UC Comment Letters

This comment letter responds to the National Institutes of Health (NIH)'s Draft Policy on Sharing Summary Level Results with Clinical Research Participants. UC supports sharing summary-level study results with participants but urges NIH to let IRBs make study-specific decisions and to pilot the policy before implementation, particularly to assess its scope, privacy risks, communication methods, timelines, exceptions, and infrastructure needs. UC also recommends model templates and clearer guidance, flexible dissemination and record-retention requirements, adequate federal funding, and a substantially longer implementation period to prevent unintended harms and excessive administrative burdens.