Bioethics Blogs

Ask the Right Questions

By Vinisha Bhatia, research associate, Staff Development and Knowledge Management at Innovations for Poverty Action

As an IRB Coordinator for an international research and policy nonprofit, Innovations for Poverty Action (IPA), I had the opportunity to attend PRIM&R’s IRB Administrator 201 course during the 2015 Spring Regional Meeting in April. My goal was to learn more about IRB administration and review processes in order to apply this knowledge to my organization’s work in social and behavioral research in the international development sector. My biggest takeaway from this meeting? That we need to ask the right questions from the very beginning in order to gather all the necessary information to set up the framework to assess risks and benefits for those participating in the study.

During a group submission review exercise, many of us quickly jumped to critiquing the informed consent document of the protocol under discussion. The seasoned instructors politely pointed out that the class had gotten ahead of themselves – before we get to the informed consent stage, we need to take a step back and first ask two important questions:

  1. Is IRB review required?
    It is important for IRB coordinators to answer this question initially when reviewing IRB submissions in order to properly allocate the IRB’s time for protocols that actually need the review. This question can be answered by a two-part test: 
  1. Is it research, program evaluation, or quality improvement?
  2. Does the research involve human subjects?

  • Is informed consent required?
    The answer to this question is partially dependent on the answer to the first question.
  • The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.