01-6010. Submission for OMB Review; Comment Request; Survey of IRB Chairs Concerning the Implementation of Pediatric Research Regulations

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 17, 2000, page 61341 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Proposed Collection: Title: Survey of IRB Chairs Concerning the Implementation of Pediatric Research Regulations. Type of information Collection Request: New. Need for 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 45 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 chair. 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 assent 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. 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 Costs to report.

Respondent and Burden Estimate Information

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
IRB chairs	400	1	0.5	200
Total	400			200

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 the 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.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. 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 [phone] or fax or e-mail your request, including your address, to: Facsimile number [phone] and email address [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received on or before April 11, 2001.

Dated: March 2, 2001.

David K. Henderson,

Deputy Director, Warren G. Magnuson Clinical Center, National Institutes of Health.