In this article, we ask what it might be about the process of research ethics review in research ethics committees (RECs) that makes "ethics review equivalency" (ERE) between RECs so difficult to achieve, and suggest possible solutions from administrative law and theoretical ethics. First, we consider why the European Union's Clinical Trials Regulation - a regulatory instrument that should achieve ERE - does not do so. We then approach the problem of ERE through a reflection on the purpose of RECs. This leads us to consider how two different approaches - "gatekeeper" and "sounding board"might assist in producing a platform that could help to move towards ERE. RECs as "gatekeepers" suggests that they are similar to (or indeed are) tribunals, and as such should follow principles of natural justice. Natural justice in the ethics review context requires both procedural and substantive ethics harmonisation. Substantive ethics harmonisation is an intractable challenge, however. The "sounding board" model, based on a discourse approach, moves beyond the substantive ethics harmonisation challenge by shifting the focus to researchers, who ought to a) defend a robust ethics grounding fortheir research, and b) demonstrate "ethics by design" throughout their proposals. Taken together, a natural justice grounding and sounding board model, we suggest, would begin to address the fundamental problems of ERE.
|Journal||Medicine and Law|
|Publication status||Published - 31 Dec 2017|
- discourse ethics
- ethics review
- international research
- research ethics committees
- natural justice
- sounding board
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