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Practical guide for determining whether healthcare providers are research participants in cluster randomised trials

Hayden P Nix¹, Cory E Goldstein^2,3, Monica Taljaard^2,3

¹Department of Medicine, Dalhousie University, Halifax, Canada hnix@dal.ca.

|April 9, 2026

Insights

Accurately identifying healthcare providers as research participants in cluster randomized trials (CRTs) is crucial for ethical conduct. This framework helps researchers and ethics committees apply established criteria to protect provider rights and welfare.

Area of Science:

Clinical Research Ethics
Public Health Research Methodology

Background:

Cluster randomized trials (CRTs) involve group randomization, posing challenges in identifying individual research participants.
The Ottawa Statement provides ethical guidelines for CRTs, yet accurate participant identification remains a persistent issue for researchers and ethics committees.

Purpose of the Study:

To offer a practical framework for applying Ottawa Statement criteria to identify research participants in CRTs involving healthcare providers.
To illustrate key considerations and lessons learned through example CRTs.

Main Methods:

Analyzing study procedures in relation to the study objective to determine research participant status.
Defining criteria for when study interventions or data collection procedures confer participant status on healthcare providers.

Main Results:

Healthcare providers may be participants due to interventions, data collection, or both, distinguishing them from collaborators.
Some interventions involve both healthcare providers and patients as participants.
Collecting data on healthcare provider behavior can confer participant status.

Conclusions:

Accurate identification of research participants in CRTs is fundamental for ethical research conduct.
Ensuring the rights and welfare of healthcare providers identified as research participants is paramount, adhering to ethical guidelines.

Read full analysis

Abstract

Introduction:

In cluster randomised trials (CRT), groups (rather than individuals) are randomised to intervention and control conditions. Since the publication of the Ottawa Statement on the Ethical Design and Conduct of CRTs, the accurate identification of research participants has continued to challenge researchers and research ethics committees.

Objective:

In this article, we focus on CRTs involving healthcare providers and provide a practical framework for applying Ottawa Statement criteria for identifying research participants. We illustrate key lessons with example CRTs.

Framework:

Study procedures should be analysed in relation to the study objective. A study intervention confers research participant status on healthcare providers if the study objective is to evaluate its effect and it is delivered to or targeted at healthcare providers. A data collection procedure confers research participant status on healthcare providers if it informs a study outcome used to achieve the study objective and it involves interactions between researchers and healthcare providers to collect their data, or the collection of healthcare providers' identifiable private information.

Key Lessons:

In CRTs, healthcare providers may be research participants because of study interventions, data collection procedures, or both; conversely, they may simply be research collaborators. Some study interventions confer research participant status on both healthcare providers and patients. Collecting data on healthcare provider behaviour may confer research participant status on healthcare providers.

Conclusions:

Accurately identifying research participants in CRTs is essential to their ethical conduct. When healthcare providers are research participants, their rights and welfare should be protected in accordance with research ethics guidelines.

Keywords:

EDUCATION & TRAINING (see Medical Education & Training)ETHICS (see Medical Ethics)Randomized Controlled Trial STATISTICS & RESEARCH METHODS

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