Intramural Clinical Research Steering Committee (ICRSC)

The NIH Intramural Clinical Research Steering Committee (ICRSC) was established by the NIH Deputy Director for Intramural Research (DDIR) as a forum for trans-NIH governance and policy development in the area of human subjects research. It is expected that the ICRSC will interact with the Intramural Working Group, Board of Scientific Directors, the Medical Executive Committee, the Human Subjects Research Advisory Committee, and the Advisory Board for Clinical Research, as needed, to develop and implement plans to improve the environment for clinical research at the NIH and to coordinate efforts and ensure clear communications about goals, progress, and future directions.

Background

The need for high-level leadership to address the current crisis in clinical research has been noted for many years (see Benz-Goldstein report) and most recently articulated in the draft report on barriers to clinical research that was developed by the Medical Executive Committee (MEC) and presented to the Intramural Working Group. A clear consensus emerged from the discussions following the presentation of that report that there was a need for an advisory committee consisting of a cross-section of Institute or Center (IC) leadership involved in clinical research to address ways to harmonize policy and operations, develop standards for IRBs, insure that protocols receive adequate, consistent scientific review and to review the level of support provided to investigators whose work includes the development of human subjects research protocols. Moreover, an overarching and consistent theme of discussions dating back over ten years is that clinical and translational research is a vital part of the intramural research portfolio that is threatened by factors that range from concrete issues such as regulatory barriers to more ineffable but equally important considerations, such as vision and priority-setting. The ICRSC will address such important issues, and is advisory to the NIH Deputy Director for Intramural Research.

Functions

The ICRSC is specifically charged with providing guidance in the following areas:

1. Standards and strategies for the development, review, and implementation of human subjects protocols, including IRB operations, support, and accountability, and ethical interactions with the pharmaceutical industry (including technology transfer).
2. Standards and strategies for the development, review, and implementation of human subjects research more broadly, including the scientific review of protocols, and the BSC review of clinical programs.

Structure

Chair

The Chair of the ICRSC will be an IC Clinical Director appointed by the NIH Deputy Director for Intramural Research. The Chair will be the Deputy Director for Intramural Clinical Research with delegated responsibilities to review and approve appointments of tenure-track clinical Investigators and to review the career pathways of Staff Clinicians, to serve on the NIH Clinical Compensation Panel, the NIH Compensation Committee, the Central Tenure Committee (ad hoc), and the Board of Scientific Directors (ex-officio); this individual will be a full participating member of the staff of the Office of Intramural Research.

Membership

The members will be appointed by the Deputy Director for Intramural Research, NIH, and will consist of the following:

Voting Members

• Chair
• 2 IC Directors
• 2 Scientific Directors

Ex-Officio Members

• Director, Clinical Center
• Director, OHSR
• Head, Bioethics, CC
• 4 Clinical Directors
• 2 Tenured Principal Investigators (PI) expert in clinical investigation
• 1 IRB Chair
• 1 IRB Administrator

Every effort will be made to ensure fair representation and ICRSC membership across all ICs over time. The Deputy Director for Intramural Research should solicit nominations for these positions from Institute/Center Directors, Scientific Directors and Clinical Directors.

Meetings

It is expected that the ICRSC will meet twice a month, or as often as deemed necessary by the members.