Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

Andrew D Mcrae,Charles Weijer,Jeremy Grimshaw,Robert Boruch,Allan Donner,Jamie Brehaut,Judith Belle Brown,Shazia Chaudhry,Martin Eccles,Merrick Zwarenstein,Carol Bennett,Monica Taljaard

doi:10.1186/1745-6215-14-1

Abstract

BackgroundCluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.MethodsDescriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.ResultsInformants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.ConclusionsInformants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

Highlights

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees
We report on a qualitative analysis of interviews with experienced CRT investigators with the objective of documenting ethical challenges encountered in the conduct of CRTs
The objectives of this study were to document, using a descriptive qualitative approach [8-11], the views and experiences of CRT researchers with respect to: (1) ethical issues that have arisen in CRTs and how they have been addressed in practice; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs

Summary

Introduction

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. The effectiveness of the study intervention is evaluated using data collected from individual cluster members, often extracted from clinical. Because of their distinct methodological features, CRTs pose unique ethical challenges. It can be challenging to evaluate risks and potential benefits when the units of randomization, intervention, and outcome measurement are different [4,5]. It is unclear under which circumstances, and from whom, informed consent is required in large community-based CRTs [1,4,6]. Some CRTs have employed ‘gatekeepers’, that is, individuals who have made decisions regarding CRT participation on behalf of randomized clusters [7]

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