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The Revised and Final Common Rule: An Unfinished Story.

Barbara E Bierer1,2

  • 1Brigham and Women's Hospital.

IRB
|February 2, 2019
PubMed
Summary

The revised Common Rule for clinical research needs improvement. It fails to adequately define research, balance public health with individual autonomy, and implement a risk-based oversight approach, hindering efficiency and participant protection.

Keywords:
Common Rulehuman research subjectsresearch benefitsresearch oversightresearch risks

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Area of Science:

  • Bioethics
  • Clinical Research Regulation
  • Public Health Policy

Background:

  • The revised Common Rule (2017) aimed to update clinical research ethics but fell short.
  • Existing regulations create an inefficient and costly clinical trial ecosystem.
  • There's a need to rebalance ethical principles in clinical research.

Purpose of the Study:

  • To critically evaluate the shortcomings of the revised Common Rule.
  • To identify areas for improvement in clinical research governance and oversight.
  • To advocate for a reframed approach to clinical research standards.

Main Methods:

  • Analysis of the revised Common Rule's provisions and their impact.
  • Review of ethical principles in the context of clinical research and care.
  • Assessment of the current regulatory landscape for clinical trials.

Main Results:

  • The revised Common Rule inadequately defines 'research' versus 'clinical care'.
  • It fails to establish a clear risk-based oversight framework.
  • The current regulatory patchwork increases costs without improving participant protection or efficiency.

Conclusions:

  • The revised Common Rule missed opportunities to strengthen clinical research ethics and engagement.
  • A more robust risk-based approach and clearer definitions are necessary.
  • Stakeholder engagement is crucial to develop effective national and international clinical research standards.