ngenetics or biobanks. And I am sure there are more to come and are already coming.<br \/>\nI am speaking in particular of the Ebola crisis.<br \/>\nIn the case of Ebola, we can see how adequate the ethical principles of the<br \/>\nDeclaration are. We do not need a new ethics in the case of Ebola. However, we do<br \/>\nneed to make new decisions in the face of such a global crisis, but these decisions<br \/>\nmust be made on the basis of existing ethical principles. The ethical principles laid<br \/>\ndown in the declaration remain valid. They are applicable to the current situation and<br \/>\nindeed helpful.<br \/>\nThe Declaration stresses the importance of protecting participants on the one hand<br \/>\nand medicine\u2019s need for research on the other. Both must be balanced. This holds<br \/>\ntrue when it comes to Ebola as well. A balance between exposing current patients to<br \/>\npotential risks for their own benefit as well as the benefit of future patients is<br \/>\nabsolutely crucial in order to prevent a pandemic. This is precisely what needs to be<br \/>\ndone in the case of Ebola.<br \/>\nFurthermore, the declaration allows the \u201ctreatment of an individual patient, where<br \/>\nproven interventions do not exist\u201d under certain conditions and demands that these<br \/>\ncases \u201cshould subsequently be made the object of research, designed to evaluate its<br \/>\nsafety and efficacy\u201d. This is exactly what needs to be done now. All of these norms<br \/>\nare valid and applicable to the global crisis of Ebola. Allow me to reiterate: The case<br \/>\nof Ebola illustrates just how appropriate the ethical principles of the Declaration are.<br \/>\nWe do not need a new ethics but ethically well founded and courageous decisions.<br \/>\nEbola won\u2019t be the last crisis the medical world is confronted with. It would not be<br \/>\nrealistic to assume that research ethics will not be demanding in the future. But there<br \/>\nare good reasons as well that the declaration will meet the challenge. In the past 50<br \/>\nyears it was well maintained, and the proud owner \u2013 the WMA \u2013 is willing to continue<br \/>\nto maintain the document. It has always been a document that is up to date \u2013 and I<br \/>\nam optimistic it will be in the future.<br \/>\nThe frequency of the revisions has been questioned. And of course; this is a<br \/>\ndiscussable topic. However, the main question is not how often the declaration<br \/>\nshould be revised. This is a second order question. The primary question to be<br \/>\nanswered is: How does it keep providing the ethical principles for research involving<br \/>\nhuman subjects in the face of rapid developments in science and society? And after<br \/>\nanswering this question the frequency of revisions can be determined. On the one<br \/>\nhand the frequency should be low; on the other hand it must be an appropriate<br \/>\nfrequency to keep up with scientific and ethical progress.<br \/>\nAs long as the declaration remains the most important answer to one of the<br \/>\nfundamental challenges of modern medicine I have no doubt that there will be good<br \/>\nreasons to meet again in 10, 25, in 50 years for the next anniversaries. And where<br \/>\nshould a meeting take place? There is no doubt: In the city, where it started, where<br \/>\nthe original version was adopted. James Bond, the famous British secret agent would<br \/>\nanswer the question very briefly: \u201cIn Helsinki, where else?\u201d<\/p>\n"},"caption":{"rendered":"<p>Wiesing-DoH-Helsinki-20141111 \u00a0 \u00a0 1 \u00a0 \u00a0 The Declaration of Helsinki \u2013 its history and its future Urban Wiesing Helsinki, 11.11.2014 Fifty years ago, in June 1964, the delegates of the national medical associations came from all over the world to Helsinki to attend the 18th General Assembly of the World Medical Association. The Finnish president [&hellip;]<\/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\/Wiesing-DoH-Helsinki-20141111.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3939"}],"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=3939"}]}}