16 CFR 1028.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

§ 1028.110 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 Human Research Protections, HHS, or any successor office.

(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.

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 § 1028.108(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.

[ 56 FR 28012, 28019, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 16 published on 08-Jun-2018 03:49

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 16 CFR Part 1028 after this date.

  • 2018-04-20; vol. 83 # 77 - Friday, April 20, 2018
    1. 83 FR 17595 - Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
      GPO FDSys XML | Text
      DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, CONSUMER PRODUCT SAFETY COMMISSION, DEPARTMENT OF EDUCATION, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION
      Notice of proposed rulemaking.
      To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on May 21, 2018.
      6 CFR Part 46
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