Research teams should identify in their IRB applications any clinically relevant results that could be produced by study tests or procedures. Clinically relevant information may arise because of radiological examinations conducted for research purposes, physical examinations or physiologic tests, test results from samples collected from subject, or the analysis of cognitive or behavioral assessments completed by subjects. Examples include:

• MRIs of the head may identify serious medical concerns, such as brain tumors, that might not be identified if the subject had not taken part in the research
• Genetic testing may identify actual or potential conditions that may affect the health of the individual participating in the research (and their relatives) or a reproductive decision
• Validated psychological screening tests may identify potential suicidality or severe depression
• Laboratory tests that reveal severe anemia or suggest diabetes

In addition to identifying the possibility of clinically relevant results that may be discovered, you should describe whether you intend to disclose the results to subjects. The IRB would not expect (and in some cases will not allow) the dissemination of information to subjects generated from tests or procedures that are considered experimental or have not been clinically validated. This is because the clinical relevance of the results in such cases may be unclear and can create inadvertent anxiety or confusion for the participant without providing potential benefit. In addition, the IRB generally does not allow the release of laboratory analyses to subjects unless they are performed by a CLIA-approved entity. Finally, the IRB would expect that any results released to subjects from research tests should be actionable.

If the results will be disclosed to participants, the research team will be asked to identify who assesses whether the information should be reported to subjects, provide a timeframe for reporting the results to subjects (results should be reported in a timely manner, e.g. within 30 days), and describe the process for informing subjects of these results and whether other resources are in place to assist with the explaining the results and their consequences to research subjects (e.g., a genetic counselor, referral to a physician). If the study team plans to release results directly to a subject’s health care provider, this should be with the subject’s permission and a qualified member of the research team should call the health care provider to contextualize the results and highlight any that may require follow-up. Results generally may not be released, particularly if the study is covered by a Certificate of Confidentiality, to someone other than the participant (e.g., participant’s spouse or family after participant loses capacity or after death) absent participant consent.

If the IRB has not previously approved the disclosure of clinically relevant findings to subjects and a special circumstance arises for a single subject, research teams may submit a reportable event to request disclosure. The following information should be included in the new information report:

• Description of the incidental finding (e.g., abnormal result of laboratory test or MRI), when it was discovered and who discovered it
• Rationale for disclosing the incidental finding (i.e., why the subject may benefit from knowing this information)
• Process for informing the subject of the incidental finding (i.e., who is going to disclose the finding, how, and who should the subject contact regarding questions)
  • Statement clarifying whether this is expected to occur again or if this is an isolated incident (if not an isolated incident, a change of protocol is required)