• If the intervention is done for research as well as for standard clinical care and professional (clinical) interpretation of all participants’ results would occur anyway, the results should be disclosed to the participant and/or participant’s physician. The PI is responsible for disclosing results.
• If the research intervention is not approved for use clinically, the findings should not be disclosed to the participant. This must be clearly stated in the consent form.
• If the research intervention is approved clinically, but done solely for research purposes and will not be professionally interpreted, the results should not be disclosed unless there is a plan to provide interpretation of the individual results by the appropriate person (i.e. qualified to interpret the test/image/intervention) and a plan for follow up intervention or discussion.   This plan should be documented in the protocol/IRB application.  The PI is responsible for disclosing results when the decision to disclose is made.
• If the research intervention is approved clinically, but done solely for research purposes and the PI wishes to give the participant the option to get results, the PI must track which participants want and which do not want results.  This option must include a plan to provide interpretation by the appropriate qualified person and a plan for follow up intervention or discussion.  The PI remains responsible for disclosing the results.
• Incidental findings, including formal interpretation of research images and tests should be maintained in the research record.
  • If the intervention is done for research as well as for standard clinical care, the participant may request that the information be included in his/her medical record. HIPAA Authorization is required to add information to the medical record.

Review the facility policy pertaining to incidental findings. If there is no facility policy, or the policy is not to disclose, do not propose disclosure. Also, if the facility does not have a professional on site or an established relationship with a professional for clinical interpretation of results, incidental findings should not be disclosed.

Sample Consent Language:

 

“The (neuropsychological) tests are completed for research purposes only. They are not administered by a licensed (clinical psychologist) and thus, we are not able to provide a clinical interpretation of the results.”

OR

“The (MRI images) we collect are for research purposes only and we cannot provide a (radiologist’s) clinical interpretation of the results.”

1. Review the facility policy pertaining to incidental findings. If the facility does not have a policy related to incidental findings, or if their policy allows disclosure, the facility procedure should be followed. If they have no procedure, a complete process must be developed by the research team.
2. Describe the process for disclosing findings to participants in the Research Design and Procedures part of the IRB submission.
3. Provide templates for the disclosure process.
4. Assess the risk of disclosing findings to participants. Participants might find receiving the information and determining what to do  stressful. If they are provided with findings that are not actionable or clinically significant, this stress may be more harmful than beneficial. Following up with healthcare professionals could lead to further tests that might potentially cause harm or involve financial burden.
5. Provide information in the consent process about the possibility of incidental findings and the process for disclosure.
6. Participants should be given the ability to opt-out of receiving disclosure of incidental findings and this should be documented in the consent. Note: if the study team has an ethical objection to allowing participants to opt-out of receiving clinically significant, actionable, and lifesaving findings, they may add this as an exclusion criterion

Sample Consent language:

“This (MRI) is done for research purposes rather than for diagnosis.  The images will not be routinely examined by health professionals for potential abnormalities.  However, in the event a possible abnormality is detected by the investigators or the MRI operator, the images will be further examined by a trained professional and the investigator may encourage you to consult your physician.” 

“It is possible that we will notice something in the imaging scan that is unrelated to the purpose of this study. If we believe that what we see is related to your well-being, we will consult with a healthcare expert. If that individual thinks the finding has urgent medical importance, we will verbally share this information with you as soon as possible. We will follow the verbal notification with a letter and provide copies of the scan if they might be helpful to your doctor. If the expert does not believe the finding requires evaluation by a medical professional, we will not tell you about it.” 

(From CITI) “If we accidentally discover information about you during the research scans that may be important to your health, do you want us to contact you to give you that information? Yes/No” 

If it seems appropriate for the study, the “information” above can be described in more detail (particularly if there are multiple procedures from which incidental findings might arise). And the participant can choose what kind of information they would want.  

Sample language: “What types of results would you like to receive?”  

​​☐​Results about my risks that I can do something about, like have preventive screening. 

​​☐​Results about my risks that I cannot do anything about, but that might affect my future health. 

​​☐​No results. I do not want to know.” 

Neuroimaging (EEG, MEG, MRI) on campus is in the Bioimaging Research Center (BIRC). https://birc.uga.edu/  

BIRC conducts 

• scientific review of research projects 
• screening for safe scanning 
• training of study personnel in safety procedures 

BIRC has its own documents for screening and consent and securely stores and manages them. These are in addition to the IRB-approved, study-specific materials. 

BIRC has their own Operations Manual which includes a policy pertaining to return of incidental findings.

If the [imaging or MRI] technologist, MRI operator, or study team member doing data analysis is concerned about a pathological indicator for an individual subject, the following steps will be taken:

1. The MRI Operator or study team member will notify the MRI Technologist who will confer with the BIRC staff physicist. If the consensus is that the scan should be evaluated by a healthcare professional, the Director will approve the referral.
2. If needed, BIRC will send a copy of the scan and participant clearance form on the same day to a local neurologist (there are several on retainer in the community).
3. The neurologist will inspect the scans and send a report to the MRI Technologist.
4. The MRI Technologist will forward the report to the study team.
5. The PI contacts the participant.

If the neurologist judges this particular instance does not require clinical evaluation, the MRI Technologist and staff physicist will notify the PI and file the report. The participant should not be notified.

Participants should only be notified when the neurologist determines the participant should contact their physician. 

**The above information must be included in submissions to the IRB and, as applicable, in informed consent documents. 

When disclosure of incidental findings has not been included in the consent document, the following can be used as a general guide for when disclosure to a participant can be proposed to the IRB as a modification: 

• Any information that has been collected through a clinically accepted method (e.g., a CLIA certified lab); AND any of the following: 

• • Any information that reveals a condition that is likely to be life-threatening; OR 

• • Any information that reveals a condition that is likely to be grave that can be avoided or ameliorated; OR 

• • Any information that reveal a significant risk of a condition likely to be life-threatening; OR 

• • Any information that reveals genetic information that can be used to avoid or ameliorate a condition likely to be grave; OR 

• • Any information 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. 

Do not disclose to research participants as an incidental finding: 

•  Any information that has NOT been collected through a clinically accepted method (e.g., a CLIA certified lab); AND/OR 
• Any information that reveals a condition that is not likely to be of serious health or reproductive importance; or 

• Any information that reveals a condition or information that the importance of which cannot be ascertained. 

• For use of BIRC: BIRC scientific review must occur before IRB review and a copy of BIRC’s approval should be attached to the submission (e-mail is sufficient if that is consistent with their process.) BIRC approval/agreement to provide services indicates their policies related to screening, safety, and return of incidental findings apply. 
• Without use of contrast, studies using MRI are eligible for Expedited review (unless there are other procedures or components of the project that are not eligible for Expedited review).

The IRB should review the submission for: 

• A statement assuring that applicable facility policies for managing incidental findings will be followed and attachment of said policy or a robust description and link for said policy.

• A description of how the researcher will manage and report incidental findings to participants (this should include a plan for appropriate follow-up and referral for treatment options). 

The IRB should review the informed consent process and form for: 

• A description of possible incidental findings with appropriate definitions (when applicable).
• A description of the process the researcher will follow to report incidental findings (or not), and which appropriate study personnel or advisors will be involved. 

• A description of the timeframe that will be used to report incidental findings if the researchers intend to report them. 

• Attestation of the research participant’s preference for whether or not he/she agrees to receive results. 

The consent documents must clearly explain that if an incidental finding is made by the researcher they will: 

• Have a qualified professional assess the probable importance 
• Discuss the findings with the participant and/or parent if the participant is a minor only if the expert consultant advises referral to a specialist OR not disclose the findings if the expert consultant determines that clinical evaluation is not required.