December 17, 2015

Charter of the PMI Cohort Program Advisory Panel

Purpose

The Precision Medicine Initiative® (PMI) Cohort Program Advisory Panel, a working group of the NIH Council of Councils, is being convened to provide external oversight and expert advice on the vision, scientific goals, and operations of the PMI Cohort Program of the National Institutes of Health  (NIH).

Background

At the State of the Union on January 20, 2015, President Obama announced the Precision Medicine Initiative® as a national effort to revolutionize medicine and generate the scientific evidence needed to move the concept of precision medicine into every day clinical practice. In order to achieve the President’s vision, the NIH will create and manage a national research cohort of one million or more U.S. volunteers. The goal of assembling this cohort program will be to forge a new model for scientific research that emphasizes engaged participants while promoting open, responsible data sharing with strong privacy protections.

NIH Director Dr. Francis Collins established the Precision Medicine Initiative® Working Group of the Advisory Committee to the NIH Director (ACD) to chart the course for the national research PMI Cohort Program. The Precision Medicine Initiative Cohort Program — Building a Research Foundation for 21st Century Medicine was endorsed unanimously on September 17, 2015, by the ACD and subsequently accepted by Dr. Collins. It describes assembly of a transformative national research cohort of volunteers from diverse backgrounds and the collection, a vision for participant engagement, the handling of biological, environmental, and behavioral data from participants. Also included are the relevant technical and policy considerations that should be addressed to promote data sharing while maximizing data security and privacy. Importantly, the plan for the PMI Cohort Program places participants at the center of all activities, including governance. The plan is envisioned to be the foundation for the PMI Cohort and will serve as a roadmap for the agency’s investment in this program.

Description of scope and duties

The PMI Cohort Program Advisory Panel, subsequently referred to as the Panel, is charged with evaluating and providing recommendations regarding PMI Cohort Program activities. Findings and recommendations of the Panel will report to the NIH Council of Councils for further consideration. The NIH Council of Councils will use the Panel’s findings and recommendations to provide final recommendations to the PMI Cohort Program Director and the NIH Director.

Specifically, the members of the Panel will consider:

  1. The vision and direction of the PMI Cohort Program;
  2. Concept clearance for new initiatives to be established under the PMI Cohort Program;
  3. Review of preliminary funding plan proposals;
  4. Ongoing assessment of current projects and programs supported by the PMI Cohort Program; and
  5. Coordination and integration of the PMI Cohort Program with activities of individual NIH Institutes and Centers (ICs).

The Panel will provide an intensive examination of the progress of the PMI Cohort Program between years 5 and 6, to ensure its vision has shown continued adaptation to the evolving landscape of research and clinical practice.

As necessary, with approval of the chair of the Panel, the Panel may call upon special consultants, assemble ad hoc work groups, and convene conferences, workshops, and other activities.

Membership and designation

Members of the Panel will be selected by the PMI Cohort Program Director for their expertise in areas relevant to the goals of the PMI Cohort Program mission. At least one member should currently serve on the NIH Council of Councils. No less than 30% of the membership of the Panel should comprise participants or participant representatives. Each Panel member is entitled to one vote. Ex officio participants representing other Federal agencies may also be appointed.

The PMI Cohort Program Director shall serve as chair of the Panel. Members will be appointed to staggered, four-year terms. An executive secretary will be assigned to monitor the Panel’s activities to ensure that the group does not directly advise federal officials and that records (i.e., minutes, draft reports) are maintained in official files for record-keeping purposes.

Estimated number and frequency of meetings

The Panel will as needed throughout the year, preferably in advance of NIH Council of Council meetings. The Panel is encouraged to hold meetings in open session when possible.

Duration

The Panel is set to exist as long as the PMI Cohort Program is ongoing at the NIH. This charter governs the Panel’s activities for the duration of the Program. As the President’s Precision Medicine Initiative® proceeds, it may be necessary to amend the charter to reflect the changing landscape.

Support

Management and support services will be provided by the Office of the Director, NIH.

This page last reviewed on January 14, 2016