Human subjects protections in community-engaged research: a research ethics framework

Area of Science:

• Social Sciences
• Bioethics
• Public Health

Background:

• The role of community in research has evolved significantly since the Belmont Report.
• Translational research increasingly involves active community engagement, shifting from research conducted 'upon' communities to research 'with' them.
• This evolution necessitates a critical examination of potential risks inherent in community-research partnerships.

Purpose of the Study:

• To critically examine the range of risks that arise when communities become partners in research.
• To distinguish between established and unstructured community groups and outline methods for unstructured groups to gain structure for research participation.
• To propose a new framework for evaluating risks in community-engaged research, considering individuals and communities as distinct agents.

Main Methods:

• Differentiating between established communities (with existing structure) and unstructured groups (lacking defined leadership/cohesiveness).
• Identifying methods for unstructured groups to develop necessary structure (external partnership or internal empowerment).
• Developing a 3-by-3 risk assessment grid evaluating risks to well-being (process and outcome) and agency across three agent categories: individuals (as individuals, as group members), and communities.

Main Results:

• Risks in community-engaged research can affect individuals (as individuals or group members) and communities as a whole.
• Risks manifest through research processes, research outcomes, and impacts on agency.
• A structured framework is proposed to systematically evaluate these multifaceted risks.

Conclusions:

• Community-engaged research requires careful consideration of risks to individuals and the community entity.
• The proposed 3-by-3 risk assessment framework aids academic researchers and community partners in navigating ethical complexities.
• This framework promotes mutual respect and enhances the ethical conduct of community-engaged research.