HLTH 3098 Chapter 2: Guidance for IRBs and Reviewers
Document Summary
Therefore, a stepwise approach to consideration of the research proposal may be helpful. It is important to ask researchers to fully describe the population to be studied and the situations in which the potential research subjects find themselves. This should answer both the question about the intrinsic factors or attributes, as well as the situational forces that may give rise to different types of vulnerability. It will also help the irb and researchers quickly identify if there are any regulations that must be applied. Researchers generally have a much clearer understanding of the circumstances and potential challenges their research subjects face. They are in a unique position to share their insight. When irb"s request this information, it facilitates the review of research and in the best circumstances leads to better designed research studies, improved review of research, and better protection of human subjects.
