Institutional Review Board Members’ Experiences of Justice Issues during Research Ethics Review 公开

Abstract

The global health research field is growing rapidly, often engaging in human subjects research among populations that are underserved, underrepresented, and marginalized. Institutional Review Boards (IRBs) are groups constituted to review and monitor biomedical research on human subjects(Center for Drug Evaluation and Research, 2019), and are granted much power over whether research is approved, denied, or if more information is needed. However, little is known about the experiences of global health justice issues among IRB members during research ethics review.

This thesis was a cross-sectional, quantitative study conducted to describe the experiences of global health justice issues in research proposals reviewed by IRBs. The aim of the study was: (1) understand if IRBs experience global health justice issues, (2) if IRBs experience global health justice issues, understand what guidance they use in addressing them, and (3) understand if IRBs experience moral ambiguity or concern as a result of the global health justice issues in proposal review. A survey was developed and offered to all subscribers of Public Responsibility in Medicine and Research’s (PRIM&R) blog, Ampersand, past or presently serving on an IRB. Data were analyzed using descriptive statistics and four typologies were created to attempt to explain IRB member experiences.

Findings were limited due to a low survey response rate, but seem to suggest that IRB members: (1) experience justice issues during research ethics review; (2) lack sufficient guidance for how to address global health justice issues; and (3) may experience concern and moral ambiguity as a result of insufficient guidance.

 

Table of Contents

PREFACE .......................................................................................................................................................... 1

LIST OF ACRONYMS ....................................................................................................................................................... 1

INTRODUCTION .............................................................................................................................................. 2

BACKGROUND ................................................................................................................................................. 2

DEFINING GLOBAL HEALTH AND RESEARCH ETHICS .............................................................................................................. 2

EXPLORING IRB MEMBER EXPERIENCES WITH JUSTICE ISSUES ................................................................................................ 4

SOURCES OF GUIDANCE FOR IRB REVIEW .......................................................................................................................... 6

MORAL AMBIGUITY .................................................................................................................................................... 12

SIGNIFICANCE ............................................................................................................................................................ 13

METHODS ....................................................................................................................................................... 16

STUDY DESIGN ........................................................................................................................................................... 16

SAMPLING FRAME ...................................................................................................................................................... 16

SAMPLING RATIONALE ................................................................................................................................................. 17

INSTRUMENT DEVELOPMENT ........................................................................................................................................ 17

SURVEY STRUCTURE .................................................................................................................................................... 19

Survey Section 1: Demographics ...................................................................................................................... 19

Survey Section 2: Features of IRBs ................................................................................................................... 19

Survey Section 3: Experiences with Ethical Issues and Concerns .................................................................... 19

Survey Section 4: Guidance .............................................................................................................................. 20

DETERMINING TYPOLOGIES ........................................................................................................................................... 21

ETHICAL CONSIDERATIONS ............................................................................................................................................ 23

STATISTICAL ANALYSIS ................................................................................................................................................. 23

FINDINGS ........................................................................................................................................................ 24

SECTIONS 1 AND 2: RESPONDENT DEMOGRAPHICS AND CHARACTERISTICS OF IRB WORK ......................................................... 25

SECTION 2: EXPERIENCES WITH GLOBAL HEALTH JUSTICE ISSUES AND CONCERNS .................................................................... 27

SECTION 3: TYPOLOGY OF EXPERIENCES .......................................................................................................................... 32

SECTION 4 GUIDANCE .................................................................................................................................................. 34

SECTION 5: MORAL AMBIGUITY .................................................................................................................................... 36

SECTION 6: ADDITIONAL RELEVANT ISSUES FOR CONSIDERATION - OPEN-RESPONSE ANSWERS .................................................. 37

DISCUSSION ................................................................................................................................................... 38

DISCUSSION OF TYPOLOGIES ......................................................................................................................................... 38

Typology 3: Affected ......................................................................................................................................... 38

Typology 2: Aware ............................................................................................................................................ 41

Typology 4: Unaffected ..................................................................................................................................... 43

Typology 1: Unaware ....................................................................................................................................... 44

DIFFICULTIES WITH TYPOLOGIES ..................................................................................................................................... 46

VARIETY IN EXPERIENCES .............................................................................................................................................. 46

LIMITATIONS ................................................................................................................................................ 49

CONCLUSION ................................................................................................................................................. 50

REFERENCES ................................................................................................................................................. 52

APPENDICES .................................................................................................................................................. 58

APPENDIX A .............................................................................................................................................................. 58

About this Master's Thesis

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• Permission granted by the author to include this thesis or dissertation in this repository. All rights reserved by the author. Please contact the author for information regarding the reproduction and use of this thesis or dissertation.

School	Rollins School of Public Health
Department	Hubert Department of Global Health
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Ethics Health Sciences, Public Health
关键词	Institutional Review Board public health justice issues research ethics Moral ambiguity guidance global health
Committee Chair / Thesis Advisor	Lavery, James, Emory University

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