What does the acronym ‘IACUC’ mean?
Institutional Animal Care and Use Committee.
How often does the IACUC meet?
The committee is scheduled to meet monthly on the first Tuesday of each month. However, if no protocols are ready for full committee review 10 days before the date, the meeting is cancelled.
How soon after the meeting can I expect to hear back from the IACUC?
The IACUC Administrator (Animal Research Compliance Manager) sends all meeting correspondence within 3-7 business days following the meeting. Correspondence will be sent via email and no work may begin until an official approval memo has been issued and all personnel involved have completed the appropriate training and have been issued a health clearance.
Why is the deadline for protocol submission 2 weeks before the monthly meeting?
The IACUC is composed primarily of faculty and members need time to read and comment on all of the protocols before the meeting. An example timeline follows:
- Protocol submitted to the Animal Research Compliance Manager (ARCM).
- The ARCM looks over the protocol for information that is missing or needs to be clarified and communicates with the researcher about additional information that is needed.
- Once the ARCM is satisfied with the information in the protocol, it is sent to a pre-review sub-committee, which includes the Attending Veterinarian and IACUC Chair.
- The pre-review provides additional feedback that is compiled and sent by the ARCM to the researcher.
- The researcher must address all concerns (or provide adequate justification if specific concerns are not addressed, modify the protocol and all supplemental materials as requested, and then resubmit the materials to the ARCM.
- Protocol materials are sent to the full IACUC in preparation for the IACUC meeting at least 7 days before the next scheduled meeting.
- IACUC discusses protocols at the meeting and additional concerns are sent back to the researcher. Once all concerns are addressed, an approval memo is issued.
I'm working with another institution with their own IACUC. What do I need, as far as IACUC approval from my home institution?
Contact the ARCM for guidance. In some cases, an Inter-Institutional Agreement Form (IIA) is required or proof of IACUC approval from the other institution.
Do I need an IACUC approval for field studies or behavioral studies?
Yes. Field studies and behavioral research conducted in the field must also be conducted under an approved IACUC protocol. Even studies that do not involve direct contact with vertebrate animals may need IACUC Protocol.
What are the laws and regulations for the care and use of laboratory animals in the United States?
There are two regulatory guidelines: the Animal Welfare Act (AWA) enforced by United States Department of Agriculture (USDA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) enforced by Office for Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH)
The PHS Policy covers all cold- and warm-blooded vertebrates used in research, testing, or teaching funded by any of the PHS agencies (e.g. NIH, CDC, FDA), as well as NSF. The PHS Policy utilizes The Guide for the Care and Use of Laboratory Animals (The Guide) as the guidelines and standards with which institutions must comply.
Why do I have to submit a new application every three years for IACUC review and approval?
PHS Policy states that the IACUC must perform a new review every three years. Under the Animal Welfare Act, the IACUC must review an ongoing protocol every year. In order to satisfy both agencies, the IACUC performs annual review of all open protocols (also referred to as ‘Continuing Review’). Every three years, a new protocol must be submitted for ongoing research and it should include justification for the use of animals beyond what has already been conducted in the past three years.
What do I do if I have a complaint or concern about animal care?
The IACUC and Office of Institutional Compliance takes seriously all concerns regarding the care and use of animals at the institution, regardless of who submits the concern. Concerns may be reported in a number of ways: in person, via phone call, email, or anonymously by calling the Compliance Hotline at 978-934-3100.
Who must submit an animal research protocol to the IACUC?
Only full time faculty are allowed to serve as Principal Investigators for research activities.
How often do I need to renew my animal protocol?
An Annual Renewal form must be filed annually for review by the IACUC. Protocols must be updated and resubmitted for full IACUC review every three years with justification provided if the research activities remain the same.
What are the training requirements in order to conduct animal research?
There are multiple types of training required for anyone working with research animals. ‘Working with the IACUC’ is an online training available from the CITI Program website. A completion certificate should be noted on the protocol application and training must be renewed every 3 years. In addition, hands on training is required to demonstrate proficiency in general animal handling. An annual meeting is sponsored for the Office of Institutional Compliance that is mandatory for all researchers and students engaged in animal research and covers general animal facility information as well as occupational health hazards from working with animals. Protocol specific training is done by the lead researcher on the protocol. There may be other training required as well.
What is an OLAW assurance?
Public Health Service Policy designates the Office of Laboratory Animal Welfare (OLAW) with compliance oversight of animal use on PHS funded projects. The policy further requires that institutions receiving PHS funding file an Assurance with OLAW that speaks to the Institution's commitment to following the Guide, the government Principles, and all PHS Policy requirements. In order to continue to be eligible to receive funds from PHS (primarily from NIH and related funding agencies), all animal use must conform to the Assurance. Any deviation from it must be reported to OLAW.
My protocol is past due for annual review. What should I do?
Contact the ARCM immediately! You may need to stop all animal work until your annual continuation is approved.
My protocol is past due for its three-year renewal. What should I do?
You must cease all animal work immediately, and contact the ARCM. Any animals that you still have will need to be transferred to holding protocol or humanely euthanized. Any work you have done after the three-year approval period has ended is considered ‘unapproved animal research’ and must be reported to regulatory and funding agencies.
What does the IACUC expect in the ‘Justification of Numbers’ section of my protocol?
This section is to explain how you determined the number of animals required for the activities described in this protocol. The numbers in this justification should match the animal numbers in the other sections of the protocol. (Note: Approved numbers may not be exceeded without an amendment.) When your choice of species, strain or experimental model allowed reduction in numbers, include this information in the justification. The number of animals must be justified statistically with a power analysis. However, certain kinds of activities (e.g. teaching, harvest of tissues for in vitro research) are not amenable to a power analysis but a justification for the number of animals requested must be provided.
What does the IACUC expect in the ‘Alternatives’ section of the protocol?
Provide a written narrative description of methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to animals. State how you determined that alternatives were not available. Address the 3 R’s – Replacement (with non-animal systems, or species lower on the phylogenetic scale), Refinement (decreasing or eliminating pain or distress), and Reduction (in number of animals necessary). If database searches are carried out, more than one database must be searched.
What does the IACUC expect in the ‘Study Objectives’ section of my protocol?
Briefly describe the major goals of the research (in non-technical or lay language) and why the animal model you chose is the appropriate model. All abbreviations/acronyms should be defined on first use. Be clear and concise; several sentences to one or two short paragraphs should be adequate.
What does the IACUC expect in the ‘Scientific Design’ section of my protocol?
Provide scientific justification for your experimental design, focusing on the use and need for animals to achieve your goals. This section will depend on the design complexity but should include clear descriptions of every experimental process to achieve the goals. The purpose of this section is to enable the IACUC to evaluate how the proposed work or activity affects animal welfare, and whether the use of animals is appropriately justified. Details of post mortem procedures are not required and should not be provided. Do not copy sections from any grant proposals or say ‘see attached’. The IACUC protocol must be a stand-alone document outlining all of your research activities with animals.
How do I (and my students) get access to the animal facility?
When all training has been completed, including hands on training and the ARCM has deemed you proficient, UCAPS will be notified to activate your ID card(s) for access to the facility.
When is an amendment to my protocol required and how do I submit one?
Whenever you make a change to the protocol, an amendment must be submitted to the ARCM review and approval prior to the new work starting. There are two types of amendments: Major and Minor. Minor amendments may include changes in personnel working on the protocol; additions to animal numbers (≥10% of the currently approved number); minor changes or additions to any procedures (non-surgical procedures) animal’s species, sex or age etc. Major amendments may include changes to research objectives, addition of methods that cause pain or distress, change in PI, etc.
Can I submit a proposal for funding before receiving IACUC approval of the protocol?
Yes. Protocol approval is not a pre-condition for proposal submission, however, federal funding agencies typically require that there will be an IACUC approved protocol in place in order to release the awarded funds. As soon as you are informed that your proposal will likely be awarded, then you should submit an IACUC protocol for approval. In some instances, the institution may be able to accept the award but not release any funds until the IACUC protocol is approved. Be aware that some protocols are complicated and may take a few months to secure final approval!
Does my protocol and grant proposal have to match?
Yes. As a condition for accepting federal funds, UMass Lowell must certify that the work described in the funded proposal has been reviewed and approved by the IACUC. The ARCM requires a copy of your awarded proposal to review against all protocols for sponsored research. Any discrepancies will at a minimum delay the release of funds and most likely involve amendments to protocols.
What is the procedure to obtain animals or materials from another institution?
Animals requested from non-approved vendors will need to be quarantined at an off-site facility that can manage such animals in a quarantine environment. Before animals are transferred to UMass Lowell a health screening report must be submitted and reviewed by the UML AV who will accept the transfer request. Researchers are required to pay for any quarantine costs incurred at the off-site facility. Animals may not be used for research projects until they are cleared from quarantine. In some cases, a researcher may need to submit a Materials Transfer Agreement (MTA).
- What is an MTA? A Material Transfer Agreement (MTA) is used when there is a transfer of a tangible item from the University to an outside party or from an outside party to the University; this applies to both research and industrial uses of the materials. For example, a MTA is required for sending a sample of your novel polymer or a cell line to an outside organization in support of their research. The MTA documents the permitted uses, controls further transfer, defines confidentiality, and determines the rights for arising Intellectual Property. It also defines the publication rights as well as establishes liabilities and warranties.
- When would you need one? Anytime a material exchange takes place between a university researcher and an outside institution/entity, a MTA should be put into the place prior to the exchange. In addition to protecting intellectual property rights with a MTA, UMass Lowell also ensures that export control and other laws are not violated by the transfer. Please contact the Office of Technology Commercialization (OTC) at least 14 days before the scheduled exchange to prepare the MTA. If an outside party provides their own MTA, please send it to the OTC for our review and execution of the agreement.
- Who would you contact? The Office of Technology Commercialization negotiates and executes MTAs on behalf of UMass Lowell researchers. Please email: firstname.lastname@example.org for help or questions in regards to MTAs.