Animal Welfare Assurance
|Oversight Unit:||GRANTS AND RESEARCH|
To provide assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
All students, staff, and faculty.
NORTHERN MICHIGAN UNIVERSITY
ANIMAL WELFARE ASSURANCE
in accordance with the PHS Policy for
Humane Care and Use of Laboratory Animals
I, Brian Cherry, as named Institutional Official for animal care and use at Northern Michigan University, hereinafter referred to as Institution, by means of this document, provide assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
I. APPLICABILITY OF ASSURANCE
This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as activities, involving live vertebrate animals supported by the Public Health Service (PHS) and conducted at this Institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS‑conducted or -supported activity by this Institution.
"Institution" includes the following branches and major components of Northern Michigan University: All components of the University (Colleges, Schools, Centers, Departments, etc.) that are physically located on the NMU Main Campus in Marquette, Michigan. There are no off-campus satellite facilities and/or other covered components.
II. INSTITUTIONAL COMMITMENT
A. This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
B. This Institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
C. This Institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility, this Institution will ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance, as well as all other applicable laws and regulations pertaining to animal care and use.
D. This Institution has established and will maintain a program for activities involving animals in accordance with the “Guide for the Care and Use of Laboratory Animals” (“Guide”).
III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE
A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are as follows:
(Chart is missing due to technical restrictions of database)
1. As Indicated in the organizational chart above, there are open and direct lines of communication between the IACUC and the Institutional Official (IO) and between the Institutional Veterinarian and the IO.
2. The animal facilities are managed either by principle investigators or by other staff members. These facility managers must meet the approval of the IACUC and for all issues pertaining to the care and use of animals, they report directly to the IACUC.
B. The qualifications, authority, and percent of time contributed by the veterinarian(s) who will participate in the program are as follows:
Name: Laura Klar
Authority: Dr. Klar has delegated program authority and responsibility for the Institution’s animal care and use program including the authority to implement the PHS Policy and the recommendations of the Guide. This authority includes 24 hour/7 day per week access to all animal facilities at the Institution.
Time Contributed to Program: Dr. Klar is present at the Institution an average of approximately five (5)hours per month. One hundred percent of this time is contributed to the animal care and use program. In addition Dr. Klar contributes on average approximately 10 hours per month to the program while off-site reviewing protocols and providing consultation on various program related topics.
Name: Kellie Holmstrom
Responsibilities: Dr. Holmstrom has delegated program authority and responsibility for the Institution’s animal care and use program when Dr. Klar is unavailable (i.e., a back-up veterinarian). This authority includes 24 hour/7 day per week access to all animal facilities at the Institution.
Time Contributed to Program: As needed for back-up veterinary services.
C. The Institutional Animal Care and Use Committee (IACUC) at this Institution is properly appointed in accordance with the PHS Policy IV.A.3.a and is qualified through the experience and expertise of its members to oversee the Institution's animal care and use program and facilities. The President & C.E.O. has delegated to the Institutional Official the authority to appoint the members of the IACUC. In accordance with the Health Research Extension Act of 1985, this delegation of authority is specific and is in writing. The IACUC consists of at least five members, and its membership meets the composition requirements set forth in the PHS Policy, Section IV.A.3.b. Attached is a list of the chairperson and members of the IACUC and their names, degrees, profession, titles or specialties, and institutional affiliations (Attachment A).
D. The IACUC will:
1. Review at least once every six months the Institution's program for humane care and use of animals, using the “Guide” as a basis for evaluation. The IACUC procedures for conducting semiannual program reviews are as follows:
The IACUC will meet at least once every six months to review the Institutional Program for the Humane Care and Use of Animals. The Committee uses the Guide and other pertinent resources, e.g., the PHS Policy, the Code of Federal Regulations (Animal Welfare) as a basis for the review. To facilitate the evaluation, the Committee will use a checklist based on the Sample OLAW Program and Facility Review Checklist from the OLAW website.
The evaluation will include, but not necessarily be limited to, a review of the following:
a) IACUC Membership and Functions;
b) IACUC Records and Reporting Requirements;
c) Husbandry and Veterinary Care (all aspects);
d) Personnel Qualifications (Experience and Training); and
e) Occupational Health and Safety.
In addition, the evaluation will include a review of the Institution’s PHS Assurance.
If program deficiencies are noted during the review, they will be categorized as significant or minor and the Committee will develop a reasonable and specific plan and schedule for correcting each deficiency. A significant deficiency is one that is or may be a threat to the health and safety of the animals or personnel. No member will be involuntarily excluded from participating in any portion of the reviews.
2. Inspect at least once every six months all of the Institution's animal facilities, including satellite facilities, using the “Guide” as a basis for evaluation. The IACUC procedures for conducting semiannual facility inspections are as follows:
At least once every six months, members of the IACUC visually inspect all animal facilities, including both housing areas and experimental areas, at the Institution. Equipment used for transporting of the animals is also inspected. Moreover, inspectors conduct interviews with key animal facility personnel, including principle investigators and students. Inspections are conducted using subcommittees of at least two IACUC members and no member wishing to participate in any portion of an inspection is involuntarily excluded. Inspections are conducted using the Guide as a basis for evaluation, and a checklist is used that includes the following items:
If deficiencies are noted during the inspection, they will be categorized as significant or minor and the Committee will develop a reasonable and specific plan and schedule for correcting each deficiency. A significant deficiency is one that is or may be a threat to the health and safety of the animals or personnel.
Within one or two weeks after completing all facility inspections during a semi-annual review, a full meeting of the IACUC is convened to discuss the inspection findings.
3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy IV.B.3 and submit the reports to the Institutional Official. The IACUC procedures for developing reports and submitting them to the Institutional Official are as follows:
Individual IACUC members will convey their observations to the IACUC Chairperson, or his or her designee, who, in turn, will draft the reports using the sample OLAW Semiannual Report to the Institutional Official format from the OLAW website. The reports will contain a description of the nature and extent of the institution's adherence to the Guide and the PHS Policy, identify specifically any deficiencies, departures from the provisions of the Guide and the PHS Policy, and state the reasons for each departure or deficiency. The reports will distinguish significant deficiencies and departures from minor deficiencies and departures. If program or facility deficiencies are noted, the reports will contain a reasonable and specific plan and schedule for correcting each deficiency. If some or all of the institution's facilities are accredited by AAALAC International the report will identify those facilities as such. Copies of the draft reports will be reviewed, revised as appropriate, and approved by the Committee. The final reports will be signed by a majority of the IACUC members and will include any minority opinions. If there are no minority opinions, the reports will reflect such. Following completion of each evaluation, the completed report will be submitted to the Institutional Official in a timely manner.
4. Review concerns involving the care and use of animals at the Institution. The IACUC procedures for reviewing concerns are as follows:
Any individual may report concerns to the IO, IACUC Chair, Institutional Veterinarian, or any member of the IACUC. Notices are located in the animal facilities advising individuals how and where to report animal welfare concerns and stating that any individual who, in good faith, reports an animal welfare concern will be protected against reprisals. All reported concerns will be brought to the attention of the full Committee. If necessary the IACUC Chair will convene a meeting to discuss, investigate, and address any reported concern. Reported concerns and all associated IACUC actions will be recorded in the IACUC meeting minutes. The Committee will report such actions to the IO and, as warranted, to OLAW.
5. Make written recommendations to the Institutional Official regarding any aspect of the Institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are as follows:
As part of the semi-annual review report, the IACUC determines ways that the animal care and use program, facilities or personnel training at the Institution may be improved. These recommendations stem from an evaluation of the overall animal care and use program, including such components as the animal environment, housing and management, role of the attending veterinarian, occupational health and safety, personnel training and education, and emergency preparedness. Recommendations to be included in the report are determined through a majority vote of a full convened meeting of the IACUC, although minority views will be included if so requested. Once the report is compiled, it is signed by the IACUC members present and submitted to the Institutional Official. The report filing is followed up with a meeting between the IACUC Chair and the Institutional Official.
6. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications to (in order to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are as follows:
Administrative Review (IACUC Chair)
Prior to the review, each IACUC member will be provided with written descriptions of activities (protocols) that involve the care and use of animals and any member of the IACUC may obtain, upon request, full committee review of those protocols. If full-committee review (FCR) is not requested, at least one member of the IACUC, designated by the chairperson and qualified to conduct the review, may be assigned to review those protocols and have the authority to approve, require modifications in (to secure approval) or request full committee review of those protocols. Other IACUC members may provide the designated reviewer with comments and/or suggestions for the reviewer’s consideration only. That is, concurrence to use the DMR method may not be conditioned. If multiple designated reviewers are used, their decisions must be unanimous; if not, the protocol will be referred for FCR. If FCR is requested, approval of those protocols may be granted only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present.
In instances where the IACUC uses the designated-member review (DMR) method the protocol will be distributed to all IACUC members to allow all members the opportunity to call for FCR; records of polling of members to obtain concurrence to use the DMR method, or concurrence by silent assent after 10 working days, and approval of protocols via DMR are maintained and recorded in the minutes of the next convened IACUC meeting.
Required modifications. When the IACUC requires modifications (to secure approval), of a protocol, such modifications are reviewed as follows:
1. FCR or DMR following the procedures delineated above.
2. DMR if approved unanimously by all members at the meeting at which the required modifications are developed delineated AND if the entire current Committee has previously approved and documented a policy of DMR for required modifications, provided however, that if any member calls for FCR of the modifications, such modifications can only be reviewed and approved by FCR.
3. Minor modifications of an administrative nature, i.e., typographical or grammatical errors, required signatures, etc. may be confirmed by IACUC administrative/support personnel.
No member may participate in the IACUC review or approval of a protocol in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum. The IACUC may invite consultants to assist in reviewing complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC unless they are also members of the IACUC.
Note: Any use of telecommunications will be in accordance with NIH Notice NOT-OD-06-052 of March 24th, 2006, entitled Guidance on Use of Telecommunications for IACUC Meetings under the PHS Policy on Humane Care and Use of Laboratory Animals.
In order to approve proposed protocols or proposed significant changes in ongoing protocols, the IACUC will conduct a review of those components related to the care and use of animals and determine that the proposed protocols are in accordance with the PHS Policy. In making this determination, the IACUC will confirm that the protocol will be conducted in accordance with the Animal Welfare Act insofar as it applies to the activity, and that the protocol is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the protocol conforms to the institution's PHS Assurance and meets the following requirements:
a. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
b. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.
c. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied.
e. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
f. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
g. Methods of euthanasia used will be consistent with the current recommendations of the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
7. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows:
Review and approval of significant changes are handled in the same manner as new protocols. See Paragraph III.D.6. above.
Examples of changes considered to be significant include, but are not limited to, changes:
a. in the objectives of a study
b. from non survival to survival surgery;
c. resulting in greater discomfort or in a greater degree of invasiveness;
d. in the species or in approximate number of animals used;
e. in Principal Investigator;
f. in anesthetic agent(s) or the use or withholding of analgesics;
g. in the method of euthanasia; and
h. in the duration, frequency, or number of procedures performed on an animal
8. Notify investigators and the Institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are as follows:
Upon approval of a new protocol or modification to an approved protocol by the IACUC, the application is signed by the IACUC Chair, indicating approval by the IACUC, and then the application is forwarded to the Institution Official. A signature of approval also is required of the Institutional Official. Upon approval by the Institutional Official, the approved protocol is sent to the IACUC administrative assistant, who produces a letter of
approval. The letter of approval also is assigned by the Institutional Official and provides the following information:
Upon a decision by the IACUC to withhold approval of a new protocol or modification of an approved protocol, the principle investigator will be notified in writing, through the campus mail system, of the IACUC’s decision and be reminded that the proposed studies using animals cannot be conducted at the Institution.
9. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing reviews are as follows:
All ongoing activities are monitored continuously by the animal care and use staff and the associated protocols are reviewed by a member or members of the IACUC at least annually. Annual protocol reviews are recorded in the IACUC meeting minutes. The IACUC meeting minutes are reviewed and approved by the Committee.
In addition, IACUC members may review protocols and procedures and conduct post-approval monitoring in conjunction with the semi-annual facility inspections.
Protocols are approved for a maximum of 36 months. That is, all protocols expire no later than the three-year anniversary of the initial IACUC review. If activities will continue beyond the expiration date, a new protocol must be submitted, reviewed, and approved [prior to expiration of the original or preceding protocol] as described in Paragraph III.D.6. above.
10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as follows:
The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution's Assurance, or IV.C.1.a.-g. of the PHS Policy. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present. If the IACUC suspends an activity involving animals, or any other institutional intervention results in the temporary or permanent suspension of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution's Assurance, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW.
E. The occupational health and safety program for personnel working in laboratory animal facilities or have frequent contact with animals is as follows:
The Occupational Safety Office is responsible for the occupational health and safety program that covers all personnel who work in laboratory animal facilities or have frequent contact with animals.
F. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed therein and the average daily inventory of animals, by species, in each facility is provided in the attached Facility and Species Inventory table (Attachment B).
G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:
Training is provided for all levels of participants in the animal care and use program at the Institution.
Each IACUC member will be provided with a copy of the following:
1) The PHS Policy for the Humane Care and Use of Laboratory Animals;
2) The National Research Council (NRC) Guide for the Care and Use of Laboratory Animals;
3) The ARENA/OLAW IACUC Guidebook;
4) The AVMA Guidelines on Euthanasia;
5) A copy of this Assurance.
All new IACUC members are provided an orientation to the IACUC during the first full meeting of the IACUC in which they attend. New members are also mentored in protocol review and semi-annual review activities until they are comfortable conducting these
activities on their own. In addition, they are required to take the “Training for IACUC Members” module offered through www.CITIProgram.org .
All IACUC members will visit the OLAW website at least semi-annually and will complete the IACUC tutorial module (initial visit) and will familiarize themselves with the other pertinent modules and information, e.g., OLAW FAQs, Policies and Laws, Guidance, Educational and other Resources.
Efforts also are made to send new members to IACUC workshops (e.g., IACUC 101), and all IACUC members are kept apprised of new policies and procedures through reading notices and FAQs at OLAW’s website and through newsletters and other postings offered by PRIM&R.
Animal Care and Use Personnel
Animal Care and Use Personnel involve all individuals with designated responsibility for the care and use or supervision of care and use of animals at the Institution. All personnel and supervisors (e.g., department heads) with roles in the care and use of animals at the Institution are required by the Institutional Official, in consultation with the IACUC, to take online training relevant to specific responsibilities in the animal care program from www.CITIprogram.org . In addition, all personnel must trained be according to standard operating procedures, specific to the assigned responsibilities within the animal care and use program, which were developed in consultation with, and ultimately approved by, the IACUC. Moreover, the IACUC holds an annual informational session for the purpose of educating all personnel involved in the care and use of animals at the Institution about key components of the animal care and use program, the procedures for protocol approval, the procedures for significant and minor changes to IACUC-approved protocols, the semi-annual review process, post-approval monitoring, and any updates to the Institution policies on the care and use of animals. The effectiveness of personnel training is determined through interviews and assessing training logs during semi-annual reviews and post-approval monitoring.
All personnel performing procedures using animals must be identified in the Institutional Animal Care and Use Protocol. A description of each individual’s qualifications, experience and/or training with the specific animal species, model and procedures must be provided for IACUC review. Any person needing additional protocol-specific training will be identified during the review process and such required training will be a condition of approval of the protocol.
All persons involved in animal care and use will be required to attend an orientation seminar given by the IACUC Chair, Consulting Veterinarian, or other qualified individual(s), which covers the laws and regulations covering laboratory animal care and use with an emphasis on the contents of the NRC Guide and the 3R’s. The training includes training or instruction on research or testing methods that minimize the numbers of animals required to obtain valid results and limit animal pain or distress as well as other requirements delineated in 9 CFR, Part 2, Subpart C, Section 2.32(c).
Specifically, training and instruction of personnel must include guidance in at least the following areas:
1. Humane methods of animal maintenance and experimentation, including:
a. The basic needs of each species of animal;
b. Proper handling and care for the various species of animals used by the facility;
c. Proper pre-procedural and post-procedural care of animals; and
d. Aseptic surgical methods and procedures;
2. The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress;
3. Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility;
4. Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act;
5. Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information:
a. On appropriate methods of animal care and use;
b. On alternatives to the use of live animals in research;
c. That could prevent unintended and unnecessary duplication of research involving animals; and
d. Regarding the intent and requirements of the Animal Welfare Act and USDA-APHIS Regulations
On-line training may be used and accepted in lieu in-house training. Any use of on-line training to fulfill training requirements must be approved by the IACUC. Approval and completion of on-line training will be documented.
Specialized Training: Training in experimental methods, i.e., specific animal manipulations and techniques and in the care of new and nontraditional laboratory animal species, will be conducted based on the types of research being conducted and the species being used at the institution.
Note: For investigators transferring from other facilities at which they have received similar training, verification of previous training may be accepted in lieu some Institutional required training. Acceptance of previous training in lieu of the Institution’s training is solely at the IACUC’s discretion.
IV. INSTITUTIONAL PROGRAM EVALUATION AND ACCREDITATION
All of this Institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC within the past six months and will be re-evaluated by the IACUC at least once every six months thereafter, in accord with the PHS Policy IV.B.1-2. Reports have been and will continue to be prepared in accord with the PHS Policy IV.B.3. All IACUC semiannual reports will include a description of the nature and extent of this Institution's adherence to the “Guide.” Any departures from the “Guide” will be identified specifically and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency. Semiannual reports of the IACUC’s evaluations will be submitted to the Institutional Official. Semiannual reports of IACUC evaluations will be maintained by this Institution and made available to the OLAW upon request.
This Institution is Category Two (2)—not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). As noted above, reports of the IACUC’s semiannual evaluations (program reviews and facility inspections) will be made available upon request. The report of the most recent evaluations (program review and facility inspection) is attached (Attachment C).
V. RECORDKEEPING REQUIREMENTS
A. This Institution will maintain for at least three years:
B. This Institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.
C. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.
VI. REPORTING REQUIREMENTS
A. This Institution’s reporting period is January 1 – December 31. The IACUC, through the Institutional Official, will submit an annual report to OLAW on January 31 of each year. The report will include:
B. The IACUC, through the Institutional Official, will promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:
C. Reports filed under sections VI.A. and VI.B. of this document shall include any minority views filed by members of the IACUC.
VII. INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL
A. Authorized Institutional Official
Name: Brian Cherry
Title: Assistant Provost
Name of Institution: Northern Michigan University
Address: 1401 Presque Isle Ave., Marquette, MI 49855
Date: September 18, 2009
B. PHS Approving Official
C. Effective Date of Assurance:
D. Expiration Date of Assurance:
MEMBERSHIP OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
DATE: September 18, 2009
NAME OF INSTITUTION: Northern Michigan University
ASSURANCE NUMBER: A3894-01
FACILITY AND SPECIES INVENTORY
DATE: September 18, 2009
NAME OF INSTITUTION: Northern Michigan University
ASSURANCE NUMBER: A3894-01
*Institutions may identify animal areas in any manner, e.g., initials, ID number, etc. However, the name and location must be provided to OLAW upon request.