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Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule

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Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule Research Report Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule Sandra H. Berry, Dmitry Khodyakov, David Matthew Grant, Alexandra Mendoza-Graf, Elizabeth Bromley, Gina Karimi, Barbara Levitan, Karin Liu, Sydne Newberry C O R P O R A T I O N For more information on this publication, visit www.rand.org/t/RR2648 Published by the RAND Corporation, Santa Monica, Calif. © Copyright 2019 RAND Corporation R® is a registered trademark. Limited Print and Electronic Distribution Rights This document and trademark(s) contained herein are protected by law. This representation of RAND intellectual property is provided for noncommercial use only. Unauthorized posting of this publication online is prohibited. Permission is given to duplicate this document for personal use only, as long as it is unaltered and complete. Permission is required from RAND to reproduce, or reuse in another form, any of its research documents for commercial use. For information on reprint and linking permissions, please visit www.rand.org/pubs/permissions. The RAND Corporation is a research organization that develops solutions to public policy challenges to help make communities throughout the world safer and more secure, healthier and more prosperous. RAND is nonprofit, nonpartisan, and committed to the public interest. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. Support RAND Make a tax-deductible charitable contribution at www.rand.org/giving/contribute www.rand.org Preface In the 1990s, the National Institutes of Health (NIH) sponsored an evaluation of the implementation of Section 491 of the Public Health Service Act, which mandates a program of protections for human research subjects. The study was undertaken by James Bell Associates, and the resulting report became known as the “Bell Report” (Bell, Whiton, and Connelly, 1998). The report described how perspectives on human subjects protections changed between the 1960s and the 1990s. The authors described how institutional review boards (IRBs) functioned in the 1990s: their workloads, characteristics of principal investigators (PIs) and protocols, IRB policies and practices, the investigator burden associated with IRB review, and the protections afforded to human subjects as a result of IRB review, based on reports from IRBs and PIs. Over time, the volume and landscape of research involving human subjects have continued to change. Research with human subjects has grown in scale and has become more diverse. Recognizing these changes, the U.S. Department of Health and Human Services (HHS) and the Office of Science and Technology Policy have been working on proposing revisions to the HHS regulations governing human subjects research (45 CFR 46, subpart A), also known as the Common Rule. The goal of the changes is to enhance the effectiveness of human subjects’ research protections while facilitating research and reducing burden, delay, and ambiguity for PIs. In September 2015, a Notice of Proposed Rulemaking to Revise the Common Rule was published for public comment,1 and a final revised rule was published in the fall of 2016,2 although the full implementation of the Revised Common Rule was delayed until January 2019.3 An evidence base is needed to enable evaluations of the adequacy and effectiveness of current protections in the Common Rule and, going forward, the effectiveness of reforms that appear in the final Revised Common Rule. To begin the process of creating such an evidence base, NIH commissioned a study to assess existing measures for evaluating the outcomes and impact of protections for human subjects and to survey the perceptions of current IRBs and researchers regarding the existing human subjects protections and the proposed changes in the Revised Common Rule. Tools will be needed for ongoing measurement and evaluation that 1 Federal Policy for the Protection of Human Subjects; Notice of Proposed Rulemaking to Revise the Common Rule. Federal Register. September 8, 2015;80(173):53933–54061. 2 Federal Policy for the Protection of Human Subjects; Final Rule. Federal Register. January 19, 2017;82(12):7149– 7274. 3 Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period; Proposed Rule. Federal Register. April 20, 2018;83(77):17595–17613; Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period. Federal Register. June 19, 2018;83(118):28497–28520. iii should enable assessments of changes to the Common Rule and the development of an evolving, evidence-based approach to ensuring the effectiveness of human subjects protections. This evaluation will be useful from a historic perspective, as it will provide metrics to evaluate human subjects protections. Finally, the findings will serve as a new baseline against which the Revised Common Rule can be compared in the future. This report will be of interest to IRB participants and staff, as well as policymakers and others concerned with the issues surrounding human subjects protection. This study was conducted under the Quality Measurement and Improvement Program of RAND Health Care for the National Institutes of Health, under contract to the Scripps Research Translational Institute. Further information may be obtained by contacting [email protected]. RAND Health Care, a division of the RAND Corporation, promotes healthier societies by improving health care systems in the United States and other countries. We do this by providing health care decisionmakers, practitioners, and consumers with actionable, rigorous, objective evidence to support their most complex decisions. For more information, see www.rand.org/health-care, or contact RAND Health Care Communications 1776 Main Street P.O. Box 2138 Santa Monica, CA 90407-2138 (310) 393-0411, ext. 7775 [email protected] iv Contents Preface ............................................................................................................................................ iii Tables ............................................................................................................................................. vi Summary ...................................................................................................................................... viii Acknowledgments ........................................................................................................................ xxi Abbreviations .............................................................................................................................. xxii 1. Introduction ................................................................................................................................. 1 Background ............................................................................................................................................... 1 Organization of This Report ..................................................................................................................... 4 2. Methods....................................................................................................................................... 5 Instrument Design ..................................................................................................................................... 5 Sample Selection ..................................................................................................................................... 13 Survey Administration and Data Collection ........................................................................................... 17 3. Results of IRB Surveys ............................................................................................................. 19 What Is the Landscape of IRBs? ............................................................................................................. 19 Who Responded to the Survey? .............................................................................................................. 20 Characteristics of Participating IRBs ...................................................................................................... 23 What IRBs Should and Should Not Be Doing ........................................................................................ 33 Familiarity with and Expectations About Common Rule Changes ........................................................ 40 4. Results of Principal Investigator Surveys ................................................................................. 46 Principal Investigator Characteristics ..................................................................................................... 46 Principal Investigator Perceptions of IRB Review Characteristics ........................................................ 47 What Do Principal Investigators Say, Overall, About Their IRBs? ....................................................... 48 Experience with Most Recent Protocol Submitted ................................................................................. 49 Investigator Perceptions of What IRBs Should and Should Not Be Doing ............................................ 51 Principal Investigator Views on IRB Efficiency, Process, and Effectiveness
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