UTHSC, Office of Research Compliance (ORC)Information about Proposal-Protocol Congruency

1) Why are we checking congruence between grant proposals and animal activity protocols?
The Public Health Service (PHS) expects all animal activities proposed in a grant to be approved by an organization's Institutional Animal Care and Use Committee (IACUC) prior to the beginning of those activities.

- Public Health Service (PHS) policy states that awards may not be issued unless the awardee's IACUC "provide[s] verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals,... ." ". If an application is selected for award and the verification of IACUC review has not been submitted, the awarding office will contact the organization with instructions for negotiating an assurance or submitting the IACUC verification."

Although other funding agencies may adopt different polices, UTHSC applies PHS/NIH standards for the use of all live vertebrate animal research. This is because the NIH Office of Laboratory Animal Welfare (OLAW) discourages multiple standards of review, approval or compliance measures for different funding sources.

Further guidance is provided in other sections of PHS and NIH policies and in NOT-OD-10-027 (Instructions for Completion and Peer Review of the Vertebrate Section (VAS) in NIH Grant Applications and Cooperative Agreements and a slide presentation by the OLAW Director).

2) How are we are checking for congruence between grant proposals and animal activity protocols?
UTHSC has implemented a procedure for direct comparison of grant proposals with animal activity protocols in order to prevent non-congruence between the information submitted to PHS/NIH and the information contained in corresponding IACUC protocols.

At UTHSC, a Compliance Officer from ORC will compare grant proposals and animal activity protocols. The PHS and NIH polices have no explicit requirement for side-by-side comparisons of grant applications and animal activity protocols. However, it is an institution's responsibility to provide assurance that all animal activities proposed in a grant application have been reviewed and approved by the IACUC. Institutions are free to devise the mechanism to make this assurance.

The IACUC does not review corresponding grant applications alongside animal protocols.

3) What specifically will the Compliance Officer be looking at when comparing a grant proposal with animal activity protocols?
Congruence (and potential non- congruence) will be evaluated for several important parts of protocols and proposals. These include:
- Personnel, i.e. all personnel have received the proper training to conduct the animal work.
- Animal strains, including transgenic strains, and species.
- Number of animals, sex and age of animals.
- Drugs and dosages as related to level of distress and risk of adverse reactions.
- Class of biohazard, if present.
- Anesthetics and Analgesics used.
- Method of euthanasia.
- Procedures/ treatments and distress category.
- Survival times and endpoints.

For examples of minor animal protocol changes that would require the submission of a protocol revision form, please refer to the Revisions/Amendments to Approved Protocols Memorandum.

For examples of major animal protocol changes that would require the submission of a revised protocol and IACUC review, please refer to the Revisions/Amendments to Approved Protocols Memorandum.

4) When will congruence be determined?
Ensuring congruence between grant funded activities and IACUC-approved activities is an ongoing process. In order to accept PHS/NIH funds, the awardee's IACUC must verify that it has reviewed and approved the grant's proposed animal activities. In addition, if the grant-funded animal activities need to be modified during the duration of funding or at the time of renewal, the IACUC must first approve these modifications to the animal activities. Failure to follow these practices will result in noncompliance with PHS/NIH polices and could jeopardize current and future funding.

For further information please review these relevant FAQ's off of the OLAW site (http://grants.nih.gov/grants/olaw/faqs.htm) which state:

D. Protocol Review

10. Is the IACUC required to review the grant application?
PHS Policy and the NIH Grants Policy Statement (Part II, Terms and Conditions) require the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. This is not an explicit requirement for the IACUC to do a side-by-side comparison of an application/proposal and the IACUC protocol. However, institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with what is in the application/proposal. Institutions are free to devise a workable mechanism to accomplish this end. One method to prevent inconsistencies between the information submitted to PHS and that on the IACUC protocol is to implement a procedure for direct comparison. Some institutions have delegated this responsibility to a particular office or position (e.g., sponsored programs or compliance office); others ask departmental chairs to verify consistency.

20. Does the IACUC have to review proposed animal research activities at the time of grant award if the animal research activities will not be conducted until year 4 or 5 of a grant?
Yes, with rare exception.

Information about use of research animal subjects is required by PHS in the Vertebrate Animal Section (VAS) of the Research Plan of grant applications and in contract proposals:

  1. 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.
  2. 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.
  3. Provide information on the veterinary care of the animals involved.
  4. 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.
  5. 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 American Veterinary Medical Association Guidelines on Euthanasia. If not, present a justification for not following the recommendations.

The IACUC must approve the proposed use of animals described in the grant application or contract proposal. This is required to comply with the PHS Policy on Humane Care and Use of Laboratory Animals as stated in Section V.B.:

PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals....No award shall be made until all required Assurances have been submitted by the institution(s), been approved by OLAW, and the institution(s) have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. [emphasis added]

The IACUC review must be performed prior to the conduct of any PHS-supported animal activity. Approval is valid for a maximum of three years. Because the scientific enterprise is not static, the need for changes to animal protocols is anticipated and can occur at any time during the life of the protocol. If the changes are significant, PHS Policy, Section IV.B.7. requires prior IACUC approval of the proposed change(s). OLAW provides examples of the kinds of changes it considers to be significant in FAQ 9 of Protocol Review.

In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. This occurs if a delayed onset of animal activities is a component of the experimental research design described in the VAS of the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). In these circumstances, the funding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component.

Additional OLAW Guidance regarding IACUC review of grant applications can be found at FAQ 10 of Protocol Review and previous OLAW Commentary.

B. IACUC Composition, Functions and Authority
13. Does OLAW expect the IACUC to notify NIH when there is a change in an animal activity supported by PHS funds?
The terms "significant change" and "change in scope" have different meanings. According to NIH Grants Policy Statement (GPS), change in scope refers to a change in the direction, type of research or training from the aims, objectives, or purposes of the approved project. A change in an animal activity can be both a significant change requiring IACUC review and a change in scope requiring notification to the NIH funding component. However, a significant change is not necessarily a change in scope.

For a review of significant changes that require IACUC approval see OLAW FAQ D9 of Protocol Review. The investigator is responsible for submitting a proposed significant change in an animal activity to the IACUC for review and approval prior to implementing the change. As described in the PHS Policy IV.B.7, the IACUC is responsible for reviewing the significant change and approving, requiring modifications (to secure approval), or disapproving the proposed change. The IACUC is not required to notify OLAW or the NIH funding component of this type of change. However, conducting procedures that constitute a significant change in approved animal activities without prior IACUC approval is serious noncompliance that must be reported to OLAW. Additional information may be found at FAQ B9 of IACUC Composition, Functions and Authority and Notice NOT-OD-05-034.

Prior approval of a change in the scope of the research is required by GPS, which provides examples of potential indicators of changes in scope. These examples are not intended to imply that any change in animal model or in approved use of animals always represents a change in scope.

The IACUC is not responsible for notifying the NIH of changes in scope; rather the Principal Investigator (PI) and the Authorized Organizational Official (AOO) are responsible for requesting approval of a change in scope. The request for a change in scope must be made in writing to the Grants Management Officer (GMO) of the NIH Institute or Center (IC) that funds the grant (the funding component). The request must be made no less than 30 days before the proposed change and must be signed by both the PI and the AOO.

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