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Streamlining ethical review.

Joseph Millum1, Jerry Menikoff

  • 1Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. millumj@cc.nih.gov

Annals of Internal Medicine
|November 17, 2010
PubMed
Summary
This summary is machine-generated.

Streamlined ethics reviews for human subjects research are underutilized. Researchers and institutional review boards (IRBs) can improve efficiency and participant protection by using existing options for exempt or expedited review.

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Area of Science:

  • Biomedical Ethics
  • Research Administration
  • Regulatory Science

Background:

  • The current human subjects research review system in the U.S. faces criticism for causing delays without enhancing participant protections.
  • Major regulatory reforms are lengthy processes, leaving a need for immediate improvements.

Purpose of the Study:

  • To highlight underutilized mechanisms within current regulations for streamlining ethics reviews.
  • To encourage the adoption of these mechanisms by institutional review boards (IRBs) and researchers.

Main Methods:

  • Discussion of existing regulatory options for human subjects research review.
  • Identification of research categories that may be exempt or require expedited review.
  • Exploration of strategies for simplifying multicenter research reviews.

Main Results:

  • Current regulations permit streamlined ethics reviews, such as exempt or expedited reviews, which can maintain or improve participant protections.
  • Underutilization of these efficient review pathways has been observed.

Conclusions:

  • IRBs and researchers should actively utilize existing underused options for research that need not be classified as human subjects research, exempt categories, expedited reviews, and single-IRB reviews for multicenter studies.
  • Leveraging these mechanisms can significantly improve the efficiency of the human subjects research review process without compromising ethical standards.