|
|
Animal Care and Use
Contact: (503) 725-4288
Portland State University Policies
Federal Policies and Laws on the Humane Care and Use of Laboratory Animals can be found online at: http://grants.nih.gov/grants/olaw/
Assurance of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals
Portland State University, hereinafter referred to as institution, hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.
I. Applicability
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 all vertebrate care facilities at Portland State University.
II. Institutional Policy
- This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
- This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
- 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 make a reasonable effort to 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.
- 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
- The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:
- President
- Provost
- Vice Provost for Research
- Associate Vice Provost for Research
- Institutional Animal Care and Use Committee (IACUC)
- Researchers
- The qualifications, authority, and percent of time contributed by the veterinarian(s) who will participate in the program are:
- The qualifications of the veterinarians who will participate in the program is as follows. The veterinarian will spend about 5 hours every year on the program:
Kim Saunders, DVM, Dipl. ACLAM is Director and Professor of the Department of Comparative Medicine at Oregon Health & Science University (OHSU). Dr. Saunders is a voting member of the IACUC. She is responsible for implementing the recommendations in the Guide and the recommendations of the IACUC within the DAC.
- The authority and responsibility of the veterinarians to implement the applicable provisions of the PHS Policy is as follows:
- The veterinary staff consults with the PSU faculty and staff about the PSU animal care and use program. This program is developed and managed by the PSU IACUC.
- The IACUC has the authority to maintain compliance with all rules and regulations. It can cancel, stop, or modify any animal procedure which does not comply with all laws, rules, or regulations. When any violations of rules, regulations, or laws are discovered, the veterinarian can intercede on behalf of the University and the IACUC, and take immediate and appropriate action to correct the violation or inappropriate animal care. Immediately following the corrective action, the veterinarian will inform the Chair of the IACUC and the Vice Provost for Research of the violation and describe the actions of the veterinary staff.
- The IACUC is responsible for consulting as necessary with the veterinarian to provide supervision of care of all animals at PSU.
- The IACUC monitors experimental procedures requiring the use of live animals.
- The IACUC establishes or identifies the training programs to provide principle investigators, graduate students and research technicians and staff with the appropriate training and guidance to conduct research using live animals. Training courses are available to the PSU community at the Oregon Health & Sciences University. OHSU is two miles from PSU.
- The IACUC reviews all protocols and alerts the researchers and the IACUC of potential difficulties; for example: appropriate use of drugs, humane care of animals, or potential conflict with regulations.
- The IACUC reviews current local, state, and national laws, rules, and regulations, and informs the Vice Provost and the Chair of the IACUC of the changes in these rules and regulations.
- Dr. Kim Saunders, the consulting veterinarian, is a voting member of the PSU IACUC.
- This Institution has established a veterinary service contract with the Oregon Health & Science University Department of Comparative Medicine. The OHSU veterinarians are available at any time for consultation or animal care functions. The OHSU training programs are available to the PSU Animal Care program. PSU and OHSU locations are approximately 2 miles apart.
- This Institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the Institution's animal program, facilities, and procedures. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS Policy at IV.A.3.b. Attachment A provides a list of the names, position titles, earned degrees, and other credentials of the IACUC Chair and members.
- The IACUC will:
- 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 evaluations are:
The Chair of the IACUC calls meetings of the committee members twice per year. The meetings take place in early November and April at a time and day convenient for IACUC members. The convened committee initially reviews the program and any program changes are discussed and recorded
- 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:
At the time the IACUC convenes, and following program review (above), the committee, along with the consulting veterinarian, tours the animal housing facilities and any laboratories where vertebrate animals are used in funded research. The condition of every space is noted.
- Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to Vice Provost for Research and Sponsored Projects. The IACUC process for developing reports and submitting them to the Institutional Official is:
Following each IACUC semi-annual meeting, an internal report is issued documenting the committee's findings. The report includes a written statement of findings on the condition of the animal spaces by the committee veterinary consultant. Also included are a report of the committee's agenda and findings relative to program changes written by the IACUC Chair. The Chair keeps a copy of this report on file and sends a copy to the Vice Provost for Research (kept on file in the Office of Research & Sponsored Projects). The IACUC members are also sent copies.
- Review concerns involving the care and use of animals at the institution. The IACUC procedures for reviewing concerns are:
An individual's concern may come to the committee via several routes. The individual may contact an IACUC member directly, or contact the administrative official or a faculty/staff member who then relays this information to an IACUC committee member. Regardless, the IACUC Chair will take the following steps upon learning about the concern:
- If the concern requires immediate attention, the IACUC Chair will personally investigate the issue and contact the other IACUC committee members to solicit their views and recommendations.
- If the concern does not require immediate action, the IACUC Chair will document the issue and present it to the committee as an agenda item for the next semi-annual meeting.
- Based on the consensus of the committee members and in keeping with accepted standards of animal care, the IACUC committee, through its Chair, may (i) recommend to the administration actions to correct the problem or (ii) directly contact the investigator or supervised person using research animals to correct the problem or (iii) make changes to its own review policies, procedures or general recommendations.
Queries, instructions or requests to an investigator or supervised person using research animals are made by the IACUC Chair or administrative official without inclusion of information about the source of a concern. This makes reprisals for communicating information unlikely.
- Make written recommendations to Vice Provost for Research regarding any aspect of the institution's animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are:
The results of special actions or meetings regarding situations that require immediate action are communicated in writing to the Vice Provost for Research. All concerns are documented in the semi-annual report that is submitted to the Vice Provost (see #3 above).
- Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C. The IACUC procedures for protocol review are:
Investigators (faculty and graduate students) must submit the "Application for Care and Use of Animals in Research" to the IACUC, when proposing to use vertebrate animals in a funded research project. The form is submitted to the IACUC Chair, who then reviews the material and takes one of two actions. 1) If there are obvious flaws in the proposed protocol(s), the deficiencies are communicated to the investigator and an amended (revised) form is requested. 2) If the protocol(s) appears to be sufficient, it is sent to the other members of the IACUC for their review. Concerns or comments from the IACUC members are communicated to the IACUC Chair, who then contacts the investigator to obtain clarification, and, if necessary, requests a revised form. Following IACUC committee consensus that a protocol or protocol set is appropriate, the IACUC Chair provides an authorization letter to the Principal Investigator to approve the protocol(s). A copy of this authorization is sent to the Vice Provost and another copy is maintained in the office of the IACUC Chair.
- 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 at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are:
A change requested to an active protocol must be communicated to the IACUC Chair. The Chair then takes one of two actions: 1) If the change is a simple modification of an existing protocol (e.g. substitution of one animal strain for another) then the requested change is communicated by the IACUC Chair to the other IACUC members who express their views. The consensus view is communicated to the investigator. If favorable, a letter is provided to the investigator authorizing the change. If not favorable, an amendment to the protocol is requested by the Chair. 2) If the protocol change is complex or extensive, the investigator is asked to submit a new application form, indicating on it that it is an amendment to an existing protocol. The new "Application for the Care and Use of Animals in Research" is reviewed by the IACUC members using the same procedures for review as all new applications, and recommendations are made as described above.
- 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 at IV.C.4. The IACUC procedures to notify investigators and the institution of its decisions regarding protocol review are:
The IACUC Chair is responsible for communicating the IACUC's recommendations concerning the status of a protocol submitted for review or any recommendations relative to observed deficiencies in the animal housing or research-use space. All such communications are written to the responsible investigator.
- 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 at IV.C. 1-4. at least once every three years. The IACUC procedures for conducting continuing review are:
Research projects funded for more than three years require a third year review. Principle investigators are notified six months prior to the three year expiration date that a review is required. Principle investigators are required to report in writing to the IACUC the total use of animals and outcome of the project. If acceptable written authorization is sent by the IACUC Chair approving continued work under the defined protocol.
- Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6. The IACUC procedures for suspending an ongoing activity are:
Suspension of activities is accomplished by reporting deficiencies to the Vice Provost for Research, the university officer ultimately responsible for oversight of animal research at this institution. This person or a designee has the authority to suspend activities of a funded research project that is not in compliance with animal care guidelines. Typically the IACUC Chair would first become aware of any potential violations and upon investigation, and possible consultation with other IACUC members, make recommendation to the Vice Provost for Research.
- After determining the status of the animal(s) and consulting with the Chair and veterinary consultant, appropriate care will be given to the animal. This may involve putting the animal(s) under the control of different university personnel or may require euthanasia.
- The Vice Provost or designee will inform the investigator and department officials that the research is suspended.
- Depending on the nature of the violations, the research may be permanently terminated or issued a set of conditions, with concurrence of the IACUC, under which the research may be revived, along with a set of standards for determining whether those conditions are met.
- If permanent termination is involved, the Vice Provost will ensure that the researcher(s) involved no longer have access to the physical space (return keys, change locks).
- The sponsors of the research, if any, will be notified and all research expenditures involved in the activity, including research funds, departmental funds, and Portland State University foundation funds will be suspended.
- The individual(s) authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals is/are: Vice Provost for Research, William H. Feyerherm.
- The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is:
Each investigator and any personnel working with research animals will receive risk assessment training relative to their protocols. PSU's health and safety officers are available to all personnel for consultation.
The university's occupational health and safety plan is under review.
- The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is:
- The IACUC will review all proposals for compliance with humane practice of animal care and use, for acceptable testing methods to minimize the number of animals required to obtain valid results, and for procedures to minimize animal distress. The formal review and compliance process will assure that scientists are well acquainted with acceptable procedures; and
- The training of technicians and other personnel in proper care, treatment, and use will be the responsibility of the principle investigators. They will provide individual instruction to each person in the laboratory under their supervision. The veterinarian will provide surgical training where appropriate for investigators and graduate students. Routine surgical procedures (implantation, cannulation, catheterization) are characteristically supervised by the scientists. The IACUC ensures scientist qualification by past published expertise in a technique. If the proposed procedure was a significant departure from past experience based on complexity or taxon, training by the veterinarian would be expected.
IV. Institutional Status
As specified in the PHS Policy at IV.A.2, as Category 2, all of this institution's programs and facilities, including satellite facilities, for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accord with IV.B.1. and 2. of the PHS Policy, and reports prepared in accord with IV.B.3. of the PHS Policy.
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 evaluations will be submitted to William H. Feyerherm, Vice Provost for Research. Semiannual reports of IACUC evaluations will be maintained by this institution and made available to the Office of Laboratory Animal Welfare (OLAW) upon request.
V. Record Keeping Requirements
- This institution will maintain for at least three years:
- A copy of this Assurance and any modifications thereto, as approved by PHS.
- Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.
- Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
- Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to Vice Provost for Research.
- Records of accrediting body determinations.
- 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.
- 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
- At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to OLAW:
- Any change in the status of the institution, any change in the description of the institution's program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will provide OLAW with written notification that there are no changes.
- Notification of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the Vice Provost for Research.
- The IACUC, through the Institutional Official, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:
- Any serious or continuing noncompliance with the PHS Policy.
- Any serious deviations from the provisions of the Guide.
- Any suspension of an activity by the IACUC.
- Reports filed under VI.A. and VI.B. above shall include any minority views filed by members of the IACUC.
VII. Institutional Endorsement and PHS Approval
View the signed institutional endorsement and PHS approval form.
|