Release of Client-Owned Animals When Conducting a Study to Develop Human Therapeutics Using Recombinant or Synthetic Nucleic Acid Molecules

For research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), any animal administered recombinant or synthetic nucleic acid molecules may not be released from containment unless another Federal agency has jurisdiction over the experiment and approves the proposed release. Specifically, the NIH Guidelines state in Section I-A-1:

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.

CVM advises that it will not object to release of animals to owners that are or were enrolled in this type of research when developing therapeutics solely for human use¹ and, therefore, researchers will be considered to have the necessary “applicable clearance” for purpose of compliance with the NIH Guidelines, if they comply with the following conditions: 

1. The purpose of the study is for bona fide scientific investigations conducted as part of exploratory, discovery, or proof-of-concept studies intended to develop human therapeutics.
2. There is appropriate oversight by an Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and/or other appropriate oversight group.
3. There is a protocol in place that has been reviewed and approved by the IACUC, IBC, and/or other appropriate oversight group.
4. The study is limited to administering the product to up to 15 client-owned animals of nonfood-producing species.²
5. The study is conducted by investigators qualified by scientific training and experience to conduct such research. 
6. Complete records of the investigation are maintained.
7. The study is conducted at a primary location and up to 2 additional investigational sites.
8. There are mitigation strategies in place to protect researchers, veterinarians, animal care takers, and other personnel that may have contact with the treated animal in regard to contact with excretions from the animal including urine, feces, and saliva, as appropriate.
9. There is an informed consent form that provides the client with information on the risks to the treated animal, other animals, and the owner; appropriate and truthful safety information; and potential mitigation strategies for the owner to follow in regard to contact with excretions from the animal including urine, feces and saliva as appropriate.
10. If a serious adverse event occurs during the conduct of the study, the study sponsor should inform all researchers immediately and the appropriate oversight group. 
11. The researcher may not charge for, recoup costs for, or market the investigational product.

If a researcher believes they cannot meet one or more of these conditions, or if you have questions, 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.

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¹ Contact CVM (AskCVM@fda.hhs.gov) regarding research to develop products for veterinary use.

² If you plan to enroll more than 15 animals in a study, please contact CVM.