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IRB Decision‐Making about Minimal Risk Research with Pregnant Participants
Author(s) -
White Amina,
Grady Christine,
Little Margaret,
Sullivan Kristen,
Clark Katie,
Ngwu Monalisa,
Lyerly Anne Drapkin
Publication year - 2021
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500100
Subject(s) - harm , institutional review board , inclusion (mineral) , risk assessment , medicine , family medicine , clinical research , psychology , social psychology , pathology , psychiatry , management , economics
Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision‐making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States to elicit their interpretations of “minimal risk”—a formal regulatory category—and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant people in research.