22 CFR 225.109 - IRB review of research.

Status message

There is 1 Update appearing in the Federal Register for 22 CFR Part 225. View below or at eCFR (GPOAccess)
§ 225.109 IRB review of research.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 225.104 for which limited IRB review is a condition of exemption (under § 225.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).

(b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 225.116. The IRB may require that information, in addition to that specifically mentioned in § 225.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 225.117.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in § 225.109(f).

(f)

(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

(i) Research eligible for expedited review in accordance with § 225.110;

(ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 225.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);

(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or

(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

(2) [Reserved.]

(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.

(Approved by the Office of Management and Budget under Control Number 0990-0260)

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 22 published on 2015-11-25

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 22 CFR Part 225 after this date.

  • 2017-01-19; vol. 82 # 12 - Thursday, January 19, 2017
    1. 82 FR 7149 - Federal Policy for the Protection of Human Subjects
      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, DEPARTMENT OF EDUCATION, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION
      Final rule.
      This rule is effective on January 19, 2018. The compliance date for this rule, except for § __.114(b) (cooperative research), is January 19, 2018. The compliance date for § __.114(b) (cooperative research) is January 20, 2020.
      6 CFR Part 46
The section you are viewing is cited by the following CFR sections.

Title 22 published on 2015-11-25.

The following are only the Rules published in the Federal Register after the published date of Title 22.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2017-01-19; vol. 82 # 12 - Thursday, January 19, 2017
    1. 82 FR 7149 - Federal Policy for the Protection of Human Subjects
      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, DEPARTMENT OF EDUCATION, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION
      Final rule.
      This rule is effective on January 19, 2018. The compliance date for this rule, except for § __.114(b) (cooperative research), is January 19, 2018. The compliance date for § __.114(b) (cooperative research) is January 20, 2020.
      6 CFR Part 46