What do I do About Incidental Findings in Research?
An incidental finding is a “finding” or result from an intervention or test that uncovers a condition or problem that was not originally known and was not part of the expected test-result scheme. Simply put: it is something extra found from a test.
Discovery of these extras can result from a standard, approved clinical test or intervention. They can also be found from a research test or intervention. Each incidental finding has an impact on how research professionals handle the result and what you do with that result.
If you are conducting research that has a potential to uncover an incidental finding, it is best to plan ahead for how you’ll treat the result and if you plan to return that result to a participant.
Returning results to a participant when an incidental finding has been uncovered may seem easy and straightforward. However, there are many considerations to think through before returning any results. And while most participants desire to have their results returned, there are circumstances where it might not be in the participant’s best interest to receive a result.
It is important to consider the design of the research, as well as the interventions proposed, in order to formulate a plan for if and when any incidental findings should be returned to individual participants.
For example, is the intervention done for research purposes, standard care, or both? If the intervention is done for research as well as for standard clinical care, and the interpretation of the results would occur anyway, the results should be disclosed to the participant and/or the participant’s physician.
However, if the research intervention is not approved for use clinically, generally, the findings should not be disclosed to the participant. This information should clearly be outlined in the informed consent form (ICF).
Returning results may seem fairly straightforward and easy to implement; however, it gets trickier with research-only results. For example, consider a research intervention that is approved clinically but done solely for research purposes and will not be professionally interpreted. In this case, the results should not be disclosed unless there is a plan to provide interpretation by someone qualified to interpret the test, image, or intervention. There should also be a plan for follow-up interventions or discussions (e.g., genetic counseling, continued treatment). This plan should be documented in the protocol.
Another nuance to consider is if the research intervention is approved clinically but done solely for research purposes, and the principal investigator (PI) wishes to give the participant the option to receive results. Here, the PI must track which participants want results and which do not. This option must also include a plan to provide interpretation by an appropriately qualified person and a plan for follow-up intervention or discussion. These plans must be documented in the protocol.
Plan Ahead, Even if You Don’t Expect Incidental Findings
There may be circumstances where neither the protocol nor ICF mentions incidental findings. This could be because the test or intervention was not likely to provide incidental findings or because it was not contemplated during the study design. If this occurs, it may still be appropriate to formulate a plan to return findings to participants under certain circumstances.
Examples include any information collected through a clinically accepted method (e.g., a Clinical Laboratory Improvement Amendment-certified [CLIA] lab or an otherwise validated test center and/or method), plus any information that:
- Reveals a condition likely to be life-threatening, or liable to be grave and can be avoided or ameliorated,
- Reveals a significant risk of a condition likely to be life-threatening,
- Reveals genetic information that can be used to avoid or ameliorate a condition likely to be grave, or
- Any test that reveals genetic information that can be used in reproductive decision-making: (1) to avoid significant risk for offspring of a condition likely to be life-threatening or grave, or (2) to ameliorate a condition likely to be life-threatening or grave.
It is also best to consider and discuss with the participant additional treatment options or communication paths with other providers, genetic counselors, etc., as well as the potential costs associated with those treatments and/or provider visits.
Conversely, in general it is best to not disclose to research participants any finding that:
- Was not collected through a clinically accepted method (e.g., a CLIA-certified lab or an otherwise validated test center and/or method) or is not an otherwise validated test or method
- Reveals a condition that is not likely to be of serious health or reproductive importance
- Reveals a condition or information that the importance of which cannot be ascertained