ACURO Appendix FAQs
► ACURO Appendix FAQs
Section 1 (DoD Funding of Protocol)
Section 2 (Key Personnel and Administrative Data)
Section 3 (Total Number of Animals and Pain Category)
Section 4 (Justification for Unalleviated Pain and/or Distress)
Section 7 (Institution's Veterinary Care Program)
Section 12 (Considerations of Alternatives to Procedures that Cause Pain/Distress)
Section 13 (Experimental Design)
Section 14 (Description of Surgical or Other Painful Procedures)
Section 15 (Immediate and Long-term Monitoring/Observations/Treatment)
Section 17 (Paralytic Agents)
Section 20 (Use of Non-Pharmaceutical Grade Agents in Animals)
Section 23 (Exceptions/Exemptions /Departures from the Guide or Animal Welfare Regulations)
Section 26 (Death as an Endpoint)
- Can I request an expedited review of my protocol because it expires soon?
If the protocol expires within the next 90 days, and animal work cannot be completed between the time of ACURO approval and expiration of the protocol, please wait to submit documents to ACURO until the protocol rewrite is approved by the IACUC. Please contact your IACUC office for information regarding institution's requirements for rewrite/de novo review of protocols. Please contact the ACURO Manager if there are extenuating circumstances and a protocol expiring in the next 90 days must begin prior to the current protocol expiration date.
If you have further questions regarding expedited review please refer to ACURO SUBMISSION FAQ #10.
- When providing responses to each section of the Appendix, why do I need to indicate the page number where information can be located in the protocol?
Please note the current version of the ACURO Appendix is different than previous versions in that it requests page number references to identify where the information regarding DoD-funded animal work can be found in the corresponding IACUC protocol. This change was implemented to ease regulatory burden for ACURO customers and to help ACURO reviewers easily locate information regarding DoD-funded animal work in the IACUC protocol. Please be advised that paragraphs of information taken directly from the protocol must not be inserted into sections 8-28 of the ACURO Appendix.
- Can I just cut and paste sections from my protocol into the Appendix?
No, with the exception of justification for unalleviated pain or distress (USDA Pain Category E), do not cut and paste information from the protocol into the Appendix sections 8-28. Please simply provide page number references to identify where DoD-funded animal work can be found in the IACUC approved protocol submitted to ACURO for review. You should only enter information into the "Additional information not provided in the protocol" if that information is not found in the corresponding protocol.
Appendix Section 1 (DoD Funding of Protocol)
- How do I know if my protocol is fully funded?
If all the animal studies in the approved IACUC protocol submitted to ACURO for review are funded by this DoD award, then the protocol is considered fully funded. Please contact your Science Officer with funding questions.
- What is considered partially funded by the DoD?
ACURO review only covers DoD funded studies. If the animal use protocol contains some experiments, procedures, or animals that are NOT funded by this DoD award, then the submission would be considered partially funded by the DoD. A highlighted version of the IACUC protocol illustrating where studies funded by this award are located must be provided for ACURO review. ACURO will only review DoD funded activities.
- If an amendment made to my protocol prior to ACURO submission is the only thing funded by my award, and the work described in the main protocol is not funded, can I submit just the funded amendment instead of the whole protocol?
No, this submission would be considered partially funded by your award. The entire protocol, to include funded amendments and the most recent version of the complete IACUC approved protocol, must be submitted along with all other required documents for ACURO review. Refer to ACURO SUBMISSION FAQ #1 and ACURO SUBMISSION FAQ #7.
- Why do I have to highlight the funded sections of my protocol when my IACUC approved protocol is partially funded by the DoD award?
DoD's review and oversight primarily covers only those activities that are funded by the DoD. Highlighting partially funded protocols is required so that ACURO staff can easily identify DoD-funded animal work approved by your IACUC in the protocol submitted to ACURO for review. Highlighting is only required for animal use protocols partially funded by DoD. Page numbers referenced in the Appendix MUST match highlighted sections in the IACUC approved protocol submitted for review. No or limited highlighting will cause significant delay of the review.
Appendix Section 2 (Key Personnel and Administrative Data)
- If I am a subcontracted site for the Award, who is considered the Institutional Grants Manager?
The person at the subcontract site who is responsible for the management of the funds received from the awarded institution would be considered the Institutional Grants Manager.
Appendix Section 3 (Total Number of Animals and Pain Category)
- If my institution does not assign pain and distress (p/d) categories for non-USDA regulated species, what should I enter in this section of the ACURO Appendix?
Please identify the highest USDA p/d category in the IACUC approved protocol applicable to the DoD funded animal work. Pain categorization using the USDA definitions is required for all species of animals that are funded by DoD. USDA p/d definitions can be found in section 3 of the ACURO Appendix. If you are unsure which USDA pain and distress category should be identified in this section of the Appendix, please consult your IACUC to help identify the appropriate pain and distress category. Refer to ACURO SUBMISSION FAQ #12.
- If my institution does not follow USDA pain and distress categories and has specific pain and distress categories defined at the institutional level, what information do I need to provide to ACURO?
Please provide the institutional p/d category definition for the p/d category assigned to animal work funded by the DoD award.
Appendix Section 4 (Justification for Unalleviated Pain and/or Distress)
- My protocol contains justification for animals classified in USDA p/d category E. Can I reference the page number where information can be found in the protocol in lieu of restating the information approved in the IACUC protocol submitted for review?
Because of the importance of this subject, ACURO requires that the Category E justification be written in the Appendix itself, not just referenced by page number.
Appendix Section 7 (Institution's Veterinary Care Program)
- If my institution is accredited by AAALAC International, am I required to fill out section 7 of the ACURO Appendix?
No, section 7 of the ACURO Appendix only needs to be filled out if the institution is NOT accredited by AAALAC International.
Appendix Section 12 (Considerations of Alternatives to Procedures that Cause Pain/Distress)
- My DOD-funded work uses non-USDA regulated species. Is consideration of alternatives to painful/distressful procedures still required?
Yes, DoD regulations require consideration of alternatives to painful procedures information for all animal species, including those not subject to USDA regulation. Refer to ACURO SUBMISSION FAQ #13.
- If my institution does not require consideration of alternatives for non-regulated species, do I need to amend my protocol to include this information to comply with DoD regulations?
No, the information on consideration of alternatives needs to be provided to ACURO, but the IACUC approved protocol submitted to ACURO for review does not need to be amended unless your IACUC would require an amendment to include the requested information.
Appendix Section 13 (Experimental Design)
- Should I include information about my grant in the experimental design section of the Appendix?
No, ACURO does not review information described in the Statement of Work (SOW) or any other grant documents. ACURO reviews the IACUC approved animal use protocol to ensure all activities funded by this award have been captured and approved by the IACUC in the protocol submitted to ACURO for review. Do not include grant information or grant references in this or any section of the ACURO Appendix.
- I do not have IACUC approval for studies specific to my DoD award, but I have a protocol that is used for all other studies approved at my institution that is funded by multiple non-DoD sources with similar experimental designs as the funded studies. Can I submit this IACUC-approved protocol for ACURO review since it is approved by my IACUC even though studies funded by this award are not yet approved by the IACUC?
No, all studies funded by your DoD award MUST be approved by the IACUC at your institution prior to submitting required documents to ACURO for review. If studies funded by your Award are NOT approved by your IACUC, please contact your IACUC to assist you in adding DoD funded animal work to your protocol. Refer to ACURO SUBMISSION FAQ #1
Appendix Section 14 (Description of Surgical or Other Painful Procedures)
- My protocol does not include surgical procedures but includes potentially painfully procedures. Should I discuss the potentially painful procedures in this section?
Yes. A potentially painful procedure is one that may produce a level or duration of pain that would normally require the use of anesthetics or analgesics. Please include, by page number reference, ALL potentially painful procedures funded by this DoD award in this section of the ACURO Appendix.
Appendix Section 15 (Immediate and Long-term Monitoring/Observations/Treatment)
- My protocol does not include surgical or potentially painful procedures but uses anesthesia as restraint. Should I provide information in this section?
No, chemical restraint does not qualify as a painful procedure. Mechanisms used for chemical restraint should be referenced in the other procedures section.
Appendix Section 17 (Paralytic Agents)
- Is the use of anesthetic agents and the use of paralytics the same thing?
No, paralytic agents include neuromuscular blocking agents (such as pancuronium, rocuronium, gallamine, succinylcholine, and others) that produce generalized muscle paralysis without loss of consciousness. General anesthetics (e.g., isoflurane, ketamine, etc.) are NOT considered to be paralytic agents. Use of paralytics without anesthesia is prohibited.
Appendix Section 20 (Use of Non-Pharmaceutical Grade Agents in Animals)
- My protocol tests new agents which have not yet been identified (TBD) and are not pharmaceutical grade. Should these new agents be included in this section?
Yes, all non-pharmaceutical grade (NPG) products, to include test agents, used in the DoD-funded animal work must be referenced in this section of the ACURO Appendix. If NPG agents have not yet been identified within the protocol at the time of ACURO review and the protocol will be modified at a later date to include these agents, please note that a copy of the amendment and documentation of IACUC approval for the amendment identifying NPG agents must be submitted to ACURO for review/approval prior to implementation.
Appendix Section 23 (Exceptions/Exemptions /Departures from the Guide or Animal Welfare Regulations)
- I need to house my animals in metabolic cages during the course of the study. Is this an exception?
If Animal Welfare Regulation or Guide standards for minimum housing space are not met for special housing situations, this would need to be described here. Consult your IACUC if you aren't sure about which activities are exceptions/exemption/departures.
Appendix Section 26 (Death as an Endpoint)
- All of my animals are euthanized at the end of the study. Is euthanasia the same as death as an endpoint?
No, euthanasia is not synonymous with death as an endpoint. Death as an endpoint is when endpoints prior to death are not adequate to achieve study objectives and animals are allowed to die as a result of the experimental procedures without the benefits of early euthanasia, veterinary intervention, or treatment to alleviate pain.
If you have additional questions, or if you would like to suggest additional topics be added to this FAQ, please contact the ACURO Manager for assistance at email@example.com.