National Human Research Protections Advisory Committee



Charter


Purpose:

The Department of Health and Human Services (HHS), National Human Research Protections Advisory Committee (NHRPAC or Committee) will provide expert advice and recommendations to the Secretary of HHS, Assistant Secretary for Health (ASH), the Director, Office for Human Research Protections (OHRP), and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects.

Authority:

42 U.S. Code 217A; Section 222, of the Public Health Service Act, as amended. The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S. Code Appendix 2), which sets forth standards for the formation and use of advisory committees.

Function:

The Committee shall advise the Secretary and the Assistant Secretary for Health pertaining to the continuance and improvement of human subjects protection functions within the authority of HHS. The Committee will provide advice on the development and management of collaborations and communications between HHS and its operating and staff divisions and other pertinent elements of the federal government; the biomedical, academic, and research communities; non-governmental entities; and other organizations as necessary to further the interests of the human subjects protection enterprise. The Committee will provide counsel on opportunities to improve public awareness of the function and importance of human subjects protection activities.

Structure:

The NHRPAC shall consist of seventeen (17) members, including the Chair. Members and the Chair shall be selected by the Secretary, or designee. Members will be selected from among individuals possessing demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection. The Director, OHRP, shall serve as Executive Secretary of the Committee.

In addition, the Committee shall have non-voting ex officio members representing the Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); the Food and Drug Administration (FDA); and the National Institutes of Health (NIH); and such additional ex officio members as the Secretary deems necessary to effectively carry out the Committee=s function.

Members shall be appointed to serve for overlapping four year terms. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term. A member may serve up to 180 days after the expiration of the member=s term if a successor has not taken office.

In carrying out its functions, the Committee may establish subcommittees composed of members of the parent Committee; convene workshops, assemble ad hoc working groups, call conferences; and, seek advice from nonmember special consultants. The Department Committee Management Officer shall be notified upon the establishment of each subcommittee and shall be given information regarding its name, membership, function, and estimated frequency of meetings.

Meetings:

Meetings shall be held at least two times a year at the call of the Chair, with the advance approval of a Federal Government official who shall also approve the agenda. A Government official shall be present at all meetings. A quorum for the conduct of business shall consist of a majority of the Committee=s authorized membership, including ex officio members.

Meetings shall be open to the public, except as determined otherwise by the Secretary or other official to whom the authority has been delegated. Notice of all meetings shall be given to the public.

Meetings shall be conducted and records of the proceedings kept as required by applicable laws and Departmental regulations.

Compensation:

Members shall be paid at the rate of $150 per day, plus per diem and travel expenses, as authorized by Section 5703, Title 5, U.S.C., for persons in the Government Service employed intermittently. Members who are officers or employees of the United States shall not receive compensation for their services on the Committee.

Annual Cost Estimate:

The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support is $140,000. The estimate of annual person-years of staff support is 1.5, at an estimated annual cost of $158,500.

Reports:

In the event that a portion of a meeting is closed to the public a report shall be prepared which shall contain, as a minimum, a list of members and their business addresses, the Committee=s function, dates and places of meetings, and a summary of the Committee activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Officer.

Termination:

Unless renewed by appropriate action prior to its expiration, the National Human Research Protections Advisory Committee (NHRPAC), will terminate two years from the date this charter is approved.

Approved:

 

June 6, 2000                                                                      /s/ Donna E. Shalala
Date                                                                                   Secretary

Revised per Amendment

January 19, 2001


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Updated January 13, 2003