Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative

Abstract

The Open Peer Commentaries on “The Emergence of Clinical Research Ethics Consultation: Insights from a National Collaborative201D highlight the many ways in which the practice of ethics consultation for clinical research can be further advanced. We respond here to a number of key considerations highlighted by commentators, including the role and scope of research ethics consultation (REC), relationships with other institutional services and programs, efforts to ensure the quality of consultations provided, and the feasibility of widespread REC services.

Research Ethics Consultation in Nursing Studies

“…Regarding the meaning of research ethics consultation, Fost (2018) argued that such services were unnecessary by suggesting that research ethics consultation should routinely be the responsibility of the research ethics committee. In line with Porter et al (2018), we considered that the scope of research ethics consultation sometimes extends beyond protocol review and the reach of the research ethics committee.…”

“…There were no consultations in which research integrity mattered in this review. In addition, in line with Porter et al (2018), we essentially considered that the consultant should be aware of the meaning of research integrity and the institutional management resources system to support research integrity.…”

“…However, studies addressing the education of research ethics consultants remain scarce to date. Porter et al (2018) reported the establishment of the Clinical Research Consultation Affinity Group at the American Society for Bioethics and Humanities. In line with the projects “Research and development of a model teaching material/program for research ethics education” (2016–2018) and “Development of comprehensive higher education programs on research ethics and integrity for medical sciences” (2019–2021), supported by the Grant-in-Aid from Japan Agency for Medical Research and Development (supervised by Matsui, K.), we are now developing a teaching material and/or program for research ethics education in Japan, aimed primarily at “professional” research ethics consultants (Yanagawa et al, 2021).…”

Naturally occurring language as a source of evidence in suicide prevention

“…Second, also within the research ecosystem, proper review of research in this emerging area requires multidisciplinary participation, since there may be risks understood by either technologists or suicidologists that might not be readily apparent to the other—suicidologists having a greater awareness of encountering someone with acute suicidality and proper response while technologists have a heightened assessment of data management risks. Although Institutional Review Boards are central in ethical review and the legal issues, more recent models of clinical research ethics consultation (Beskow et al, 2009; Porter et al, 2018a and Porter et al, 2018b) may provide additional utility in determining and mitigating risk with broader attention to people's rights and dignity, as well as public perceptions of using the data under consideration.…”

An educational workshop designed for research ethics consultants to educate investigators on ethical considerations

“…These consultants have the capacity to advise clinical research investigators at each research institute (Beskow et al 2009;McCormick et al 2013;Sharp et al 2015;Porter et al 2018a). Notably, despite investigator-directed research ethics education, there is a paucity of information concerning such initiatives for research ethics consultants (Arnold et al 2018;Porter et al 2018b).…”