STANDARD OPERATING PROCEDURE (SOP)
INSTITUTIONAL ANIMAL ETHICS COMMITTEE (IAEC)
INDIRA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE
PUDUCHERRY
(2010)
Foreword
Animals have been used throughout the history of scientific research. It has been estimated that approximately 15 million animals are used to test drugs. The animal testing is based on the grounds of morality, the necessity of the procedure, whether such tests are actually needed and whether such tests practically provide any useful information to the scientific society.
The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) has been constituted under the provisions of the Prevention of Cruelty to Animals Act, 1960. It gives the guidelines for the conduct of animal experiments. CPCSEA has been in existence for the past 50 years and its role of is not to cause any hindrance to scientific research involving experiments on animals but to ensure that:
i) Animals are maintained in a proper and healthy manner.
ii) Animals are not subjected to unnecessary pain or suffering before, during and after performance of experiments on them
iii) There is no unnecessary sacrifice of animals for the sake of science. There should be no duplication of research.
iv) Animals are kept in disease free condition to ensure proper data collection.
v) Animals are procured from registered breeders.
vi) Experiments on large animals are to be avoided whenever it is possible to achieve the same results by experiments on small laboratory animals.
For effective implementation of these rules and guidelines, the Institutional Animals
Ethics Committees (IAEC) has been constituted in institutions conducting experiments on animals. This is a scientific body nominated by the Head of the Institution. The IAEC is required to examine proposals for conducting experiments on small animals, which would chiefly examine the necessity of performing the experiment, and ensure that experiments are not performed in a routine manner. All decisions are to be taken with the approval of the Committee. The Standard Operating Procedures (SOP) for Institutional Animal Ethics Committee for experimentations on animals will help the Principal Investigators, Animal Ethics Committee members and scientific researchers, for better understanding of the ethical procedures involved in animal experimentations.
CONTENTS
1. Standard Operating Procedure
2. Institutional Animal Ethics Committee
3. Investigator’s Declaration
4. Certificate
5. Check List
6. Record of Animals Acquired (Form D)
7. Undertaking by the Principal Investigator(s)
8. One Page CV of Principal Investigator(s)
9. One Page CV of Institutional Animal Ethics Committee Members
10. Secrecy Undertaking by Members of Institutional Animal Ethics Committee
11. Format for Progress Report (Six Monthly/Final)
12. List of Members of Institutional Animal Ethics Committee
Standard Operating Procedure (SOP) for Institutional Animal Ethics Committee for Experimentations on Animals at Indhira Gandhi Medical College & Research Institute, Puducherry.
1. Objective
The objective of Standard Operating Procedure (SOP) is to ensure quality and consistency in review of research proposals and to avoid infliction of unnecessary pain and suffering on animals before, during and after experiments.
To follow the CPCSEA guidelines under the provision of Section 15 of PCA Act 1960 (Ministry of Environment and Forests, Government of India-2008) and the Gazette of India 1998 for experiments on Animals.
In terms of Rule (2)e of Breeding and Experiments on Animals (Control and Supervision) Rule 1998 as amended “Experiment” means any programme or project involving use of animal(s) for the acquisition of knowledge of a biological, physiological, etiological, physical or chemical nature, and includes the use of animal(s) in the production of reagents and products such as antigen and antilbodies, routine diagnostics, testing activity, for the purpose of saving or prolonging life or alleviating suffering or significant gains in the well being for people of the country or for combating any disease, whether on human beings, animals or plants.
2. Functions of Institutional Animal Ethics Committee (IAEC)
IAEC should provide independent, competent and timely review of the ethics of a proposed study before the commencement of the same and regularly monitor the ongoing studies.
IAEC will review and approve all research proposals involving animal experiments with a view to assure quality maintenance and welfare of animals used in laboratory studies while conducting research.
For experiments on higher animals, the IAEC will forward its recommendation to the CPCSEA, New Delhi, for its approval.
IAEC will review the proposals before the start of the study, as well as monitor the research throughout the study and after completion of the study (through six monthly reports, final report). IAEC will visit the laboratory/animal house where the experiments are conducted. The committee will also ensure compliance with all regulatory requirements, applicable guidelines and laws.
IAEC will also:
i. Monitor and inspect the housing of animals of breeders/establishments to ensure that it is as per specified standards.
ii. Grant permission for conducting experiments on animals.
iii. Regulate experiments on animals as per stipulated conditions and standards.
iv. Ensure that animals which in course of the experiments are so injured that their recovery would involve serious sufferings are euthanized as per specified norms.
v. Ensure that experiments on animals are avoided whenever it is possible and propagate the principles of 3Rs (Reduce, Refine & Replace the use of animals in experiments).
vi. Ensure that experiments on larger animals are avoided when it is possible to achieve the same results by experiments upon small animals.
vii. Ensure that required records are maintained with respect to experiments performed on animals.
viii. Ensure that as far as possible experiments are not performed merely for the purpose of acquiring manual skill.
ix. Ensure that animals intended for the performance of experiments are properly looked after both before and after experiments.
3. Composition of IAEC
IAECs shall be multidisciplinary and multisectorial in composition.
The committee will be nominated by the Dean & will be approved by the Academic Board. The composition of the committee will be as follows, and will fulfil the CPCSEA norms vide gazette Rule 13 of Breeding of and Experiments on Animals (Control and Supervision) Rules 1998.
The composition may be as follows:
1. Chairperson
2. Dean
3. Two faculty members of the institute, preferably involved in animal experiments, out of two, one from the non-clinical discipline.
4. One veterinarian involved in the care of animals
5. In charge animal House
6. A scientist from outside the institute
7. One non-scientific socially aware person
8. One representative or nominee of CPCSEA
9. One specialist may be co-opted while reviewing special projects using hazardous agents such as radio-active substance and deadly micro - organisms
10. Member-Secretary
The Chairperson of the committee shall be from outside the Institution. The Member Secretary, drawn from college itself, shall conduct the business of the Committee. Other members will be a mix of medical and non-medical, scientific and non-scientific persons to reflect differed viewpoints.
4. Membership duration and responsibilities
1. The duration of membership will be 3 years
2. There will be no bar on the members serving for more than one term but it is desirable to have around one third fresh members.
3. A member can be replaced in the event of long-term non-availability (three consecutive meetings). Authority to replace the member shall be with the Director.
4. Members should maintain confidentiality of all discussions during the meeting and sign a confidentiality form at the start of their term. Each member of the committee will submit a declaration to maintain the confidentiality of the documents submitted to them during their membership period.
5. Quorum requirements
A minimum of 5 members, including at least two outside members, is required for quorum. The proposals of emergent need may be considered through circulation which will be decided by the Dean.
6. Offices/conduct of the meeting
The Chairperson will conduct all meetings of the IAEC. If, for reasons beyond control, the Chairperson is not available, an alternate Chairperson will be elected by the members present from among themselves. The Member Secretary will be responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get them approved by the Chairperson & nominee of CPCSEA before communicating to the Principal Investigator. In any case the meeting should not be held without the presence of CPCSEA member or nominee.
Before finalizing a project, the IAEC Chairperson should call for a preliminary meeting with the project leaders or guides and request them to detail the projects. After finalizing the project proposal, the IAEC protocols dealing with small animals should be posted to the nominee one month prior to the IAEC meeting while 16 copies with check list of each protocol dealing with large animals must be sent to CPCSEA, New Delhi Office, for scrutiny by the Sub-committee members. Clearance of large animal project will be subject to the approval received from the Sub-Committee for large animal Projects. The CPCSEA may authorize an additional representative to attend the IAEC meeting. Such authorized personnel should be permitted to attend the meeting and take part in the proceedings.
7. Application procedure
1. All proposals should be submitted in the prescribed application form, copies of which will be available with the Member Secretary.
2. All relevant documents should be enclosed with application.
3. The required number of copies of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator and Co-investigators/Collaborators should be forwarded by the Head of the Department.
4. The Member Secretary will acknowledge the receipt and indicate any lacunae. Missing information should be supplied within two weeks.
5. The date of meeting will be intimated to the Principal Investigator who should be available to offer clarifications if necessary.
6. The decision of IAEC will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication.
8. Documentation
All research proposals should be submitted with the following documents:
1. Title of the project
2. Names of the Principal Investigator and Co-investigators with designation.
3. Name of any other Institute/Hospital/Field area where research will be conducted.
4. Endorsement of the name of Head of the Department.
5. Protocol of the proposed research.
6. Ethical issues in the study and plans to address these issues.
7. Proposal should be submitted with all relevant annexure like proforma, Curriculum Vitae of outside members, undertaking etc. to be used in the study.
8. Any other information relevant to the study.
9. Agreement to submit six monthly progress report and final report at the end of study.
10. The Principal Investigator should provide the details of other ongoing research projects related to the Animal studies (Title of the project, Date of starting and duration, source and amount of funding).
9. Review procedure
1. Meetings of IAEC shall be held on scheduled intervals as prescribed (every 6 months, for which the month will be decided at the end of previous meeting). Additional meetings will be held as and when necessary.
2. Even if there are no projects, it is mandatory to call for an IAEC meeting at least once in 6 months to discuss matters related with maintenance of the animals in the animal houses. The animal house in-charge must be present with all available records at every IAEC meeting.
3. The proposals will be sent to members at least 2 weeks in advance.
4. Principal Investigator / Co-investigator should be available during the meeting and may be invited to offer clarifications.
5. Independent consultants/Experts may be invited to offer their opinion on specific research proposals.
6. The decisions of the meeting shall be recorded in the minutes book and shall be confirmed during the next meeting with signature of Chairperson at each page.
7. The minutes of each meeting will be signed by Chairperson, Member Secretary, within 15 days of the meeting.
10. Element of review
1. Scientific design and conduct of the study.
2. Approval of scientific review committee and regulatory agencies.
3. Assessment of predictable risks/harms to the animals.
4. Protocol and proforma of the study.
5. Plans for data analysis and reporting.
6. Adherence to all regulatory requirements and applicable guidelines.
7. Competence of investigators, research and supporting staff.
8. Facilities and infrastructure in the animal house.
11. Decision making
1. Decision of IAEC would normally be taken by consensus. If divergent views are expressed by the members, these may be recorded in the minutes and a broad consensus be recorded as per understanding of the Chair.
2. A member shall withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises. This shall be indicated to the chairperson prior to the review of the application and recorded in the minutes.
3. Only members will make the decision. The decisions shall be taken in the absence of investigators & consultants.
4. Decision may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection should be given.
12. Communicating the decision
1. Decision will be communicated to Principal Investigator by the Member Secretary in writing.
2. Suggestions for modifications and reasons for rejection shall be communicated to the Principal Investigator.
13. Follow up procedures
1. Deviations from the project are not allowed, without the permission from IAEC.
2. Any new information related to the study should be communicated to IAEC.
3. Premature termination of study should be notified with reasons along with summary of the data obtained so far. The un-used animals may be surrendered to Animal House.
4. Change of investigators should be done with the approval of IAEC.
14. Record keeping and archiving
All of the following documents must be stored for a period of five years.
1. Curriculum Vitae (CV) of all members of IAEC.
2. Minutes of all meetings duly signed by the Chairperson & CPCSEA nominee, copy of all correspondence with members, researchers and other regulatory bodies.