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Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure; From the Federal Register Online via GPO Access [Federal Register: November 9,1998 (Volume 63, Number 216)][Page 60364-60367](text): (http://frwebgate1.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=1181723255+3+0+0&WAISaction=retrieve) (List referred to by 45CFR46.110: [Code of Federal Regulations] [Title 45, Volume 1] [Revised as of October 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 45CFR46.110] [Page 110-111] TITLE 45--PUBLIC WELFARE AND HUMAN SERVICES PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents Subpart A--Basic HHS Policy for Protection of Human Research Subjects Sec. 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the Federal Register. A copy of the list is available from the Office for Protection from Research Risks, National Institutes of Health, HHS, Bethesda, Maryland 20892. (b) An IRB may use the expedited review procedure to review either or both of the following: (1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk, (2) Minor changes in previously approved research during the period (of one year or less) for which approval is authorized. [[Page 111]] Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in Sec. 46.108(b). (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure. Implementing change to improve Federal human resources management; Human Resources Flexibilities and Authorities in the Federal Government Data & Safety Monitoring Board (DSMB): (http://grants1.nih.gov/grants/guide/notice-files/not98-084.html) 45CFR46: (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm) (http://ohsr.od.nih.gov/mpa/45cfr46.php3#46.101) Human Subject Regulations Decision Charts: (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm) |
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