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 as well as IACUC approval for those amendments, a completed ACURO Appendix, including the ACURO PI Assurances signed by the Protocol PI. For studies conducted outside the United States protocols must be submitted in the ACURO International Protocol Format including the PI assurances (last page of protocol) signed by the Protocol PI and a copy of the International Institutional Certification signed and dated (two signatures Required) must be provided. Additionally, amendments for international protocols must be submitted in the ACURO International Amendment format which, must be signed by the IACUC Chair or equivalent approving authority.

To ensure review is not delayed, it is important to carefully read the instructions in the ACURO Appendix and ensure that all required information is provided. Additionally, during the review process, respond promptly to ACURO inquiries and provide detailed and clear responses.

Regardless of how many PIs an institution chooses to designate for a given protocol, one of the PIs must be designated as the main point of contact (POC) for communication with ACURO. The PI chosen as the POC must be identified as the Protocol PI in the ACURO Appendix or ACURO International Protocol Format and sign the ACURO PI Assurances ddocument on the last page.

No. ACURO will only accept finalized protocols that have been fully approved by the institution's IACUC (or equivalent approving authority).

Documentation of IACUC approval may be in the form of a formal approval letter, an email notification, or other means and should specify the type of review, the applicable protocol number/title, and IACUC approval date. Ideally, the approval document will also include the expiration date of the protocol.

ACURO's approval expires 30 days after the IACUC protocol expiration date. Every time a protocol previously approved by ACURO is approved as a complete rewrite by the IACUC, ACURO requires a full review. A rewrite submission must be submitted to the ACURO inbox to include the IACUC approved protocol, IACUC approval, and the ACURO Appendix with the signed ACURO PI Assurances.

For studies conducted outside the United States protocols must be submitted in the ACURO International Protocol Format including the PI assurances (last page of protocol) signed by the Protocol PI and a copy of the International Institutional Certification signed and dated (two signatures Required) must be provided.

While ACURO is reviewing the rewritten protocol, animal work previously approved by ACURO may continue as described in the previous version of the protocol. However, any changes to previously approved studies or new experiments outlined in the rewritten protocol may not be implemented until receipt of ACURO approval.

Protocols submitted more than 30 days after the IACUC protocol expiration will be considered new submissions. Animal activities previously approved by ACURO on the previous version of the expired protocol may NOT continue and animal work cannot begin or continue on the new protocol until receipt of ACURO approval.

ACURO does not review any proposed animal studies until they are approved for funding. There is no requirement to submit all animal documents with a proposal. As applicable, the PI will complete the vertebrate animal section of the proposal to give the funding agency a basic understanding of the work proposed. Once the PI is notified of intent to fund, documents can be submitted for ACURO for review.

Yes. For every submission you should receive an official notice of receipt of the submission. If you do not receive a notice within 5 business days of submission, contact ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil to confirm receipt of the submission

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ACURO may provide expedited review on a case-by-case basis, when the need is adequately justified. If you need urgent approval of a protocol, please send a message to the ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil providing an explanation of why expedited approval is needed and why the submission was not sent with sufficient advance timing for ACURO review. ACURO staff will respond to let you know if expedited approval will be possible. Please include the phrase "expedite request" in the subject line of the email to ensure proper processing of the submission.

If proposing studies that use only one sex of animal, the PI should provide scientific justification for the use of a single sex. However, PIs typically do not need to provide a written justification for certain types of studies (e.g., breast cancer, ovarian cancer, pregnancy, prostate cancer, etc.), where sex-specific research areas are being studied and it is most appropriate to conduct the research in one sex.

It is not a DoW requirement to include p/d categories for non-USDA regulated species in the IACUC approved protocol submitted to ACURO for review. However, this information is required to be provided on the ACURO Appendix, ACURO staff may reach out to the IACUC for confirmation of p/d category for non-regulated species if a p/d category in the ACURO Appendix does not seem appropriate for the work submitted to ACURO for review.

DoW requires the PI to provide a narrative description of the methods and sources used to determine that alternatives were not available for the procedures that may cause pain or distress. There are SPECIFIC REGULATORY requirements for USDA Category D and E protocols. For all procedures that may cause more than slight or momentary pain or distress (Cat D or E), you MUST show that you have considered alternatives. What does this mean? Is there something (procedure, test) less painful or distressful available that would give you the same results? At a minimum, you must include a narrative description of methods and sources used to determine that alternatives were not available for the procedures that may cause pain or distress. (literature search, extensive experience in the field and with the specific procedure). Example response: I certify that I have found no valid alternative to any procedures described in my protocol which may cause more than momentary pain or distress, whether it is relieved or not. I have determined this to be true by (list method/source).

No. DoW-funded animal use may only be initiated after receiving notification of approval from ACURO except as described above in ACURO SUBMISSION FAQ # 7 and below in ACURO SUBMISSION FAQ # 19.

No. DoW funded protocols subject to ACURO review are expected to undergo triennial review when required by the Animal Welfare Regulations or other applicable regulations.

Annual reviews only need to be submitted if significant changes to DoW funded animal work, as defined in the ACURO Protocol Change Policy, are approved by the IACUC during the annual renewal process or if the institution conducts de novo review annually.

Please submit amendments to the ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil. Amendments for international protocols must be submitted in the ACURO International Amendment format which must be signed by the IACUC Chair or equivalent approving authority. To ensure timely review of your amendment, please be sure to include the term "Amendment" in the subject line of your email submission. Amendments should never be sent to individual ACURO staff members. The only exception is in response to questions raised during the review of your protocol.

ACURO must review and approve all significant changes (as defined by ACURO) to funded animal work previously approved by ACURO prior to implementation of IACUC approved changes. Significant changes are defined in ACURO Protocol Change Policy.

If an IACUC approves a significant change using the VVC process adhering to all the stipulations of the current ACURO Protocol Change Policy, they may immediately implement the change and do not need to await receipt of ACURO approval. Submit the VVC approved amendment submission, and documentation of the veterinary consultation with IACUC notification to ACURO within 5 business days of VVC approval.

Submit the IACUC approved amendment or amended version of the IACUC approved protocol, and documentation of IACUC amendment approval. If the submission includes an amended copy of the full protocol, you must indicate clearly (e.g., by highlighting, strike-thru, etc.) specifically what parts of the protocol were amended. Alternatively, provide a detailed description of the changes made along with a statement that no other changes were made to the protocol besides those indicated. Amendments for international protocols must be submitted in the ACURO International Amendment format which must be signed and dated by the IACUC Chair or equivalent approving authority.

No. Amendments requiring ACURO review and approval may only be implemented after receiving approval from ACURO. Significant changes approved using the VVC process while adhering to the ACURO Protocol Change Policy are the only exceptions ACURO SUBMISSION FAQ #19.

ACURO does not need to review amendments that are solely for adding personnel to animal use protocols, with the exception of a change in protocol PI, which requires ACURO review and approval.

Amendment submissions are processed with high priority. Please be sure to include "AMENDMENT" in the subject line of the email message so that our staff can appropriately identify these submissions. Depending on current workload, ACURO will typically respond to amendment submissions within 3-5 business days.

For the purposes of oversight of animal use in research, an extramural institution is any non-DoW institution that uses live animals to conduct Department of War (DoW)-supported research, development, testing, evaluation (RDT&E), or training.

The provision of DoW funding, animals, facilities, equipment, or any other resources that are needed to conduct the RDT&E or training to a non-DoW institution. DoW-supported RDT&E or training is also referred to as extramural.

ACURO Appendix
ACURO Policy on Work in Foreign Countries Enclosure 1 (International Protocol Format)
ACURO Policy on Work in Foreign Countries Enclosure 2 (International Institutional Certifications)
ACURO Policy on Work in Foreign Countries Enclosure 3 (International Protocol Change Form)

The first part of each section of the Appendix contains instructions specific to that section. For additional guidance on the Appendix, please reference the ACURO Appendix FAQs. Please email additional questions regarding the ACURO Appendix not included in aforementioned documents to the ACURO inbox.

The research site protocol PI must sign the ACURO PI Assurances which can be found on the last page of the ACURO Appendix.

No. To simplify the ACURO review process, the Appendix format was revised. The Appendix document does not require duplication of protocol information to describe the funded animal use. Follow the detailed instructions provided in the ACURO Appendix.

Transfer of funded animal work to a new institution will require a new ACURO submission for review. After the animal use protocol is approved by the IACUC at the new institution, a new submission package must be submitted to the ACURO inbox for review and approval. ACURO approval CANNOT be conveyed between institutions. Please remember to contact the funding agency to coordinate the necessary changes in the award. ACURO does not perform this function.

Turnaround time varies with workload and staffing. Turnaround time can be as long as 2-3 months. ACURO recommends early and expeditious preparation and submission of protocols to avoid delays that may affect your research. If urgent approval of a protocol is needed, refer to ACURO SUBMISSION FAQ # 10.

No. ACURO will request a copy of the USDA inspection report annually from each institution. For new US institutions that ACURO hasn't reviewed previously, a copy of the institution's most recent USDA inspection report will be needed. This document will be requested from the attending veterinarian and IACUC point of contact for your institution.

All contact sections of the appendix must be completed. If you are a small business or other organization, please list a contact who manages the award funds for your institution.

Any institution receiving DoW funds for animal research, either through direct award or subcontract, must submit the animal use protocol documentation to ACURO for review and approval, refer to ACURO SUBMISSION FAQ #1.

When completing section 2 of the ACURO Appendix, you will be asked to enter the current (new) protocol number and then check a box in the table to indicate you are submitting a triennial rewrite in which the protocol number has changed. You will enter the old protocol number in the same row of the table.

There are some circumstances when multiple submissions are not required. Please contact the ACURO inbox at mailto:usarmy.detrick.medcom-usamrmc.other.acuro@health.mil with a brief description of your situation for specific instructions.

You may defer ACURO protocol review if DoW-supported work is not scheduled to be completed in the near future. Keep in mind, ACURO review and approval may take several months. In order to request deferral, submit a written request via email to the ACURO inbox at mailto:usarmy.detrick.medcom-usamrmc.other.acuro@health.mil. Please include the planned start date with the request, as that will determine whether you need a short or long term deferment. This generally will have no effect on your award other than the prohibition to use funds for animal work until ACURO approval is obtained. Check with your funding agency to confirm.

No, awards are released according to the timelines of the funding agency and contract agent. The funding document will contain the DFARS animal welfare clause and/or a prohibition clause, both of which state that you may not use funds from the award on animal studies until ACURO's review is completed. You are generally free to use funds for other purposes (non-animal activities). Please contact your funding agency with any questions regarding funding of awards.

For studies conducted outside the United States protocols must be submitted in the ACURO International Protocol Format including the PI assurances (last page of protocol) signed by the Protocol PI and a copy of the International Institutional Certification signed and dated (two signatures Required) must be provided. If additional documentation is required ACURO will contact you.

For the purposes of oversight of animal use in research, an intramural institution is any DoW institution that uses live animals to conduct research, development, testing, evaluation, or training.

ACURO must review and approve any animal use protocols for RDT&E or training that uses nonhuman primates, dogs, cats, or marine mammals; any protocols that use animals for human medical or surgical training, for those institutions that ACURO oversees through Command structure or Agreement. Likewise, if an intramural institution contracts animal work to a non-DoW institution, ACURO is required by regulation to conduct a full review.

Any extramural institution receiving DoW funds for animal research, either through direct award or subcontract, must submit the animal use protocol and supporting documentation to the ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil for review and approval. Refer to ACURO SUBMISSION FAQ #1.

Turnaround time varies with workload and staffing. Intramural protocols receive priority and are processed as soon as they are noted in the inbox by our administrative staff. Additionally, intramural protocols are routed directly to ACURO veterinarians so the review is much faster, generally being turned around within a few days. ACURO recommends early and expeditious preparation and submission of protocols to avoid delays that may affect your research. If urgent approval of a protocol is needed, contact ACURO to discuss approval timelines. Protocols contracted to non-DoW institutions do not get priority or direct review by an ACURO veterinarian.

When extramural institutions conduct research involving nonhuman primates, dogs, cats, or marine mammals, or human medical training using any species of animal, ACURO must consider performing a site visit as part of the approval process. In some cases, site visits may be waived for institutions that are AAALAC accredited. Site visits may be required for some other protocols in addition to those mentioned above when ACURO deems necessary.

Intramural site visits are conducted on a regular basis in accordance with ACURO policy. If you want to request an ACURO staff assistance visit, contact the ACURO Manager.

If a site visit is deemed necessary, the ACURO Office Manager will coordinate with the site point of contact.

The ACURO Veterinarian will accompany the institution's Attending Veterinarian on a tour of all animal use areas where DoW funded animal work is performed to include the vivarium, support areas, surgical suites, and any lab space for the PI where live animals are taken for procedures. An ACURO Program Oversight Specialist or the ACURO Manager will review all IACUC documents pertaining to DoW funded animal work. A list of IACUC documents to be reviewed by ACURO is sent in advance of the site visit.

ACURO will provide a list of documents required for review during the visit as well as the checklist that will be used to provide an overview of the areas being evaluated. ACURO does not remove any documents unless specifically requested during the visit. Plan for key personnel to be available to address questions or requests for additional information during the site visit. Refer to ACURO SUBMISSION FAQ #47 below.

There are several key staff that should be present or available during an ACURO site visit. Either the protocol PI or a representative that is familiar with the DoW-supported studies is a critical member of the site visit team and should be available for the entrance brief and for a tour of animal procedure locations. Because the visit involves a tour of the animal facilities, as well as review of medical records and animal health, the Attending Veterinarian should be available to conduct the facility tour. A representative from the IACUC should be present at the entrance brief to outline documents provided and be available to answer questions that may come up during document review throughout the visit. We recommend that all of these individuals be present at the exit brief as well as the Institutional Official (or his or her representative).

ACURO oversight is required for animal work conducted in a field setting any time the research involves an invasive procedure, harms, or materially alters the behavior of the animal under study. “Harm” is defined as “any procedure that causes lasting physical, behavioral, psychological deficits or damage, or exposes an animal to potentially perilous situations (e.g., releasing a nocturnal animal during daylight hours).” (DoDI 3216.01). ACURO additionally requires oversight in any situation where animals are euthanized for the purpose of the study.

Yes. Please be sure to provide copies of all unexpired and current, signed licenses and permits for all field locations when sending the submission to ACURO.

Yes, when using privately owned animals, a consent form must be provided indicating the animal will be used in DoW-supported research.

All significant deficiencies, noncompliance with applicable DoW regulations, suspension of activities by the IACUC, or reports of adverse events that affect DoW-supported RDT&E or training must be reported to ACURO within 5 business days. Additionally, reporting is required for changes in AAALAC accreditation status or notifications that the institution is under investigation by the USDA. ACURO also requires prompt notification of protocol suspensions, research misconduct, or FOIA requests impacting DoW-funded protocols. Refer to ACURO Reporting Policy for additional details on reporting requirements.

The responsibility for reporting adverse events lies with both the PI and the research site. ACURO receives reports from both PIs and IACUCs at institutions performing funded work. Failure to report such events on a recurring basis may lead to ACURO requesting a ‘stop work’ order from the funding agency or other consequences (e.g., recouping costs for noncompliant work performed). This affects both the PI and the institution.

ACURO staff will process and review the event and will contact the PI and/or the institution's IACUC point of contact to gather additional information as needed regarding the circumstances of the event and any corrective action.

Use of biological samples obtained from a slaughter house, commercial source, or a protocol which documents PI approval to share tissue after euthanasia does not require ACURO review.

If biological samples are obtained from live animals, specifically for use on DoW-supported animal studies, if euthanasia is delayed for sample collection, or if animals are euthanized for the express purpose of DoW-supported animal studies, ACURO approval is required. For further assistance, please contact the ACURO inbox at mailto:usarmy.detrick.medcom-usamrmc.other.acuro@health.mil

Studies using previously collected tissue samples typically would not require IACUC oversight if the study is a retrospective analysis of biopsy or necropsy specimens that were collected as part of clinical management or a routine health surveillance program (for example, one intended to inform clinical management of a population of animals), and the tissue specimens were not collected for the purpose of providing samples for research. For further assistance, contact the ACURO inbox at mailto:usarmy.detrick.medcom-usamrmc.other.acuro@health.mil

DoW-supported clinical trials in animals require a complete submission for ACURO review and approval. DoW regulations (DoDI 3216.01) do not allow a clinical study committee to replace an IACUC.

While ACURO does not maintain a publication schedule for policies or the ACURO Appendix, all policies and ACURO forms are reviewed triennially; if changes are made, updates are published soon after. Please check the ACURO website for current documents. For additional questions on ACURO policy and procedures contact the ACURO Manager, at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil.

If the breeding colony is just the source of the animals and the PI is simply purchasing animals from the breeding colony, which is no different than any other animal procurement, no documentation needs to be provided to ACURO. However, if the PI is paying for the actual breeding program with DoW funds, ACURO requires a full submission for review and approval.

All contracts for DoW supported RDT&E or training must contain DFARS clause 252.235-7002. Agreements not subject to the DFARS (e.g., grants, cooperative research, and development agreements) must contain language equivalent to that in and DFARS 252.235-7002 and DoDI 3216.01.