Assent Plan Required for Studies Enrolling Adults Who Lack Decision-Making Capacity

In November 2024, HRPP Policy 403 – Research Involving Adults Who Lack Decision-Making Capacity to Consent to Research Participation was revised to clarify the requirements for obtaining assent from adults who lack the capacity to provide informed consent. At that time, OHSRP also updated the protocol template to include instructional language regarding assent for adults who lack decision-making capacity.

These updates were communicated through the OHSRP listserv, and study teams were asked to incorporate an assent plan into their protocols with their next planned modification, as applicable. Additional guidance was also provided in the Fall 2025 OHSRP Newsletter.

At this time, approximately 285 active studies, approved to enroll adults who lack decision-making capacity, still require updates to align with the current policy and protocol template.

If your study is approved to enroll adults who lack decision-making capacity, submit a modification to:

• Include a plan describing how assent will be obtained, documented, and reassessed, as appropriate; or
• Provide a justification as to why an assent plan is not appropriate for your study.

Submit this update by November 2, 2026, or with your next Continuing Review (CR), whichever comes first.

For studies that have not yet addressed this requirement, OHSRP will include a comment in PROTECT reminding the study team that a protocol update is required.

For your convenience, review the guidance below to assist you in addressing this requirement in your protocol.

If you have any questions, please contact your IRB analyst team.