Justification and authority in institutional review board decision letters

Justin T. Clapp, Katharine A. Gleason and Steven Joffe

Social Science & Medicine, 2017, vol. 194, issue C, 25-33

Abstract: 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.

Keywords: USA; Institutional review board (IRB); Research ethics committee (REC); Human subjects research; Ethics review; Bureaucracy; Authority (search for similar items in EconPapers)
Date: 2017
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://www.sciencedirect.com/science/article/pii/S0277953617306184
Full text for ScienceDirect subscribers only

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:eee:socmed:v:194:y:2017:i:c:p:25-33

Ordering information: This journal article can be ordered from
http://www.elsevier.com/wps/find/supportfaq.cws_home/regional
http://www.elsevier. ... _01_ooc_1&version=01

DOI: 10.1016/j.socscimed.2017.10.013

Access Statistics for this article

Social Science & Medicine is currently edited by Ichiro (I.) Kawachi and S.V. (S.V.) Subramanian

More articles in Social Science & Medicine from Elsevier
Bibliographic data for series maintained by Catherine Liu ().