[Federal Register Volume 65, Number 201 (Tuesday, October 17, 2000)]
[Notices]
[Page 61341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Survey of IRB Chairs
Concerning the Implementation of Pediatric Research Regulations
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 for opportunity for public comment
on proposed data collection projects, the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: Survey of IRB Chairs Concerning the Implementation of
Pediatric Research Regulations.
Type of Information Collection Request: New.
Need and Use of Information Collection: In order to assess the
protection of children who are enrolled in clinical research, it is
important to determine how Institutional Review Boards (IRBs) reviewing
such research interpret and implement the Federal Regulations for
research with children set forth in 45 CFR 46 Subpart D. This study
aims to gather this information through telephone interviews with
chairpersons of IRBs that review clinical research with children. In
addition, we will solicit background information on each IRB from the
IRB coordinator. In particular, the survey aims to assess how IRBs
assess risk/benefit levels of research with children, when IRBs permit
children's assent to be waived, what information IRBs require children
to be presented during the asset process, and which children are
excluded from participation in riskier research. In addition, the
survey will attempt to determine how the recent NIH Policy and
Guidelines on the Inclusion of Children as Participants in Research
Involving Human Subjects has affected IRB review. Frequency of
Response: Once. Affected Public: Individuals. Type of Respondents: IRB
chairpersons and IRB coordinators. The annual reporting burden follows
in the table below. The annualized cost to respondents is estimated at:
$10,000. There are no Capital Costs to report. There are no Operating
or Maintenance Cost to report.
Respondent and Burden Estimate Information
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Estimated
Estimated Average total
Estimated number of burden annual
Type of respondents number of responses hours per burden
respondents per response hours
respondent requested
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IRB chairs.................................................. 200 1 0.5 100
IRB coordinators............................................ 200 1 0.5 100
Total................................................... ........... ........... ........... 200
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Request for Comments
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dave Wendler, Ph.D., Head, Unit on Vulnerable
Populations, Department of Clinical Bioethics, NIH, Building 10, Room
1C118, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free
number (301) 435-8726 or e-mail your request, including your address,
to: [email protected].
Comments Due Date
Comments regarding this information collection are best assured of
having their full effect if received on or before December 18, 2000.
Dated: October 4, 2000.
Ezekiel Emanuel,
Chief, Department of Clinical Bioethics.
[FR Doc. 00-26581 Filed 10-16-00; 8:45 am]
BILLING CODE 4140-01-M