Table 1.

Potential Advantages and Disadvantages of Models of Consent to Return of Incidental Findings

Model Name	Potential Advantages	Potential Disadvantages
1. Traditional Consent	-Resembles traditional process, familiar to the research community -Participant receives all IF information prior to deciding whether to participate -Participant maintains choice about types of IFs to receive, or about opting out	-Adds time and information to lengthy and complex process -Participant preferences may change after initial consent
2. Staged Consent	-Reduces time spent discussing IFs during initial consent; more detailed information provided later if IFs occur -Participant makes decisions on IFs closer to the time of receipt, can consider current circumstances -More detailed and specific information for participant -Participant maintains choice about types of IFs to receive, or about opting out altogether	-Following-up and recontacting participants for consent could be costly and burdensome -Participant’s decision to enroll in study made without full information about potential return of IFs -Depending on procedure, recontacting participant may reveal unwanted information about an IF, with negative impact on participant
3. Mandatory Return	-Simplifies consent at enrollment: participant receives information only on selected IFs, does not have to choose which findings to receive -Researchers’ obligations to return IFs clearly defined and limited to a pre-determined list -Degree of choice maintained about whether to participate in the study	-Participant choice restricted—cannot choose which findings to receive, and cannot refuse to accept designated findings -Lack of participant choice may be disincentive to enroll in genomic research -Efforts to follow-up and recontact participants could be costly and burdensome for researchers
4. Outsourcing	- Researchers don’t have to spend time explaining implications of IFs - would be outsourced to entities that specialize in interpretation/ communication of genomic information - Costs associated with return of results avoided, including recontacting participants, hiring additional staff to communicate results, etc. -Participant spared immediate task of deciding which secondary findings to receive; can pursue this question later with entity of their choice -Researchers’ obligations simplified to the return of each participant’s raw data	-Though participant receives all genomic data, may not become aware of medically significant data -Services for genomic interpretation and counseling not widely available at present—could be mitigated if demand increases -May exacerbate health disparities, since further interpretive services may be costly and hence limited to wealthy participants