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3.15 Managing Radiographic Incidental Findings in Human Subjects Research

Last Revised: 8/27/2026

For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Incidental Findings

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for disclosure or nondisclosure of radiographic incidental findings.

2.0 Policy

It is the policy of the Organization that

  • 2.1. All human subject research that includes radiographs that are performed solely for research purposes, and which would not be associated with a formal radiologist’s report saved in the medical record, must include provisions for management of unexpected incidental findings.
  • 2.2. Disclosure of incidental findings to the subject (and/or parent or LAR) will depend on the investigator’s (and, if necessary, the consultant’s) assessment of the “net benefit of disclosure.”
    • 2.2.1. Category A (Strong net benefit): (1) information revealing a condition likely to be life-threatening; or (2) information revealing a serious condition that can be avoided or ameliorated. Category A IFs must be disclosed, unless the subject explicitly refuses to receive the information.
    • 2.2.2. Category B (Possible Net Benefit): (1) information revealing a nonfatal condition that is likely to be serious but that cannot be avoided or ameliorated, when a research participant is likely to deem that information important. Category B IFs may be disclosed, at the discretion of the investigator, unless the subject explicitly refuses to receive the information.
    • 2.2.3. Category C (Unlikely Net Benefit): (1) information revealing a condition that is not likely to be of serious health importance; or (2) information whose likely health importance cannot be ascertained. Category C IFs should not be disclosed to subjects.

3.0 Definitions

  • 3.1. Radiograph: include but are not limited to MRI, fMRI, CT scan, ultrasound, nuclear medicine scans, PET scans, and plain radiographs
  • 3.2. Incidental Finding (IF): a finding on a radiograph concerning an individual research participant that may have potential health implications and is discovered in the course of conducting research but is beyond the aims of the study.

4.0 Investigator Responsibilities

  • 4.1. The PI has an obligation to handle IFs responsibly and promptly. The time frame of the initial communication with the subject should be consistent with the suspected severity of the finding and the net benefit of the disclosure.
  • 4.2. Prior to commencing the research, the PI must have a plan to validate any IF and confirm its importance for the health and wellbeing of the subject. If the researcher does not have the expertise to make this assessment, they must identify an individual who does have this competence. The plan and time course of the review must take into account the type and resolution of scans or tests performed (e.g., anatomic imaging more urgent than functional imaging), and the age and health status (and likelihood of an abnormality) of the subject population.
  • 4.3. During the process of consent, the PI must describe
    • 4.3.1. the potential for discovering IFs
    • 4.3.2. the steps researchers will follow to evaluate IFs, (including consultation with a qualified clinician)
    • 4.3.3. what types IFs the PI intends to disclose or withhold
    • 4.3.4. the process of disclosure
    • 4.3.5. the right (and the limitations of the right) of the prospective subject to refuse to receive information regarding incidental findings
    • 4.3.6. the risks associated with disclosure of incidental findings, or of the subject’s refusal to receive information.
  • 4.4. The following (or substantively similar) model language must appear in the consent forms where the determination is made to disclose incidental findings: “In the course of this research, you will undergo [type of study or studies]. These tests are done for research purposes, and not to look for any specific abnormalities. However, occasionally, scans/tests will find something unexpected which the research was not looking for. This is called an “incidental finding.” Incidental findings may be nothing to worry about, or they may be significant or even life-threatening. The scans/tests are not the same as you might get to diagnose a medical condition. They may not see something that a medical scan would find or may show something that is not real.
    If one of the researchers sees something on your test which they are concerned about, they may review the scan/test with an expert. The expert review will be supplied if needed with no cost to you. If the researcher and/or the expert thinks the finding may be of importance to you the researcher will tell you. You can refuse to get this information. If you agree they may also tell your doctor. There may be benefits to learning such results (such as early detection and treatment of a medical condition), but there are also risks. These include anxiety over a finding which may not be real or may not require treatment. You and/or your insurance company may be billed for follow-up to the incidental finding to see if the abnormality is real or a medical problem.”
  • 4.5. The PI must have a plan to disclosure incidental findings to the subject and others
    • 4.5.1. After discovery of the IF, the time frame of the initial communication with the subject should be consistent with the suspected severity of the finding and the net benefit of the disclosure
    • 4.5.2. Subjects may refuse to receive information regarding incidental findings. As appropriate, the PI is responsible for explaining to the subject the consequences of non-disclosure.
    • 4.5.3. Disclosure of IFs should include a medical professional who is knowledgeable about the type of IF found and who is experienced in communicating sensitive medical information.
    • 4.5.4. IFs should be disclosed directly to the research participant. Investigators may offer to disclose to the subject’s PCP (in addition to, or in lieu of disclosure to subject), but this decision must be made by the subject.
    • 4.5.5. If incidental findings detected in pediatric or adolescent subjects are to be disclosed disclosure should be made to parent or guardian.
      • 4.5.5.1. If the disclosed minor subject has been judged mature enough to provide assent, then the offer of disclosure should also be made to the subject. These subjects may refuse to receive this information.
    • 4.5.6. If incidental findings detected subjects who lack decisional capacity are to be disclosed disclosure should be made to LAR.
      • 4.5.6.1. If the subject has been judged to have adequate capacity to provide assent, then offer of disclosure should also be made to the subject. These subjects may refuse to receive this information.
  • 4.6. The PI is responsible for reporting all incidental findings promptly to the IRB.
    • 4.6.1. All Category A IFs must be reported to the IRB as soon as possible. The report must include the plan to disclose the results to the subject or a description of how the results were disclosed if expeditious disclosure was warranted (for example, for a life-threatening finding).
  • 4.7. The PI generally has no obligation to affirmatively search for IFs. The goal of research is to seek generalizable knowledge, not to provide health information to individuals. Thus, in the context of imaging studies, the PI is not obligated to perform extra scans or modify scans to provide clinical information.

5.0 IRB Responsibilities

  • 5.1. Prior to approval of the research, the IRB will review:
    • 5.1.1. The plan to validate any IF and confirm its importance for the health and well-being of the subject.
    • 5.1.2. The criteria for deciding whether an IF will be disclosed to subjects
    • 5.1.3. The proposed process of disclosure, including the qualifications of the persons who will be disclosing information to the subject
  • 5.2. All category A IFs will be reviewed by the convened IRB. The IRB will determine whether the IF represents an unanticipated problem involving risk to the subject, whether the risk benefit relationship of the research is still acceptable, whether risks have been minimized, and whether the CF is adequate

DOCUMENT HISTORY:

 Written: 2/28/2018 (Approved: 2/28/2018) - original author not recorded

 Revised: 8/27/2026 - Modified recommended CF language to stress limited clinical utility of research-quality scans (section 4.4); reformatting and stylistic changes

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