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There are a number of examples in the literature of researchers raising concerns about how best to respond to multiple review committees’ varying, and sometimes incompatible, requirements when seeking approval for multi-site studies (see http://globalhealthreviewers.tghn.org/resources/articles-and-reports/articles/).
Variations in decision-making, in addition to the significant administrative burden that variations in application processes for differing committees can pose, has led to the formation of multi-site and/or national review committees in many jurisdictions. Such committees have the authority to approve research taking place at a number of sites within their jurisdiction. In some cases local review will be required in additional to centralised review, and in such cases the local review may be limited to reviewing issues of particular relevance to the local context, such as the design of appropriate recruitment processes. Concerns have also been raised, however, about the consistency of decision-making even within committees, including decisions by a single committee about the same research protocol at regular intervals.
Should committees seek to be consistent in terms of their decision-making? Should a research protocol receive similar responses from differing committees or the same committee over time? There are a number of arguments in favour of consistency. A rigorous and transparent process of review should give consistent results when applied to individual protocols. Committees have obligations to conduct fair and appropriate review and, even with differences between members of individual committees and in the design of specific protocols, ethical issues and appropriate responses to these should be able to be consistently identified.
If consistent review is not possible, it is harder to argue that ethical review of research is a valuable process which protects research participants. If two committees review the same protocol and reach differing views about which issues are of significance and how they should be responded to, how can researchers have confidence in the decisions? Arguably the views of review committees should only be substantially different if there are morally significant differences between studies to justify such differences. Researchers should be able to rely on consistent review to inform the design and conduct of appropriate protections for research participants.
In contrast, a number of concerns can be raised about any attempts to require committees to make consistent decisions. Whereas it may be relatively easy to identify consensus at the level of broad statements in international guidance and regulation, such as the need for consent to be informed and voluntary, in practice, no two research protocols or committees are the same. Research is highly contextual: the same study at two different sites may have differences in the research contexts with ethical implications that review committees must be able to identify and respond to. Review committees are often established locally precisely so that they are able to identify and evaluate issues arising in the local context. Different individuals on committees will have different training and experience that they bring to decision-making. Just as no two studies are exactly the same in practice, no two reviews will be the same, and this is appropriate for the variation that exists on a case-by-case basis when conducting research.
What are your views? Is it more important for committees to strive for consistency or for responsiveness to the local research context? Should we seek consistency in some areas of ethical review and embrace diversity in others?
Interesting questions. There are four areas of consistency that, I think, we need to think about, and which you have also outlined:
a) consistency based on type of study being reviewed
b) consistency based on the issue being reviewed
c) consistency across contexts
d) consistency across time
Across these, I see areas that are more relevant for IRB’s input and others which require wider deliberations of both IRB and independent ethics review committees. It is precisely for these reasons that now there is significant deliberations around standard of care for research participants (universal versus local), levels and scope of study benefits including levels of individual participant, community and ancillary care etc; autonomy versus relational autonomy in informed consent. My take is that decision-making on fundamental ethics requirements (e.g. on individual informed consent, voluntariness, on fairness and justice etc) need to be consistency; the particularities of how these can be achieved however can be contextual (e.g. a pre-condition for individual informed consent in one context might be sensitization of the wider community on its place and importance in research; while in another context, this may not be necessary.
It sounds like you're a fan of local review even if it may be inconsistent at times. I wonder if we will get to the stage where IRBs will consistently feel able to accept decisions from other IRBs without re-reviewing studies.
There are several issues
Mushrooming IRBs are a burden on researchers
However there are several caveats
1. I know a researchers apply to a different IRB when one is rejected without a good reason (this protocol was approved by IRB in major UK university)
2. having a central or national review committee may help researchers but not without problems
3. in Sri Lanka there are moves to create a national body to facilitate trials by big pharma- which might be an obstacle for independent academic researchers-they trying to bring a new act like India
4. the solution would be to keep independent IRBs but each IRB should ask for ethical approval from other bodies. If they have obtained IRB approval from one body it should be plain sailing unless there is a regional issues (very unlikely)
have i made myself clear- we need local shops to survive and not be swept away by supermarkets
otherwise capacity in research and ethics will be even less in small universities