# Forms & Submission ## expand\_more ### I will be working with vertebrate animals in research at the Harvard Longwood Campus. I need to create an IACUC protocol. expand\_more All research involving vertebrate animals requires IACUC *review* and *approval*. This must occur *before* working with animals. Animal research proposals (i.e. IACUC protocols) are submitted in E-IACUC. Read the [Accessing E-IACUC](/accessing-e-iacuc) section for instructions on how to submit a **new protocol**. The IACUC protocol must identify a [Principal Investigator](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Forms/PoliciesandGuidelines.aspx) (PI). They and the persons working with the animals described on the IACUC protocol must adhere to all relevant *institutional policies*, which can be found on the [IACUC Wiki](/policies). If you are joining a lab, familiarize yourself with all of its *approved* IACUC protocols. Animal activities, or any aspect of an animal activity not described on an IACUC protocol cannot be pursued without the committee's approval. This includes administrative details, such as the [location](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Animal%20Use%20Area%20Requirements.pdf) (i.e. room) where you may perform the work. Depending on the scope of the new activity, modify an existing IACUC protocol or submit a new, separate IACUC protocol for the committee to review and approve. Furthermore, be sure your name is listed on the IACUC protocol before you may begin the animal work as described. The [onboarding checklist](/training) outlines the requirements for newcomers. ### I wil be working with invertebrates on campus. Do I need an IACUC protocol? expand\_more While investigators are not required to submit an IACUC protocol for the use of invertebrates at the Harvard Longwood Campus, [AAALAC International](https://www.aaalac.org/accreditation-program/faqs/#A2) expects accredited institutions to include invertebrates in research as part of the overall animal care and use program. Contact the [Office of the IACUC](mailto:IACUC@hms.harvard.edu) to inform them of the use of invertebrates in research on campus. For the time being, **provide a letter or document** that covers following: - Training of personnel caring for and handling the animals - Husbandry practices, including sanitation, diet, and adequate space (especially if contiguous with vertebrate holding areas) - Health monitoring and record keeping - Species interactions for those held in the same room or area - Physical plant provisions (e.g. emergency power availability for species whose environment would be negatively impacted by a power outage) - Occupational health and safety risks (e.g. GFI circuitry, zoonotic diseases, containment of mosquitoes used in malaria research, etc.) AAALAC has also issued [Guidelines on the Care and Welfare of Cephalopods in Research](https://www.aaalac.org/pub/?id=E9012458-E8F7-1CB9-E298-B0A29C3193A5). ### I need to make a modification to an approved IACUC protocol or renew an IACUC protocol in anticipation of its expiration. expand\_more Changes to *approved* IACUC protocols (i.e. **amendments**) are submitted in E-IACUC. Read the [Accessing E-IACUC](/accessing-e-iacuc) section for instructions. This includes administrative details, such as changes to the list of personnel allowed to perform the animal work approved on the IACUC protocol (i.e. **personnel additions**) and changes to funding that supports the animal work (i.e. **grant additions**). Renewals to *approved* IACUC protocols (i.e. **three-year renewals**) are also submitted in E-IACUC. Read the [Accessing E-IACUC](/accessing-e-iacuc) section for instructions. Please keep in mind that once it is approved by the IACUC, the three-year renewal will *supersede* the previous protocol. ### I have an approved IACUC protocol. How can I order animals? expand\_more All animal orders must be placed with HCCM. This can be done through the [**E-Sirius**](https://harvard.esirius.cayuse.com) procurement system. Financial arrangements need to be setup with the **HCCM Business Office** before orders can be placed. Visit [HCCM](https://iacuc.hms.harvard.edu/services#hccm) to learn more. ### My lab receives federal funds for animal work taking place at another institution. expand\_more Use the [Ceded Review Request Form](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Ceded%20Review%20Request.pdf) whenever your federally-funded grants awarded to HMS/HSPH/HSDM are associated with IACUC protocols from other institutions. Use the [Custom Antibody Production Form](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Custom%20Antibody%20Production.pdf) when contracting **custom antibody production**. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e. not purchased off-the-shelf). ### My lab receives funds to support the animal work on campus. expand\_more Requests to add awards that *directly* fund animal work (i.e. animal procurement, husbandry per diems, equipment, and supplies) are submitted in E-IACUC. This can be done while creating a **new protocol**, or as part of an **amendment** or **three-year renewal**. Read the [Accessing E-IACUC](/accessing-e-iacuc) section for instructions. The information in the IACUC protocol must specifically correspond to the information outlined in a grant application in regards to: - Species and the approximate number of animals to be used, - Rationale for involving animals, and for the appropriateness of the species and numbers used, - A complete description of the proposed use of animals, - A description of the procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesia, anesthetic and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals, and - A description of any euthanasia method to be used. While the requirement for congruency review only applies to PHS-, DHHS-, NSF-, and NASA-supported research, non-federal awards may still need to be added to an IACUC protocol. The [NIH Grants Policy Statement 4.1.1.2](https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf) does not apply to **fellowships** or training grants that do not *directly* fund animal research, and therefore, they should not be added to an IACUC protocol. Instead, if requested, provide the PI's IACUC approval letter that references the award directly supporting the animal research described on the fellowship application. ### I will import animals tissues or excretions. expand\_more Use the [Ex Vivo Tissue Form](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Ex%20Vivo%20Tissue.pdf) to notify the animal care program regarding the use of animal tissues, fluids, or cadavers. The use of deceased animals or parts of animals does not require IACUC approval; however, the lab or institution donating tissue must have IACUC approval for any activity involved with (1) euthanizing animals for the explicit purpose of obtaining or using their tissues or other materials, or (2) project-specific antemortem manipulation of animals prior to euthanasia. ### I would like to report an unanticipated, negative experimental outcome or accident that resulted in harm to an animal. expand\_more Use the [Incident Report Form](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Incident%20Report.pdf) to notify the animal care and use program of any event that jeopardizes the health or well-being of animals. This includes natural disasters, accidents, and mechanical failures. ## Other Forms description [### Ceded Review Request Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Ceded%20Review%20Request.pdf)Use for labs receiving federal funds for animal work taking place at another institution. description [### Custom Antibody Production Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Custom%20Antibody%20Production.pdf)Use for labs contracting external organizations to produce custom antibodies (i.e. not purchased off-the-shelf). Organizations may need to fill out a **Custom Antibodies Assurance Agreement** to be submitted along with the form. note\_add [### Custom Antibody Assurance Agreement ](https://hu.sharepoint.com/:w:/r/sites/IACUCWiki/_layouts/15/Doc.aspx?sourcedoc=%7B9E29A4A6-5C4C-45A8-98E0-3A1907EDEC41%7D&file=HMA%20IACUC%20Antibody%20Assurances%20Agreement.doc&action=default&mobileredirect=true)To be submitted with the **Custom Antibody Production** form. description [### Ex Vivo Tissue Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Ex%20Vivo%20Tissue.pdf)Use for labs using dead animals, body parts, or tissues. description [### Grant Addition Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Grant%20Addition.pdf)Use for labs that are unable to update funding information through E-IACUC. description [### Incident Report Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Incident%20Report.pdf)Use this form to notify the IACUC of an unforeseen event that negatively impacts the welfare of research animals. add\_circle [### Memorandum of Understanding ](https://hu.sharepoint.com/:w:/r/sites/IACUCWiki/_layouts/15/Doc.aspx?sourcedoc=%7B5A611F91-E3B6-4E96-BD7B-02AF4F697CA2%7D&file=HMA%20IACUC%20MOU.docx&action=default&mobileredirect=true)A MOU must be established for collaborations between HMS and any institution not covered by the **Master MOU**. description [### Personnel Addition Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Personnel%20Addition.pdf)Use for labs that are unable to update personnel information through E-IACUC. Visitors may be eligible to submit the **Short-Term Personnel Addition** form instead. description [### Short-Term Personnel Addition Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/Short-Term%20Personnel%20Addition.pdf)Read the **Training Requirements for Animal Researchers** IACUC policy for eligibility. description [### USDA Animal Transfer Form ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/USDA%20Animal%20Transfer.pdf)Use this form to transfer a USDA-covered animal to another IACUC protocol. Submit an **Animal Summary Sheet** for each animal. note\_add [### Animal Summary Sheet ](https://hu.sharepoint.com/sites/IACUCWiki/Shared%20Documents/USDA%20Animal%20Summary%20Sheet.pdf)To be submitted with the **USDA Animal Transfer** form. ## Remember... Be sure to submit IACUC protocols or amendments in E-IACUC using the **Submit Study/Amendment** activity; this will move them out of the *Pre-Submission* state and begin the review process. You must wait for the IACUC to **notify** you of approval before starting animal work - E-IACUC will automatically generate an approval letter and send out an email notification upon approval. Contact the Office of the IACUC for confirmation if unsure. Furthermore, while IACUC approval covers the animal work described on the protocol, the use of **biological agents** also requires separate *COMS approval*. Both are needed in order to work with *COMS regulated materials* in animals on campus. For the miscellaneous forms above, **email** the forms directly to the Office of the IACUC. The office will notify you when these types of requests are approved. [ E-IACUC arrow\_circle\_right ](/e-iacuc) [ COMS Office arrow\_circle\_right ](/services#coms) [ Office of the IACUC arrow\_circle\_right ](mailto:IACUC@hms.harvard.edu)