Returning Clinically Relevant Research Results to Participants: Guidelines for Investigators and the IRB

Area of Science:

• Bioethics
• Human Subject Protection
• Research Administration

Background:

• The 2019 revised Common Rule mandates informed consent documents address the return of clinically relevant research results.
• Existing national discussions lack specific guidance for institutional review boards (IRBs) on managing result return.
• A need exists for a structured approach to balance participant interests with research and IRB operational demands.

Purpose of the Study:

• To present a novel framework developed by Indiana University's human research protection program.
• To provide clear categorization of research results for return to participants.
• To offer model language for informed consent documents and define the IRB's role.

Main Methods:

• A year-long collaborative process involving IRB staff, leadership, science and bioethics faculty, and community members.
• Development of a categorization system for clinically relevant research results.
• Creation of standardized language for informed consent documents regarding result return.

Main Results:

• A comprehensive framework for managing the return of clinically relevant research results.
• Defined categories of results for researchers to consider returning.
• A model for an active yet limited IRB role in the process.

Conclusions:

• The developed framework offers a practical model for universities navigating the complexities of returning research results.
• This approach effectively balances the ethical imperative to inform participants with the need to minimize burdens on researchers and IRBs.
• The framework serves as a scalable solution for enhancing human subject protection in research settings.