OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

DIVISION OF LABORATORY ANIMAL RESOURCES

DMC Policies and Procedures for the Care and Use of Laboratory Animals in Biomedical and Behavioral Research and Education

The State University of New York Downstate Medical Center/State University Hospital, hereinafter referred to "DMC," has adopted the following policies and administrative procedures to assure compliance with the Animal Welfare Act [Public Law 89-544, 1966, as amended, (PL. 91-579 and PL. 94-279), 7 U.S.C. 2131 et.seq.], the Code of Federal Regulations, (9 C.F.R. Parts 1, 2 and 3), the State of New York Department of Health Administrative Rules and Regulations (Chapter II, Subchapter D, Part 55), and the Public Health Service (National Institutes of Health) Policy on Humane Care and Use of Laboratory Animals. All research investigators and educators will be required to fully comply with DMC's policies and procedures and any additional sponsor specific requirements.

I. Statement of Applicability, Principles and General Policies

Applicability
1. These policies and procedures are applicable to all activities that, in whole or in part, involve research or educational activities with animal subjects, if:
  1. the research or education is sponsored by DMC, or,
  2. the research or education is conducted by or under the direction of any employee or agent of DMC in connection with his or her institutional responsibilities, or,
  3. the research or education is conducted by or under the direction of any employee or agent of SCAB using any property or facility of this institution.
Institutional Principles for the Utilization and Care of Laboratory Animals
The Health Science Center at Brooklyn concurs with the principles adopted by the U.S. Interagency Research Animal Committee for the utilization and care of animals used in testing, research, and training. The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. DMC shall consider and ensure that the following principles are adhered to:
1. The transportation, care, and use of animals shall be in accordance with the Animal Welfare Act and other applicable Federal laws, guidelines, and policies.
2. The living conditions of animals shall be appropriate for their species and contribute to their health and comfort. The housing, feeding, and care of all animals used for biomedical purposes must 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. Veterinary care shall be provided as indicated.
3. The animals selected for a procedure shall be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
4. Procedures involving animals should be designed and performed with due consideration to their relevance to human or animal health, the advancement of knowledge, and the good of society.
5. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Investigators shall consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals, unless otherwise demonstrated.
6. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures will not be performed using only a paralyzing agent on unanesthetized animals.
7. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be euthanized at the end of the procedure, or if appropriate, during the procedure.
8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
9. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but will be made by, with due regard to Principle I.B.4, the DMC Animal Care and Use Committee. Such exceptions shall not be made solely for the purpose of teaching or demonstration.
Institutional Policy
1. DMC acknowledges and accepts its responsibilities for protecting the welfare of laboratory animal subjects.
2. DMC acknowledges that it bears full responsibility for the performance of all research and education involving animal subjects covered by these policies and procedures.
3. DMC bears full responsibility for complying with federal, state, and local laws as they may relate to research covered by these policies and procedures.
4. It is the policy of DMC that all research and education covered by this statement will be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC), which has been established according to the provisions of the Animal Welfare Act, Public Health Service policy, and the State of New York Department of Health Administrative Rules and Regulations. The involvement of animal subjects in research and education covered by these policies and procedures will not be permitted until the IACUC has reviewed and approved the research or education protocol. The IACUC review of continuing research and education will be conducted at appropriate intervals but not less than once per year.
5. The IACUC has the responsibility and authority to review, approve, disapprove, suspend or require changes in research and educational activities involving animal subjects according to the provisions of this policies and procedures statement.
6. The selection process for IACUC membership will conform with DMC policies regarding equal opportunity/affirmative action.
7. DMC has provided and will continue to provide both meeting space for the IACUC and sufficient staff to support the IACUC's review and record keeping duties.
8. DMC will maintain documentation of IACUC activities including the minutes of meetings (which shall include records of attendance, activities of the committee, and committee deliberations), the outcomes of research and education protocol reviews, and the results of research and education protocol compliance audits.
9. DMC encourages and promotes constructive communication among research administrators, educators, department chairpersons, research investigators, clinical care staff, the IACUC, and other institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the welfare of animal subjects.
10. When research covered by these policies and procedures is conducted at or in cooperation with another entity, all provisions of this statement remain in effect for that research. DMC may accept, for the purpose of meeting this institution's IACUC review requirements, the review of the cooperating entity's IACUC. Such acceptance must be in writing, approved and signed by DMC's IACUC, and approved and signed by corresponding officials of each of the other cooperating institutions.
11. DMC shall provide each individual conducting research and education involving laboratory animals (for example, research administrators, department chairpersons, research investigators, clinical care staff, IACUC members, and other institutional officials) with this statement and copies of any future modifications which may be made to this statement, with the exception of changes in IACUC membership. In addition, DMC will keep on file in the Division of Laboratory Animal Resources (DLAR) a copy of all applicable federal and state requirements for the care and use of laboratory animals.
12. It is the policy of DMC that each individual conducting research and education involving laboratory animals shall comply with the policies and procedures of DLAR. DMC shall provide such individuals with copies of the DLAR policies and procedures statement and will assure that copies are available in DLAR.
13. DMC will use the Guide for the Care and Use of Laboratory Animals, NIH Publication Number 86-23, 1996 edition or succeeding revised editions (the Guide), as the basis for developing and implementing the institutional program for activities involving laboratory animals.
14. DMC will provide training and instruction to personnel involved in animal care, use and treatment. On a periodic basis, DMC will review the qualifications of laboratory personnel to ensure that they are qualified to perform their responsibilities.
15. DMC will require all DLAR staff, as well as other individuals in contact with animals, to adhere to the Infection Prevention and Control policies and procedures contained in the DMC Employee Health Service Manual, as appropriate (attached as Exhibit A).
16. DMC shall employ one attending veterinarian, at the minimum, and shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care, and to oversee the adequacy of other aspects of animal care and use in compliance with acceptable veterinarian practices and applicable laws.
17. DMC will maintain full accreditation with the American Association for the Accreditation of Laboratory Animal Care International (AAALAC). AAALAC will evaluate and accredit all programs and facilities involving laboratory animals. DMC will maintain records of all AAALAC determinations. At such time as DMC may decide not to maintain accreditation with AAALAC, then it must institute a program acceptable to external funding agencies.
18. DMC advocates the refinement of existing experimental and testing methodologies and the use of in vitro or defined model systems to reduce unnecessary animal usage.
19. DMC will not engage in any reprisals or discriminatory conduct against any DMC employee, IACUC member or laboratory personnel for reporting, in good faith, violations of any pertinent regulation or standard.

II. Implementation

Responsibilities of Research Investigators, Educators and Department Chairpersons
1. Determination of Animal Subject Involvement
  1. Research investigators, educators and department chairpersons shall make a determination as to whether research will involve animal subjects. When it is not clear whether the research involves animal subjects, as defined in the Animal Welfare Act, research investigators should seek assistance from the IACUC in making this determination.
2. Preparation of Research and Education Protocols
  1. Research investigators and educators shall prepare a protocol giving a complete description of the proposed research or educational use of animals. In the protocol, research investigators and educators shall make provisions for the adequate protection and welfare of prospective animal research subjects and ensure that pertinent laws and regulations are observed. The IACUC protocol form, which must be completed, is attached as Exhibit B.
  2. Research investigators and educators must also include the following information in their protocols:
    - identification of the species and approximate number of animals to be used pursuant to the subject protocol as well as those already used or those to be used in prior and future years, respectively;
    - rationale for involving animals, and for the appropriateness of the species and number to be used;
    - a complete description of the proposed use of the animals;
    - assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals;
    - a description of any euthanasia method to be used;
    - the planned duration of the project; and
    - the qualifications of all personnel involved in the project.
3. Scientific Merit and Ethical Consideration Review
  1. Department chairpersons, through appropriate procedures established within their respective departments, are responsible for reviewing research and education protocols for ethical consideration and scientific merit.
4. Submission of Protocols to the IACUC
  1. Research investigators, educators and department chairpersons shall be responsible for ensuring that all research and education involving animal subjects is submitted to the IACUC.
5. Submission of an Amendment to an Original Protocol to the IACUC
  1. Research investigators and educators shall be responsible for submitting an amendment to the original protocol to the IACUC when it is proposed to change the involvement of animal subjects and that involvement is significantly different from that which was initially approved by the IACUC.
6. Complying with IACUC Decisions
  1. Research investigators, educators and department chairpersons shall be responsible for complying with all IACUC decisions, conditions, and requirements.
7. Submission of Injury Reports and Reports of Unanticipated Problems Involving Risks
  1. Research investigators and educators are responsible for immediately reporting, in writing, to the IACUC any unanticipated injury to animal subjects. This statement must be signed by the research investigator's or educator's department chairperson prior to submission to the IACUC.
  2. Research investigators and educators are responsible for immediately reporting, in writing, to the IACUC any unanticipated problems which involve risks to animal subjects or others. This statement must be signed by the research investigator's or educator's department chairperson prior to submission to the IACUC.
8. Reporting of Non-Compliance
  1. Research investigators, educators and department chairpersons are responsible for reporting promptly, in writing, to the IACUC any serious or continuing noncompliance with the requirements of these policies and procedures or the determinations of the IACUC.
9. Attending IACUC Meetings
  1. In order to facilitate the review of protocols and to protect the welfare of animal subjects, research investigators, educators and department chairpersons are expected to attend IACUC meetings upon IACUC's request.
IACUC Structure
1. Institutional Establishment of the IACUC
  1. One IACUC is established within DMC to review all research and education involving animal subjects covered by this policies and procedures statement.
  2. The President of DMC shall select and appoint individuals to serve on IACUC. The IACUC shall consist of at least ten members and shall include at least:
    - one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at DMC;
    - one practicing scientist experienced in research involving animals;
    - one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy, or administrator); and
    - one individual who is not affiliated with DMC in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with DMC;
    - ten (10) individuals representing DMC basic science and clinical departments, but no one basic science or clinical department shall be represented by more than three members;
    - one individual representing the DMC animal caretaker staff; and
    - An individual who meets the requirements of more than one of the categories detailed above may fulfill more than one requirement.
    IACUC members serve at the discretion of the President of DMC.
  3. Prospective candidates for IACUC membership are nominated by department heads and chairpersons from each basic science and clinical department and then submitted to the President of DMC for consideration. The President of DMC will appoint five (5) members representing basic science and clinical departments to two (2) year terms and five (5) members representing basic science and clinical departments to three (3) year terms. Representatives from the animal caretaker staff will receive three (3) year appointments.
  4. The chairperson and deputy chairperson of the IACUC are selected from among the members of the IACUC by the President of DMC. The appointment terms for the chairperson and deputy chairperson of the IACUC, the IACUC member not affiliated with DMC, and the Doctor of Veterinary Medicine who has direct or delegated responsibility for animal programs at DMC are established by the President of DMC.
Responsibilities of the IACUC
1. Institutional Determinations Concerning Exemptions, Sponsorships, and Certification
  1. The IACUC shall receive from the research investigators and educators, with the signed approval of their department chairperson, all research and education protocols which involve animal subjects.
  2. The IACUC shall review all research and education proposals and shall determine whether or not DMC will support or sponsor such research and education.
  3. All research protocols approved by the IACUC shall be forwarded to the DMC Office of Scientific Affairs.
  4. All education protocols approved by the IACUC shall be forwarded to the educators and their respective department chairperson.
  5. All research protocols approved by the IACUC which are being submitted for Department of Human and Health Services (HHS) funding shall be forwarded to HHS by the Office of Research Administration of Health Science Center at Brooklyn. When IACUC approves a protocol on the condition that the research investigator make modifications to the protocol, the Office of Scientific Affairs shall not forward the protocol to HHS until it has determined that such modifications are made. As appropriate, the IACUC may negotiate protocol modifications with the research investigator. Each protocol submitted to HHS must include:
    - certification that the research was reviewed and approved by the IACUC, as established under DMC's PHS approved Animal Welfare Assurance. (The identification numbers of the Assurance and the IACUC must be included in the certification); or
    - certification that the research was reviewed and approved by an IACUC under another Assurance.
  6. The IACUC shall keep research investigators and educators aware of decisions and administrative processing affecting their respective protocols and shall return all disapproved protocols to the research investigators or educators.
2. IACUC Review and Approval of Research
  1. The IACUC shall have the responsibility to review and the authority to approve, require modification in, suspend or disapprove, all research and educational activities or proposed changes in previously approved research and educational activities covered by this policies and procedures statement.
  2. The IACUC shall approve research and educational use of laboratory animals based on its determinations that the following requirements are satisfied:
    - Care and use of animals are consistent with DMC's policies and procedures, Animal Welfare Act, the Code of Federal Regulations, the Guide, the State of New York Department of Health Administrative Rules and Regulations, and Public Health Service policy.
    - Risks to animal subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
    - Risks to animal subjects are reasonable in relation to anticipated benefits and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IACUC shall consider only those risks and benefits that may result from the research. The IACUC shall not consider long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
    - Selection of the number and type of animal subjects is reasonable. In making this assessment, the IACUC shall take into account the purposes of the research or education, the research or education protocol, and the final disposition of animal subjects.
    - Procedures with animals will avoid or minimize discomfort, distress and pain to the animals, consistent with sound research design.
    - The proposed activity does not unnecessarily duplicate previous experiments and the investigator has provided an adequate written assurance.
    - 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 or educator and
      - the procedure will continue for only the necessary period of time,
      - the veterinarian or his/her designee was consulted during the planning phase and
      - the procedure does not include the use of paralytics without anesthesia.
    - The research investigator or educator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animal subjects and has provided a written narrative description of the methods and sources used to determine that alternatives were not available.
    - More than one surgical procedure on any given laboratory animal subject is prohibited unless additional surgical procedures are justified for scientific reasons, in writing, by the research investigator or educator, or as necessary to protect the health or well-being of the animal as determined by the attending veterinarian.
    - Any activity involving surgery will include appropriate provisions for pre-operative and post-operative care of the animals in accordance with veterinary medical practices.
      - All major and minor survival surgery for non-rodents will be performed in dedicated aseptic surgical facilities using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques.
      - All survival surgery on rodents will be performed under aseptic conditions using aseptic procedures.
    - Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure. The selected method of euthanasia will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (Journal of the American Veterinary Medical Association, 1993, volume 202, number 2, pp. 230-259, or succeeding revised editions) unless a deviation for scientific reasons is justified, in writing, by the investigator or educator.
      - Humane methods for destroying animals shall include but not be limited to the following:
        
        inhalant agents such as carbon dioxide for small rodents;
        
        non-inhalant pharmacological agents such as barbituric acid derivatives or a combination of chloral hydrate, magnesium sulfate and sodium pentobarbital for large animals; and
        
        physical methods such as decapitation for small animals.
      - Inhumane methods which are prohibited shall include but not be limited to the following:
        
        non-inhalant pharmacological agents such as chloral hydrate alone, strychnine, magnesium sulfate alone or curariform drugs or agents with curariform activity; and
        
        physical methods such as drowning or exsanguination without causing prior unconsciousness.
    - The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical 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.
    - Routine and post-operative medical and nursing care for animals will be available and provided as necessary by qualified professionals.
    - Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
    - Where appropriate, the research or education protocol will make adequate provision for monitoring the data collected to ensure the safety of animal subjects.
    - Where appropriate, there will be adequate provisions to protect and maintain confidentiality of research and education protocols and data.
  3. The IACUC shall determine, in its review of research and education protocols, which projects will require IACUC review more often than annually.
3. Appeal Requests
  1. The IACUC shall receive all requested appeals from research investigators and educators, in writing, with the signed approval of their department chairperson concerning review of its decisions with or without modifications of the protocol. Research investigators and educators have fifteen (15) working days from the receipt of an IACUC decision to submit an appeal request.
  2. A full committee review will be held within fifteen (15) working days of the receipt of all appeal requests. The investigator or educator will have the opportunity to meet with the committee and individuals with expertise on the subject or outside consultants may be called to aid in the appeal decision. The committee will issue a final decision, in writing, within fifteen (15) working days.
4. Continuing Review
  1. The IACUC shall conduct continuing review of all research and education applications and proposals at intervals appropriate to the degree of risk, but not less than once per year. Research investigators and educators are required to submit a renewal to the IACUC at least once per year.
5. Verification of Change
  1. The IACUC shall determine which projects need verification, from sources other than the research investigators and educators, that no material changes have occurred since previous IACUC review.
6. Authority to Suspend or Terminate Approval of Research
  1. The IACUC shall have authority to suspend or terminate research and education if it determines that the research or educational use of animals is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Code of Federal Regulations, the Guide, the State of New York Department of Health Administrative Rules and Regulations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, or any requirements of an outside funding agency.
  2. The IACUC shall have authority to suspend or terminate approval of a research or education project that is not being conducted in accordance with the IACUC's decisions, conditions and requirements or that has been associated with unexpected serious harm to animals subjects.
  3. The IACUC may suspend or terminate a research or education project only after review of the matter at a convened meeting of a quorum of the IACUC and with the vote of a majority of the quorum present.
  4. If the IACUC suspends or terminates a research or education project, the Committee shall issue a statement describing the reasons for the IACUC's action and shall report the action promptly to the educator or research investigator by certified mail, and to the NIH Office for Protection from Research Risks (OPRR), as well as the President of DMC or his/her designee, department chairpersons and other appropriate administrators.
  5. Research investigators and educators will have fifteen (15) working days from receipt of the suspension or termination statement to submit a written appeal to the IACUC. The appeal will not act to stay the decision to suspend or terminate the research or education. If no appeal is made, the decision will stand as final. The President of DMC or his/her designee, in consultation with the IACUC, will take the following actions:
    - review the reasons for suspension,
    - take appropriate remedial action and
    - report the corrective action to the Regulatory Enforcement and Animal Care Service, United States Department of Agriculture (REAC), to OPRR and to any federal agency funding that activity.
  6. A full committee review will be held within fifteen (15) working days of all appeal requests. The investigator or educator will have the opportunity to meet with the committee and individuals with expertise on the subject or outside consultants may be called to aid in the appeal decision. The committee will issue a final decision within fifteen (15) working days.
7. IACUC Review and Evaluation
  1. Twice annually, the IACUC shall:
    - Review and evaluate DMC's program for humane care and use of animals for compliance with applicable federal regulations, and,
    - Inspect and evaluate all of DMC's animal facilities, including animal study areas for compliance with applicable federal regulations.
  2. IACUC will prepare reports of its evaluations and submit to the President of DMC or his/her designee:
    - The reports will be reviewed and signed by a majority of IACUC members and include any minority views. The reports will be updated at least once every six months upon completion of the semiannual evaluations.
    - In the event that a program or facility report identifies a significant deficiency which threatens or may threaten the health or safety of the animals, the report must contain a reasonable and specific plan and schedule for remedial action. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing by IACUC, through the President of DMC or his/her designee, to REAC and any federal agency funding that activity.
  3. IACUC may not exclude any member who wishes to participate in any evaluation. In order to conduct evaluations, IACUC may use sub-committees composed of at least two IACUC members or invite consultants to assist in conducting the evaluations. IACUC, however, will remain responsible for the evaluations and reports.
8. Information Dissemination and Reporting Requirements
  1. The IACUC shall have the authority and be responsible for promptly reporting information to the OPRR, principal investigators, educators, department chairpersons, and appropriate administrators on a variety of issues. In conjunction with this requirement, the IACUC must be prepared to receive and act on information received from a variety of sources, such as research investigators, educators, other institutional staff, and other external or internal sources. For reporting purposes, the IACUC will follow the procedures described below:
    - Report any serious or continuing noncompliance by research investigators or educators with the requirements of the IACUC promptly to the OPRR (for Public Health Service sponsored research only), department chairpersons, and appropriate administrators.
    - Information received by the IACUC concerning unanticipated problems involving added risks to animal subjects or others shall be reported promptly to the OPRR (for Public Health Service sponsored research only), department chairpersons, principal investigators, and appropriate administrators.
    - Report promptly to the OPRR (for Public Health Service sponsored research only), department chairpersons, and appropriate administrators, each instance of suspended or terminated IACUC approval of research projects.
    - Adhere to the procedures set forth in the attached DMC policy regarding alleged scientific misconduct.
    - Maintain information concerning its reasons for the termination or suspension of research or education.
    - Document IACUC reviews and investigations conducted in response to written complaints received by IACUC from the public and research personnel.
    - Report promptly any changes in IACUC membership to the OPRR.
  2. The Director of the Division of Laboratory Animals Resources (DLAR), in collaboration with IACUC, shall make available in-service education to research investigators, educators, and animal caretakers on the humane care and use of laboratory animals. The education will include, but is not limited to: humane methods of animal maintenance and experimentation; the concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; and the proper use of anesthetics, analgesics and tranquilizers for any species of animals used by DMC.
9. IACUC Records
  1. The IACUC shall prepare and maintain adequate documentation of IACUC activities, including the following:
    - Copies of all research and education protocols reviewed, scientific evaluations, if any, that accompany the proposals and renewals submitted by research investigators and educators, and reports of injuries to subjects.
    - Minutes of IACUC meetings which shall be in sufficient detail to show the names of attendees at the meetings; actions taken by the IACUC; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research or educational use of animals; a written summary of the discussion of controversial issues and their resolution and dissenting reports and opinions. If a member in attendance has a conflicting interest regarding any project, minutes shall show that this member did not participate in the review, except to provide information requested by the IACUC.
    - Records of continuing review activities.
    - Copies of all correspondence between the IACUC and the research investigators and educators.
    - A list of IACUC members.
    - Written procedures for the IACUC.
    - Approved Animal Welfare Assurance from the PHS.
    - Records of accrediting agency determinations.
  2. The IACUC shall provide for the maintenance of records relating to a specific research and education activity for at least five (5) years after termination of the last IACUC approval period for the activity. IACUC shall provide for the maintenance of all other records, such as reports, for at least three (3) years.
  3. IACUC records shall be accessible for inspection and copying by authorized representatives of HHS, REAC or any research sponsor at reasonable times and in a reasonable manner, or shall be copied and forwarded to HHS or REAC when requested by authorized HHS or REAC representatives.
10. General Recommendations
  1. The IACUC may make recommendations to DMC, in accordance with institutional policies and procedures, regarding any aspect of the institution's animal program, facilities, or personnel training.
IACUC Procedures
1. The IACUC receives all research and education protocols from the investigators or educators with the signed approval of their department chairperson.
2. Frequency of IACUC Meetings
  1. Except as may be otherwise provided in this Assurance, all convened IACUC meetings shall be conducted under and pursuant to Robert's Rules of Order.
  2. The IACUC shall meet on a regular basis, usually monthly.
  3. Convened meeting of the IACUC may occur:
    - at the call of the chairperson when the chairperson judges the meeting to be necessary or advantageous; or
    - at the call of the chairperson upon the receipt of a written request by any IACUC member.
  4. In the event that an IACUC member is unable to attend an IACUC meeting, the member must offer his/her excuse prior to the date of the scheduled meeting. The failure to attend three (3) consecutive IACUC meetings, without presenting an excuse in advance of the meeting to the IACUC Chair, may be cause for removal by the President of DMC.
3. Determination of review procedure
  1. The IACUC chairperson shall determine whether the research or education protocol meets the criteria necessary for an expedited review process.
  2. The IACUC chairperson refers all research or education protocols to either full committee review or expedited review.
4. Expedited Review
  1. The eligibility of some research or educational use of animals for review through the expedited procedure is in no way intended to negate or modify DMC's policies and procedures or the requirements of the Animal Welfare Act, the Code of Federal Regulations, the State of New York Department of Health Administrative Rules and Regulations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide, or the guidelines of any external funding agency.
  2. The IACUC may use the expedited review procedure to review minor changes in previously approved research or educational use of animals during the period for which approval is authorized.
  3. On an emergency basis, the IACUC may use the expedited review procedure provided that written justification is submitted by the research investigator.
  4. Research or educational use of animals for which the IACUC may use an expedited review procedure is that which involves no more than minimal risk to the animal subjects and in which the only involvement of animal subjects will be in one or more of the following categories:
    - Collection of hair and nail clippings in a non-disfiguring manner or the extraction of deciduous teeth.
    - Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
    - Recording of data from animal subjects using noninvasive procedures routinely employed in human clinical practice. This includes the use of physical sensors that are applied either to surface of the body or at a distance and do not involve input of matter or significant amounts of energy into animal subject. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
    - Collection of both supra- and sub-gingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
    - Voice recordings made for research purposes.
    - Moderate exercise by healthy animals.
    - The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
    - Research or demonstration of individual or group animal behavior or characteristics of individual animals, such as studies of perception, cognition, or game theory, where the research investigator or educator does not manipulate subjects' behavior and the research or educational use will not involve stress to animal subjects.
    - Any other category specifically added to this list by DMC or the federal, state, or local government.
  5. All IACUC members shall review the protocols within 72 hours.
  6. If full Committee review is not requested, the Veterinarian, as designated by the IACUC Chairperson to review expedited protocols, shall review those protocols and shall make recommendations to the IACUC Chairperson to approve, require modifications or request full Committee review. If full Committee review is requested, approval of those protocols may be granted only after review at the convened meeting.
  7. At a convened IACUC meeting, any member may request that any research or educational activity which has been approved under the expedited procedure be reviewed to reaffirm the vote.
  8. The only other research or educational use of animals for which the IACUC may use an expedited review procedure is "administrative review." Administrative review shall include protocols submitted by the research investigators which are identical in every respect to earlier approved protocols, but are being submitted to different sponsors for funding. Under administrative review the protocols must be reviewed by the veterinarian and a designated reviewer before approval by the IACUC Chairman.
5. Full Committee Review
  1. IACUC protocol forms, for research and education protocols scheduled for review, shall be distributed to all members of the IACUC prior to the meeting. Any additional material, i.e., full or appropriate portions of research grant proposals (if not already attached) will be provided to any IACUC member upon request prior to the meeting.
  2. When it is determined that consultants or experts will be required to advise the IACUC in its review of a protocol, the protocol shall also be distributed to the consultants or experts prior to the meeting. Consultants and experts may not approve or withhold approval of an application or proposal or vote with the IACUC. The role of any consultant or expert is solely advisory.
  3. All IACUC initial review and continuing review shall be conducted at convened meetings and at timely intervals.
  4. A majority of the membership of the IACUC constitutes a quorum and is required in order to convene a meeting for the review of research and education protocols.
  5. An IACUC member whose concerns are primarily in non-scientific areas must be present at the convened meeting before the IACUC can conduct its review of research and education protocols.
  6. In order for a research or education protocol to be approved, it must receive the approval of a majority of those members present at the convened meeting.
  7. Any protocol requiring minor changes, i.e., incorrect drug dosage, funding source identification, incorrect project dates, etc., may be approved under "approved with revision category." Approval shall be contingent upon PI's revision of the protocol and review and approval of DLAR Director or Clinical Veterinarian and the IACUC Chairman. IACUC protocols that have information missing relevant to the animal experimentation and is necessary for an informed deliberation shall be disapproved and brought back to the full Committee review at the next convened meeting.
  8. No IACUC may have a member participating in the IACUC's initial or continuing review of any project 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.
  9. In cases where research or educational activities were initially approved under expedited procedures and subsequently reviewed under non-expedited procedures, the decisions reached at the convened meeting shall supersede any decisions made through the expedited review.
6. IACUC Notification to Research Investigators and Educators of Decision(s)
  1. The IACUC shall notify research investigators, educators, the department chairperson, the Office of Scientific Affairs, and appropriate administrators, in writing, of its decisions, conditions and requirements.
  2. The IACUC shall also provide to research investigators, educators, the department chairperson, the Office of Scientific Affairs, and appropriate administrators, reasons for its decision to disapprove a research or education protocol and an opportunity for the research investigator or educator to respond in person or in writing.

III. Written Assurance to the Public Health Service (PHS)

No activity involving animals will be supported by the PHS until DMC provides a written assurance acceptable to the PHS, setting forth compliance with policies for PHS-supported activities. The PHS Policies and Procedures for the Care and Use of Laboratory Animals in Biomedical and Behavioral Research and Education will serve as the guide for the preparation of DMC's Animal Welfare Assurance.
DMC's Assurance to the PHS must include a written program description for animal care and use. The program description must include the following:
1. a list of every branch and major component of the institution, as well as a list of every branch and major component of any other institution which is to be included under the PHS Assurance;
2. the lines of authority and responsibility for administering the program and ensuring compliance with this policy;
3. the qualifications, authority and responsibility of the veterinarian(s) who will participate in the program;
4. the membership list of the IACUC including their names, position titles and credentials:
5. the procedures which the IACUC will follow to fulfill the requirements set forth in II.C.;
6. the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;
7. the gross square footage of each animal facility (including any satellite facilities), the species housed therein and the average daily inventory, by species, of animals in each facility; and
8. any other pertinent information requested by OPRR.
DMC's Animal Welfare Assurance shall be submitted to the Office for Protection from Research Risks (OPRR), Office of the Director, National Institutes of Health, 9000 Rockville Pike, Building 31, Room 4B09, Bethesda, Maryland 20205.
The OPRR will approve the Assurance for a specific period of time [no longer than five (5) years] after which time DMC must submit a new Assurance to OPRR.
On or before each anniversary of approval of the Assurance, DMC shall report in writing to OPRR:
1. any change in the DMC's program or facilities which would place the institution in a different institutional status (i.e., Category 1 and Category 2);
2. any change in the description of DMC's program for animal care and use; and
3. any changes in the membership of DMC's IACUC.
If there are no changes on or before the anniversary of approval of the Assurance, DMC shall submit a letter to OPRR stating that there are no changes.
DMC shall provide OPRR promptly with a full explanation of the circumstances and actions taken with respect to:
1. any serious or continuing noncompliance with these policies and procedures;
2. any serious deviation from the provisions of the Guide; or
3. any suspension of an activity by the DMC/IACUC.

Copies of the signed assurance and all related references, attachments and exhibits can be obtained from the Division of Laboratory Animal Resources (BSB 9-3, 270-1194) or the Office of Scientific Affairs (BSB2-71E, 270-2680).