G2TT
来源类型Report
规范类型报告
DOIhttps://doi.org/10.7249/RR2648
来源IDRR-2648-NIH
Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule
Sandra H. Berry; Dmitry Khodyakov; David Grant; Alexandra Mendoza-Graf; Elizabeth Bromley; Gina Karimi; Barbara Levitan; Karin Liu; Sydne Newberry
发表日期2019-07-31
出版年2019
页码100
语种英语
结论

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.
摘要

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.

目录
  • 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

主题Bioethics ; Biomedical Research ; Science and Technology Legislation ; Science ; Technology ; and Innovation Policy ; United States
URLhttps://www.rand.org/pubs/research_reports/RR2648.html
来源智库RAND Corporation (United States)
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资源类型智库出版物
条目标识符http://119.78.100.153/handle/2XGU8XDN/523860
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Sandra H. Berry,Dmitry Khodyakov,David Grant,et al. Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule. 2019.
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