04-23764. Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections

AGENCY:

Department of Health and Human Services (HHS), Office of the Secretary, Office of Public Health and Science.

ACTION:

Notice.

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 Pub. L. 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

SUMMARY:

The Office for Human Research Protections (OHRP), a program office within the Office of Public Health and Science, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP was established by the Secretary of Health and Human Services on October 1, 2002. The Committee provides advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of the Department directed toward protections for human subjects in research. Individuals selected to serve as members of the Committee are appointed by the Secretary.

The terms of three Committee members are scheduled to end in January 2005. OHRP is seeking applications of qualified candidates to nominate for appointment to the Committee to fill the pending vacancies.

DATES:

Nominations for membership on the Committee must be received no later than 5 p.m. e.s.t. on November 19, 2004, at the address listed below.

ADDRESSES:

Dr. Bernard Schwetz, Director, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200; Rockville, MD 20852. Nominations will not be accepted by either e-mail or facsimile.

FOR FURTHER INFORMATION CONTACT:

Ms. Catherine Slatinshek, Executive Director, SACHRP, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Telephone: [phone].

A copy of the Committee charter and list of the current membership can be obtained by contacting Ms. Slatinshek or by accessing the SACHRP Web site, [e-mail].

SUPPLEMENTARY INFORMATION:

1. The Committee shall advise on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. Specifically, the Committee will provide 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 is responsible for reviewing selected ongoing work and planned activities of the 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.

2. Nominations. Nominations of potential candidates for consideration are being sought from a wide array of career fields, including but not limited to: Public health and medicine; behavioral and social sciences; health administration; biomedical ethics. To qualify for consideration of appointment to the Committee, an individual must possess demonstrated experience and expertise in any of the several disciplines and fields pertinent to human subjects protection and/or clinical research.

An individual selected for appointment to the Committee will serve as a voting member. An individual selected for appointment to the Committee can be invited to serve a term of up to four years. Committee members receive a stipend for attending Committee meetings and conducting other business in the interest of the Committee, including per diem and reimbursement for travel expenses incurred.

Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee is willing to serve as a member of the Committee; (2) the nominator's name, address and daytime telephone number, and the home and/or work address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee's curriculum vitae. The names of Federal employees should not be nominated for consideration of appointment to this Committee.

The Department makes every effort to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that a broad representation of geographic areas, females, ethnic and minority groups, and the disabled are given consideration for membership on HHS Federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Nominations must state that the nominee is willing to serve as a member of SACHRP and appears to have no conflict of interest that would preclude membership. Potential candidates are required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts to permit evaluation of possible sources of conflict of interest.

Dated: October 19, 2004.

Bernard A. Schwetz,

Executive Secretary, Secretary's Advisory Committee on Human Research Protections, Director, Office for Human Research Protections.