Co-design and implementation research: challenges and solutions for ethics committees.

Area of Science:

• Implementation Science
• Participatory Research
• Co-design Methodology

Background:

• Implementation science research, particularly participatory and co-design approaches, poses unique ethical challenges.
• Existing ethics committee approval and governance mechanisms are often ill-suited for these innovative research methodologies, being designed for traditional trials.

Purpose of the Study:

• To address the ethical challenges posed by co-design in implementation science research.
• To propose guiding principles for aligning co-design methodologies with ethics committee requirements.

Main Methods:

• The study discusses the inherent conflict between the emergent, adaptive nature of co-creation and the pre-specification requirements of ethics committees.
• It reviews the purpose of ethics committee protocols: participant protection and research rigor.

Main Results:

• Co-creation's emergent nature conflicts with ethics committee needs for pre-defined interventions and outcomes.
• Strict ethics protocols, while protective, can hinder adaptive, participatory research.

Conclusions:

• Ethics committees need training to value diverse research approaches like co-design.
• Clear ground rules are necessary to distinguish co-design research from consultation.
• Recognizing the benefits of power-sharing is crucial, especially in research with vulnerable populations.