Concurrent Session #3 (1:30pm – 2:45pm)

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.

Public Health Surveillance Under the Common Rule 
Presented by Laura Youngblood of Centers from the Disease Control and Prevention

Title 45 of the US Code of Federal Regulations, Part 46 (45 CFR 46), also known as the Common Rule, defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule requires review by an Institutional Review Board (IRB) for all non-exempt human subjects research conducted or supported by the federal government. As such, it is necessary to correctly identify research involving human subjects in order to comply with regulatory review requirements for federally-conducted or -supported research.

Recent revisions to the Rule have explicitly removed certain classes of activities from this definition, including public health surveillance. The explicit removal of public health surveillance from the definition of research in the revised Rule represents a shift in how the definition of research has historically been interpreted and applied to public health surveillance. The absence of clear guidance on how to interpret “designed to develop or contribute to generalizable knowledge” in the context of public health surveillance has contributed to observed variation in how public health surveillance activities have been classified under the pre-2018 Rule.

Although activities not meeting the definition of research are not subject to the requirements of the Common Rule, including requirements for IRB review, institutions have a duty to ensure that their scientific activities adhere to accepted ethical standards. We believe that this duty, coupled with uncertainty about whether public health surveillance activities should be considered research or non-research, has led many institutions to treat all public health surveillance activities as research.

In this presentation, we propose best practices for interpreting and applying the new public health surveillance category under the revised Rule, documenting decisions regarding the applicability of human subjects research regulations under this provision and assessing adherence to ethical standards for activities found to be outside the scope of IRB review requirements.

The Basics of US Export Controls
Presented by Melissa McGee & Victor Sosa from the University of New HampshireThis session will cover the basic elements of Export Controls, focusing on the issues particularly relevant to higher-education and research institutions.
Export Controls are a complex set of laws and implementing regulations through which the U.S. Government controls the physical export of, and limits access by certain foreign entities and foreign persons to, sensitive equipment, software, technical data, technology and services, in order to promote several of the U.S. Government’s objectives and interests, such as:
  • Restricting the export of technologies that have actual or potential military applications, and could contribute to the military potential of U.S. adversaries;
  • Advancing U.S. trade protection and economic goals;
  • Implementing U.S. foreign policy, including honoring treaties (such as The Treaty on the Non-Proliferation of Nuclear Weapons or the Biological and Toxin Weapons Convention); and
  • Preventing the proliferation of weapons of mass destruction and terrorism, particularly to countries, organizations, individuals, end-users or end-uses of concern.

Certain elements of Export Control compliance may seem to conflict with traditional values and practices of an academic culture in that they tend to discourage free and open exchange of information and they institutionalize barriers to collaboration with foreign colleagues. However, Export Control laws apply to all activities and technologies –not just sponsored research– and they constitute a major element of the University’s overall compliance program. Violations can result in significant civil and criminal penalties for the individual as well as the institution.