IRB Oversight of Patient-Centered Outcomes Research A National Survey of IRB Chairpersons

• Published in: Journal of empirical research on human research ethics Vol. 13; no. 4; pp. 421 - 431
• Main Authors: Weissman, Joel S., Campbell, Eric G., Cohen, I. Glenn, Lynch, Holly Fernandez, Largent, Emily A., Gupta, Avni, Rozenblum, Ronen, Abraham, Melissa, Spikes, Karen, Fagan, Maureen, Carnie, Martie
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA Sage Publications, Inc 01.10.2018; SAGE Publications; Sage Publications Ltd
• Subjects: Attitude; Biomedical Research - ethics; Ethical Review; Ethics Committees, Research; Ethics, Research; Humans; IRB/REC and Institutional Issues; Leadership; Patient Participation; Research ethics; Research Subjects; Social Responsibility; Surveys and Questionnaires; United States; United States; ethics and public policy; human subjects regulation and oversight; human subjects ethics; patient-centered outcomes research; empirical studies of research ethics
• ISSN: 1556-2646; 1556-2654; 1556-2654
• DOI: 10.1177/1556264618779785

Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from researchintensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR's overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.