Fistein, E. and Quilligan, S.
Journal of Medical Ethics 2012:38:224-227
This article is written by two researchers from the University of Cambridge who reflect upon their experiences with ethics committees in obtaining approval of observational research in clinical settings. The researchers submitted different protocols to two ethics committees. The authors describe the similarities of decisions of the research ethics committees as well as their divergence in what they would approve and how the committee suggested the protocols should be changed, including their views on consent, audio and video-recording, and maintaining participant confidentiality. The researchers were pleased that the committee scrutinized their proposal and made suggestions, but they felt overwhelmed during their meetings with the committees and were unable to effectively voice a defense of their protocols or correct factual misunderstandings. The authors agree that it is important for ethics committees to be committed to the protection of prospective research participants and take a robust approach to the consideration of risk. The authors conclude with several suggestions for researchers:
- Don't assume detailed knowledge of law or codes of practice. Providing these in advance and quoting relevant sections verbatim may help the committee, which will consist of lay members, clinicians and scientists.
- Take great care explaining methodology, especially if you diverge from the dominant paradigm of clinical trials into areas where the committee may have less experience.
- Consider whether or not to attend alone. Novice researchers may feel more confident defending their protocols to a committee of 12 members if they are accompanied by an advisor or supervisor.
- Keep an open mind. A divergence in values between you and the committee is not a personal attack on you. Their opinions are valid and deserve consideration.
- Don't give up. Although only a minority of protocols receives approval on first consideration, the majority is approved following amendments; we have both now had projects successfully approved by ethics committees.
Link to publication: http://jme.bmj.com/content/early/2011/11/01/medethics-2011-100124.abstract