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Have you had the experience when sitting on a committee reviewing research, when a relatively high risk protocol comes before you but can be approved with confidence and relatively little discussion? In such cases applicants are often experienced in their fields, and engaged with the relevant ethical and regulatory issues. The protocol shows both that potential issues have been clearly identified, and that appropriate responses to these have been developed.
Conversely, a relatively low risk protocol may raise significant concerns. Some of these concerns may focus on the way that the research protocol or committee application forms are filled out. The errors and concerns may be primarily procedural, with inconsistencies within and between documents, spelling mistakes, grammatical errors and inappropriate language levels (such consistently using complex scientific terminology which is unfamiliar to some members of the committee). Questions are often asked about whether these errors are the result of rushing to meet a review deadline, or overlooked when multiple different forms of paperwork about a study are being prepared for review by different committees and boards. Questions then arise about whether such carelessness will carry over to the way in which the research is conducted, with potential consequences for the care and attention paid to addressing regulatory and ethical issues arising during research.
An alternative scenario that can cause concern is when researchers confidently state that there are no ethical issues raised by their research, or only recognise some of the relevant issues. Sometimes researchers don’t seem to recognise that their research touches on sensitive or potentially stigmatising issues, or that they are proposing to engage with a particularly vulnerable group of research participants. In other cases the potential issues have been identified, but there are concerns about whether proposed responses to these are well-informed and appropriate, particularly when less-experienced researchers have drafted the protocol and are leading the study.
For many researchers relatively unfamiliar with review processes, engaging with the ethical and regulatory issues raised by their research and drafting applications for review can be daunting, particularly when they don’t have effective mentors to guide them through the process. Online training in ethical and regulatory issues may be very useful (see http://globalhealthreviewers.tghn.org/elearning/ for examples) but may not provide specific enough advice to be ideal for those developing protocols. Similar issues arise when providing capacity building for members of committees reviewing research. Training courses may provide an excellent general grounding in the issues that can arise, but the chance to consider issues raised by particular protocols may be rare. Much of the experience of reviewing specific studies arises only when in post as a committee member, often under some time pressure when there is a substantial agenda to move through.
A recently launched response to this lack is The Ethics Application Respository (TEAR). This allows researchers to donate specific protocols that have been approved by their review boards to the repository. Researchers must be prepared to be identified on the protocols and the protocols will be embargoed for two years before being made available, in case of commercial sensitivities. Protocols are commented on and filed by topic for later searching. Access to such protocols can be very valuable for junior researchers, and also for supervisors and ethics committee members who are unfamiliar with a particular form of research. At present the protocols in TEAR focus on methodologies in the social sciences, but plans are underway to incorporate a broader range of research methodologies, including clinical studies from around the world.
The Elearning courses currently in development by GlobalHealthReviewers, are focusing on issues raised when reviewing specific kinds of research, such as genomic research, cluster randomised trials, and social science research. Ideally, such courses could be accompanied by archived protocols in these fields in a repository like TEAR. This combination would provide a more complete illustration of general ethical and regulatory issues raised by such studies, and how these are negotiated by experienced researchers in the field on a case by case basis. To develop a resource of such protocols, committees reviewing research and researchers will need to donate protocols that they have worked on. If you are aware of high quality protocols that have been reviewed, and where researchers may be prepared to share their materials, please read the terms and conditions on the TEAR website and confirm if the relevant parties are willing to sign up to them. If you email us on email@example.com to let us know when there is agreement that such protocols can be shared, we can work with TEAR to support the archiving process.