Revisions to the Declaration of Helsinki

On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki.  The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.”

You can see a side by side analysis of the proposed revisions and explanatory comments here.  We’ll see what happens down the road, but a few things are worth noting:

  1. The working group responsible for the revisions explicitly acknowledges that it cannot literally be true that the well-being of the individual research subjects must take precedence over all other interests (new paragraph 8/old para. 6).  Nonetheless, it retains that language for aspirational purposes – a strange choice, IMHO, which could conceivably lead to less respect for the Declaration as a whole.
  2. The revised Declaration would (in line with almost every other ethical body to consider the issue) add a new paragraph indicating that “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured” (new para. 15).  The current version (old para. 14) states only that the protocol should include “provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.”  The nature of the Declaration is such that it doesn’t provide much detail, but even this revised statement is a step in the right direction.  Will US regulators ever take the hint?
  3. The revisions would take a harder stance toward research involving disadvantaged or vulnerable populations, permitting research with these groups only when it could not be carried out in a non-vulnerable population (new para. 20/old para. 17).  I understand the sentiment…really I do.  But this approach seems to unduly discount the real benefits that accrue to research participants and communities just by virtue of having the research done there.  And if research is responsive to population/community needs and priorities AND the population/community stands to benefit from the research – two standards that remain in the revised Declaration – why do we need the third criterion that research couldn’t be conducted in an alternative population?
  4. The revisions would more strongly encourage post-trial access to interventions identified as beneficial (new para. 34/old para. 33), but would still use the permissive “should” instead of “must” and would still be quite open-ended with regard to the party on which this burden would fall – sponsors, researchers, and/or host countries.
  5. Unlike the current version, the revised Declaration would no longer support the use of identifiable biospecimens or data without consent when a consent requirement would pose a threat to the validity of the research (new para. 32/old para. 25), which seems to be in line with the general trend toward stricter protections for the human sources of such research material.
  6. And finally, the ever controversial topic of placebos.  Here, the proposed revisions (new para. 33/old para. 32) clarify that placebos aren’t the only worrisome type of control, explicitly applying the standards for acceptable use of placebo to “any intervention less effective than the best proven one.”  This revision is sure to get a great deal of attention, as the WMA seems to be sticking to its guns – not endorsing use of placebo/less-than-the-best interventions even when doing so might be the only way to get locally relevant data on interventions that could be tremendously useful in resource-poor settings.  I was really hoping they’d fall in line with CIOMS and its exceptions to Guideline 11.
Many sponsors include boilerplate language in their research protocols indicating compliance with the Declaration of Helsinki, while simultaneously including contradictory approaches in the remainder of the protocol.  I have a hunch that this has to do with the aspirational nature of the Declaration itself, but I wonder if (read: suspect that) these revisions – if approved – will make the Declaration even further removed from research realities.
Comments on the revisions should be submitted to the WMA secretariat no later than June 15, 2013.

Holly Fernandez Lynch

Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at Penn’s Perelman School of Medicine. She is also the Assistant Faculty Director of Online Education, helping to lead the university’s first online master’s degree, the Master of Health Care Innovation, and other online offerings.

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