[Federal Register Volume 69, Number 205 (Monday, October 25, 2004)]
[Notices]
[Pages 62274-62275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23764]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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: 1-301-496-7005.
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, [email protected].
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
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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.
[FR Doc. 04-23764 Filed 10-22-04; 8:45 am]
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