Authorized by 42 U.S.C. 282(b)(16), section 402(b)(16) of the Public Health Services (PHS) Act, as amended. The National Institutes of Health (NIH) Clinical Center Research Hospital Board (Board) is governed by the provisions of the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. §§ 1001-1014).
Objectives and Scope of Activities
The purpose of the Board is to advise, consult with, and make recommendations to the NIH Principal Deputy Director (or designee) and the NIH Clinical Center Chief Executive Officer (CEO) with respect to maintaining excellence in hospital operations, safety and quality, unique clinical research care requirements for Clinical Center patients, regulatory compliance, clinical research, and hospital leadership performance oversight. The Board’s advice and recommendations may regard issues, processes, studies, and/or reports on a range of topics in relation to the NIH Clinical Center and CEO's duties and authorities.
Description of Duties
The purpose of the Board is to provide advice and recommendations to the NIH Principal Deputy Director (or designee) and CEO of the NIH Clinical Center on the NIH Clinical Center’s policies and procedures regarding hospital operations, safety and quality, and regulatory compliance. Using leading institutions in health care and research as benchmarks, the Board will provide advice in the following areas:
Management, quality and safety, and compliance of hospital operations
Policies and organizational approaches that promote quality and safety for all organizational stakeholders, including patients and research participants
Risk areas that need to be addressed by hospital and agency leadership
Implementation of policies and strategic plans
Requirements for hospital leadership
Performance of the CEO including evaluation based on operating plans and quality metrics
The Board may request reports on quality and safety measures, risk assessment, violations and remediation measures/corrective action plans, and additional measures.
The duties of the Board are solely advisory and shall extend only to the submission of advice and recommendations to the NIH Principal Deputy Director (or designee) and CEO of the NIH Clinical Center, which will be non-binding to the NIH. No determination of fact or policy will be made by the Board. Unlike hospital boards in the community, the Board does not have financial authority.
Agency or Federal Officer Receiving the Advisory Committee’s Advice/Recommendations.
The Board will advise, consult with, and make recommendations to the NIH Principal Deputy Director (or designee) and CEO of the NIH Clinical Center.
Support
Management and support services will be provided by the Office of the Director, NIH in collaboration with the Office of the Chief Executive Officer, NIH Clinical Center.
Estimated Annual Operating Costs and Staff Years
The estimated annual costs to operate the Clinical Center Research Hospital Board include the following:
Federal personnel (based on full-time equivalent (FTE) usage basis) and other Federal internal costs. The estimated annual person years of staff support required is 0.1, at an estimated annual cost of $15,709. The estimate for other Federal internal costs is $0.0.
Proposed payments to members and number of members. The estimated payments for 9 non-Federal members is $5,400; the estimated prorated salary of 0 Federal members is $0.
Reimbursable costs. The estimate for reimbursable costs, including members’ travel expenses, is $41,548.
Estimated Number and Frequency of Meetings
The Board will meet approximately three times within a fiscal year. Meetings will be open to the public except as determined by the Secretary of Health and Human Services (Secretary) at the request of the Designated Federal Officer (DFO) in accordance with 5 U.S.C. 552b(c) and 41 C.F.R. 102-3.155 including specifying the specific exception(s) that justifies closure. Notice of all meetings will be given to the public. In the event a portion of a meeting is closed to the public, as determined by the Secretary in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and FACA, an annual report of closed or partially-closed meetings will be prepared which will contain, at a minimum, a list of members and their business addresses, the committee’s functions, dates and places of meetings, and a summary of the committee’s activities and recommendations made during the fiscal year.
Duration
The duration of the Board is continuing, subject to the Termination section below.
Termination
Unless renewed by appropriate action, the NIH Clinical Center Research Hospital Board will terminate two years from the date the charter is filed.
Membership and Designation
The Board will consist of up to 14 non-federal members, including the chair, appointed by the NIH Director (or delegee). The appointed members will consist of (a) authorities who are nationally recognized leaders in sectors related to the NIH Clinical Center’s duties and authorities, including but not limited to research hospital administration/operations, clinical care, safety and quality, clinical and research compliance, or clinical research, and (b) two individuals who have participated in clinical research studies as patients. Appointed members will be selected from the academic and private sector research community, as well as the general public.
Appointed members must be eligible to serve as Special Government Employees (SGEs) and will serve as SGEs, as defined by 18 U.S.C. § 202. Members and the chair will be invited to serve for overlapping terms of up to four years. Terms of more than two years are contingent upon the renewal of the Board charter by appropriate action prior to its termination. Members may serve after the expiration of their terms until their successors have taken office. A quorum for the conduct of business by the full committee will consist of a majority of currently appointed members.
Subcommittees
As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Board’s jurisdiction. The advice/recommendations of a subcommittee/working group must be deliberated by the parent advisory committee, which is the Board. A subcommittee/working group may not report directly to a Federal officer.
Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. Ad hoc consultants are not considered subcommittee members, do not count towards the quorum, and may not vote. A quorum for a subcommittee will be three members. The Department Committee Management Officer will be notified upon establishment of each standing subcommittee and will be provided with information on its name, membership, function, and estimated frequency of meetings.
