PHS 398 Application Information
To comply with current NIH Office of Laboratory Animal Welfare (OLAW) regulatory requirements, the Office of Sponsored Programs and Contract (OSPC) and the IACUC have established an administrative procedure through which it can verify that animal protocols used for grant applications accurately describe the care and use of animals. These methods satisfy the requirement without putting major additional burdens on the investigators, the OSPC or IACUC members. The following procedures satisfy OLAW regulations while adding only minor administrative burdens.
The IACUC requests that investigators use the language from the relevant IACUC protocol to answer the 5 animal welfare questions in section "F. Vertebrate Animals" of the Research Plan as required by the instructions for the current PHS Form 398. These questions are included below from the PHS 398 instructions, and narratives have been included as near "cut and paste" examples for use.
OSPC and IACUC Protocol Submission Processes
- The investigator writes and submits the grant with the appropriate language in section "F. Vertebrate Animals" of the Research Plan.
- If the grant award is made, at the time the final business arrangements are made to receive the funding, the Grant Coordinator in the OSPC handling the routing of the grant will forward a copy Section "F. Vertebrate Animals" of the grant to the IACUC Chair. This information will be matched with the language in the protocol number being used. If the language matches, the IACUC chair will certify the match and the review process will continue in the OSPC. This portion of the compliance review should take no longer than one or two working days, assuming the language in this section matches corresponding language of the protocol on file.
- If the language within section "F. Vertebrate Animals" and the protocol does not match, the Principal Investigator will be required to write a new protocol that fits the work proposed in the grant. This will enter into the standard IACUC protocol review cycle and funding cannot be accepted until the protocol is approved by the IACUC.
- Grants can be submitted and reviewed with a "Protocol Pending" designation in the Animal Welfare line on the face page, but the 5 relevant animal welfare questions (below) must be answered in Section "F. Vertebrate Animals" as per NIH review policy. The grant will not be funded until there is an IACUC-approved protocol whose language matches the answers to these 5 questions.
- It is permissible for an investigator to use a single animal protocol number for multiple grants. The IACUC requirements are that the protocol be active and that the language in the protocol matches the work done each of the grants.
PHS 398 Section "F. Vertebrate Animals" Instructions
If you have marked "Yes" on Item 5 on the Face Page of the PHS 398 application, create a section heading entitled "Vertebrate Animals." Place it immediately following the "Research Design and Methods" section of the application (or after Item e, if applicable.)
- Failure to address the following elements will result in the application being designated as incomplete and it and will be grounds for the PHS to return the application without peer review.
Under the Vertebrate Animals heading within Research Design and Methods, address the following five points. In addition, when research involving vertebrate animals will take place at collaborating site(s) or other performance site(s), provide this information before discussing the five points. Although no specific page limitation applies to this section of the application, be succinct.
- Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.
- Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
- Provide information on the veterinary care of the animals involved.
- Example Narrative: "Baylor University operates to comply with the USDA Animal Welfare Act (Public Law 89-544) as amended by PL91-579 (1970), PL94-279 (1976), and CRF37618 (6-30-80); Health Research Extension Act of 1985 (Public Law 99158); follows the Public Health Service (PHS) and National Institutes of Health (NIH) Policy of Humane Care and Use of Laboratory Animals (NIH Manual Ch. 4206 and PHS Manual Ch. 1-43 [revised] September 1986); and the Guide for the Care and Use of Laboratory Animals (DHEW of Assurance on file with the Office for Protection from Research Risks in compliance with NIH Policy). Baylor University dedicates approximately 4000 square feet to animal facilities in Baylor Sciences Building. The Baylor animal housing facility has a current Letter of Assurance on file with the Office of Laboratory Animal Welfare, in compliance with NIH. This facility is supervised by a full-time technician and supported by veterinarian care."
- Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.
- Example Narrative: "All laboratory animal users will comply with institutional and federal guidelines and regulations to assist them in carrying out their responsibilities for the human care and use of animals in research projects. The Policy of Humane Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals are available in the laboratory for training purposes. The principle investigator for this project is appropriately trained to perform all experimental manipulations described by this protocol in accordance to the ethical standards described by federal regulations. The investigator gives unqualified assurance that ALL laboratory personnel will receive high quality training to minimize animal discomfort." Address additional care and use issues as needed, including specific procedures to minimize discomfort, distress, pain, and injury.
- Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.