45 CFR 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

§ 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

(a) The risk is justified by the anticipated benefit to the subjects;

(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 46.408.

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 45 published on 19-May-2018 04:34

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR Part 46 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