When Was the First International Agreement on Medical Research Created

In cases of lack of legal competence, the informed consent of the legal guardian should be obtained in accordance with national law. If a physical or mental disability makes it impossible to obtain informed consent, or if the person concerned is a minor, the authorisation of the responsible parent shall replace that of the subject in accordance with national law. Has the DoH gained its authority precisely because it has articulated deep-rooted and broad ethical principles regarding the ethics of medical research? Almost like an old religious text in which comments debate the meaning of individual words, the DoH is almost the subject of a word-for-word analysis. Take Article 29, where a huge amount of ink was spilled on the meaning of “better electricity”. The Nuffield Council document on “Research in developing countries” devotes an entire chapter to what is indeed a debate on the true interpretation of this sentence [49]. The obligation to provide negative results also seems to raise few objections, but should be recognized for the significant progress it represents. As Godlee pointed out, “negative results are just as important for scientific understanding, although less exciting for researchers and publishers than positive studies.” She asks, “What does publication bias have to do with ethics?” and replies, “There is only part of the picture, distorting our view of what is the best treatment for patients” [43]. The recent iteration of Helsinki (2013) reflected the standard of care controversy that resulted from vertical transmission testing. The 2013 Revised Declaration also highlights the need to disseminate research findings, including negative and inconclusive studies, and also includes a commitment to treat and compensate for research-related injuries. [67] In addition, the updated version is considered more relevant for limited resource parameters, in particular for the need to ensure access to an intervention if it proves effective. In medical research on humans, considerations of human well-being should take precedence over the interests of science and society. Although most of the meetings did not result in consensus on the proposed revisions and many argued that the Declaration should remain unchanged or be amended only minimally, after extensive consultations, the Working Group [35] finally drafted a text that was approved by the WMA Council and adopted by the General Assembly on 7 October 2000 [36] and which turned out to be the revision.

the deepest and most controversial to date. One of the reasons for this was to take into account the expanded scope of biomedical research since 1975. [37] This included a restructuring of the document, including the renumbering and reorganization of all sections whose amendments are listed in this table. The introduction exposes the rights of subjects and describes the inherent tension between the need for research to improve the common good and the rights of the individual. The Basic Principles provide a guide for assessing the extent to which proposed research meets expected ethical standards. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticized by Levine[19][38], has been removed to emphasize the more general application of ethical principles, but the application of the principles to healthy volunteers is set out in Articles 18 and 9 and they are identified as particularly vulnerable in Article 8 (“those who will not personally benefit from the research”). The scope of ethical review has been expanded to include human tissues and data (Article 1), the need to question accepted care has been added (Article 6) and the primacy of ethical requirements over laws and regulations (Article 9) has been established. This is an important logical reformulation of how the DoH categorizes different types of research with human subjects. Pre-2000 versions of the statement effectively dichotomized therapeutic research (which can directly benefit the subject) and non-therapeutic research (no direct benefit to the subject). In the Edinburgh revision (2000), the new category “Medical research in combination with medical care” is recognized as a subset of “total medical research on humans”.

The physician may combine medical research with professional care, with the aim of acquiring new medical knowledge, only to the extent that the medical research is justified by its potential diagnostic or therapeutic value for the patient. The IPbpR states that “no one may be subjected to medical or scientific experiments without his free consent”. [15] Analyzing its genesis, it can be clearly seen that Article 7 was the result of the broad consensus of participants to explicitly include the ban in response to atrocities committed in concentration camps during World War II. [16] The UN Human Rights Committee subsequently interpreted Article 7 as requiring “special protection” and noted that the prohibition in Article 7 applies not only to acts that cause physical pain, but also to acts that cause psychological suffering to the victim. In addition, the prohibition extends to corporal punishment, including excessive punishment, which is ordered as punishment for a crime or as an educational or disciplinary measure. [17] The World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving humans. Medical research on humans includes research on identifiable human material or data. [70]. See in general L. O.

Gostin, “Ethical principles for the conduct of human subject research: population-based research and ethics,” Law, Medicine and Health Care 19 (1991), p. . . .