Annual Meeting of the NCI Cohort Consortium (Abstract Submission): Submission #2

Lightning Talks Abstract
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Presenter's First Name: : Tamara









Presenter's Last Name:: Litwin









Title (eg: professor, assistant professor, chair, etc):: Epidemiologist









Degree(s): Ph.D., MPH









Contact Email:: tamara.litwin@nih.gov









Organization:: All of Us Research Program, Office of the Director, National Institutes of Health









Project Title:: Lessons Learned from Return of DNA Results in the All of Us Research Program









Additional Authors:
1. First Name: Sheri
   Last Name: Schully
   Degree(s): Ph.D.
   Organization: All of Us Research Program, Office of the Director, National Institutes of Health
2. First Name: Anastasia
   Last Name: Wise
   Degree(s): Ph.D.
   Organization: All of Us Research Program, Office of the Director, National Institutes of Health










Abstract::
Background
The All of Us Research Program sought to return research DNA results to study participants, including both engaging insights and health-related reports. 

Methods
The program obtained Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) to return health-related DNA results. Participants were offered the opportunity to opt into receiving genetic results. Results including genetic ancestry and traits and two health-related reports were returned via a web-based participant portal. Pathogenic and likely pathogenic variant calls were returned through a genetic counseling service and all participants had access to genetic counselors.

Results
There were often extensive delays between sample donation and return of DNA results, taking up to four months to generate reports for significant findings. Over 220,000 All of Us participants have viewed their genetic ancestry report and over 222,000 have viewed any genetic trait report. Over 124,000 participants have viewed their Hereditary Disease Risk report​, of whom ~2% (>2,500) have a pathogenic or likely pathogenic genetic variant in one of 59 included genes. Over 119,000 participants have viewed their Medicine and Your DNA report, of whom 89% (>106,000) have a result that could impact how their body processes one of seven included medications.

Conclusion/Discussion
The DNA results workflow includes many partners and is expensive to maintain and update. The FDA IDE delays changes to the protocol. Participants value DNA results and have high expectations for return of personalized results from All of Us.