Returning Personally Valuable Results

HOW WE DEFINE PERSONALLY VALUABLE RESULTS

A personally valuable result is information that might be of value to the participant or their healthcare provider regardless of whether the result is actionable. These results do not require immediate action.

Examples:

  • Genetic screening of a normal individual returns cystic fibrosis carrier status.
  • The participant is found to have Gilbert’s syndrome with an abnormal bilirubin secondary to a variant of a gene but one that does not cause liver disease. It is important to know, however, so that unnecessary tests are not performed.
  • The participant is found to have a rare blood type.

Review the Basics for Returning Personally Valuable Results:

How to Prepare and Additional Points to Consider

Regulatory Requirements & CLIA Confirmation

A research result that falls within the category of personally valuable must comply with necessary regulatory requirements (e.g., the test was performed in a CLIA lab) in order to be returned to the participant. It can be returning during the study if feasible and unrelated to study integrity and/or outcomes. If it is related to study outcomes or will impact study integrity, it should be returned only after the study.

If the research result will NOT comply with all necessary regulations for return, the resources needed to return it may not be justified. This is dependent on the study and the priorities of the study population, and should be considered on a study-by-study basis.

See more here about regulations that pertain to IRR.

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