VA Flashcards
ACURO FAQs & Animal Use Assurances
Signatures
VA: To whom should I send protocol submissions, adverse event reports, and protocol amendments?
All submissions, regardless of action (e.g. initial review, de novo review, amendment, adverse event, etc.) are sent to the ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil. This ensures your submission will be received, tracked, and processed in a timely manner. Our administrative staff will contact you if additional documentation is needed to process the submission. Once a complete submission is received and processed for review, one of our Oversight Specialists will contact you for additional information if needed. New submissions of any kind should never be sent to individual staff members.
VA: Should I submit documents as I receive them, or should I wait until I have a complete package?
Send only complete submissions for ACURO review. ACURO can only review complete submissions that include all required documentation. A complete protocol submission includes IACUC approved protocol, IACUC approval, any amendments to the approved protocol that are funded by the subject award as well as IACUC approval for those amendments, a completed ACURO Appendix, including the ACURO PI Assurances signed by the Protocol PI.
VA: What is the Protocol PI Assurances?
U.S. DoD and Federal regulations specifically require several written assurances from the PI. PI must read each assurance and sign to confirm.
VA: Who needs to sign the ACURO Animal Use Appendix (ver. 14 July 2020) Animal Use Assurances in order for the submission to be complete?
The Protocol PI
VA: Painful Procedures Assurance
Pain and distress in animals will be limited to what is unavoidable in the conduct of scientifically valuable research; analgesic, anesthetic, or tranquilizing drugs will be used when appropriate to minimize pain or distress; and a veterinarian was consulted regarding any painful procedures in this protocol.
VA: Animal Use Assurance
The animals authorized for use in this protocol will be used only in the activities and manner
described herein unless a modification is approved by the IACUC, or equivalent animal welfare body, and ACURO prior to implementation.
VA: Duplication of Effort Assurance
I have made a reasonable, good faith effort to ensure that this protocol is not an
unnecessary duplication of previous experiments.
VA: Statistical Assurance
I have consulted with a qualified individual who evaluated the experimental design
with respect to the statistical analysis and determined that the most appropriate number of animals needed for
scientific validity will be used.
VA: Training Assurance
I verify that the personnel performing the animal procedures, manipulations, or observations
described in this protocol are technically competent and qualified and have been properly trained to ensure that animals will experience no unnecessary pain or distress as a result of the procedures/manipulations.
VA: Responsibility Assurance
I assure that all individuals associated with this project will demonstrate the appropriate
regard for the health, comfort, welfare, and well-being of the research animals. I pledge to implement animal use
alternatives where feasible, and conduct humane and lawful research.
VA: Scientific Review Assurance
This proposed animal use protocol has received appropriate peer scientific review, and
is consistent with good scientific research practice.
VA: Wildlife Studies Assurance
All research involving wildlife will be performed in compliance with all
applicable laws and regulations and with all required permits or licenses.
VA: Animal Procurement Assurance
All animals will be procured in compliance with all applicable laws and regulations. Furthermore, USDA regulated animals will be obtained only from USDA licensed suppliers unless exempted under the provisions of the Animal Welfare Regulations.
VA: Disposition Assurance
Animals used in RDT&E or training will have a nonterminal disposition (e.g., adoption, retirement, inter-institutional transfer) whenever possible.
