Beware side effects of research ethics revision.

The World Medical Association's Declaration of Helsinki is one of the most important ethical guidelines pertaining to biomedical research. It was originally adopted in 1964 as a statement of ethical principles in research involving human subjects, addressed primarily to physicians. The Declaration's roots are in the Nuremberg code, which grew out of the trials against Nazi doctors. Since the first revision of the document in 1975, it has explicitly stated that the interests of the research subject should prevail over those of science and society. It has been modified six times, most recently in 2008 ([ 1 ][1]). Although it is not legally binding, it has influenced legislation in many countries and become a cornerstone in research ethics. In October 2011, the General Assembly of the World Medical Association decided to initiate a new revision of the Declaration ([ 2 ][2]). In the current version, the Declaration states that consent should be required for all research that uses identifiable tissue samples and data. It then adds, “There may be situations where consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research.” The proposed revision would strike the phrase “or would pose a threat to the validity of the research” ([ 3 ][3]). We question this change and believe that further discussion on the issue is needed. In medical research, the risks must always be weighed against the benefits. When the risks are significant, the interests of the individual should obviously prevail over the interests of society. It is uncontroversial that one person should not be sacrificed for the benefit of the many, a principle reflected in the declaration since 1975. But when the risks are minimal, it is not clear that the individual's interest in having a say should automatically outweigh the good that can result from robust research. For example, many countries have cancer registries that collect data without consent, because universal inclusion is deemed more important than respecting the preferences of each individual. The proposed change suggests that no research on samples and data is important enough to be conducted without consent, if it is practically possible to ask for it. From such a perspective, not even major challenges to people's health (e.g., cancer) would be sufficient to outweigh the right of individuals to decide whether their material can be used. Although we acknowledge the value of self-determination, this is a narrow interpretation of research ethics that can affect a wide range of research activities using public health data and sample collections. 1. [↵][4] 1. R. V. Carlson, 2. K. M. Boyd, 3. D. J. Webb , Br. J. Clin. Pharmacol. 57, 695 (2004). [OpenUrl][5][CrossRef][6][PubMed][7][Web of Science][8] 2. [↵][9] World Medical Association, DoH Public Consultation 2013 ([www.wma.net/en/20activities/10ethics/10helsinki/15publicconsult/index.html][10]). 3. [↵][11] World Medical Association Declaration of Helsinki ([www.wma.net/en/20activities/10ethics/10helsinki/15publicconsult/DoH-draft-for-public-consultation_annotated.pdf][12]). [1]: #ref-1 [2]: #ref-2 [3]: #ref-3 [4]: #xref-ref-1-1 "View reference 1 in text" [5]: {openurl}?query=rft.jtitle%253DBritish%2Bjournal%2Bof%2Bclinical%2Bpharmacology%26rft.stitle%253DBr%2BJ%2BClin%2BPharmacol%26rft.aulast%253DCarlson%26rft.auinit1%253DR.%2BV.%26rft.volume%253D57%26rft.issue%253D6%26rft.spage%253D695%26rft.epage%253D713%26rft.atitle%253DThe%2Brevision%2Bof%2Bthe%2BDeclaration%2Bof%2BHelsinki%253A%2Bpast%252C%2Bpresent%2Band%2Bfuture.%26rft_id%253Dinfo%253Adoi%252F10.1111%252Fj.1365-2125.2004.02103.x%26rft_id%253Dinfo%253Apmid%252F15151515%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [6]: /lookup/external-ref?access_num=10.1111/j.1365-2125.2004.02103.x&link_type=DOI [7]: /lookup/external-ref?access_num=15151515&link_type=MED&atom=%2Fsci%2F341%2F6152%2F1341.2.atom [8]: /lookup/external-ref?access_num=000221508400002&link_type=ISI [9]: #xref-ref-2-1 "View reference 2 in text" [10]: http://www.wma.net/en/20activities/10ethics/10helsinki/15publicconsult/index.html [11]: #xref-ref-3-1 "View reference 3 in text" [12]: http://www.wma.net/en/20activities/10ethics/10helsinki/15publicconsult/DoH-draft-for-public-consultation_annotated.pdf