I have prepared this Policy for the FC College. Hopefully, it will be adopted by the College. Other institutions should feel free to adopt it by using it, after making the necessary modifications.
Anees Jillani
Forman Christian College Policy for the Utilization and Care of Vertebrate 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.
Whenever Forman Christian College develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever any of the departments or agencies within the Forman Christian College actually perform or sponsor such procedures, the responsible Departmental or Agency Official shall ensure that these principles are adhered to:
I. The transportation, care, and use of animals should be in accordance with the The Prevention of Cruelty of Animals Act, 1890. (XI of 1890) and other applicable laws, rules and regulations.
II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
III. The animals selected for a procedure should 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.
IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
V. 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 should not be performed on unanesthetized animals paralyzed by chemical agents.
VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, 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. In any case, veterinary care shall be provided as indicated.
VIII. 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.
IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.
I. Introduction
It is the Policy of Forman Christian College to require all its Departments and Agencies to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities (hereinafter referred to as activities) conducted or supported by Forman Christian College.
II. Applicability
This Policy is applicable to all Forman Christian College – conducted or supported activities involving animals, whether the activities are performed at a Forman Christian College Department or Agency, an awardee institution, or any other institution. No Forman Christian College support for an activity involving animals will be provided to an individual unless that individual is affiliated with or sponsored by an institution which can and does assume responsibility for compliance with this Policy, unless the individual makes other arrangements with the Forman Christian College. This Policy does not affect applicable Federal or Provincial laws, rules or regulations which impose more stringent standards for the care and use of laboratory animals. All departments, agencies and institutions are required to comply, as applicable, with the Prevention of Cruelty of Animals Act, 1890 (XI of 1890), and other Federal or Provincial laws, rules and regulations relating to animals.
III. Definitions
- Animal – Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.
B. Animal Facility – Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A satellite facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours.
C. Prevention of Cruelty of Animals Act – The Prevention of Cruelty of Animals Act, 1890 (XI of 1890), and other Federal or Provincial rules and regulations relating prescribed therein.
D. Animal Welfare Assurance – The documentation from a department, agency or institution assuring institutional compliance with this Policy.
E. Institution – Any public or private organization, business, or agency (including components of Federal, provincial, and local governments).
F. Institutional Official – An individual who signs, and has the authority to sign the Department, Agency or Institution’s Assurance, making a commitment on behalf of the institution that the requirements of this Policy will be met.
G. Forman Christian College – Formal Christian College includes all its departments, agencies, and/ or institutions and covers all its employees, and students, whether full time or part-time, and its contractors and sub-contractors.
H. Quorum – A majority of the members of the Departmental Animal Care and Use Committee.
IV. Implementation by Institutions
A. Animal Welfare Assurance
No activity involving animals may be conducted or supported by the Forman Christian College until the institution conducting the activity has provided a written Assurance accept-able to the Forman Christian College, setting forth compliance with this Policy. Assurances shall be submitted to the Office of the Rector.The Assurance shall be signed by the Head of the Department. The Office of the Rector will provide the Department with necessary instructions and an example of an acceptable Assurance. All Assurances submitted to the Forman Christian College in accordance with this Policy will be evaluated by the Office of the Rector to determine the adequacy of the institution’s proposed program for the care and use of animals in Forman Christian College – conducted or supported activities. On the basis of this evaluation Office of the Rector may approve or disapprove the Assurance, or negotiate an approvable Assurance with the institution. Approval of an Assurance will be for a specified period of time (no longer than three years) after which time the department, agency, or institution must submit a new Assurance to the Office of the Rector. The Office of the Rector may limit the period during which any particular approved Assurance shall remain effective or otherwise condition, restrict, or withdraw approval. Without an applicable Forman Christian College-approved Assurance, no Forman Christian College-conducted or supported activity involving animals at the institution will be permitted to continue.
1. Departmental Program for Animal Care and Use
The Assurance shall fully describe the institution’s program for the care and use of animals in Forman Christian College-conducted or supported activities. The program description must include the following:
a. a list of every branch and major component of the department, agency, or institution, as well as a list of every branch and major component of any other institution, which is to be included under the Assurance;
b. the lines of authority and responsibility for administering the program and ensuring compliance with this Policy;
- the qualifications, authority, and responsibility of the veterinarian(s) who will participate in the program and the percent of time each will contribute to the program;
d. the membership list of the Departmental Animal Care and Use Committee(s) established in accordance with the requirements set forth in IV.A.3. of this Policy;
e. the procedures which the Department will follow to fulfill the requirements set forth in this Policy;
f. the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;
g. a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;
h. the gross square footage of each animal facility (including satellite facilities), the species housed therein and the average daily inventory, by species, of animals in each facility; and
i. any other pertinent information requested by the Office of the Rector.
2. Institutional Status
All of the department, agency or institution’s programs and facilities (including satellite facilities) for activities involving animals will be reevaluated by the Office of the Rector least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports prepared in accordance with IV.B.3. of this Policy.
3. Departmental Animal Care and Use Committee
a. The Head of the Department, Agency or the Institution, shall appoint an Institutional Animal Care and Use Committee, qualified through the experience and expertise of its members to oversee the institution’s animal program, facilities, and procedures.
b. The Assurance must include the names,position titles, and credentials of the Departmental Animal Care Committee’s chairperson and the members. The committee shall consist of not less than five members, and shall include at least:
(1) one Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution (see IV.A.1.c.);
(2) one practicing scientist experienced in research involving animals;
(3) one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy); and
(4) one individual who is not affiliated with the institution in any way other than as a member of the Departmental Animal Care Committee, and is not a member of the immediate family of a person who is affiliated with the institution.
c. An individual who meets the requirements of more than one of the categories detailed in IV.A.3.b.(1)-(4) of this Policy may fulfill more than one requirement. However, no committee may consist of less than five members.
B. Functions of the Departmental Animal Care and Use Committee
As an agent of the department, agency or institution, the Departmental Animal Care Committee shall with respect to Forman Christian College-conducted or supported activities:
- 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;
- inspect at least once every six months all of the institution’s animal facilities (including satellite facilities) using this Policy as a basis for evaluation;
- prepare reports of the Departmental Animal Care Committee evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Head of the Department; (NOTE: the reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the institution and made available to the Office of the Rector upon request. The reports must contain a description of the nature and extent of the institution’s adherence to this Policy and must identify specifically any departures from the provisions of this Policy, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, consistent with this Policy, and, in the judgment of the Departmental Animal Care Committee and the Head of the Department, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.
- review concerns involving the care and use of animals at the institution;
- make recommendations to the Head of the Department regarding any aspect of the department’s animal program, facilities, or personnel training;
- review and approve, require modifications in (to secure approval) or withhold approval of those components of Forman Christian College-conducted or sup-ported activities related to the care and use of animals as specified in IV.C. of this Policy;
- review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and
- be authorized to suspend an activity involving animals in accordance with the specifications set forth in IV.C.6 of this Policy.
C. Review of Forman Christian College -Conducted or Supported Research Projects
1. In order to approve proposed research projects or proposed significant changes in ongoing research projects, the Departmental Animal Care Committee shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. In making this determination, the Departmental Animal Care Committee shall confirm that the research project will be conducted in accordance with the Prevention of Cruelty Against Animals Act insofar as it applies to the research project, and that the research project is consistent with this Policyunless acceptable justification for a departure is presented.Further, the Departmental Animal Care Committee shall determine that the research project conforms with the department’s 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 recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
2. Prior to the review, each Departmental Animal Care Committee’s member shall be provided with a list of proposed research projects to be reviewed. Written descriptions of research projects that involve the care and use of animals shall be available to all Departmental Animal Care Committee’s members, and any member of the Departmental Animal Care Committee may obtain, upon request, full committee review of those research projects. If full committee review is not requested, at least one member of the Departmental Animal Care Committee, designated by the chairperson and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval) or request full committee review of those research projects. If full committee review is requested, approval of those research projects may be granted only after review at a convened meeting of a quorum of the Departmental Animal Care Committee and with the approval vote of a majority of the quorum present. No member may participate in the Departmental Animal Care Committee’s review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the Departmental Animal Care Committee; nor may a member who has a conflicting interest contribute to the constitution of a quorum.
3. The Departmental Animal Care Committee may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the Departmental Animal Care Committee unless they are also members of the Departmental Animal Care Committee.
4. The Departmental Animal Care Committee shall 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 Departmental Animal Care Committee’s approval. If the decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
5. The Departmental Animal Care Committee shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the Departmental Animal Care Committee, including a complete review in accordance with IV.C.1.-4. at least once every three years.
6. The Departmental Animal Care Committee 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 Prevention of Cruelty Against the Animals Act, the Guide, the Institution’s Assurance, or IV.C.1.a.-g. of this 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.
7. If the IACUC suspends an activity involving animals, 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.
8. Applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the institution. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC.
D. Information Required in Applications and Proposals for Awards Submitted to Forman Christian College
1. All Institutions
Applications and proposals (competing and non-competing) for awards submitted to Forman Christian College that involve the care and use of animals shall contain the following information:
a. identification of the species and approximate number of animals to be used;
b. rationale for involving animals, and for the appropriateness of the species and numbers used;
c. a complete description of the proposed use of the animals;
d. a description of procedures designed to assure 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; and
e. a description of any euthanasia method to be used.
Non-competing applications and contract proposals for other than full and open competitions need not repeat the information required by IV.D.1.a.-e. if the information was complete in the last competing application or proposal and there are no significant changes to that information. However, the application or proposal must contain a statement to that effect. If there are significant changes in the information, then the application or proposal must specifically identify them and state the reasons for the changes.
2. Departments That Have an Approved Assurance
Applications or proposals (competing and non-competing) covered by this Policy from departments, agencies or institutions which have an approved Assurance on file with the Office of the Rector shall include verification of approval (including the date of the most recent approval) by the Departmental Animal Care Committee of those components related to the care and use of animals. For competing applications or proposals only, such verification may be filed any time prior to award unless specifically required earlier by the funding component. If verification of Departmental Animal Care Committee’s approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the Departmental Animal Care Committee. The verification shall be signed by an individual authorized by the department, but need not be signed by the Departmental Official.
3. Departments That Do Not Have an Approved Assurance
For applications and proposals covered by this Policy from departments that do not have an approved Assurance on file with the Office of the Rector, the signature of the official signing for the applicant department shall constitute a declaration that the department will submit an Assurance when requested by the Office of the Rector. Upon such request, the department shall prepare the Assurance as instructed by the Office of the Rector and in accordance with IV.A. of this Policy. The authorized Departmental Animal Care Committee shall review those components of the application or proposal as required by IV.C. of this Policy. Upon Departmental Animal Care Committee approval of those components of the application or proposal, the department shall submit the Assurance to the Office of the Rector.
E. Recordkeeping Requirements
1. The awardee department shall maintain:
a. a copy of the Assurance which has been approved by the Forman Christian College;
b. minutes of Departmental Animal Care Committee’s meetings, including records of attendance, activities of the committee, and committee deliberations;
c. records of applications, proposals, and proposed significant changes in the care and use of animals and whether Departmental Animal Care Committee approval was given or withheld;
d. records of semiannual Departmental Animal Care Committee’s reports and recommendations (including minority views) as forwarded to the Departmental Official; and
e. records of accrediting body determinations.
2. All records shall be maintained for at least one year; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the Departmental Animal Care Committee shall be maintained for the duration of the activity and for an additional one year after completion of the activity. All records shall be accessible for inspection and copying by authorized Office of the Rector or other Forman Christian College representatives at reasonable times and in a reasonable manner.
F. Reporting Requirements
1. At least once every 12 months, the Departmental Animal Care Committee, through the Institutional Official, shall report in writing to the Office of the Rector:
a. any change in the department’s program or facilities which would place the institution in a different category than specified in its Assurance (see IV.A.2.of this Policy);
b. any change in the description of the department’s program for animal care and use as required by IV.A.1.a.-i. of this Policy;
c. any changes in the Departmental Animal Care Committee membership; and
d. notice of the dates that the Departmental Animal Care Committee conducted its semiannual evaluations of the department’s program and facilities and submitted the evaluations to the Departmental Official.
2. At least once every 12 months, the Departmental Animal Care Committee, at a department which has no changes to report as specified in IV.F.1.a.-c. of this Policy, shall report to the Office of the Rector in writing, through the Departmental Official, that there are no changes and inform the Office of the Rector of the dates of the required Departmental Animal Care Committee’s evaluations and submissions to the Departmental Official.
3. The Departmental Animal Care Committee, through the Departmental Official, shall promptly provide the Office of the Rector with a full explanation of the circumstances and actions taken with respect to:
a. any serious or continuing noncompliance with this Policy;
b. any suspension of an activity by the Departmental Animal Care Committee.
4. Reports filed under IV.F. of this Policy shall include any minority views filed by members of the Departmental Animal Care Committee.
V. Implementation by Forman Christian College
A. Responsibilities of the Office of the Rector
The Office of the Rector is responsible for the general administration and coordination of this Policy and will:
1. request and negotiate, approve or disapprove, and, as necessary, restrict or withdraw approval of Assurances;
2. distribute to Scientific Review Administrators of initial review and technical evaluation groups, and to Forman Christian College awarding units, lists of institutions that have an approved Assurance;
3. advise awarding units and awardee institutions concerning the implementation of this Policy;
4. evaluate allegations of noncompliance with this Policy;
5. have the authority to review and approve or disapprove waivers to this Policy (see V.D. of this Policy); and
6. conduct site visits to selected institutions.
B. Responsibilities of Forman Christian College Awarding Units
Forman Christian College awarding units may not make an award for an activity involving animals unless the prospective awardee department and all other participating institutions have approved Assurances on file with the Office of the Rector, and the awardee department has provided verification of approval by the Departmental Animal Care Committee of those components of the application or proposal related to the care and use of animals. If any one of these departments do not have an approved Assurance on file with the Office of the Rector, the awarding unit will ask the Office of the Rector to negotiate an Assurance with the institution(s) before an award is made. No award shall be made until all required Assurances have been submitted by the department(s), been approved by the Office of the Rector, and the department(s) have provided verification of approval by the Departmental Animal Care Committee of those components of the application or proposal related to the care and use of animals.
C. Conduct of Special Reviews/Site Visits
Each awardee department is subject to review at any time by Forman Christian College staff and advisors, which may include a site visit, in order to assess the adequacy or accuracy of the department’s compliance or expressed compliance with this Policy.
D. Waiver
Departments may request a waiver of a provision or provisions of this Policy by submitting a request to the Office of the Rector. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by the Office of the Rector.