Returning Urgent Results


An urgent result is any result that requires immediate follow-up, typically by a healthcare professional. This result could have been anticipated due to the research and condition under study, or it may be unanticipated and/or related to a previously undiagnosed condition.


  • A “routine” blood pressure found to be 220/120 mmHg
  • A participant reports suicidal ideation
  • A mass is discovered on a routine Chest Xray

Review the Basics for Returning Urgent Results:

How to Prepare and Additional Points to Consider

Healthcare provider contact information

If the involvement of the healthcare provider is necessary, the provider’s contact information should be collected as early in the study as possible, ideally during enrollment (see template here). Requesting this information can also facilitate a conversation with the research participant not only about their preferences for whom to include but also to establish realistic expectations should an urgent result arise.

Note that, along with the urgent result, any other data that might inform the healthcare provider’s action/interpretation of the urgent result should also be returned.

It should be anticipated that a potential participant without health insurance or a HCP may wish to join the study. A plan should be made for how their participation will or will not be accommodated and, if participating, how any urgent result will be handled.

This plan will vary depending on the study. For example, a PI may be asked to assist the patient to follow up locally for appropriate next steps and care. In some instances, additional funds can be made available if safety follow-up is needed

Regulatory Requirements & CLIA Confirmation

If an urgent result complies with necessary regulatory requirements for return (e.g., the test was performed in a CLIA lab), it should be returned to the participant ASAP.

If the urgent result will NOT comply with all necessary regulatory requirements for return, a plan should be made in advance for a medically responsible course of action (e.g., the study team will rerun the test in a compliant, clinically reliable manner and return it to the participant ASAP.)

See more here about regulations that pertain to IRR.

Access to appropriate expertise

Some results are challenging to interpret for actionability or validity, and/or difficult to explain to participants. A responsible medical professional, listed on the study protocol IRB application, should be identified before the study begins, to advise as needed.

If needed, referral to or provision of support (e.g., genetic counseling) should also be considered when appropriate.

Role of the IRB or Ethics Review Committee

The IRB should not be expected to interpret a medical or clinical result nor to determine actionability.

The IRB should review and decide whether the urgent finding will be considered an adverse event or unanticipated problem requiring reporting to the IRB, and if so, whether there is flexibility in timing of the report and/or other obligations to be considered.

See more here about the role of IRBs.

Process Flow