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:
- 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:
- Is it research, program evaluation, or quality improvement?
- 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. If IRB review is not required, then the IRB coordinator does not need to review the informed consent process. If IRB review is required, then informed consent may be required. However, some or all of these requirements for informed consent can be waived in cases of minimal risk studies.
Decisions charts on these questions are clearly written by the Office of Human Research Protections (OHRP) here.
I am sure the course attendees got ahead of themselves because the research ethics field is full of passionate people who are keen to identify risks and ensure adequate informed consent processes are in place. However, as an IRB coordinator, I often find myself questioning how best to draw the line between program evaluation and research.
IPA is a unique research organization that uses randomized controlled trials (RCTs) to measure impact of a social or economic program by comparing groups who received the program compared to a similar group who did not. We use RCTs because they provide the highest quality and most reliable answers about what works and what does not. We also repeat studies in different countries to test if findings are transferable and work in different local contexts. IPA collaborates with social scientists, such as economists and political scientists, to conduct these studies across domains such as agriculture, education, health, finance, governance, social protection, and post-conflict recovery.
Often, the dichotomy between research and program evaluation is not so clear. IPA's projects work closely with implementing organizations in developing countries to conduct RCTs. Using John Lavelle's diagram from an American Evaluation Association blog on the relationship between research and evaluation for illustration, IPA's work touches points on both sides. We seek to develop generalizable knowledge for the international development industry and provide evidence for informed decision making. We work with academic researchers and stakeholders, make research recommendations and programmatic recommendations, and publish results and report to stakeholders. As an example of this cross-over between program evaluation and research see the recent Bloomberg article "Can You Lift a Family Out of Poverty With 6.53 Goats?"
At the IRB Administrator 201 course, I certainly learned to pause and ask crucial questions upfront instead of jumping immediately to the informed consent. However, I also came away with more questions. The course demonstrated that as the research world evolves and more organizations like IPA are executing innovative projects globally, the nuances that exist within OHRP regulations grow larger. As an IRB coordinator, I look forward to working with the PRIM&R community to answer these questions and to continuing to build stronger guidelines for all types of human subject research.
Interested in learning more about IRB Administrator 201? The next offering of the IRB Administrator 201 course will be held on September 16-17 in San Antonio, TX during PRIM&R’s 2015 Fall Regional Meeting. Learn more.