Prior Approval Requests for Vertebrate Animal Research (VAR)
Under governing Public Health Service (PHS) Policy, federal funds administered by the PHS shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW).
Under governing Public Health Service (PHS) Policy, federal funds administered by the PHS shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW) of an Animal Welfare Assurance to comply with the PHS Policy on Humane Care and Use of Laboratory Animals and the project has been reviewed and approved by the Institutional Animal Care and Use Committee (IACUC). Prior approval is required for any change in the approved use of live vertebrate animals and/or any substitution of one animal model for another. Any new study involving live vertebrate animals that was not reviewed in the competing application must be submitted for prior approval. Requests for prior approval of planned research involving live vertebrate animals conducted through NCATS UL1/UM1 pilot projects, UM1 element E and KL2/K12 scholar projects must be submitted to the Prior Approval Module in the eRA Commons no later than 30 days before the proposed implementation of research involving live vertebrate animals. Official notification of NCATS’ Prior Approval is required before the project can begin.
Instructions
The following should be included in the NIH eRA module, Prior Approval – Other Request:
Description*: The VAR study title; VAR study Principal Investigator.
Effective Date*: The date the study is requested to start.
Justification Document*: Use the instructions provided on the OLAW landing page for Vertebrate Animals Section (VAS) requirements and provide the following 4 requirements:
Description of Procedures
Justifications
Minimization of Pain and Distress
Method of Euthanasia
Budget Document: Total budget to be supported with NCATS funds.
List a line-item budget for each specific aspect to be supported with NCATS funds (list supplies, services and personnel costs).
Note:
UM1 Element E projects may not be less than $125,000 and must not exceed $500,000 direct costs, for a suggested period of 2-3 years.
UM1 pilots may not be less than $25,000 and not more than $50,000 direct costs and cannot exceed 12 months.
KL2/K12 Scholar salaries should not be included in the budget.
Other Supporting Document:
Provide the verification of IACUC approval.
Additional Resources
- Refer to CTSA Prior Approval FAQs for additional information.
- Visit the NIH FAQs on PHS Policy on Humane Care and Use of Laboratory Animals.
- NIH Notice: Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (NOT-OD-16-006)
- NIH Office of Laboratory Animal Welfare
- Animals in NIH Research
Comments and Questions About This Process?
Contact your Program Official.