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Post-approval process: A challenge for ethics committees.

Aarti Halwai1, Vina Vaswani2

  • 1Former MSc (Research Ethics) Scholar, YU-FIC Research Ethics Master's Program for India, Yenepoya Deemed to be University, Mangalore, India.

Perspectives in Clinical Research
|August 9, 2023
PubMed
Summary
This summary is machine-generated.

Ethics committees face significant post-approval oversight challenges, including site monitoring and review processes. Addressing these issues is crucial for participant safety and research integrity.

Keywords:
Challengesethics committeesfollow-uppost-approval processreview

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Area of Science:

  • Clinical Research Ethics
  • Regulatory Science

Background:

  • Ethics committees (ECs) are vital for protecting research participants' rights, dignity, safety, and well-being.
  • ECs conduct pre- and post-approval oversight, with post-approval activities presenting significant operational challenges.

Purpose of the Study:

  • To explore the specific challenges encountered by ECs during post-approval processes.
  • To identify and propose solutions for common obstacles in post-approval oversight.

Main Methods:

  • A quantitative study was conducted using an online Google Forms questionnaire distributed to member secretaries of various ECs.
  • The questionnaire gathered data on EC descriptions, post-approval activities, and encountered challenges.

Main Results:

  • Sixty-one member secretaries responded, highlighting challenges in site monitoring, review of post-approval submissions (e.g., late/incomplete documents, reviewer availability, excessive paperwork), serious adverse events, and protocol deviations.
  • Differences in challenges were noted between accredited/assessed ECs and registered ECs.

Conclusions:

  • Post-approval oversight by ECs is complex and faces numerous hurdles, impacting efficient functioning.
  • Systemic improvements are needed to address challenges related to submission reviews, monitoring, and resource allocation for ECs.