Office of the Secretary.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services (HHS), is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.email@example.com, or call the Reports Clearance Office on (202) 690-5683. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60 days.
Proposed Project: Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation—OMB No. 0990-0260—Office for Human Research Protections.
Abstract: Section 491(a) of Public Law 99-158 states that the Secretary of HHS shall by regulation require that each entity applying for HHS support (e.g., a grant, contract, or cooperative agreement) to conduct research involving human subjects submit to HHS assurances satisfactory to the Secretary that it has established an institutional review board (IRB) to review the research in order to ensure protection of the rights and welfare of the human research subjects. IRBs are boards, committees, or groups formally designated by an entity to review, approve, and have continuing oversight of research involving human subjects.
Pursuant to the requirement of the Public Law 99-158, HHS promulgated regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects. The June 18, 1991 adoption of the common Federal Policy (56 FR 28003) by 15 departments and agencies implements a recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research which was established on November 9, 1974, by Public Law 95-622. The Common Rule is based on HHS regulations at 45 CFR part 46, subpart A, the basic HHS Policy for the Protection of Human Subjects.
The respondents for this collection are institutions engaged in such research. Institutional adherence to the Common Rules also is required by other federal departments and agencies that have codified or follow the Common Rule which is identical to 45 CFR part 46, subpart A.
The information being requested related to the Common Rule should be readily available to the institution or organization that registers the IRB.
The burden estimates for the Common Rule include those recently approved for use of the Federalwide Assurance (FWA) form under Control Number 0990-0278 and for the IRB Registration Form that was recently approved under Control Number 0990-0279, and for the institutional review board (IRB) verification (former Optional Form 310).
The burden estimate for the sections of the Common Rule that require reporting or recordkeeping are shown in the burden table below. The number of respondents is the number of IRBs registered utilizing OMB 0990-0279.Start Printed Page 56829
|Title||Number of respondents||Number of responses per respondent||Average burden per response (in hours)||Total burden hours|
|.103(b)(4), .109(d) IRB Actions, .116 and .117 Informed Consent||6,000||39.33||1||235,980|
|.115(a) IRB Recordkeeping||6,000||15||10||900,000|
|.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting||6,000||0.5||45/60||2,250|
Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer.
[FR Doc. E8-22976 Filed 9-29-08; 8:45 am]
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