Who Should Explain an Incidental Finding to the Participant?

Should the Researcher Who Found It Be the One Who Explains It?

A data analyst notices a potentially pathogenic genomic variant. An imaging researcher sees an unexpected abnormality on a scan. A psychology researcher identifies a result that may warrant clinical assessment.

The research team decides that the finding meets its threshold for communication. Someone now has to tell the participant.

It is tempting to assume that this should simply be the principal investigator or whoever first noticed the finding. But incidental findings often fall outside the researcher's own expertise. The person qualified to conduct the study may not be qualified to explain the medical, genetic, psychological, or other consequences of an unexpected result.

The Right Communicator Depends on the Finding and the Expertise It Requires

Returning a Finding Requires More Than Delivering the Result

Discovery does not establish communication competence

The person who first recognizes an incidental finding may have excellent expertise for the research question but limited expertise in the unexpected condition.

A cognitive neuroscientist may know how to acquire and analyze MRI data without being qualified to diagnose a brain lesion. A bioinformatician may identify a genomic variant without being qualified to counsel a participant about penetrance, family implications, and clinical management. A research assistant administering psychological measures should not independently turn an unusual score into a psychiatric diagnosis.

The communication plan should therefore follow expertise rather than authorship, seniority, or who happened to notice the finding first.

The researcher still has responsibility for the process

Using a specialist does not mean the research team can simply hand over the result and disappear. Researchers remain responsible for following the approved protocol and ensuring that the finding moves through the appropriate validation, review, communication, documentation, and referral pathway.

The division of labor may therefore look something like this:

What does good communication need to accomplish?

A responsible disclosure should help the participant understand more than the name of the finding. Depending on the situation, the participant may need to know what was actually observed, how certain the finding is, whether the research method was diagnostic, what the finding could mean, what it does not establish, whether confirmation is required, and what reasonable next step is available.

TCPS 2 states that researchers should exercise care and sensitivity in determining both who discloses material incidental findings and how disclosure occurs. It also says researchers should assist participants in understanding those findings and, when necessary, direct them to an appropriately qualified professional to discuss possible implications for their welfare.

The communicator therefore needs both subject-matter competence and the ability to explain uncertainty without either minimizing or exaggerating it.

Communication should match the certainty of the evidence

An incidental finding can be serious without being diagnostic. If a research scan contains a suspicious abnormality, the appropriate message might be that the scan warrants clinical evaluation rather than that a particular disease has been discovered.

This becomes especially important with highly uncertain incidental findings. The communicator must distinguish what is known from what remains uncertain and avoid allowing the participant to hear a possibility as a diagnosis.

Genomic findings may require genetic counseling

Genetic information can create distinctive communication needs. A result may have implications for biological relatives, reproductive decisions, future disease risk, and clinical surveillance. Concepts such as penetrance and variable expression may be unfamiliar to participants but crucial to understanding what a result means.

CIOMS states that research ethics committees should evaluate whether individual counseling is necessary when particular genetic findings are returned.

NHGRI provides a concrete operational example through its Secondary Genomics Findings Service. Possible actionable secondary variants identified in participating research protocols are clinically confirmed, and a genetic counselor discloses confirmed results. The counseling session can include healthcare recommendations, family history and risk assessment, psychosocial assessment, and referral to an appropriate healthcare provider.

This is one institutional model rather than a universal requirement, but it illustrates how return can be structured as a professional communication process rather than a result simply being emailed to the participant.

Some findings require a clinician or other specialist

A radiological finding may require a radiologist or other appropriately qualified clinician. A cardiovascular abnormality may require clinical evaluation by someone competent in that area. A psychologically consequential finding may require appropriate mental-health expertise.

The principle is not that every incidental finding must pass through a physician. It is that the professional expertise involved should match the information being communicated and the decisions the participant may reasonably make because of it.

The participant's own healthcare professional may become important

Research teams often do not provide continuing clinical care. Once a finding requires diagnostic evaluation or treatment, the participant's healthcare professional may be better positioned to coordinate subsequent care.

The research team may therefore provide the participant with appropriate documentation or, with the necessary authorization and according to applicable procedures, communicate relevant information to the participant's healthcare professional.

NHGRI clinical research provides examples in which confirmed results are communicated to participants and relevant healthcare recommendations and referrals are provided. Some NIH protocols also send confirmed research-related genetic results to participants and their referring medical providers.

Researchers should not assume, however, that every participant has easy access to specialist care. The feasibility and consequences of referral should be considered when planning for incidental findings before data collection.

Who communicates can depend on urgency

A routine but important finding may permit a scheduled counseling appointment. A finding suggesting an immediate health threat may require faster communication through the study's safety pathway.

In urgent situations, the priority is to connect the participant with appropriate evaluation without sacrificing accuracy. Researchers should follow the protocol for findings that may affect participant health or safety rather than waiting for the ordinary return-of-results workflow if delay could materially increase harm.

Communication should include the limits of the research finding

Participants should understand whether the result was generated in a research or clinical setting and whether further confirmation is needed. This helps prevent therapeutic misconception and the assumption that the research team has provided a definitive clinical diagnosis.

NHGRI's Secondary Genomics Findings Service, for example, clinically confirms possible actionable secondary variants before return. If confirmation refutes the research finding, the service communicates that the research result was not confirmed.

The communication plan should similarly distinguish research evidence from whatever level of clinical confirmation the particular finding requires.

Communication is not complete merely because information was sent

A technically accurate PDF attached to an email may transmit information without ensuring that the participant understands it. The more consequential or complex the finding, the less adequate one-way delivery may be.

TCPS guidance emphasizes helping participants understand material incidental findings and, where necessary, directing them to qualified professionals. NHGRI's genomic return model likewise incorporates counseling, risk assessment, psychosocial assessment, healthcare recommendations, and referral rather than treating disclosure as document delivery alone.

This does not mean every low-complexity result requires a lengthy counseling session. Communication should be proportionate to the finding's complexity, uncertainty, and potential consequences.

Plan who communicates before anyone has something difficult to say

The protocol should identify, where reasonably foreseeable, who reviews possible findings, who decides whether the return threshold has been met, who contacts the participant, who explains the finding, who handles questions, and who coordinates referral.

Without that plan, the first difficult case can trigger hurried improvisation. A junior researcher may disclose information outside their expertise, the principal investigator may assume someone else is handling it, or the participant may be passed among professionals without anyone owning the process. Research administration has enough relay races already.

A Bioinformatician Identifies a Potentially Actionable Genetic Finding

The bioinformatician's role was essential, but discovering the variant did not make them the appropriate person to counsel the participant about hereditary cancer risk.

Common Mistakes When Communicating Incidental Findings

Assign the Communicator According to the Finding, Not the Organizational Chart

Your protocol should distinguish responsibility for discovering, validating, deciding to return, communicating, and clinically following up a finding. One person may perform several of these functions, but that should follow from competence and study design rather than assumption.

The best communicator is therefore not necessarily one person. For consequential findings, the strongest model may be coordinated communication in which the research team explains the research context while a relevant specialist explains the clinical or other professional implications.

Before Someone Contacts the Participant

Questions About Who Should Communicate a Finding

The Person Who Finds It Is Not Automatically the Person Who Should Explain It

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