Table 6.

Recommendations for policy development

1. IRBs and/or research ethics consultation services should develop guidelines for researchers to assess the likelihood that the study will reveal clinically relevant information and develop policies to guide how these findings should be managed (i.e., whether they should be communicated to the research participant and/or the treating physician).
2. As part of IRB and grant applications, researchers should assess the likelihood that clinically relevant research results, including incidental findings, would be revealed in the study and develop a plan, in collaboration with the IRB, to determine how the findings should be managed.
3. The researcher should indicate and justify in the informed consent process and document whether or not individual research or incidental findings will be disclosed to the participant and their family.
4. The researcher should plan for the release of aggregate data, in the form of plain language summaries, describing in general terms the findings of the study and not rely on the technical manuscript as the means of communication of aggregate results.
5. If individual research results or incidental findings are to be disclosed to the participant, all of the following should apply:
    a. The researcher should interact with his/her IRB to determine a management and coordination plan for review, validation, and return of findings.
    b. The findings must be determined to be analytically and clinically valid and be confirmed in a CLIA approved laboratory or under the supervision of a CLIA approved laboratory.
    c. The findings must be reviewed by an oversight or DSMB-like committee and deemed appropriate for communication to the research participant.
    d. The participant be given the opportunity to know or not know the findings.
    e. The individual communicating the results must be a medical professional with training in genetic counseling.