IACUC - Info for Researchers

As a general rule, any activities at UMD that involve vertebrate animals and cephalopods in research, testing, or teaching must be reviewed and approved by the IACUC prior to ordering animals for the purposes of the activity and before beginning any work involving animals.

This includes faculty/staff research or teaching where they are the Principal Investigator (PI) and/or prime awardee of funding, and includes activities that may occur on- or off-campus (field studies may be exempt under certain conditions). See “What activities DO NOT require an ASP?” for more information about when an ASP is not required.

This also includes student research where they will be the main individual carrying out the animal-related activities (the PI may not even have contact with the animals), but the protocol must be submitted by their faculty advisor.

If a faculty member or student will carry out research funded by the PHS at a non PHS-assured institution then they must ensure that the outside institution either negotiates its own PHS Assurance or becomes covered by UMD’s PHS Assurance. UMD must then treat it the same as all other facilities included in their program such as participating in semi-annual inspections, reports to federal agencies and accrediting bodies, etc.

Some activities may also require approval from other regulatory entities on campus. Specifically, animal-related research that requires the use of certain biohazards must receive approval from the Institutional Biosafety Committee (IBC). You may submit protocols to both committees simultaneously, but the IBC must approve a protocol before the IACUC can grant approval to an ASP.

Grants Congruency Reviews: Prior to conducting work under sponsored projects for research involving animals, PIs are required to obtain evidence that the proposed project has been reviewed and approved by the UMD IACUC. Some sponsors of these projects require such evidence prior to issuing an award to the University. See the Grants Congruency Reviews section on the Submit a Protocol or Amendment page for more information.

If any of the following are true, you may not need an ASP. We recommend you contact the IACUC Office as soon as possible to confirm.

• Faculty/Staff who will conduct animal-related research or teaching activities under another PI/faculty member at UMD do not need their own protocol, but will need to be added as key personnel on the PI’s ASP.
• Faculty/Staff who will conduct animal-related research activities as a sub-awardee or key personnel (the PI works for another institution that acts as the prime awardee/recipient of funding) do not need their own protocol if the outside institution is PHS-assured and their IACUC has already approved a protocol. However, a copy of the protocol, protocol approval, and external funding information must be submitted to the UMD IACUC and a Memorandum of Understanding (MOU) may be required. See the "How to document external collaborations" item in the IRBnet How-Tos section of our Submit a Protocol or Amendment page.
• Students and other personnel who may be the awardee or will be the main individual carrying out the animal-related activities (the PI may not even have contact with the animals) do not submit their own protocols. The protocol must be submitted by their faculty advisor.
• Field studies where animals will not be handled or manipulated, but observed only, may not need an ASP, but an evaluation form must be completed and submitted to the IACUC Office for review.
• Agricultural Extension and production activities with UMD-owned animals do not require an ASP, but these facilities will still be included in program activities such as semi-annual inspections, reports to federal agencies and accrediting boards, and are still overseen by the University Attending Veterinarian. IACUC members may also observe some activities such as auctions and events where UMD-owned animals must be transported to another location may. If these animals will be used in teaching activities and certain demonstrations or will join a research study, then an ASP may be required.

Most PIs are faculty (tenured/tenure track or professional track) with a few exceptions. Animal research activities may also be carried out by students under an approved ASP which must be submitted by the faculty advisor. The faculty advisor is responsible for all research activities under that protocol.

Yes, there is an onboarding process available for new PIs and the IACUC is charged with developing and maintaining a training program. Animal researchers that are new to UMD, and UMD researchers that are new to animal research should consult with a member of our team. Please contact the IACUC Office and a member of our team will set up an appointment to meet with you (the veterinary staff may also be involved). There are 4 required components to the onboarding and training process:

1. Consultation and Onboarding: This phase of the process is an opportunity for us to learn more about our new PIs and their project. We will collect basic information and help you create a plan to be prepare you to submit you ASP as efficiently as possible. This is also an opportunity for us to loop in the Department of Laboratory Animal Resources (DLAR) to plan for housing and procedure space usage, animal ordering, and other animal care and business related topics. We may also be able to help you identify approved Standard Operating Procedures (SOPs) that apply to your project and help you identify training opportunities if you are new to those procedures.
2. New PI Orientation: New PIs will attend a New PI Training and Orientation with a member of our team to learn more about the IACUC’s role in regulatory compliance and how it works. The PI will also learn how to use IRBnet, our protocol submission management system.
3. PI/Animal User Training: This course will cover topics related to animal care, husbandry, handling, and what to do if an adverse event or emergency were to arise. All PIs should take the Initial PI/Animal User course with an IACUC administrator unless they will not be working directly with live vertebrate animals. All other individuals who WILL be working directly with animals (including the handling of animals, unpreserved tissues/fluids/waste, soiled cages or accessories, and carcasses) must complete this training and Occupational Health enrollment (below) and be listed in an approved ASP.
4. Occupational Health Enrollment: Enrollment is required for faculty, staff and students who have direct contact with live vertebrate animals (as above). All personnel that may participate in those tasks must complete the Animal Handler Risk Assessment and Animal Handler Immunization and Allergy History Forms and submit them to the Occupational Health and Safety Program.

There are few exceptions to these onboarding and training requirements, and other lab specific training may be required depending on the project. Visit our Register for Training  and Occ Health page for more detailed information.

Per federal regulations, and animal housing area is defined as any location where animals are kept for more than 12 hours. These facilities must meet standards for animal housing. Where your animals are housed and where you can work with those animals depends on your particular research projects. For housing, there are 3 main types of facilities:

1. Centrally-Managed Housing Areas (CMHAs), often called vivarium/vivaria, are predominantly maintained by DLAR staff. DLAR staff will provide animal care and husbandry for your animals and will maintain daily, weekly and monthly records. Per diem rates are charged and you can find more information about these rates here.
2. PI-Managed Housing Areas (PMHAs) are located outside of the vivaria and are maintained by the PI and trained key personnel approved on their ASP. The PI and their staff are responsible for all daily animal care tasks and recordkeeping in addition to other daily, weekly and monthly lab maintenance tasks. DLAR has templates of these records that PIs can adapt for their own lab.
3. Farms and Other Satellite Facilities are located off campus (with the exception of the Campus Farm) and often have a functional facility manager to oversee animal care and other tasks. Animals used for agricultural production usually do not require approved IACUC protocols, but some animals used in research, testing or teaching may be housed in these areas. In this case, the facility manager acts as the liaison between the PI and the IACUC and may assist with animal care and farm maintenance tasks, recordkeeping and may submit information to the IACUC on the PIs behalf. Other satellite facilities may also have facility managers or may be completely PI-managed depending on several variables.

Centrally-managed vivaria, farms and other satellite facilities have dedicated storage rooms. All centrally-managed vivaria and some satellite facilities also have procedure rooms and dedicated surgical suites that PIs and trained key personnel can utilize. PIs may also maintain lab spaces outside of these vivaria (e.g., animals are housed in the vivaria, but animals are taken to a different lab outside of the vivaria for procedures lasting less than 12 hours). 

Conversely, PIs who manage a PMHA may utilize procedure and surgical suites in centrally-managed vivaria. Those who keep all of the work in their PMHA must ensure that the proper conditions for storage, procedure labs and surgical areas are maintained. Other support spaces include cage wash, dump stations, and autoclaves, and these exist in all centrally-managed vivaria and are usable by all PIs (some PMHAs may use disposable caging or have their own autoclave). Transportation of live animals between various spaces should be documented and approved in your ASP submission.

The IACUC manages ASP submissions with IRBnet. PIs can register for an account by visiting the IRBnet homepage and clicking “New User Registration” near the top right corner of the screen. Once registered, users can create new project, view their existing projects, and find forms and templates needed for their submission. Visit our Submit a Protocol or Amendment page for more detailed information.

All PIs will fill out an application with answers to basic questions driven by a wizard built into IRBnet. The supplemental forms you may also need to include depends heavily on the details of your project and what is required—this is why we highly recommend reaching out to use for a consultation as early in your project development as possible so that we can help you prepare. Below is a list of our various forms:

• 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 (see our Find Resources page).
• 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” section on our Submit a Protocol or Amendment page. 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): A 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.

Yes! In fact, with some protocols a veterinary consultation may be required. The earlier you get our team involved, the better we can work together to anticipate needs, make a plan and efficiently approve your ASP—especially if you are planning on utilizing a brand new facility/space that has not been used for animal work before. Contact the IACUC Office as soon as possible for a consultation.

Due to the variable nature and volume of protocols reviewed in any given month, we cannot provide exact timelines for approval. We recommend submitting your protocol 3 months prior to whenever you intend to start your work with animals. See Meeting Dates and Deadlines on our homepage as a guideline.

Once you submit your ASP, the review process can begin. The UMD IACUC uses a pre-review process to check for administrative and technical errors and omissions so that the PI can make modifications before the ASP is reviewed by the full IACUC. All new projects are then sent to the full IACUC for Full Committee Review (FCR) where notes on necessary modifications will be provided to the PI. In rare cases, the ASP may be approved at this point, but it is more common for the ASP to either come back to FCR or back for Designated Member Review (DMR) in which approval from those members are the only ones required, but anyone on the IACUC can call the ASP back to FCR at any time before approval. There may be a few rounds of modifications that the PI must make in some instances. Nearly all communications surrounding this process will come through IRBnet including approval, but there may be instances where a reviewer will reach out to the PI directly. See our Submit a Protocol or Amendment page for more detailed information.

After your ASP is approved, you are free and clear to order animals and begin your work. DLAR can assist researchers with everything from animal facility access, procurement of animals and supplies, animal care in centrally-managed facilities, imaging services, room and equipment reservations, lab-specific and facility training, and various other services. For more information, visit the DLAR website.

The IACUC can also assist with topics related to compliance, reporting, amendments, inspections and post approval monitoring visits, protocol renewals and annual/closure reports.

• Reporting Adverse Events and Unexpected Animal Health Issues: We know that our researchers do everything they can to prevent adverse events and health issues, but it is required that these events are reported to the IACUC and/or veterinary staff in order to remain compliant. Best practice is to self-report on our Contact Us and Report Concerns page and a member of our team will get in touch with you as soon as possible. See UMD Standard A.1 Adverse Event Reporting.
• Amendments to Your Approved ASP: As you progress through your project, you may realize that you need to make some changes. Situations that call for amendments might include adding/removing personnel from an ASP, adding a new species or strain, increasing animal numbers, change in pain category, changes in experimental design/objectives, changes to anesthetic procedures and methods, changes to euthanasia procedures and methods, and more. All amendments to approved ASPs will have to be reviewed via Administrative Review, Designated Member Review, Veterinary Verification and Consultation or Full Committee Review. See the Submitting Amendments section on our Submit a Protocol or Amendment page for more detailed information.
• Semi-Annual Inspections: Semi-annual inspections of all animal housing areas and support spaces used for approved ASP activities occur every April and October. See the Semi-Annual Inspections section on our Post Approval Activities page for more detailed information and a checklist to use in preparation.
• Post Approval Monitoring (PAM) Visits: Any facility may be randomly selected for audit of specific procedures approved by the IACUC. The purpose is to monitor procedures, experiments, husbandry and general daily activities of approved protocols and SOPs in order to maintain excellence in animal use activities, help ensure compliance, prevent experimental drift and provide education when needed. See the Post Approval Monitoring Program section on our Post Approval Activities page for more detailed information.
• Protocol Renewal: ASPs expire three years after the approval date and must be renewed in order for PIs to continue doing research, testing or teaching with animals. You must provide justification for how the renewal will expand on previous research and you should aim for approval of the renewal before your previous ASP expires. See the Protocol Renewal section on our Post Approval Activities page for more detailed information.
• Annual/Closure Reports: Some projects require annual reviews and reports (USDA and VA in particular) and closure reports. Someone from our office will reach out to you when these are required and/or when your project is nearing expiration.

Our semi-annual inspection checklist may be helpful in determining what signage and documentation requirements are needed, and can be downloaded here (DOCX).

There is required signage to be posted in all animal research areas. You can download all required signage here (external site). Refrigerators, microwaves and other appliances that are used for animal work must also be labeled “For Animal Use Only”. Emergency contact information outside the lab should also accurately reflect the PI and other emergency contacts—these and ESSR Emergency Contacts booklets can be acquired from labsafety@umd.edu.

You must also have hard copies of the following documents readily accessible by all lab members:

• Copy of the most recent version of your approved protocol(s) including Standard Operating Procedures (SOPs), pain scoring sheets, humane endpoint criteria, syllabi and other course materials, and other administrative documents.
• Up-to-date training documentation for all lab personnel (old records for past lab members and trainings that have been re-upped should be removed to moved to the back of your log).
• Daily, weekly, and monthly husbandry, cleaning and sanitation logs.
• Environmental logs with appropriate readings such as temperature and relative humidity.
• Accurate cage cards and notes on each cage/tank where animals are housed.
• Temperature logs for appliances and spaces where sensitive materials are stored (feed, special diets, drugs, carcasses, tissues) as applies.
• Detailed inventory and use records for all controlled substances as applies.
• Detailed maintenance records for all euthanasia equipment as applies.
• Detailed surgical records and documentation of sanitation as applies.
• Certifications for biosafety cabinets, fume hoods, gas vaporizers and scavengers, caging racks, cage wash, autoclaves, etc., as applies.
• Temperature strips for cage wash and autoclaves as applies.

Blank templates of several forms mentioned above can be downloaded from IRBnet “Forms and Templates” under “Documents for Researchers” (IRBnet login required). We may also be able to help you with customizing logs to fit your specific research needs—Contact the IACUC Office.

ALL adverse events and unexpected health issues and deaths must be reported to the University Attending Veterinarian and IACUC. See DLAR's Veterinary Care and Services webpage for more information and additional contact information.