Traditional Consent: Obtain consent to return of incidental or secondary findings at the time of enrollment in the genomic research study.
Participants would be told, at the time of initial consent, about the nature and likelihood of incidental or secondary findings, and the categories of findings that may be detected. Participants would decide at the time of enrollment which incidental/secondary findings or categories of findings that are being offered they would like to receive.
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Staged Consent: Obtain consent in stages, with brief mention at the time of initial consent that incidental or secondary findings may occur, but with more detailed information provided and a decision made by the participant later when/if reportable results are found.
This model requires a system of follow-up (e.g., a web-based portal, email, regular mail) to notify participants that findings exist, to provide access to information that would permit participants to decide whether they want to receive the findings, and to allow participants to indicate their preferences.
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Mandatory Return: Obtain consent to return of specific categories of incidental or secondary findings at the time of—and as a condition of—enrollment.
This model involves the return of a pre-determined list, or general grouping, of clinically actionable findings for high penetrance genes (e.g., hereditary colon cancer due to mismatch repair gene mutations), should any of these findings be discovered. Participants would not have the option to refuse the information. This model is similar to the initial ACMG recommendations for return of incidental findings in clinical sequencing.
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Outsourced Consent: Refer participants to third parties for consent and return of incidental or secondary findings.
This model involves researchers providing each participant with their raw genomic data. A participant would then have the option of seeking further expert genetic services to interpret the data and to provide assistance in deciding which, if any, results they choose to receive. The cost of this outsourced service would not be borne by the researcher.
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