Release of Client-Owned Animals After Participation in Research Subject to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

Because the NIH Guidelines address contained research, any animal administered recombinant or synthetic nucleic acid molecules may only be released from containment after another Federal agency approves or otherwise provides clearance for the proposed release.

Section I-A-1 of the NIH Guidelines states:

• Any nucleic acid molecule experiment, which according to the NIH Guidelines requires approval by NIH, must be submitted to NIH or to another Federal agency that has jurisdiction for review and approval. Once approvals, or other applicable clearances, have been obtained from a Federal agency other than NIH (whether the experiment is referred to that agency by NIH or sent directly there by the submitter), the experiment may proceed without the necessity for NIH review or approval.

For client-owned animals that are or were enrolled in research subject to the NIH Guidelines, the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has issued a statement advising that it will not object to release of the animals when the goal of the research is the development of therapeutics solely for human use, subject to certain conditions.

This statement fulfills the clearance required by the NIH Guidelines; thus, for research meeting the criteria and conditions specified in the FDA statement, institutions subject to the NIH Guidelines will be permitted to release animals to their owners.

Institutional Biosafety Committee (IBC) approval and oversight will still be required for the research, along with approvals from all other relevant oversight bodies.

For questions about the FDA statement and its applicability to a specific research protocol, please contact: AskCVM@fda.hhs.gov and put “client-owned animal study” in the subject line of the email.

Questions related to the NIH Guidelines and IBC oversight should be directed to the NIH Office of Science Policy at: NIHguidelines@od.nih.gov.