Return of Results

By which criteria will we determine if our data analytic models are sufficiently valid and reliable for us to share the individual research results and data with the research participant and/or the participant’s clinician?

1. Have we considered whether our study will generate any “actionable” results, based on established guidelines and how we have defined actionability?

2. Have we established with which frequency results will be returned, e.g. should participants have daily, weekly, monthly access to some subset of their data?

3. Have we clarified the protocols and mechanisms for returning different types of information, e.g. raw data, interpreted data, and so on?

4. Do we have a protocol in place for contacting a participant’s clinician?

Resources:

Improved ethical guidance for the return of results from psychiatric genomics research

https://onesearch.nihlibrary.ors.nih.gov/discovery/fulldisplay?vid=01NIH_INST:NIH&search_scope=NIHAll&tab=NIHCampus&docid=nature_a10.1038~2Fmp.2017.228&lang=en&context=PC&adaptor=Primo%20Central&query=any,contains,return%20of%20results,AND&sortby=rank&mode=advanced&offset=0

Shared decision making: Implications for return of results from whole-exome and whole-genome sequencing

https://onesearch.nihlibrary.ors.nih.gov/discovery/fulldisplay?vid=01NIH_INST:NIH&search_scope=NIHAll&tab=NIHCampus&docid=oxford10.1093~2Ftbm~2Fibx048&lang=en&context=PC&adaptor=Primo%20Central&query=any,contains,return%20of%20results,AND&sortby=rank&mode=advanced&offset=0

Points-to-consider on the return of results in epigenetic research

https://onesearch.nihlibrary.ors.nih.gov/discovery/fulldisplay?vid=01NIH_INST:NIH&search_scope=NIHAll&tab=NIHCampus&docid=medline31122281&lang=en&context=PC&adaptor=Primo%20Central&query=any,contains,return%20of%20results,AND&sortby=rank&mode=advanced&offset=0

SACHRP Recommendation on Return of Individual Research Results

https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-return-individual-research-results/index.html