[Federal Register Volume 70, Number 58 (Monday, March 28, 2005)]
[Page 15625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6021]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Secretary, Department of Health and Human 

ACTION: Notice.


SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that the 
Secretary's Advisory Committee on Human Research Protections (SACHRP) 
will hold its seventh meeting. The meeting will be open to the public.

DATES: The meeting will be held on Monday, April 18, 2005, from 8:30 
a.m. to 5 p.m. and on Tuesday, April 19, 2005 from 8:30 a.m. until 4:30 

ADDRESSES: The Radisson Hotel Old Town Alexandria, 901 North Fairfax 
Street, Alexandria, Virginia 22314.

Director, Office for Human Research Protections (OHRP), or Catherine 
Slatinshek, Executive Director, Secretary's Advisory Committee on Human 
Research Protections; Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200; Rockville, MD 20852; (301) 496-7005; fax: 
(301) 496-0527; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services (HHS) and the Assistant 
Secretary for Health on issues and topics pertaining to or associated 
with the protection of human research subjects.
    On April 18, 2005, SACHRP will receive and discuss preliminary 
reports from its two subcommittees, the Subpart A Subcommittee, which 
is evaluating the application of HHS regulations for the protection of 
human subjects at subpart A of 45 CFR part 46 in the current research 
environment, and the Subcommittee on Research involving Children, which 
is assessing the HHS regulations and policies for research involving 
children. The subcommittees were established by SACHRP at its October 
4-5, 2004, meeting and at its inaugural meeting on July 22, 2003, 
respectively. In addition, the Committee will receive the final report 
from the Subpart C Subcommittee which addressed issues related to HHS 
regulations and policies for research involving prisoners.
    On April 19, 2005, the Committee will receive presentations and 
participate in discussions on the following topics: investigator 
education; human research protection program accreditation standards 
for investigator education; the role of the institutional official in a 
human research protection program; and incentives and disincentives for 
IRB monitoring and audit programs.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend the meeting and need special assistance, 
such as sign language interpretation or other reasonable 
accommodations, should notify the designated contact persons. Members 
of the public will have the opportunity to provide comments on both 
days of the meeting. Public comment will be limited to five minutes per 
speaker. Any members of the public who wish to have printed material 
distributed to SACHRP members for this scheduled meeting should submit 
materials to the Executive Director, SACHRP, prior to the close of 
business on Wednesday, April 13, 2005. Information about SACHRP and the 
draft meeting agenda will be posted on the SACHRP Web site at http://www.hhs.gov/ohrp/sachrp.

    Dated: March 22, 2005.
Bernard A. Schwetz,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protection.
[FR Doc. 05-6021 Filed 3-25-05; 8:45 am]