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IACUC Procedures and GuidelinesIndex
Categories of Animal Use Subject to IACUC Review
· Classroom exercises, demonstrations and lab projects unless the demonstrations and projects are of routine care of animals that is part of their normal husbandry. · Faculty or staff research projects. · Graduate student projects. · Undergraduate student honor projects. · University-approved research by investigators not affiliated with the university who propose to involve university students, staff or faculty in a proposed research project. Projects involving dead animals killed for purposes other than the study should be reported to the IACUC but do not need a protocol. Because UMass Amherst is covered by an Animal Welfare Assurance it must comply with PHS Policy. PHS Policy does not distinguish between field studies and laboratory studies. Therefore before a field study can start the PI must submit a protocol for the study for IACUC review and the IACUC must approve it. All personnel listed on a field study protocol must take the training for researchers who work with wildlife. Use of Animal Blood and Tissues. If animals are euthanized for a research project for the purpose of obtaining the blood or tissue an IACUC protocol is required. IACUC approval is not required if tissue collection takes place postmortem as a by-product of a commercial enterprise like a slaughterhouse. IACUC approval is not required for the harvest of tissues from dead animals from other research projects as long as the collection of tissues does not alter the approved procedures in any way and the animals were used exclusively for the other research project. PIs should be aware that if the “use of vertebrate animals” box is not checked on the face page of a PHS grant application form references to use of animals in the grant proposal may trigger questions about IACUC approval. To avoid delays in peer review of the proposal the PI is advised to explain in the grant application the source of the tissues. Hazardous Materials and Animals Use of any hazardous materials (biohazards, toxic chemicals or drugs and radiation hazards) in animals is limited to activities which can be safely carried out given the available facilities and personnel training. Investigators using hazardous agents in animals must have knowledge in the use of the hazardous material in accordance with the Material Safety Data Sheet (MSDS), federal and state regulations, and University policies. Hazardous Materials and Right to Know training is required by Massachusetts law before working with hazardous materials. Contact EHS for a training schedule. Before the project involving hazardous materials is approved the IACUC requires review of the project by appropriate Environmental Health and Safety personnel for management of the material to prevent exposure of the investigators, animal care, and veterinary staff and prevention of release of the hazardous agent into the environment. Biohazardous Agents in Animals Use of any biohazardous agents in animals, including recombinant DNA, is limited to activities which can be safely carried out given the available facilities and personnel training. The Biosafety Officer and the Institutional Biosafety Committee (IBC) review and approve projects using biohazardous agents which include all agents on the list of Select Agents. The IACUC will not give final approval of a protocol employing biohazardous agents in animals until the project has also received approval by the IBC. Research using knock-out or knock-in animals does not need review by the BSO or IBC if the animals are genetically stable. The Radiation Use Committee oversees procedures and training for users of radioactive materials. The Radiation Safety Officer (RSO) reviews the project concurrently with the IACUC's review. The RSO's mandate is to ensure that all the investigators using radioactive materials in animals have appropriate training and that the facilities where the radioactive materials will be used, stored and disposed of are in compliance with federal and state regulations before the research begins. Animals from Non-Conventional Sources When an animal is brought to campus from a non-conventional source (i.e. any source other than an approved vendor) there is a chance the animal is harboring either an animal or zoonotic disease even though it appears healthy. "Non-conventional" sources of animals include wild-caught, non-approved vendors, and other institutions. A PI who plans to bring such animals to campus must complete Appendix AS as an attachment to either an IACUC protocol or addendum. Appendix AS must be reviewed and approved by the IACUC, Animal Care Director, Attending Veterinarian and the Biosafety Officer. If animals to be shipped from other institutions have received a recent and documented health screening at the place of origin, this may be acceptable evidence that the animals are healthy. In all other cases the animals will need to be quarantined and screened in the UMass animal care facilities to ensure they are free of animal and zoonotic diseases. Animals may not be used for research projects until they are clear of quarantine. Principal Investigator status for submitting protocols University faculty and senior staff (e.g. museum curators) may be PI on an animal use protocol. The IACUC can advise whether a staff person may be a PI. Students may prepare a protocol but the signatory preparer must be a faculty or staff member who has responsibility for oversight of a student's project. International collaborations that use laboratory animals conducted at a foreign institution International collaborations conducted at a foreign institution that use laboratory animals must be reviewed by the UMass IACUC if the funding for the project flows through this institution. For PHS-funded projects the Office of Laboratory Animal Welfare (OLAW) at NIH requires that the host foreign institution has a "Foreign Assurance" approved by OLAW. A list of foreign institutions with Foreign Assurances and their Assurance numbers can be found via http://grants2.nih.gov/grants/olaw/assurance/500index.htm. If the foreign institution does not already have a Foreign Assurance with OLAW it will need to obtain one. The process begins after you hear that the project will be funded. For more information call Hilary Woodcock at 545-0668. The Animal Welfare Act Subpart C, Section 2.32, Personnel Qualification, requires that:
The IACUC requires that all personnel listed in an animal use protocol that have contact with living vertebrate animals receive appropriate training for animal users. Users include faculty, postdocs, research technicians and other staff, graduate and undergraduate students, and visiting scientists. PIs and Co-PIs on Animal Use Protocols must take the training even if those individuals will not have direct contact with animals. The IACUC may accept a visiting scientist's training certification from another institution if that institution has AAALAC certification or an OLAW/NIH Assurance. An animal use protocol and annual reviews will not be approved until the IACUC is satisfied that each person listed on the protocol has current animal users' training certification. The Compliance Coordinator conducts monthly one-hour classroom training sessions for new animal users that meets federal requirements. IACUC members (past or present) may also conduct training sessions. Individual investigators develop and provide their own staff training in techniques and practices needed in their own labs. Sufficiently detailed information on the experience and training of each individual involved must be included on the protocol and approved by the IACUC before any hands-on work may start. All animal users must take the animal users' update training each year on or before the anniversary of their first training. Animal users will receive a reminder at least one month prior to the expiration of their training. The update training requirements can be satisfied by either attending a session of the classroom training for new users or by taking an on-line version of the training which can be accessed by following instructions found at the Animal Use web site. If an animal users training certification has expired he/she may not work with animals until he/she has completed the update training. As well as the basic animal users training, there are web-based training modules in “Wildlife Studies”, “Surgery”, and “ Post-Procedure Care of Mice and Rats in Research: Reducing Pain and Distress" available. Individuals that need to take one of these training modules are notified by IACUC staff. Animal User Training - Teaching Assistants These guidelines are intended to clarify the UMass Amherst IACUC training requirements for instructors and teaching assistants using animals in teaching. It is the responsibility of the Principal Investigator on a teaching protocol to assure everyone involved in teaching the class (staff, teaching assistants) are properly trained in the regulations, animal handling and the procedures described in the protocol before the activities using animals start. PI’s responsibilities:
To obtain a copy of these guidelines, plus a handout for TAs who will not be taking the IACUC training click here.
Off Campus Internships and Employment that Involves the Use of Live Animals There are many opportunities for students to do internships or find summer employment at facilities that work with live animals. These include zoos, animal shelters and rescue organizations, farms etc. Students may or may not receive UMass credit for internships. The IACUC does not need to review a student's activities involving live animals when: 1) that activity does not involve any change in the activities associated with the care of these animals (i.e., the student's activities do not involve a change in the usual routine for the animals), 2) the student is supervised by a person with appropriate expertise who has overall responsibility for the care and husbandry of the animals.
The Animal Welfare Act (9CFR part 2.38b) allows the Animal and Plant Health Inspection Service of the USDA (APHIS) to access and inspect the records, facilities, property, and animals of animal research facilities. APHIS officials conduct unannounced inspections as considered necessary to enforce the provisions of the Animal Welfare Act. At the end of an inspection the USDA inspector details his/her findings via a report. The report gives a deadline for addressing areas of non-compliance. The Animal Care Director distributes the inspection report as soon as possible after receipt to the IO, IACUC Chair and the IACUC members, and the Compliance Coordinator. The IACUC Chair reviews the inspection report and assigns each non-compliant item listed to one or more responsible persons or units, such as the study PI, the Animal Care Director, Department Head and/or the IACUC. The IACUC Chair may request a corrective action plan within a specified time period and completion date which will be reviewed by the IACUC. Following the date of completion, the Compliance Coordinator will inspect to verify that the corrective action plan is in place and working. A current IACUC approval is required before animals can be purchased or housed. Contact the Animal Care Office for procedures for ordering animals and/or arranging for housing. The Institutional Animal Care and Use Committee (IACUC) uses Key Solution's e-Protocol IACUC for on-line protocol submission and review. Eprotocol IACUC is password protected. Everyone who plans to submit an eprotocol, or who wish to edit an eprotocol, needs a username and password. Requests for eprotocol username and password should be submitted in writing to the IACUC office at iacuc@resgs.umass.edu with: Name, Department, Title, e-mail and UMass NETID (the login you use to check e-mail through UMAIL). Contact Barbara Miller, bsmiller@research.umass.edu (413) 545-0668, for more information about accessing eprotocol. Effective July 1 2009, all new animal use protocols and addenda must be submitted through eprotocol IACUC, with the exception of custom antibody production protocols and a ppendices to existing paper protocols . These must continue to be submitted for IACUC review on the paper forms. Protocols must be received for review at least 10 working days before a scheduled IACUC meeting to allow time for pre-review. Thoroughly check it for completeness and accuracy before submitting it for IACUC review. Once the protocol has been submitted it will not be available to you for editing until reviewers' comments are forwarded to you for response. To ensure IACUC approval is in place for animal work that will be conducted at another institution see Protocol requirements for use of animals at facilities other than UMass and its associated facilities. Protocol Review and Approval Procedures The IACUC has two options for handling an IACUC review: full review or designated review (DR). Full review is conducted at a convened meeting of the IACUC. Designated reviews are handled electronically. On receipt of a protocol or amendment to a protocol the IACUC coordinator may request the IACUC members consider using DR. If no vote for full review is received the review may proceed using DR. A vote for full review sends the review to full review at a convened meeting of the IACUC. In general, protocols involving procedures in USDA pain/distress categories D and E will go to full review. The IACUC review process follows these steps: Step 1: Assignment of reviewers Full review . The Compliance Coordinator (IACUC Administrator) assigns a primary and secondary IACUC reviewer to each protocol. Designated review (DR) . The IACUC Chair assigns designated reviewers. Step 2: Review Full committee review . Full reviews are conducted at a convened meeting of the IACUC. If a protocol is received > 10 days prior to an IACUC meeting reviewers may submit pre-review comments and the PI may address the comments prior to the meeting. After discussion of the protocol, reviewers' comments and PI responses, members present vote on the outcome of the review. A quorum must be present for a vote. A majority vote determines the decision. Possible outcomes of a review are: approval; a vote to complete the review using DR (for protocols with minor points of clarification that need to be addressed); table (defer the review to a future meeting), or reject. Designated review. Once the IACUC has voted to conduct a review by DR the review is conducted by the designated reviewers. If a DR results in major changes to the protocol the revised protocol may be forwarded to the IACUC members to provide them an opportunity to comment on the new version. Otherwise, a decision to approve is made by the reviewers. Step 3: Investigator Notification. When a protocol has been approved, e-protocol generates an email to the PI notifying him/her the protocol is approved. Protocol approval is for three years, contingent upon satisfactory annual review of the project. An approval letter is published to, and can be accessed by the PI from, the Events menu for that eprotocol. Although a protocol is approved for three years, at the time of protocol approval eprotocol will notify the PI that the protocol will expire one year from the approval date. This expiration date refers to the date by which an annual update review of the protocol must be completed.
Making changes to approved protocols Modifying an eprotocol. Minor changes may be reported to the IACUC in the form of a memo or letter which the IACUC coordinator will attach to the protocol. Significant changes to an eprotocol. To submit significant changes for review and approval to the IACUC the PI must edit and resubmit the protocol for IACUC review. Significant changes include, but are not limited to: increasing the number of animals by more than 5% of the original total; adding a new species; changing the study goals; changing or adding procedures; changing and adding drugs or dosages; changing the euthanasia method; switching from non-survival to survival surgery. The IACUC may determine that complex changes need to be submitted as a new protocol. A change in PI requires submission of a new protocol. This is an NIH/OPRR requirement. In preparing the new protocol, the new PI should review correspondence between the IACUC and original PI and ensure IACUC questions related to review of the old protocol are addressed in the new version. Process for obtaining IACUC approval for Custom Antibody Production in the UMass Antibody Production Facility PIs who wish to contract with Animal Care for antibody production using the UMass Antibody Production Service must submit an amendment on form Appendix AP for review by the IACUC. Once approved, this amendment is attached to the master Antibody Production protocol for the facility. PIs should check the antibody production standard methods and procedures used by animal care staff. If a PI wants staff to use a non-standard procedure this must be detailed and justified in Appendix AP. T he Antibody Production Service does not use the ascites method for production of monoclonal antibodies. Process for obtaining IACUC approval for Custom Antibody Production by an off-campus facility The generation of custom antibodies is an activity involving vertebrate animals and is therefore covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the PI (i.e. not purchased off-the-shelf). Any organization producing custom antibodies for a UMass PI must have an OLAW Assurance and, if AWA-covered species are to be used, a USDA registration. The PI must provide the date (verification) of project-specific IACUC approval for the production of the antibodies to the UMass IACUC Office. The IACUC Office can advise on obtaining the necessary verification of IACUC approval. Continuing Review, Renewal, and Cloning of Protocols Animal research and teaching protocols are approved for a three-year term, subject to satisfactory continuing review. A continuing review must be conducted by the IACUC at the end of a protocol's first and second years. At the end of the third year the PI must submit a new protocol for IACUC review in order to continue the project. Eprotocol sends a reminder to the PI 60 days before an annual report is due. A llow at least seven working days for the IACUC office to process a Protocol Renewal that reports no changes to the protocol, and 14 days for Renewals that report minor changes. A Protocol Renewal may be approved for up to one more year or until a date three years from the initial approval date, whichever comes first . To ensure continuation of a project past its 3-year expiration date a PI must submit a new protocol for IACUC review at least 60 days before the protocol is due to expire. Eprotocol allows a PI to clone an old protocol to facilitate submission of a renewal protocol. A renewal protocol must undergo the same review process as any other new submission.
When a protocol expires, approval to use animals on the project ends unless a newprotocol has been approved by the IACUC. If animals covered by an expired protocol are housed in a UMass facility the animals are transferred to the Animal Care Director's holding protocol. The PI will no longer have access to these animals and management and disposition of the animals becomes the responsibility of the Animal Care Director.
Closing and Suspension of IACUC Protocols Closing a protocol: A PI may close out a protocol at any time by notifying the IACUC office in writing but should be aware that a closing out a protocol is final. In order to reactivate a closed out protocol, the PI must update and resubmit it for IACUC review. Suspension of a protocol: In the event of an incident of non-compliance the IACUC may vote to suspend a protocol pending resolution of the problem. NIH is notified when an NIH-funded project is suspended. Animals covered by a suspended protocol are transferred to the Animal Care Director's holding protocol and the PI no longer has access to them. Decisions regarding management and disposition of animals on the holding protocol are the responsibility of the Animal Care Director. Deliberations and decisions of the IACUC and substantive information associated with specific projects or research activities acquired by the members in the course of IACUC business shall be considered confidential, to the extent permitted by Massachusetts law, except insofar as the dissemination of information regarding research projects or activities and IACUC deliberations, decisions, and recommendations to appropriate Institutional officials is required to effectuate or support the policies or interests of the Institution. Protocol Requirements for use of Animals at Facilities other than UMass and its Associated Facilities If biomedical animal research activities involving UMass personnel are conducted at domestic or foreign sites other than UMass Amherst and its satellite facilities then the IACUC must satisfy itself that PHS policies are being followed. The IACUC, at its discretion and depending on the nature of the study and the roles of UMass personnel in the study, choose one of three options to ensure appropriate oversight of the project: § Accept the performance institution's IACUC approval, especially if the performance institution holds a current Asssurance with OLAW or is AAALAS certified. § Conduct its own review of the protocol in the host institution's protocol format, i.e. not require the PI to write a second protocol for review. § Conduct its own review of the project submitted on the UMass protocol form. In any case, the UMass IACUC will need to see documentation from the performance institution that the performance institution's IACUC has reviewed and approved the project before giving its final approval. Procedures for Reporting Violations to the IACUC The State of Massachusetts Whistle-Blower legislation (M.G.L. c. 149, § 185) protects state employees from retaliation for 'whistleblowing' activities. As a general matter employees are protected against retaliatory action so long as the employee has brought the matter to the attention of a supervisor by written notice and has given the employer a reasonable opportunity to correct the activity, policy, or practice. The IACUC recommends that UMass employees with concerns or complaints about animal use first try to resolve their concerns by talking with their supervisor. In addition, anyone with concerns can bring allegations of non-compliance involving animals to the IACUC, the Compliance Coordinator, the Attending Veterinarian, the Animal Care Director, or the Institutional Official. Confidentiality will be maintained if requested by the complainant to the extent allowable by law. However, anyone filing a complaint should be aware that the University of Massachusetts Amherst is an agency of the Commonwealth of Massachusetts and is therefore subject to the Massachusetts Public Records law, G.L. c.66, § 10. This law states the general rule that any record made or received by an officer of the Commonwealth is presumed to be a public record and must be released to "any person" who requests it. A complaint need not be addressed directly to the IACUC although any allegation of non-compliance will eventually reach the IACUC Chair. The IACUC will also investigate complaints received anonymously. The IACUC will review all allegations brought to its attention but need not investigate all of them. There are three circumstances when it is likely that the IACUC will become actively involved:
If the allegation is against the IACUC Chair and/or the Attending Vet the Vice Chancellor for Research and Engagement will help adjudicate the complaint. Policy on Non-Compliance with the Institutional Animal Use Program Protocol non-compliance indicates that procedures or policies affecting animal use are not being followed. Examples include, but are not limited to: unauthorized surgery, unauthorized persons participating in a project, using drugs the IACUC has not approved, conducting a project using animals without IACUC approval. The IACUC is empowered to suspend any research or teaching project if it finds significant violations. Deviations from IACUC policies are reported to the IO. For Public Health Service funded research the IO is required to report serious or continuing non-compliance with the PHS policy, any serious deviations from the provisions of the Guide, and any suspension of a research activity to the PHS Office of Laboratory Animal Welfare (OLAW). Regardless of the funding source the IO must notify the USDA of any suspensions of activities involving USDA covered species. Failure to comply with the Animal Welfare Act can carry penalties that range from reprimands to substantial fines and “cease and desist” orders in which all activities associated with the use of animals by the individual investigator, or by the entire institution, may be suspended. These regulations are not subject to negotiation or individual interpretation by investigators. Semiannual Review of Program and Facilities Every six months, in April and October, Animal Care Facilities are inspected by a subcommittee of the IACUC and the IACUC conducts a complete review of the Animal Care and Use Program. The NIH Guide for the Care and Use of Laboratory Animals, Animal Welfare Regulations, and Office of Laboratory Animal Welfare (OLAW) guidelines are the principal guides on which the IACUC bases its evaluations. All surgical areas in animal care facilities and survival surgery areas in investigator's laboratory are included in the inspections. This includes areas in laboratories where survival surgery on rodents is practiced in order to maintain compliance with, and meet the spirit of, the AWAR, PHS Policy and Guide (both the AWAR and the Guide detail facility and procedural requirements for conducting survival surgery on rodents or APHIS/AC covered species). The need for inclusion of field sites in semi-annual inspections is decided on a case by case basis. Areas where the animals are free-living in their natural habitat are not inspected. The IACUC attempts to inspect sites that include housing enclosures. When review of such sites is not be feasible the IACUC may request that photographs, videos and husbandry SOPs be submitted for review. As well as the animal use facilities, drugs, materials intended for in vivo use, daily care sheets, health records, surgical logs, and other records are inspected. At the conclusion of the inspections the Animal Care Director prepares a Semiannual Inspection spreadsheet which includes correction dates and which is reviewed by the IACUC. The Compliance Coordinator complies the information into the Semiannual Report from the IACUC to the Institutional Official (the Chancellor). When a deficiency is identified in the course of an inspection follow-up action depends on who is responsible. Where an animal personnel are responsible the Director of Animal Care informs his staff verbally and directs them to correct the item by the correction date. Following the date of completion, the Director of Animal Care or the Animal Care Supervisor re-inspects to verify that the deficiency has been corrected. When a researcher is responsible the Compliance Coordinator informs him/her via a written memo of the deficiency with a correction date for correcting the deficiency. Following the date of completion, the Compliance Coordinator or the Animal Care Supervisor will verify that the deficiency has been corrected. If the researcher believes that he/she has been given insufficient time to correct the deficiency he may request an extension of the correction deadline.
Euthanasia Criteria
Category II
Any animal exhibiting any two of Category I clinical signs or any one of Category II clinical signs will be humanely euthanized using the method of euthanasia listed on the original animal subjects approval form. The UMass IACUC follows NIH's "Guidelines for Genotyping Mice and Rats,"
The UMass IACUC requires researchers conducting Rodent Survival Surgery to use aseptic practices and follow the UMass Rodent Surgery Guidelines.
The AWA covers fish that are able to feed on their own and no longer are reliant on the yolk sac. According to "The Zebrafish Book", zebrafish embryos use up their yolk sacs in about 4 days after which they must feed or die. The UMass IACUC requires a protocol for studies using zebrafish embryos older than 4 days post-hatch.
The preferred method of zebrafish euthanasia is the method consistent with the 2000 Report of the AVMA Panel on Euthanasia. However, the choice of method depends on the intended use of the fish after euthanasia. An overdose of MS-222 is the most common method, using a slightly more concentrated solution (e.g., 200–500 mg/liter) than is typical for anesthesia. Fish are left in the MS-222 solution for 5–10 min following the cessation of opercular movement. A second acceptable method is immobilization by submersion in ice water followed by cranial concussion and decapitation. Another third method, useful when tissues must be preserved, is anesthesia with MS-222 followed by quick freezing in liquid nitrogen.
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