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The IBC Review of IRB and IACUC Protocols

F6.1 - DU Policy Document 9/1/2006

PURPOSE

To describe procedures for the coordination between Institutional Biosafety Committee (IBC) and protocols submitted to the Institutional Review Board for the Protection of Human Subjects in Research (IRB) and the Institutional Animal Care and Use Committee (IACUC) involving recombinant DNA, human pathogens, and/or human samples (tissues or fluids). These protocols will require IBC approval before they are initiated to ensure they are carried out in accordance with NIH and CDC guidelines.

DEFINITIONS

Recombinant DNA: (sometimes referred to as rDNA) is an artificial DNA sequence resulting from the combining of two other DNA sequences. This includes the engineered introduction of any DNA sequences from one species into cells of another.

Human Pathogens: is a biological agent that causes disease or illness to its human host.

Bodily fluids: are found in the bodies of human beings and animals. They include fluids that are excreted or secreted from the body as well as fluids that normally are not.

Human or Animal Tissues: Any animal or human tissue extracted from or maintained independently in cell culture.

POLICY

The Institutional Biosafety Committee (IBC), the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC) are committed to ensuring the protection of human and animal subjects involved in research.

The IBC will review protocols passed on by the IACUC and the IRB involving recombinant DNA, human or animal tissue/bodily fluids and/or pathogenic organisms to ensure that relevant IBC protocols have been applied for, and approved, before research is initiated. It is the responsibility of the PI to insure they are in compliance with IRB or IACUC and IBC. If the PI anticipates the use of recombinant DNA and/or pathogenic organisms s/he should submit concurrently to the IBC and IRB or IACUC. However, some experiments needing IBC review may not need IACUC or IRB review. In this case, the PI should submit a protocol to IBC independent of any IACUC or IRB protocol.

Failure to abide with this policy may result in research misconduct or non-compliance.

ROLES AND RESPONSIBILITIES

Principal Investigator is responsible for submitting concurrent protocols and ensures they are in compliance with IRB, IACUC and IBC.

IRB and IACUC Committee Chairs shall forward any protocols that may need review by the IBC and vice versa; the IBC should forward protocols to the IRB or IACUC for review if necessary.

Committee Administrator shall forward each protocol to the appropriate Committee, upon receiving final protocol/proposal for submittal to Committee review.

Office of Research and Sponsored Programs (ORSP) serves as the primary liaison for ensuring coordination between the IBC, IRB, and IACUC with respect to protocol review.

PROCEDURES

When a proposal is prepared, the PI shall work with ORSP to ensure protocols have been submitted to all required Committees.

When a Principal Investigator (PI) proposes research which falls under the purview of the IRB, IACUC and/or IBC the PI is required to submit his/her protocol to the relevant committees and obtain approval prior to initiating research.
It is the full responsibility of the PI to ensure his/her protocol is in compliance.

The IRB will not approve new protocols falling under IBC purview unless IBC review and approval has been obtained first or is pending, and copies of the required IBC documentation is included in the IRB or IACUC protocol submission.

If ORSP is in receipt of a proposal that in their judgment may require IBC approval, and the required IBC documentation has not been included in the submission, ORSP and/or Committee Administrator will contact the IBC Chair for assistance in making a determination whether IBC review is required.

Current active protocols that have been submitted to the IRB or IACUC will have 30 days to comply with this policy.

If it is determined that the proposal does fall under the IBC’s purview ORSP will inform the PI in writing of the IBC/IRB/IACUC requirement.
The ORSP Research Compliance Manager, when appropriate, is responsible for initiating efforts to establish joint IRB/IACUC/IBC policy and procedure. Suggestions or recommendations for the joint policy/procedure initiatives may be submitted directly to ORSP Research Compliance, IBC, IACUC, IRB Chairs or Committee members.