As part of the Obama administration’s Precision Medicine Initiative, an advisory committee recommends the National Institutes of Health leverage electronic health records and mobile healthcare technologies to gather data from a research cohort of one million or more Americans.
The recommendations to NIH Director Francis Collins, M.D., were made public on Thursday during a press conference unveiling a detailed design framework for building the large-scale, national research cohort intended as a broad resource for researchers working on a variety of health issues.
Under the plan, cohort participants will voluntarily enroll in the study to share a broad range of data including their EHRs, health survey information, and mHealth data on lifestyle habits and environmental exposures over many years. Participants will also undergo a standard baseline physical exam and provide a blood sample.
“Americans are engaging in their health, participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated and health technologies have become mobile,” Collins said. “The stars are aligning. Now is the time for us to take bold action, which the President called for in his State of the Union address in January.”
Collins emphasized that genomics information is just one of many types of biological data that will be gathered as part of the research cohort, including clinical information from EHRs. He highlighted mobile health technologies for their ability to “correlate activity, physiological measures and environmental exposures with health outcomes.”
Participants will have access to their study results, including aggregated results from all study participants, and will be provided with tools to make sense of the data. However, the security and privacy of this information is paramount, according to Collins, who said the working group made recommendations for establishing safeguards against unintended release of data and penalties for the unauthorized re-identification of participants.
NIH will begin recruiting participants for the cohort in 2016, with a goal of at least one million volunteers—including children—by 2020. Any person living in the United States can voluntarily enroll in the study directly or through participating healthcare provider organizations.
“We now have a design plan and it is time to move forward with implementation,” Collins concluded. However, he cautioned that “this is all contingent on congressional appropriations.”
Of the $215 million requested by the Obama administration for the Precision Medicine Initiative in the President’s fiscal 2016 budget, $130 million is earmarked for NIH to build the national research cohort. Collins said he is “hopeful” that Congress will fund the effort given that “appropriations mark-ups of the subcommittees have included dollars for this.”
One of the workgroup’s approved recommendations was that NIH should appoint a director for the NIH Precision Medicine Initiative Cohort Program. Collins said the agency has initiated an executive search for this leadership position. In the meantime, NIH has appointed Josephine Briggs, M.D., as the interim director of the program. Briggs, a nephrologist, is the director of the National Center for Complementary and Integrative Health.
The workgroup’s full report can be found here.
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