Compliance Considerations

Research involving Human Subjects, Animals, Recombinant DNA, Toxins, or Infectious Agents

Federal regulations require that principal investigators planning to use human subjects; animal subjects; or recombinant DNA, toxins, or infectious agents as part of their research projects must have their protocols reviewed and approved by federally mandated and regulated compliance committees.

In accordance with this mandate, NDSU has established three committees to review and approve human, animal, and biosafety research and to set institutional policies and procedures involving these regulated areas.

Human subject research is reviewed by the Institutional Review Board (IRB). Animal research, teaching, testing, or exhibition projects are reviewed by the Institutional Animal Care and Use Committee (IACUC). And research using recombinant DNA, infectious agents, human blood, bodily fluids or tissues is reviewed by the Institutional Biosafety Committee (IBC).

In completing grant applications, agencies usually require certification that the relevant compliance committee has reviewed and approved the proposed research. For example, the National Institutes of Health (NIH) of the Public Health Service (PHS), the U.S. Department of Agriculture (USDA), and the National Science Foundation (NSF) require that a specific form be completed and sent along with the grant application indicating the status of IRB, IACUC, and/or IBC approval.

Some agencies require that compliance committee approval be obtained BEFORE the submission of a grant application; others require only that approval be obtained IF funds are awarded. However, in general, agencies do not release any awarded funds until proof of compliance approval has been received. Individual agency guidelines should be consulted for each agency's policies on compliance certification.

In all cases of research involving humans, animals, or potential biohazards, BEFORE any project—grant funded or otherwise at NDSU—may begin, the project must be approved by the IRB, IACUC, or IBC.

Last Updated: 8/30/07


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