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Informed consent in cluster randomised trials: a guide for the perplexed.

Hayden P Nix1, Charles Weijer2,3,4, Jamie C Brehaut5,6

  • 1Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada hnix@uwo.ca.

BMJ Open
|September 28, 2021
PubMed
Summary
This summary is machine-generated.

Navigating informed consent in cluster randomised trials (CRTs) is complex. This paper offers a practical framework, emphasizing the intervention unit over randomisation, to guide researchers and ethics committees through consent procedures.

Keywords:
education & training (see medical education & training)ethics (see medical ethics)statistics & research methods

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Area of Science:

  • Public Health Research Ethics
  • Clinical Trial Methodology
  • Research Integrity

Background:

  • Cluster randomised trials (CRTs) involve randomizing intact groups, posing unique informed consent challenges.
  • Systematic reviews indicate CRTs often have inadequate consent reporting and inappropriate waivers.
  • Existing guidance for informed consent in CRTs is insufficient for researchers and ethics committees.

Purpose of the Study:

  • To provide a practical framework for addressing informed consent in cluster randomised trials (CRTs).
  • To clarify confusion surrounding consent procedures in CRTs for researchers and ethics committees.
  • To guide ethical decision-making in CRTs by focusing on the unit of intervention.

Main Methods:

  • Explication of a three-step framework for informed consent in CRTs.
  • Identification of research participants within the cluster.
  • Assessment of exposure to study elements and determination of waiver appropriateness.
  • Application of the framework to various CRT intervention levels (cluster, professional, individual).

Main Results:

  • The unit of intervention, not the unit of randomisation, dictates informed consent requirements in CRTs.
  • A structured three-step process aids in navigating consent issues across different CRT designs.
  • Key lessons derived from applying the framework to diverse CRT examples.

Conclusions:

  • The proposed framework offers practical guidance for ethical conduct in CRTs.
  • Clarifying consent procedures enhances research integrity and participant protection in cluster trials.
  • Researchers and ethics committees can utilize this framework to improve consent practices in CRTs.