Authority Of The Institutional Review Boards

I. PURPOSE / BACKGROUND

This policy establishes the authority of the University of Louisville Institutional Review Boards (IRB).

II. POLICY

It is the policy of the University of Louisville that human research activities conducted under the oversight of the organization will be conducted in accordance with applicable federal law and regulations that include but are not limited to Federal Regulations 45 CFR 46, 21 CFR 50, 21 CFR 56, and 45 CFR 160 and 164, applicable Kentucky state statutes and regulations, the principles of The Belmont Report and local University Institutional Review Board (IRBs) requirements.

The University of Louisville authorizes the IRBs of the organization to review and have authority to:

  1. Approve, modify (to secure approval), or disapprove all human research conducted by the organization,
  2. Suspend or terminate research not conducted in accordance with the regulations, statutes and principles or IRB's requirements mentioned above or that has been associated with unexpected serious harm to subjects,
  3. Observe, or to have a third party observe, the consent process,
  4. Observe, or have a third party observe, the conduct of the research, and
  5. Serve as the Privacy Board for the University of Louisville that approves waivers of authorization in accordance with the HIPAA Privacy Rule.

Research covered by this policy that has been approved by a University IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, as per 45 CFR 46.112 and 21 CFR 56.112, those officials may not approve the research if a University of Louisville IRB has disapproved it.

Any IRB member or staff who believes that they have been subject to inappropriate influence should report this immediately to the IRB chair or the Director, Human Subjects Protection Program, who will report the attempt to influence to the Executive Vice President for Research (EVPR). The EVPR will investigate, or have investigated, the attempt to influence and determine an appropriate response to the attempt based on penalties similar to those outlined in the University’s

 

Administrative Sanctions for Violations of University of Louisville Research Policies. This policy may be found on the Research Integrity Program Home Page (http://research.louisville.edu/researchintegrity) under research policies.

III. PROCEDURE FOR POLICY

Procedures for conducting the business of the University of Louisville IRBs may be found in the

IRB Standard Operating Procedures (SOP), the Investigator’s Guide, the IRB Member Handbook, the Privacy Board SOP and the Human Subjects Protection Program Office (HSPPO) SOP.

Subject: Authority of the Institutional Review Boards Policy and Procedure | Approved Board of Trustees 9-23-2004 | Author: Institutional Review Board Original Effective Date: 10-1-2004 | Last Revised Date: 5-8-2007