Ethical Challenges in Cluster Randomized Trials

Research Questions: This dissertation examines how ethical challenges in CRTs are addressed in practice. This dissertation also provides guidance as to who must be considered a research subject in a CRT, and when consent must be sought from research subjects. Methods: The association between consent practices in healthcare CRTs and particular trial features were examined using multivariable logistic regression modelling. Information on ethical challenges encountered by CRT researchers in practice was obtained by analyzing semi-structured interviews with experienced CRT investigators. Two normative questions, “Who is the research subject in CRTs?” and “When is consent required in CRTs?” were also addressed. Results: Consent in CRTs is associated with smaller cluster sizes, and the use of individual-level experimental and data collection interventions. CRT researchers are most concerned with issues around informed consent, and less concerned with issues related to the analysis of harms and benefits in CRTs. Research subjects are individuals who are intervened upon by investigators; who interact with investigators; or who contribute identifiable private information. Consent must be sought for CRT participation from research subjects. Consent is not required from cluster members who are not research subjects. Consent after randomization of clusters is permissible if necessary. Some CRTs may meet criteria for a waiver of informed consent. Conclusions: This dissertation describes the state of the art of ethics practices in CRTs, and presents guidance around consent issues in CRTs that will inform the development of international ethics guidelines for CRTs.

Name thesis:degree_name

Ph D

Discipline thesis:degree_discipline

Epidemiology and Biostatistics

Grantor dc:publisher

The University of Western Ontario

Year dc:date.issued

2011

Author dc:creator

• McRae, Andrew

Advisors dc:contributor.advisor

• Donner, Allan
• Charles Weijer

• Research Ethics
• Cluster Randomized Trials
• Informed Consent
• Health Services Research
• Quality Improvement
• Knowledge Translation.

Language dc:language.iso

en_ca

Handle dc:identifier.uri

https://hdl.handle.net/20.500.14721/32735

OAI identifier oai:identifier

oai:uwo.scholaris.ca:20.500.14721/32735