Will All of Us capture the change in medicine use for a participant who has received pharmacogenetic results back from the program, discussed/validated the results with their physician, and made changes to their prescriptions as a return of those results?
The program plans to perform reassessments through surveys every two to three years. The reassessments will include updating personal medical information, including any changes in current medications. However, we currently do not have a question specifically asking participants whether they changed their prescriptions based on the All of Us return of pharmacogenomics results. We expect that some of this information will be captured in Electronic Health Records (EHR) for those participants who have shared their EHRs and opted to receive genomic results. We anticipate that EHR data available on the Research Hub will be updated on a quarterly basis. However, we recognize that this may not allow for confirmation that changes in prescriptions resulted directly from health provider actions taken in response to pharmacogenetic results returned by All of Us. The program may also explore collecting these data in the future as part of pilot programs for returning pharmacogenetic results to participants.
Social scientists need multi-level data to work on social determinants of health, such as community factors, health system–level factors, and broader data that can be linked to geocodes. What is the program’s plan for getting those data?
Data elements available through the registered tier currently include EHRs, survey responses, and physical measurements. All of Us is also exploring ways to enhance the data in the future by linking to external data sources such as the National Death Index, Census tract data, and other publicly available sources and by implementation of geocoding. All of Us will continue to consider other sources of community and health system data, based on researcher, community, and participant feedback.
At this time, All of Us is also working to create policies about the types of data and tools that researchers can safely upload into their workspaces. This may include software packages for statistical analyses, phenotype algorithms, and information in public knowledge bases, among other categories. Any external data or software uploaded into the workspaces must be compliant with the All of Us Data Use Agreement (DUA), which prohibits reidentification of All of Us Research Program participants, stigmatizing research, or any other malicious use.
Will phone use and health literacy information be collected from participants?
All of Us surveys include questions on health literacy. However, the program does not currently ask about landline or mobile phone use. More data on these topics may be collected from participants in other ways in the future for research. All of Us will continue to consider other types of data for collection based on researcher, community, and participant feedback. There will be a feedback form through the researcher workbench that allows for structured feedback on scientific suggestions and data types that we should capture in the future. This form will be sent directly to NIH staff.
Will ELSI researchers be allowed to recontact participants to do qualitative and other types of data collection?
All of Us is planning to allow participant recontact for approved ancillary studies. The program is in the process of developing the requisite policies and technical infrastructure to support this aspect of the program. However, at this time, external researchers cannot recontact All of Us participants. We will notify prospective and current users about these and other All of Us developments through the Research Hub.
Can family members (twins, siblings) choose to have their data linked together (rather than looking at genetic similarity)?
Currently, the ability to link familial relations through the participant portal is not available, due to the potential risk of reidentification. Familial data linkage is a functionality that the program will consider for the future, but if it is added, the appropriate data protection and participant notification and controls will be proactively implemented.