Variation in interpretation of Subpart B conditions by stakeholders in the IRB review process of abortion research, United States, 2019 Public

Abstract

Background: Federal regulations for the protection of human research participants in the United States include specific protections for pregnant women, known as Subpart B. These protections are meant to prevent pregnant women from being coerced into abortion but may restrict investigators’ involvement in investigational abortion procedures. No published report has evaluated how IRB stakeholders interpret the conditions of Subpart B when applied to abortion research.

Methods: 117 IRB personnel from U.S.-based institutions considered to be stakeholders in the ethical review process for abortion research participated in an online survey. The survey measured participant confidence in applying the conditions of Subpart B to prospectively enrolling research on abortion and specific interpretations of the Subpart B conditions to this type of study. The survey also collected information on participants’ personal experience with IRB review of abortion research. Descriptive statistics were run using SAS 9.4. 

Results: Confidence in reviewing abortion research under Subpart B is high, with 83.8% of respondents reporting confidence in applying the special protections for pregnant women to this type of study. Despite high confidence in applying the conditions, interpretation of the Subpart B conditions varies, even among participants with high confidence. Overall, 73.9% interpreted that Subpart B prevents investigators from randomizing subjects to different methods of abortion, 68.2% of respondents believe Subpart B prohibits researchers from serving as a study’s abortion practitioner, and. 46.6% of participants believe Subpart B prohibits research compensation. 

Conclusions: Confidence in applying Subpart B does not correspond to manner of interpreting the conditions of Subpart B. In this study, we were unable to determine a way to predict which IRB personnel will interpret the conditions more literally than others will. Standardization of interpretation of Subpart B may prevent IRB review from serving as a barrier to conducting abortion research.

Table of Contents

I. Introduction 1

Definition of terms 3

II. Literature Review 4

III. Methods 11

IV. Results 21

V. Discussion 35

References 40

Appendix 1: Key Informant Interview Guide 42

Appendix 2: Survey Instrument 43

About this Master's Thesis

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School	Rollins School of Public Health
Department	Hubert Department of Global Health
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Ethics
Mot-clé	Subpart B women's rights women human subjects research abortion clinical research review board 45 CFR 46 pregnant women research ethics IRB informed consent induced termination of pregnancy compliance ethical review vulnerable ethics Common Rule
Committee Chair / Thesis Advisor	Roger Rochat, Emory University
Committee Members	Sarah Cordes, Emory University Lisa Haddad, Emory University

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