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Research Questions

  1. What are the demographics of chairs, administrators, and members of IRBs operating in the United States?
  2. What volume and kinds of projects do IRBs review? How do they conduct reviews?
  3. What do IRB chairs, administrators, and members view as their responsibilities?
  4. What expectations do IRB chairs, administrators, and members have about how the Revised Common Rule may affect their operations in the future?
  5. What are principal investigators' perspectives on the IRB review process and outcomes?

The United States adopted the Common Rule in the 1970s to protect human subjects in research, and research organizations created institutional research boards (IRBs) to ensure the protection of human research participants. A set of proposed changes to the Common Rule was first proposed in 2011 and eventually adopted in 2019.

To assess possible changes in attitudes about IRBs as the Revised Common Rule takes effect, a baseline is needed. This report details the results of surveys of IRB chairs, administrators, and members, as well as principal investigators, to obtain baseline information on their demographics and their attitudes about their IRB's efficacy and efficiency and the likely effects of proposed changes in the Revised Common Rule. Where possible, the authors also compare the survey results with the 1998 Bell Report, which used a similar survey to evaluate IRBs' perspectives on the protection of human subjects.

Key Findings

The landscape of IRBs is extensive and varied

  • There is considerable variation in IRB sizes and resources, suggesting wide variation in the ability of IRBs to fully understand and operationalize complexity in the regulations and guidance for implementing change.
  • Many IRBs have taken on or have been assigned additional roles within their institutions, beyond protection of human subjects. In many institutions, the IRB review process provides a convenient checkpoint for ensuring that other kinds of review occur.
  • IRB chairs, administrators, and members are very satisfied with their performance in terms of protecting the rights and welfare of human subjects.
  • Most IRB chairs, administrators, and members reported that they were at least somewhat familiar with the Revised Common Rule, which was scheduled to go into effect in January 2019, and most administrators said that they were extremely or very familiar with it.
  • There was disagreement among survey respondents about whether proposed changes to the IRB review process would positively or negatively affect the scientific quality of research. This likely reflects varying beliefs regarding the role of IRBs in assessing scientific quality versus the quality of human subjects protections afforded by the study design.

Table of Contents

  • Chapter One

    Introduction

  • Chapter Two

    Methods

  • Chapter Three

    Results of IRB Surveys

  • Chapter Four

    Results of Principal Investigator Surveys

  • Chapter Five

    Discussion and Conclusions

  • Appendix A

    Literature Review

  • Appendix B

    Survey Instruments

Research conducted by

The research described in this report was prepared for the National Institutes of Health and conducted by the Quality Measurement and Improvement Program within RAND Health Care.

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