Holly Fernandez Lynch, JD, MBe, “Defining and Advancing IRB Quality and Effectiveness.”
Empirical data demonstrates various concerns regarding the existing system of research ethics oversight by Institutional Review Boards, including inconsistent decisions, inefficiency, and nontransparency. However, evaluating positive elements of IRB oversight is far more challenging. How can we tell if IRBs are successfully doing what they were created to do? In this lecture, Professor Holly Fernandez Lynch will examine the difficulties associated with defining and measuring IRB quality and effectiveness and introduce several projects underway by the Consortium to Advance Effective Research Ethics Oversight (AEREO). She will discuss preliminary data from interviews with IRB stakeholders and analysis of existing IRB evaluation instruments, introduce a pilot project to promote the development of IRB precedent, describe a proposal to incorporate the patient perspective into IRB review, and explore whether IRBs are intended to provide substantive or procedural protections.