Concurrent Session #1
New Rule Exemptions – Exemptions
Ada Sue Selwitz of the University of Kentucky
One of the most significant changes in the new Federal Policy on Human Research Protection (i.e. the Common Rule) is the new exemption categories. Many studies that in the past were approved using expedited or even convened IRB review procedures will now be eligible for exemption. Also, the new rules introduces a new type of review (i.e. limited IRB) that applies to select exemptions. This session will discuss the eight new categories, outline the conditions for limited IRB review, and provide the participants with the opportunity to apply the categories to mini cases.
Framing, Perspective and Hot Cognition: A preliminary exploration of the experiential case scenario as a tool for a training advanced issue spotting in protocol review.
Presented by Robert Bruce Thompson and Carol Nemeroff from the University of Southern Maine
We report qualitative and quantitative results of a recent experimental study that investigated how the framing of a study and participant role (professional perspective) would affect judgments of risk, ethics and adverse event culpability, in a highly realistic, emotionally charged, fictional drug trial study. A key goal was to explore how the spontaneous dialogue of compliance officers (RIOs) and IRB members reflected the capacity to identify problem areas within a protocol. The aim of this study and continuing, related work is to develop risk assessment and ethics training for researchers and RCR personnel that provokes awareness of the role of metacognitive reasoning (advanced critical thinking) in complex, ethically ambiguous cases.
Thirty-five participants, approximately equally divided into research integrity officers (RIOs) and two IRBs were introduced to a fictional phase-2 human drug trial study, designed to include ethically ambiguous statistical procedures, questionable logic around risk assessment, and incomplete/inadequate informed consent. Content analysis on transcripts of participants’ deliberations, combined with formal votes were used to assess how each group responded to the protocol.
Each group experienced a slightly different framing of the protocol: 1. Prior knowledge of a fatal adverse event (RIOs and IRB -1); and “naïve” evaluation of the protocol with no knowledge of an adverse event (IRB 2). One key focus was on potential hindsight biasing effects of knowing in advanced that a fatal adverse event had occurred, when evaluating the behavior of the PI . Another focus was on how salient features of the case scenario– A PI with impressive credentials, research on a life-saving drug, the death of a new-born infant, etc. may differentially affect the capacity of RCR professions to use metacognitive reasoning to evaluate the risk-benefit ratio of a study.
Preliminary qualitative transcript analyses indicated patterns of “hot cognition” in which emotion and scenario framing played a role in both positive and negative evaluations of the study. An overall result was that researchers and RCR staff felt that the experience helped highlight how break-downs in metacognitive reason can impact one’s ability to objectively evaluate the risk and benefits of complex and emotionally charged research topics.
Experiences in Implementing Single IRB Review: Developing Policies and Practices
Presented by Joseph Datko & Evelyne Bital from the University of Miami
In late 2015 the University of Miami Human Subject Research Office began laying the groundwork for its Central Institutional Review Board (UM CIRB), motivated both by the anticipated change in NIH award policy for multi-site research and by investigators at UM interested in using a single IRB. Since that time our project has expanded to oversee over 50 relying study sites with an anticipated demand of several hundred more from our partner research consortia.
Our session discusses the approach we took to program development for a single IRB at an academic medical center, including policy decisions made to fit that setting, feedback and adaptations made, and preliminary recommendations for similar institutions looking to set up their own single IRB. Our hope is to exchange developing best practices in the pursuit of increasing nationwide harmonization.
Through the course of the program we have established a dedicated committee of faculty and non-affiliated reviewers, expanded our regulatory support staff from two to four full-time positions, and implemented a customization to the software for UM’s electronic protocol management system to facilitate multi-site review.
Highlights of the program as implemented include:
- Adaptation of AAHRPP accredited-policies and procedures
- Communication model employing partnership with coordinating centers for research networks
- Support from in-house Quality Assurance team
- Embrace of SMART IRB reliance agreement
Ongoing challenges facing the program include:
- Updating written procedures to match adaptations in practice
- Limitations in software platform and upgrade timeline
- Hesitation by institutions unfamiliar with external reliance practices