Justification and authority in institutional review board decision letters

• Published in: Social science & medicine (1982) Vol. 194; pp. 25 - 33
• Main Authors: Clapp, Justin T., Gleason, Katharine A., Joffe, Steven
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2017; Pergamon Press Inc
• Subjects: Accountability; Authority; Biomedicine; Bureaucracy; Committees; Compliance; Decision Making, Organizational; Ethics; Ethics Committees, Research - legislation & jurisprudence; Ethics review; Health behavior; Health research; Human subjects; Human subjects research; Humans; Institutional review board (IRB); Justification; Letters (Correspondence); Missing information; Qualitative research; Research Design - legislation & jurisprudence; Research ethics; Research ethics committee (REC); Research subjects; Review boards; USA; Variability; USA; Ethics review; Authority; Institutional review board (IRB); Human subjects research; Bureaucracy; Research ethics committee (REC)
• ISSN: 0277-9536; 1873-5347; 1873-5347
• DOI: 10.1016/j.socscimed.2017.10.013

While ethnographic study has described the discussions that occur during human subjects research ethics review, investigators have minimal access to the interactions of ethics oversight committees. They instead receive letters stipulating changes to their proposed studies. Ethics committee letters are central to the practice of research ethics: they change the nature of research, alter the knowledge it produces, and in doing so construct what ethical research is and how it is pursued. However, these letters have rarely been objects of analysis. Accordingly, we conducted a qualitative analysis of letters written by American institutional review boards (IRBs) overseeing biomedical and health behavioral research. We sought to clarify how IRBs exercise their authority by assessing the frequency with which they provided reasons for their stipulations as well as the nature of these reasons. We found that IRBs frequently do not justify their stipulations; rather, they often leave ethical or regulatory concerns implicit or frame their comments as boilerplate language replacements, procedural instructions, or demands for missing information. When they do provide justifications, their rationales exhibit substantial variability in explicitness and clarity. These rhetorical tendencies indicate that the authority of IRBs is grounded primarily in their role as bureaucratic gatekeepers. We conclude by suggesting that greater attention to justification could help shift the basis of the IRB-researcher relationship from compliance to mutual accountability. •First study of U.S. institutional review board (IRB) decision letters.•Assesses frequency with which IRBs justify their stipulations.•Analyzes discursive strategies by which IRBs justify (or not) stipulations.•IRBs often do not provide justification; their authority is largely bureaucratic.•With more robust justification, ethics review could become more substantive.