Exact(7)
The issues of whether and how to return incidental genetic findings, including the costs of doing so, should be considered when developing clinical trial protocols.
The issues of whether and how to return incidental genetic findings should be considered when determining which results from a trial will be reported.
Although linkage and family designs differ in numerous ways from sequencing-based approaches, this experience may be helpful as investigators consider whether and how to return incidental findings uncovered by sequencing research.
Institutional Review Boards (IRBs) and other study-specific governing bodies should be part of the decision as to if, when, and how to return incidental findings, including when plans in this regard are being reconsidered.
In this issue, the P3G consortium proposes an important step to cross the boundary between research and individual health care by proposing to consider to return incidental findings (IFs) to participants under certain conditions.
IRBs and other study-specific governing bodies should be consulted when deciding if, when, and how to return incidental genetic findings, as they share responsibility with investigators for study policies and procedures, and participant safety.
Similar(52)
There are arguments in support of as well as against returning incidental genetic findings in clinical trials.
Many investigators have stated that the practical difficulty of returning incidental findings is a major barrier to reporting back incidental findings to participants.
Finally, returning incidental genetic findings to individuals requires the investigator(s) who may be communicating the results to have appropriate genetic training and expertise [ 31, 32].
If we imaginatively combine the findings provided by Henderson et al. with recent studies that demonstrate that incidental findings generated through DNA-based tests are relatively common [ 7], we may conclude that returning incidental findings to 100,000 or 500,000 participants included in a genomic biorepository could represent a remarkably expensive and time-consuming effort.
She provided an in-depth study of participant preferences regarding the return of incidental or secondary findings; 95% of patients in her sample said they would prefer unrestricted access to their incidental findings regardless of how applicable it was to their own known clinical condition.
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