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The Declaration of Helsinki is a comparatively fluid document, with amendments being considered on a regular basis. Since 1996, there have been two major revisions (in 2000 and 2008) and two minor notes of clarification (in 2002 and 2004). The two month public consultation period for the latest proposed revisions to the Declaration of Helsinki is closing on 15 June. The Working Group putting together the draft found value in the unique nature of the Declaration and decided to keep it at a similar length and focused on ethical principles, rather than detailed regulation. There, have, however, been some interesting changes aimed at strengthening protection of research participants.
With regard to ethical review, paragraph 15 of the 2008 Declaration has become paragraph 23 in the draft revision. Proposed additions to the current text are shown in bold below.
Draft paragraph 23.
The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration… At the end of the study, the investigators must submit a final report to the committee containing a summary of the study’s findings and conclusions.
While the requirement that committees must be duly qualified seems appropriately aspirational, it will be interesting to see how this is interpreted in practice. There is considerable variation in training requirements for ethics committee members around the world, ranging from no formal training being necessary, to annual certified training being required. There is also some variation in the forms of expertise that committees' seek to have in their members.
Transparency of committee functioning also appears to be valuable and uncontroversial. When a proposal is submitted, it is important to know which process for review it will go through, and that a fair, appropriate and timely decision will be reached. There is more controversy, however, about the value of making committee deliberations transparent to applicants and the public. While some committees permit interested parties and the public to observe their deliberations, many do not. Transparency of meetings can arguably promote careful and rigorous consideration of protocols, under the eye of interested parties. An alternative view is that it can stifle the review process, for example when committee members feel unable to voice concerns in front of senior staff observing meetings. Additionally, observers may stifle committee reflections, as members are unwilling to voice reservations that have not yet been completely thought through, and which would subsequently be discussed and clarified amongst committee members, in some cases with lively debates arising.
The final novel provision, that it is mandatory to provide end of study reports, is routine in many settings. It is not clear, however, what response to these reports, if any, committees are required to make. Assessing and responding to end of study reports could add significantly to committee workloads, and should arguably not be permitted to reduce the time members have available to review protocols.
Please let us know what you think of these proposed revisions.