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.

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. If the IACUC protocol submitted for review is only partially funded by this award (not all procedures are funded by DoD), be sure to submit a highlighted version of the protocol so that ACURO reviewers can easily identify the specific experiments and animals funded by the award. Additionally, during the review process, respond promptly to ACURO queries 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 section 2 of the ACURO Appendix and sign the ACURO PI Assurances document on the last page of the ACURO Appendix.

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

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. If not, please provide the expiration date at the time of submission (this will need to be verified by the IACUC).

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.

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, changes 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 protocol may NOT continue and animal work cannot begin or continue 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

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 DOD 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 to the work submitted to ACURO for review.

DOD requires the PI to provide a narrative description of the methods and sources used to determine alternatives to all painful or distressful procedure(s), including those procedures in which pain or distress is alleviated.

No. DoD-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, in accordance with the updates to the Animal Welfare Act Regulations, DOD no longer requires annual review of funded or conducted animal use protocols.

DOD no longer requires annual review of animal research protocols.

Please submit amendments to the ACURO inbox at usarmy.detrick.medcom-usamrmc.other.acuro@health.mil. 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 staff members. The only exception to this is amendments submitted in response to questions raised during the review of a 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 Guidance.

If an IACUC approves a major amendment using the VVC process adhering to all the stipulations of the current ACURO Protocol Change Guidance, they may immediately implement the change and do not need to wait for ACURO review and approval. Submit the VVC approved amendment, or amended version of the IACUC approved protocol, and IACUC approval documentation 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 other than those indicated.

Amendments requiring ACURO review and approval may only be implemented after receiving approval from ACURO. Amendments approved by VVC are the only exceptions. Refer to 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. See the ACURO protocol change guidance.

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-DoD institution that uses live animals to conduct Department of Defense (DoD)-supported research, development, testing, evaluation (RDT&E), or training.

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

Use the link to download the ACURO Appendix and ensure that all required information is provided. If the IACUC protocol submitted for review is only partially funded by this award (not all procedures are funded by DoD), be sure to submit a highlighted version of the protocol so that ACURO reviewers can easily identify the specific experiments and animals funded by the award. Additionally, during the review process, respond promptly to ACURO queries and provide detailed and clear responses.

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.

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.

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 DoD 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 DoD-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.

Please refer to the instructions to protocol submissions. If additional documentation is required ACURO will contact you.

For the purposes of oversight of animal use in research, an intramural institution is any DoD 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; and protocols that involve wounding with a weapon, for those institutions that ACURO oversees through Command structure or Agreement. Likewise, if an intramural institution contracts animal work to a non-DOD institution, ACURO is required by regulation to conduct a full review. Refer to ACURO SUBMISSION FAQ #42.

Any extramural institution receiving DoD 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-DOD 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 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 DOD 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 DOD 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 DOD-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.

Please be sure to provide copies of all unexpired, 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 DoD-supported research.

All significant deficiencies, noncompliance with applicable DoD regulations, reports of adverse events, suspension of activities by the IACUC, or reports of adverse events that affect DoD-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 DoD-funded protocols. Refer to ACURO Reporting Guidance 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 DoD-supported animal studies, if euthanasia is delayed for sample collection, or if animals are euthanized for the express purpose of DOD-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

For research involving COVID-19, please be prepared to provide the following additional information to the Program Oversight Specialist reviewing the submission:

• Have you considered that the animals could already have been exposed to the virus, SARS-CoV-2, that causes this disease?
• Please state what considerations have been given to address potential exposure and how this may impact your research.
• For example, if animals have been screened for SARS-CoV-2, please provide details. If additional PPE was used to handle these animals, please describe.
• Refer to COVID Guidance

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

While ACURO does not maintain a publication schedule for guidance documents or the ACURO Appendix, all policies and ACURO forms are reviewed annually; 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. Refer to Guidance Documents and the ACURO Appendix.

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 DoD funds, ACURO requires a full submission for review and approval.

All contracts for DoD 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.