The Precision Medicine Initiative’s All of Us Research Program: an agenda for research on its ethical, legal, and social issues

Abstract

The Precision Medicine Initiative (PMI) is an innovative approach to developing a new model of health care that takes into account individual differences in people's genes, environments, and lifestyles. A cornerstone of the initiative is the PMI All of Us Research Program (formerly known as PMI-Cohort Program) which will create a cohort of 1 million volunteers who will contribute their health data and biospecimens to a centralized national database to support precision medicine research. The PMI All of US Research Program is the largest longitudinal study in the history of the United States. The designers of the Program anticipated and addressed some of the ethical, legal, and social issues (ELSI) associated with the initiative. To date, however, there is no plan to call for research regarding ELSI associated with the Program-PMI All of Us program. Based on analysis of National Institutes of Health (NIH) funding announcements for the PMI All of Us program, we have identified three ELSI themes: cohort diversity and health disparities, participant engagement, and privacy and security. We review All of Us Research Program plans to address these issues and then identify additional ELSI within each domain that warrant ongoing investigation as the All of Us Research Program develops. We conclude that PMI's All of Us Research Program represents a significant opportunity and obligation to identify, analyze, and respond to ELSI, and we call on the PMI to initiate a research program capable of taking on these challenges.Genet Med advance online publication 01 December 2016.

Analysis commons, a team approach to discovery in a big-data environment for genetic epidemiology

“…The number of WGS studies with large sample sizes is rapidly expanding. Projects such as the National Heart, Lung, and Blood Institute (NHLBI) Trans-Omics for Precision Medicine (TOPMed) Program, Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) Consortium 1,2 , and the Centers for Common Disease Genomics (CCDG) 3 , among others, have already conducted WGS in more than 100,000 individuals, and the Personalized Medicine Initiative 4 promises whole-genome sequencing in over a million samples. These programs span a diverse set of studies and institutions, many of which lack the computational infrastructure to store and compute on this scale of data.…”

mActive-Smoke: A Prospective Observational Study Using Mobile Health Tools to Assess the Association of Physical Activity With Smoking Urges (Preprint)

“…Among these 'extreme responders', six (11 percent of our study population) exhibited a consistently inverse association. While these results are exploratory and hypothesisgenerating in nature, they suggest that physical activity could be targeted as a means to curb smoking urges among select individuals, an insight consistent with the Precision Medicine Initiative (PMI)'s focus on individual variability in genes, environments and lifestyles [48]. Further research is needed to determine whether equally robust inverse 14 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 relationships between steps and urge could be replicated among these select individuals in an interventional study, which might help illuminate the underlying genetic, environmental, and lifestyle factors associated with these behaviors.…”

Precisely Where Are We Going? Charting the New Terrain of Precision Prevention

“…For example, how should precision prevention in the service of public health be operationalized (4)? What challenges might its different applications face (103)? In this review, we examine two proposed applications of translational genomic research that raise these questions: the integration of genomic tools into risk stratification for screening, and the use of genomic variation to reduce health disparities among population groups.…”