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Transparency in the conduct of research is frequently promoted . National and international clinical trial registries seek to provide a record of studies that have been conducted, regardless of their results and any subsequent publications. Commentators claim that accurate reporting of research is an ethical imperative and an essential component of good research practice. The 2011 World Health Organization Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants also mention the importance of transparency in the review process. It recommends that committee decisions, excluding confidential information, are made publicly available, through mechanisms such as clinical trial registries, web sites, newsletters, and bulletin board.
In addition to the issue of reporting committee decisions, a question arises about whether it is valuable for the review process itself to be transparent. Committees that review research have a range of approaches to the transparency of the review processes. Some committee’s meetings are open to the public or members of a relevant institution. Others may invite specific interested parties to attend all or parts of meetings: including applicants, students or senior staff providing advice on the development of protocols for review. In contrast, some committees meetings are closed to external observers, and just have members of the committee and support staff present.
Transparency in the review process can offer a number of benefits. Having the chance to observe committee deliberations can be a valuable learning experience for applicants, advisors and students. Committee members often have differing views about ethical issues in specific protocols. Committee discussions about appropriate ways to resolve differences in opinion can give observers insights into identifying ethical and regulatory issues in various forms of research; a range of opinions that may be held about such issues; and how debates about appropriate ways forward are resolved. Even when observers have already had training in research ethics and regulatory issues, a chance to observe how such issues are addressed on a case by case basis can be enlightening. As individual ethics committees frequently differ in how they consider ethical and regulatory issues should be resolved in protocols, it may also be very helpful for those submitting protocols to specific committees to see the kinds of views that committee tends to have about certain issues in research. Promoting observation in these circumstances can lead to capacity building amongst applicants and improve the standard of protocols submitted for review.
Having observers may also prompt committees to maintain consistently high standards of review, and seek to ensure that rigorous and well-reasoned assessment of individual protocols take place. Expert independent observers may be valuable in assessing and providing feedback on committee review and such review is recommended in the WHO Organization Standards and Operational Guidance mentioned above. Concerns have been raised by committee members however, that having open meetings or observers from amongst the applicants submitting protocols and staff from local institutions may hamper review.
One issue of concern is that identifying ethical issues and appropriate means of responding to these is not always a straightforward process. It may be harder for members to explore ideas and talk around appropriate means of resolving them, and to discard earlier ideas or express disagreement, with faced with an audience of non-committee members. Other concerns relate to whether members will be able to have free and frank discussions when colleagues, and particular senior colleagues are observing. It is one thing for the committee to report a decision, and another for it to be known beyond the committee which members proposed that amendments to a protocol be requested.
I have sat on two committees, both of which held closed meetings but encouraged students or advisors to attend. One of the committees occasionally requested researchers who had submitted particularly complicated protocols to attend the first part of the review of that protocol and answer questions of clarification – they were then excused from the meeting while a final discussion about the protocol took place. I think where it’s possible, this process saves time and what can be a lengthy correspondence to clarify matters of fact outside the meeting. One committee reported results of its decisions, but only in an aggregated form outlining the number of applications, the groups from whom applications come, what the initial decision was, and how long it took to reach the decision and respond to applicants.
I would be very interested to hear whether your review committee holds any part of its meeting in public or invites visitors to attend. Are decisions published in any format?