The UW IRB application form asks researchers to describe their plans (if any) for returning individual results to participants. This guidance provides a decision-making framework describing which results should be offered to participants. In general, every effort should be made to offer results that are clinically actionable, valid and pose life-threatening or severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if this can be accomplished without compromising the research. The guidance also discusses the importance of validity, the applicability of the Clinical Laboratory Improvement Amendment (CLIA), requirements for consent, and considerations for communication of the results.
Revised laboratory certification section to remove the option of a clinical hand-off; simplify decision-making framework – 02.25.2021