Establishment and Request for Nominations; National Human Research Protections Advisory Committee

AGENCY:

Office of Public Health and Science, DHHS.

ACTION:

Notice of establishment and request for nominations for members on National Human Research Protections Advisory Committee.

SUMMARY:

Pursuant to the Federal Advisory Committee Act, Public Law 92-493, as amended (5 U.S.C. App. 2), the Office of Public Health and Science (OPHS), announces the establishment of the Advisory Committee on National Human Research Protections by the Secretary, DHHS, June 6, 2000, of the following Federal advisory committee:

The Department of Health and Human Services (DHHS), National Human Research Protections Advisory Committee (NHRPAC or Committee) will provide expert advice and counsel to the Secretary of DHHS, Assistant Secretary for Health (ASH), the Director, Office for Human Research Protection (OHRP), and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects. NHRPAC will serve as the Department's principal advisory body on matters pertaining to human subjects protection.

Members will be selected from among individuals possessing demonstrated experience and expertise in any of the several areas pertinent to human subjects protection. The Director, OHRP, shall serve as Executive Secretary of the Committee.

Duration of this Committee is continuing unless formally determined by the Secretary, DHHS, that termination would be in the public interest.

The Secretary, Department of Health and Human Services (DHHS), has established the Office for Human Research Protections (OHRP) within the Office of Public Health and Science (OPHS), Office of the Secretary (OS), which will be under the direction of the Assistant Secretary for Health (ASH), for the purpose of assuming the responsibilities for human subjects protection activities currently carried out by the former Office of Protection from Research Risks (OPRR), National Institutes for Health (NIH).

The National Human Research Protections Advisory Committee (NHRPAC), consisting of members appointed from nominees with demonstrated expertise in the protection of human subjects in research and federal officials has been chartered in accordance with the Federal Advisory Committee Act (FACA) to provide expert advice and counsel to the Secretary, ASH, the Director, OHRP, and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects.

Nominations are sought of individuals who possess demonstrated expertise in human subjects protections, the conduct of research involving human subjects, the oversight of research involving human subjects, patient representation or advocacy, biomedical ethics, researchers, and others possessing pertinent experience and expertise in the field. Self-nominations or nominations of individuals by organizations or third parties are invited.

Self-nominations must include a complete curriculum vitae which provides descriptions of pertinent experience and expertise and a letter expressing interest in being considered for appointment. The curriculum vitae, cover letter, or both must contain full contact information.

Nominations proffered by organizations or third parties must include a complete curriculum vitae which provides descriptions of the nominee's pertinent experience and a cover letter of nomination that indicates that the nominee has been contacted and agreed to the nomination. Nomination letters from organizations should be on organizational letterhead and signed by an officer or recognized representative of the organization. Full contact information for the nominator and the nominee must be included. Third parties not acting for an organization need not use letterhead.

Each nominee will be provided with a complete copy of the fully executed charter for the NHRPAC as soon as it becomes available.

Candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, research grants, contracts, and associated financial relationships to develop sufficient information to permit evaluation of possible sources of conflicts of interest. Committee members will be compensated for the time spent in Committee meetings as well as per diem costs, each at established standard federal rates.

DATES:

Nominations will be accepted at the above address until 5 p.m. eastern time on August 18, 2000.

ADDRESSES:

All nominations for membership should be submitted to: RADM Arthur J. Lawrence (address below).

FOR FURTHER INFORMATION CONTACT:

RADM Arthur J. Lawrence, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations), Office of Public Health and Science, OS, DHHS, Room 716G, Humphrey Building, 200 Independence Ave. SW, Washington, DC 20201; contact number (202) 690-7439.