THE SECRETARY OF HEALTH AND HUMAN SERVICES WASHINGTON, D.C. 20201

CHARTER

SECRETARY'S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS

PURPOSE

The Secretary is responsible for implementing and enforcing the policy stipulated under 45 CFR Part 46 that applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research. The Secretary's Advisory Committee on Human Research Protections shall provide expert advice and recommendations to the Secretary and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protection of human research subjects. The Committee will work to further strengthen the protection of human research subjects in clinical trials, provide better oversight by the Federal Government of biomedical research, and reinforce the responsibility of research institutions to provide better oversight for their clinical researchers and institutional review boards (IRBs).

AUTHORITY

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

FUNCTION

The Committee shall advise, consult with, and make recommendations on matters pertaining to the continuance and improvement of functions within the authority of the Department of Health and Human Services (HHS) directed toward protections for human subjects in research. Specifically, examples include but are not limited to advice relating to the responsible conduct of research involving human subjects with particular emphasis on:

•   Special populations, such as neonates and children, prisoners, and the decisionally impaired;

•   Pregnant women, embryos, and fetuses;

•   Individuals and populations in international studies;

•   Populations in which there are individually identifiable samples, data, or information; and

•   Investigator conflicts of interest.

In addition, the Committee shall be responsible for reviewing selected ongoing work and planned activities of the Office of Human Research Protections (OHRP) and other offices/agencies within HHS responsible for human subjects protection. These evaluations may include but are not limited to a review of assurance systems, the application of minimal research risk standards, the granting of waivers, education programs sponsored by OHRP, and the ongoing monitoring and oversight of institutional review boards (IRBs) and the institutions that sponsor research.

STRUCTURE

The Committee shall consist of eleven (11) voting members, including the Chair. The Secretary or designee shall select members and the Chair. 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 and/or clinical research. In addition, the Committee shall include non-voting ex-officio members representing the following HHS agencies: Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); Food and Drug Administration (FDA); Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH); other Federal departments/agencies shall be invited to participate as non-voting ex officio members, as the Secretary, or designee, deems necessary to effectively carry out the Committee's function. The Director, OHRP, shall serve as the Executive Secretary of the Committee.

Members shall be appointed to serve for overlapping terms of up to four years. Terms of more than two years are contingent upon the renewal of the Committee's charter by appropriate action prior to its expiration. Any member appointed to fill a vacancy for an un-expired term shall be appointed only for the remainder of that term. A member may serve no more than 180 days after the expiration of the member's term if a successor has not taken office.

In carrying out its function, the Committee may establish subcommittees composed of members of the parent committee and seek advice from non-member special consultants, with the approval of the Secretary or designee. The Department Committee Management Officer shall be notified upon establishment of each subcommittee and shall be given information regarding its name, membership, function, and estimated frequency of meetings.

The advice of a subcommittee shall be reported to the parent committee. The full committee shall review reports and any recommendations made by the subcommittees. The Committee will discuss their findings at a public meeting, at which time the full committee will determine the appropriate action.

Management and support services for Committee operations and activities shall be provided by the Office of Public Health and Science, through the Office of Human Research Protections.

MEETINGS

Meetings shall be held not less than two times a year. Meetings shall be held at the call of the designated Federal officer (DFO), who is responsible for developing the meeting agenda. Development of the meeting agenda may be done in collaboration with the Committee Chair. The DFO or other official to whom the authority has been delegated shall be present at all meetings of the full Committee and any subcommittees that have been assembled to assist this Committee. A quorum for the conduct of business by the full Committee shall consist of a majority of the Committee's voting members.

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

COMPENSATION

Members shall be paid at a rate not to exceed $200 per day, plus per diem and travel expenses, as authorized by Section 5703, Title 5, U.S.C., for persons employed intermittently in the Government service. Members who are officers or employees of the United States Government shall not receive compensation for services on the Committee.

ANNUAL COST ESTIMATE

Estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support is $390,500. Estimate of annual person-years of staff support is 2.0 at an estimated annual cost of $267,407.

REPORTS

When it is determined that a meeting shall be closed or partially closed to the public, as determined by the Secretary or designee, in accordance with Government in the Sunshine Act at 5 U.S.C. 552b(c) and the Federal Advisory Committee Act, then a report shall be prepared that will contain, at a minimum, a list of members and their business addresses, the Committee's functions, dates, places of meetings, and a summary of committee activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Officer.

TERMINATION DATE

Unless renewed by appropriate action prior to its expiration, the charter for the Secretary's Advisory Committee on Human Research Protections will expire on October 1, 2010.

Approved:

September 25, 2008                                    /S/ Michael O. Leavitt

                                                                                                                          
   Date                                                              Secretary of Health and Human Services