Clinically Relevant Information and Reporting Guidance
Guidance on disclosing clinical relevant information to research subjects
Version Date: August 4, 2011
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 be created as a result 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. Below are some examples of potentially clinically relevant information that might be discovered during a research study:
- 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
When research procedures can yield clinically relevant results, in addition to identifying this possibility in the IRB application, research teams should also describe whether they 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 because the clinical relevance of the results in these cases usually is unclear and can create inadvertent anxiety or confusion without providing potential benefit to the subject. In addition, the IRB generally does not allow the release of laboratory analyses to subjects unless they are performed by a CLIA-approved entity.
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 (and potentially subjects’ physicians), 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). This information is solicited to help to provide the IRB with assurances that appropriately qualified individuals will assess and relay results to participants and the results are analyzed and reported to subjects in a timely manner.
The IRBs are in the process of developing specific guidance for the disclosure of clinically relevant information that is incidentally discovered in the course of research for a variety of research types. Guidance for the discovery of incidental findings for studies involving brain imaging is available here.