Request for Information: NIH Precision Medicine Cohort - Strategies to Address Community Engagement and Health Disparities

Notice Number: NOT-OD-15-107

Key Dates
Release Date: May 29, 2015
Response Date: June 19, 2015

Related Announcements
June 8, 2015 - Registration Open for Participant Engagement and Health Equity Workshop of the Precision Medicine Initiative Working Group of the Advisory Committee to the NIH Director, July 1-2, 2015. See Notice NOT-OD-15-110.

Issued by
National Institutes of Health (NIH)


This Request for Information (RFI) seeks feedback to help guide creating the National Institutes of Health (NIH)’s national research cohort of 1 million or more Americans as part of the President’s proposed Precision Medicine Initiative (PMI), specifically as it relates to the development and implementation of effective community engagement strategies for the cohort, and to the advancement the cohort’s ability to conduct transformative research to address health disparities. Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle. In order for the benefits of precision medicine and the PMI to be available to all people, including those who are medically underserved and/or historically underrepresented in biomedical research, or who, for reasons of systematic social disadvantage experience disparities in health, the NIH aims to assemble a cohort reflective of the rich diversity of the U.S. population.

The concept of precision medicine - the application of prevention and treatment strategies that take individual variability into account - is not new, but opportunities for evidence-based precision medicine have greatly expanded recently due to the development of better large-scale biologic databases and computational tools, among other things. What is needed is a research resource for developing and validating new approaches to precision medicine that could be used to guide clinical practice ultimately to improve health. The goals of the NIH Precision Medicine cohort are to enable better assessment of disease risk, understand disease mechanisms, and predict optimal therapy for a broad range of diseases through the study of a large group of people who have volunteered to provide data and biospecimens over time to a large multidisciplinary community of authorized researchers pursuing these research goals. These data will also enable observational studies of drugs and devices and potentially prompt more rigorous interventional studies that address specific questions.

Participants will be asked to give consent for extensive characterization of biologic specimens (potentially including cell populations, proteins, metabolites, RNA, and DNA whole-genome sequencing, if/when costs permit) and behavioral and environmental data, all linked to their electronic health records (EHRs). Qualified researchers from many organizations will, with appropriate protection of participant confidentiality, have access to the cohort's de-identified data for research and analysis.
Characteristics of such a large-scale study that might maximize its research value may include: 1) a sufficiently large number of participants to achieve adequate power for evaluation of common disorders and reasonable representation of rare disorders; 2) intentional over-sampling of populations underrepresented in research to permit meaningful inferences about these groups and to study health disparities; 3) a broad age range to provide information on disorders from infancy to old age; 4) a broad range of genetic backgrounds and environmental exposures; 5) a broad array of clinical and laboratory information, not limited to any single disease, 6) sophisticated dietary, other lifestyle, and environmental exposure assessments, preferably provided directly from participants using mobile devices or wearable sensors; 7) access to comprehensive electronic health data on participants for baseline, follow-up, and possibly also retrospective (prior to study entry) data collection, as well as return of actionable results for use in their clinical care; 8) return of appropriate information and results to participants as they desire; 9) collection and storage of biological specimens; 10) access to study data and biologic materials to qualified researchers to empower research on many diseases by researchers in many sectors; 11) community engagement in the design and implementation of the study, including a state-of-the-art consent process, to allow multiple uses of the data, regular feedback to participants about findings and progress; and 12) a study design, recruitment and implementation process that ensures a high follow-up rate and comparable follow up rates across diverse population groups.

Sharing data consistent with achieving the goals of this project and in accordance with the NIH’s data sharing policies will be expected.

Background Information

On January 20, 2015, President Obama announced a new Precision Medicine Initiative for fiscal year 2016 in his State of the Union address, and expanded on the announcement at a White House event on January 30, 2015. On that same day, Drs. Francis Collins and Harold Varmus published a Perspective in the New England Journal of Medicine, A New Initiative on Precision Medicine. Opportunities and obstacles for developing such a cohort were explored in a preliminary way in a February 2015 NIH workshop, Building a Large U.S. Research Cohort. Steps arising from that workshop included establishing a PMI Working Group of the Advisory Committee to the NIH Director (ACD). NIH is taking various steps to gather input from participant, scientific, and other stakeholder groups as it plans the development of the President’s Precision Medicine Initiative and the vision for building the national participant group, including a series of public workshops. To ensure that the PMI Working Group’s contributions can be incorporated into the funding plan for fiscal year 2016, a report will be delivered to the ACD in September 2015. Funding solicitations to establish the cohort, if warranted, will be developed shortly thereafter for award in mid- to late fiscal 2016.
Information Requested.

The NIH seeks information regarding community engagement strategies that would enable diverse, broad, sustained participation and acceptance of the approach by diverse communities of scientists, policy makers and community leaders in this large U.S. cohort. Information on issues of trust, willingness to undergo biomedical research testing, and racial/ethnic differences in attitudes towards precision medicine are particularly important. In addition, community-specific, culturally sensitive strategies that include system, environmental, individual-level perspectives are requested. Information is also sought on potential issues and opportunities associated with the development and implementation of a large diverse U.S. Precision Medicine cohort.

Information Requested

The NIH seeks comment on any or all of the following topics in order to create a diverse cohort representative of the U.S.

A. Community Engagement Strategies for a diverse sustained U.S. precision medicine cohort.
1. The factors and incentives that would enable participation or make it more likely for people historically underrepresented in research to participate, including examples of successful models of recruiting and retaining participants from communities historically underrepresented in research

2. Community engagement strategies and partnerships that can facilitate and integrate multiple perspectives at the community and individual level and account for diverse, social, religious, economic, and geographic settings

3. The barriers to participation in the precision medicine cohort and strategies to address those barriers

4. Ways to avoid potential stigmatization of subpopulations, and to manage unintended adverse consequences of the precision medicine cohort

5. Safeguards that should be implemented to reassure communities of the net positive potential of the precision medicine cohort to understand health and disease and improve the health of all segments of the US population

B. Health Disparities
1. Priority health disparities research questions that can be uniquely addressed within the proposed precision medicine cohort

2. Opportunities to study the relative influence of health determinants (e.g. personal, social, economic, environmental factors) on disease risk, disease mechanism, and individual response to therapy

3. Opportunities to obtain new scientific knowledge regarding individual variability in genes, environment, and lifestyle and their interactions as they affect the incidence of progression of illness where there are significant population disparities in disease incidence, prevalence, and outcomes

4. Novel methods to gather data on geographic, environmental, and social determinants of health.

5. Novel ways to assess the historical as well as current factors that predispose the individuals in certain population groups to higher disease incidence or shorter survival.


All responses must be submitted online via the following website: by June 19, 2015. Response to this RFI is voluntary. Responders are free to address any or all of the items listed above; respondents should not feel compelled to address all items. Please note that the text box for each topic has a maximum limit of 250 words.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the United States Government will not pay for the preparation of any information submitted or for its use of that information.

Responses will be compiled and may be shared publically. We look forward to your input and hope that you will share this RFI document with your colleagues. Updates to this document, if any, will be noted. Please check before submission.


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