IACUC - Submit a Protocol or Amendment

In order for your protocol to be considered by the committee, there are several items that should be included in your ASP submission. Depending on your project, there may also be supplemental forms to submit along with your ASP. Amendments also require inclusion of an Amendment Form. A blank template can be downloaded from IRBnet “Forms and Templates” under “Documents for Researchers” (IRBnet login required).

The ASP wizard in IRBnet will walk you through the initial ASP form step-by-step. The PI will provide administrative information about themself and their project, information about key personnel if others will be working with them, funding information if applicable, animal information, and indicate their compliance with PI responsibilities.

Some PIs may also need to Consider Alternatives to Potentially Painful Procedures: Required by the Animal Welfare Act (AWA) regulations. PIs must consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine availability of alternatives, including refinements, reductions, and replacements. The UMD IACUC requires this in the form of a literature search. Use our LibGuide or consult a librarian for more information on completing an adequate literature search.

The ASP wizard may also help the PI determine additional forms that must be submitted with their ASP. These forms can be downloaded from  IRBnet “Forms and Templates” under “Documents for Researchers” (IRBnet login required).

• Personnel Qualification Form (PQF): Required for all personnel working directly with live vertebrate animals (including the handling of animals, unpreserved tissues/fluids/waste, soiled cages or accessories, and carcasses) related to your ASP objectives.
• Section E Experimental Design: Required for nearly all projects (some field studies may be exempt—reach out to us at iacuc@umd.edu for more instructions).
• Section F Hazardous Agents: Required for project utilizing biological, chemical, radiological agents.
• Section G Anesthetic Procedures: Required for all surgical and non-surgical procedures using anesthesia.
• Section I Field Studies: Required to evaluate if your study may be exempt from needing IACUC approval.
• Section J Breeding Colonies: Required for protocols that will maintain their own breeding colonies (e.g., specific genotypes needed and not commercially available).
• Section K Antibody Production: Required if the lab will be creating their own antibodies rather than using off-the-shelf options.
• Section L PI-Managed Housing Facility: Required if the PI will house animals in their own space for more than 12 hours (requires inspection prior to usage).
• Section M Exceptions/Exemptions from Policy: Required for all planned deviations from Federal policies and/or UMD IACUC Standards.
• Section N Emergency Treatment and Care: Required for nearly all projects.

You may also be asked to submit lab-specific training certificates, logs and Standard Operating Procedures (SOPs), pain scoring sheets, humane endpoint criteria, syllabi and other course materials, and other administrative documents. Blank templates of several forms mentioned above can be downloaded from IRBnet “Forms and Templates” under “Documents for Researchers” (IRBnet login required).

For new ASPs and renewal submissions, once your ASP and supplemental forms have been uploaded, signatures from the PI, facility manager, and Department Chair (or Dean in some cases) are also required. See the “How to Share a Project” item under IRBnet How-To’s below. For amendments, only the PI signature is required in most cases.

Researchers may find these documents helpful to ensure that their protocol package is ready for submission.

• Protocol Review Worksheets (PDF): LA tool to help with IACUC committee review protocols. PIs can use this worksheet to help ensure that their protocol package is complete.
• Regulatory Source Language (PDF): Shows which federal policies, regulations, and guidelines the IACUC uses during protocol review.
• Commonly Overlooked Submission Details (PDF): There are many parts to an Animal Study Protocol, and supporting documents to include.

1. To set up an IRBnet account, click “New User Registration” under the login request at the top right of the IRBnet homepage.
2. Enter your information for all fields (you may use any email address you like, but we recommend a UMD email address for security and privacy purposes) and select University of Maryland, College Park from the dropdown menu in the “Your Research Institution or Organization” field. You may choose any username and password you like then click the Continue button.
3. On the next page you will need to review your details, check the “Agree to Terms of Service” box, then click the Register button.
4. Check your email for an activation message from IRBnet to finalize your account setup.

1. After logging in, click “Create New Project” at the top of the left-hand menu.
2. In the “Research Institution” field, choose “University of Maryland College Park (UMCP), College Park, MD” from the dropdown menu then fill in the rest of the required fields marked with a red asterisk with your information. Click continue.
3. For Step 1, in the “Select a Library” field, choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” from the dropdown menu. Make sure it is the IACUC option. This will give you a list of relevant documents you may need to download later on.
4. For Step 2, click “Start a Wizard” to start the initial ASP wizard. It may prompt you to choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” before continuing.
5. On the following page, choose “Create a new wizard from scratch” then click the Continue button.
6. The wizard will walk you through the various sections that you may need to complete.
7. Upload all other supplemental forms and documents necessary by clicking the Attach New Document button. This will open your device’s file browser where you can select the new document to upload. Once you click open, it will be listed under “Documents in this Package:”. You must select a Document Type from the dropdown menu where it says “(please select)” in red. You must also enter a Description—this can be the same name as the document.
8. When you have completed your updates, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu.
9. Once the package is signed, you may “Submit this Package” by clicking the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item below.

1. After logging in, click “Create New Project” at the top of the left-hand menu.
2. In the “Research Institution” field, choose “University of Maryland College Park (UMCP), College Park, MD” from the dropdown menu then fill in the rest of the required fields marked with a red asterisk with your information. Click continue.
3. For Step 1, in the “Select a Library” field, choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” from the dropdown menu. Make sure it is the IACUC option. This will give you a list of relevant documents you may need to download later on.
4. For Step 2, click “Start a Wizard” to start the initial ASP wizard. It may prompt you to choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” before continuing.
5. On the following page, choose “Clone one of my existing wizards” then click the radio button for the appropriate project in which this renewal will be a continuance of. Click the Continue button.
6. The wizard will walk you through the various sections that you may need to revise or complete. The data from your previous project will be automatically imported.
7. Upload all other supplemental forms and documents necessary by clicking the Attach New Document button. This will open your device’s file browser where you can select the new document to upload. Once you click open, it will be listed under “Documents in this Package:”. You must select a Document Type from the dropdown menu where it says “(please select)” in red. You must also enter a Description—this can be the same name as the document.
8. When you have completed your updates, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu.
9. Once the package is signed, you may “Submit this Package” by clicking the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item below.

1. After logging in, click “My Projects” at the top of the left-hand menu.
2. You will see a list of all of your submissions and works in progress. Choose the appropriate project that you need to share with others.
3. In the next dashboard, scroll down to the last box with the header “Shared with the following users:”. Click the word “Shared” highlighted in blue.
4. On the next page, click the word “Share” highlighted in blue (first bullet).
5. On the next page, search “UMCP” if that isn’t the default option selected in the “Select an Organization” field.
6. On the next page, you can search for other IRBnet users who are registered with UMD. Search for the individuals you need to add (recommend using their surname) and click the radio button for the appropriate level of access.
7. Read the access level descriptions carefully. Usually, lab personnel and individuals you just need signatures from only need “Read” access. Lab managers, Co-PIs, and other admin figures may need “Write” or “Full” access in order to assist you with certain tasks.
8. After you have chosen the appropriate access level, click the Save button.
9. You can change access levels later on using the same steps above.

These instructions should only be followed if your project says “Work in progress (Not submitted)” in the Submission Type field OR if the submission have not yet been approved. After a submission has been made, you must wait for it to be reviewed and you may be asked to revise documents. The package will be unlocked and you should update the documents in the same package (do not create a new package unless the current package has been approved). 

1. After logging in, click “My Projects” at the top of the left-hand menu.
2. You will see a list of all of your submissions and works in progress. Choose the appropriate project that you need to edit.
3. In the next dashboard, find where it says “The documents for this project can be accessed from the Designer” underneath the first blue box. Click the word “Designer” highlighted in blue.
4. Under Step 2, you will see all of the documents you have submitted including the ASP wizard form and all supplemental forms you may have already uploaded.
5. If you need to edit the ASP wizard form, usually titled “UMCP – IACUC Animal Study Protocol”, click the pencil icon to the far right of the blue box. On the next page, you can use the “Jump To:” dropdown to navigate to the specific sections you need to update, or you can start from the beginning and go page by page. Make sure you click Save and Exit when you are done making updates. You may also delete the document by clicking the red X, but you should save the current version.
6. If you need to edit a supplemental form, usually the titles start with the section ID (e.g., Section E) or descriptive titles, click the pencil icon to the far right of the blue box. On the next page, you can upload a new version of the document by clicking the “Choose File” button. You may add today’s date to the end of the document, then click Update. You may also delete the document by clicking the red X, but you should save the current version.
7. If you need to add a new supplemental form, click the Attach New Document button. This will open your device’s file browser where you can select the new document to upload. Once you click open, it will be listed under “Documents in this Package:”. You must select a Document Type from the dropdown menu where it says “(please select)” in red. You must also enter a Description—this can be the same name as the document.
8. When you have completed your updates, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu.
9. Once the package is signed, you may “Submit this Package” by click the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item below. 

Once you have completed the ASP wizard form and uploaded all supplemental documents and obtained signatures from all necessary parties, you can submit the documents to the IACUC. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete.

1. Click on “Submit this Package” in the left-hand menu.
2. On the next page, you must select the appropriate review board. The form usually defaults to UMD’s IRB so you must make sure that you select “University of Maryland College Park (UMCP) IACUC, College Park, MD” from the “Select a Board” field. Click the Continue button.
3. In the next dashboard, find where it says “The documents for this project can be accessed from the Designer” underneath the first blue box. Click the word “Designer” highlighted in blue.
4. In the event you accidentally submit the package before it is ready to be reviewed by the IACUC, please contact the IACUC Office immediately to request your package be unlocked. Be ready to provide the IRBnet ID number or internal reference number if applied.

If you decide to change anything about your project once it has been approved, you must submit an “Amendment to an Approved Protocol” form and also revise each form that was part of the original submission if information contained in them will be changed. This includes the “UMCP – IACUC Animal Study Protocol” ASP wizard form, where appropriate (ie., adding animals or animal numbers, or changing species, pain categories, method of euthanasia, or exceptions to the Guide). The goal is to have the amendment stand alone as much as possible, which will speed up the approval process.

*NOTE: If your amendment includes any changes in animal species, animal numbers, pain category, literature search, experimental conditions requiring exceptions from the Guide, or method of euthanasia, you must submit a revised version of your UMCP – IACUC Animal Study Protocol (ASP) form with your amendment package. See the “How to clone an ASP form” item below. 

1. After logging in, click “My Projects” at the top of the left-hand menu.
2. You will see a list of all of your submissions and works in progress. Choose the appropriate project that you need to edit.
3. On the next page, click “Create New Package” in the left-hand menu.
4. In the next dashboard, find where it says “The documents for this project can be accessed from the Designer” underneath the first blue box. Click the word “Designer” highlighted in blue.
5. An Amendment Form must be submitted with all amendments. Locate the link “Need Forms? Show Form Libraries” at the top right of the dashboard.
6. For Step 1, in the “Select a Library” field, choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” from the dropdown menu. Make sure it is the IACUC option. You can then select “A Amendment Form 05.16.25” from the “Select a Document:” field and then click download.
7. Once you have filled out your amendment form, click the Attach New Document button. This will open your device’s file browser where you can select the amendment form to upload. Once you click open, it will be listed under “Documents in this Package:”. You must select “Amendment” Document Type from the dropdown menu where it says “(please select)” in red. You must also enter a Description—this can be the same name as the document.
8. If your amendment requires changes to the ASP wizard form (*see top of this menu item), you must clone your most recent ASP and revise it accordingly. See the “How to clone an ASP form” item below.
9. If your amendments requires you to edit or add supplemental forms, see steps 6 and 7 under the “How to edit your project” item above.
10. When you have completed your updates, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu. Some amendments may require signatures from other parties (e.g., if you are increasing animal numbers in a centrally-managed facility, a DLAR facility manager may need to sign the package).
11. Once the package is signed, you may “Submit this Package” by click the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item above. 

1. After logging in, click “My Projects” at the top of the left-hand menu.
2. You will see a list of all of your submissions and works in progress. Choose the appropriate project that you need to amend.
3. If you have already created a new package, you may continue. If you have not, see steps 3-7 in the “How to submit an amendment” item above.
4. On the next page, for Step 2, click “Start a Wizard” to start the initial ASP wizard. It may prompt you to choose “University of Maryland College Park (UMCP) IACUC, College Park, MD” before continuing.
5. On the following page, choose “Clone one of my existing wizards” then click the radio button for the appropriate project in which this renewal will be a continuance of. Click the Continue button.
6. The wizard will walk you through the various sections that you may need to revise or complete. The data from your previous project will be automatically imported.
7. Upload all other supplemental forms and documents necessary.
8. When you have completed your updates, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu.
9. Once the package is signed, you may “Submit this Package” by clicking the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item below.

When collaborating on a project where animal research will be performed at another institution, we ask that you provide documentation of the collaborating institution’s approval of the research protocol. 

Note: Collaborating institutions must have a PHS assurance and an IACUC or be willing to be covered under an MOU with UMD.  

To submit a new protocol for acknowledgement of another institution’s IACUC approval of protocol  (on which a UMD researcher will work): 

1. After logging in, click "Create New Project” from the left-hand menu.
2. You do not need to submit an ASP wizard form so you may just click the Attach New Document button. This will open your device’s file browser where you can select the full, approved IACUC protocol from the other institution to upload. Once you click open, it will be listed under “Documents in this Package:”. You must select “Other” from the dropdown menu where it says “(please select)” in red. You must also enter a Description—this can be the same name as the document.
3. After the protocol is attached, click the Attach New Document button again. You must now upload the IACUC approval letter from the other institution and follow the same instructions as step 2.
4. Repeat step 2 again to upload the grant (or pertinent portions of the grant) as well.
5. When you have completed your uploads, you must sign the package by following the instructions after clicking “Sign this Package” in the left-hand menu.
6. Once the package is signed, you may “Submit this Package” by clicking the button in the left-hand menu. Once a package is submitted, it is locked and cannot be modified. Please do not submit until all documents are complete. See the “How to submit a protocol” item below.