The U.S. Presidential Commission recently reviewed 32 reports from the United States and worldwide on returning of findings in diverse contexts (4); it is striking that access to raw data by participants was not addressed in any of them.
Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings.
Bennette CS, Trinidad SB, Fullerton SM, et al. Return of incidental findings in genomic medicine: measuring what patients value development of an instrument to measure preferences for information from next-generation testing (IMPRINT).
Personal experiences with return of genomic findings.
Another study simulated the return of incidental findings by first classifying 2,016 genes linked to Mendelian disorders into "bins" based on their clinical utility and validity.
One topic raised in multiple sessions that will be increasingly important in the future was the return of incidental findings, and this was the focus of Holly Tabor's talk (University of Washington, USA).
Although the return of incidental findings represents an important step forward in the use of sequencing for medical benefit, implementing these recommendations requires the development of infrastructure to support evaluation and reporting.
27 Although a minimum list of genes was not designed to apply to genomic research it is possible these recommendations may contribute to the effort 'to design thresholds and lists for the return of genomic findings to research participants'.
Advocates for widespread use of personal genomic profiling recommend that it is best done as early as possible in life, underscoring the need for comprehensive management plans and multidisciplinary discussion on the return of incidental findings (IFs) in clinical research.
As such, in clinical trials in which the researcher-participant relationship may be intense and the participant may be particularly vulnerable, the ethical duty to the participant, which may involve the return of incidental findings, is amplified.
