| Session Title: Institutional Review Board Options for Evaluation: Benefits and Risks |
| Expert Lecture Session 552 to be held in Capitol Ballroom Section 5 on Friday, Nov 7, 10:55 AM to 11:40 AM |
| Sponsored by the AEA Conference Committee |
| Presenter(s): |
| D Paul Moberg, University of Wisconsin Madison, dpmoberg@wisc.edu |
| Nichelle Cobb, University of Wisconsin, nlc@medicine.wisc.edu |
| Abstract: It is a given that in any evaluation, mechanisms are put in place to protect the confidentiality, privacy and other rights of participants. However, standards and requirements for oversight of evaluation and quality improvement studies by Institutional Review Boards (IRBs) are ambiguous, not always well understood by evaluators, and are highly variable across institutional settings. In this paper, we seek to systematically describe the various options available to evaluators and the IRBs they work with for meeting review requirements. We also summarize the risks and the benefits (to investigators, IRBs and institutions) of these options. Each of the following options provided for in the “Common Rule” (federal regulations for human subjects research) will be discussed: 1. Determination of evaluation studies as not constituting human subjects research, either because the data used do not meet the definition of being from “human subjects” or the work does not meet the definition of “research”. 2. Determination of the evaluation as exempt from IRB review and oversight under one of several applicable conditions (e.g., as survey research); or 3. The evaluation constitutes minimal risk human subjects research requiring IRB review. The paper will provide examples of evaluations meeting each of these categories, with recommendations of applicability, benefits and risks of applying them. This information can be used to inform the decisions made by both evaluators and their IRBs to demystify this process. |