Any liability concerns about sharing individual research results should be addressed on a case-by-case basis. Most liability concerns, however, can be adequately addressed with proper planning and generally should not inhibit the return of IRR.

For this brief review, we discuss three common concerns:


Duty to care

In the event of an urgent result, the investigator or designated medically-responsible person assigned to a study has a duty to care for the participant and must review results and respond accordingly. How these results are handled depends on the study, the result, and the participant, and may involve communication and referral to the participant’s healthcare provider, the coordination of follow-up care, or other appropriate courses of action. For this reason, planning for potential urgent situations within a study is important.

Clear communication

Clear explanation to and both verbal and written communication with participants are necessary. While it is important to include these details in the informed consent process and form, it is equally important to discuss and document the reliability, utility, and limitations of the returned results when giving them to participants. Clear communication and confirmation of participant understanding, and written documentation of the information provided, can enable participants to respond to and act on the information that is received and, additionally, may mitigate liability concerns. See more here.

Careful decision-making

Participants should decide whether to receive results, especially when considering genetic results or results with no known current medical or personal implications. Providing appropriate information to help the participant takes time, and may include discussion of the implications for the participant’s and family’s immediate and future health, eligibility for life and disability insurance, and other considerations. Existing decision-support tools may support participant decision-making, but they should not replace the discussion itself.

Establishing expectations within the study team

While it is important to establish expectations with the participant, it is equally important to establish processes for and expectations of the study team. This means a priori planning for urgent, routine, and incidental results. A robust written plan will clarify the delineation of responsibilities thereby reducing the opportunity for steps to be missed or mishandled.


When returning individual results, it is important to establish whether any interpretation of the result will be provided, when, and by whom. This should be clearly communicated during the informed consent process and whenever there are any changes to plans for return or of interpretation.

Not medical advice

In general, results returned should include a clear statement that the results should not be considered medical advice and that the participant should contact their healthcare provider with questions and before introducing any change in their medical care, treatment, or practice.


In general, results returned should include an explanation, interpretation, and/or information for a reliable point-of-contact or external resource for interpretation (e.g., investigator, help desk, contracted vendor, etc.). Participants should be encouraged to seek any additional guidance from their healthcare provider.


After a study has ended, there is no obligation to re-interpret results for participants or to reopen old datasets as new information becomes available. This is particularly salient for genetic results. This limitation should be documented and explained to participants when they are deciding whether or not to receive results, and again when results are returned.

Lack of interpretation

There are often study results that have no known implications for a participant and/or cannot currently be interpreted. While these results may be confusing and sometimes stressful to participants (and their healthcare provider,) participants may still wish to have this information. It is important to communicate the quality and validity of these results, and document that communication, both in written communication to the participant and a note to file that highlights what was explained/given to the participant. The limitations of the interpretation of the data should be made clear, along with the participant’s options for future re-interpretation outside of the study.

Data Sharing

Return of individual results plans should consider what data will be shared and with whom. It is important to establish clear processes and expectations if data will be shared with a participant and/or their healthcare provider, or 3rd parties such as guardians or the relatives of the participants.


Participants should be able to choose whether or not they receive individual results, but they should understand that urgent results will be returned as a matter of safety. Participants should not be enrolled in a study that may uncover urgent findings if they do not want to receive urgent results (given the study investigator’s duty to care in an emergent situation, see above).

Healthcare providers

Participants may elect to have their results shared with their healthcare provider, or it may be required in the case of an urgent or medically actionable result. Study plans should consider these possibilities and adjust informed consent forms and processes accordingly. Plans should also include how the transfer of responsibility will be documented in these cases, and contact information should be proactively collected so that it is readily available in these situations.

Medical records

If any research result will be entered into the participant’s medical record, that information must be clearly stated, and the participant should understand and consent. The information shared should include that the result will be available to any medical professional and others (e.g., insurance underwriter) who later access their medical record.

Relatives of the participant

The concept of a physician’s “duty to warn” family members implicated by individual results has been widely discussed, and the US regulations do not direct how to proceed. Professional groups advise that physicians have a duty to protect their patient’s genetic information and further advise physicians to discuss with the patient the implications of genetic information on family members prior to testing. They should explain circumstances under which patients would be expected to notify their relatives of the risks associated with that information. For more on this topic, see here. This reinforces the need for clear communication during consent and decision-making processes.