Animal Ethics Committee Member List as on July 2006
Guidelines The guidelines for conducting a research project for Ethics Committee approval are as follows :
All prospective studies on drugs, investigational techniques as well as devices or any other procedure involving animals, to be conducted at Seth G.S. Medical College & K.E.M. Hospital, must have Animal Ethics Committee permission before commencing such a study.
Investigators and other personnel should treat animals with kindness and should proper care by avoiding or minimizing discomfort, distress or pain. Procedures that may cause more than momentary pain or distress should be performed with appropriate sedation, analgesia or anaesthesia in accordance with accepted veterinary practice. Surgical or other painful procedures should not be performed on unanaesthetized animals. At the end of the experiments or whenever appropriate during an experiment an animal that would otherwise suffer any pain distress or disable mint that can not be relieved or repaired should be painlessly killed under anaesthesia. The best possible living conditions should be provided to animals used for research purpose. It is a responsibility of an investigator to ensure that personnel conducting experiments on animals possess appropriate qualifications and / or experience for conducting the required procedure.
Each research proposal should be submitted along with a duly completed Animal Ethics Committee proforma, which is available at the office of the Animal Ethics Committee & also on intranet. The proforma should be typed and not hand written. It should have names and designation of Principal Investigator and co-investigators. The form should be forwarded through the Head of Department. The other details in the proforma such as type of animals, nature of the study, duration of study, rationale for study, whether survival surgery will be performed etc. must be completed.
A user fee of Rs. 1000/- will be charged for all sponsored projects. Academic projects, which are not sponsored, will be charged a nominal-processing fee of Rs. 250/-. The fee will be collected at the time of submission of the project. The amount to be collected, as processing fee will be reviewed at the end of 1 year.
Along with the AEC proforma, the project summary & the detailed study proposal, which includes background and rationale, objectives, study procedures, statistical methods should be submitted.
AEC proforma, summary & study proposal should be submitted as one original copy & 2 photocopies. The filled forms should be submitted on /before 5th of every month in the AEC office.
INTRODUCTION
Animal Ethics Committees have the responsibility to safeguard the safety and well being of animals involved in research. The Animal Ethics Committee (AEC) of the Seth GS Medical College and K.E.M. Hospital was instituted in 1998.
At present, this committee works according to the guidelines laid down in the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA). The ethical principles laid in these guidelines direct the institution in the conduct of all its animal research.
The members listed on page 8 declare this document to be the Standard Operating Procedure of the Animal Ethics Committee, Seth G.S. Medical College & K. E. M. Hospital.
I. Name
This committee is known as the Animal Ethics Committee for Research on Human Subjects (AEC). This name will remain unchanged until the members choose to change it by a vote of three-fourths of the current strength.
II. Purpose
The primary purpose of this committee is:
To promote the human care of animals used in biomedical and behavioral research. To safeguard the welfare of animals used in research. To assist investigators to conduct animal research in accordance with the CPCSEA guidelines.
III.Membership
As of July 2006, the committee consists of 10 members who collectively have the experience to review and evaluate the scientific, and ethical aspects of a proposed animal research project. A list of committee members, their qualifications and their affiliations is maintained in the committee’s records as described on page 8 of this document.
Members
The Members will be regular members for a period of up to five (5) years, or until they cease to be members either at their own request or by a decision of the other committee members, whichever happens first. New members will be elected to replace members who have resigned or whose tenures of membership have expired, according to the process described on
Regular Members
The regular members of the committee will ideally include at least 7, and a maximum of 11, individuals as follows: Scientists with experience and expertise in animal research. CPCSEA nominee A veterinary doctor The committee will have representation from both men and women At least one of the members will be independent of the institution or study site of the research proposal
Chairperson
The committee members will elect a Chairperson from among themselves. The Chairperson will be responsible for conducting all committee meetings, and will lead all discussions and deliberations pertinent to the review of
research proposals.
The Chairperson will preside over all administrative matters pertinent to the committee’s functions. In case of anticipated absence, the Chairperson will nominate a committee member as Acting Chairperson. The Acting Chairperson will have all the powers of the Chairperson for that meeting.
Member Secretary
The committee members will elect a Member Secretary from among themselves In consultation with the Chairperson, the Member Secretary will be responsible for the following functions : Receiving all research proposals concerning animals. Forwarding all proposals for review by the committee members. Establishing time limits for receipt of reviewers’ comments. Preparation and dissemination of agenda for all committee meetings. Inviting special attendees from relevant therapeutic areas to the scheduled meetings. Notification of review outcome to investigators of research proposals. Prepar ation of minutes of the meeting. Retention and safekeeping of all records and documentation. Performance of other duties assigned by the Chairperson.
Tenure of Membership
Except for the CPCSEA nominee,
The tenure of committee membership will be for a continuous period of five (5) years. Extension of membership will be determined by a vote of two-thirds of the members present in a quorum at a regular committee meeting. There is no limit to the number of times that membership can be extended.
Election of New Members
All new members other than the CPCSEA nominee will be elected if a regular member: completes his tenure and does not wish to continue his membership. resigns is unable to continue working on the committee. fails to perform his responsibilities as described in this document, and as judged by the Chairperson on specific grounds. retires from the position in the institution
A new member is elected from the same category as that of the member being replaced.
IV. Responsibilities of the Committee
The committee’s primary responsibility is the protection of well- being of animals used for the pursuit of knowledge. The committee also upholds the investigator’s right to confidentiality of proprietary information. The committee will review all research proposals submitted to it within specified time limits. The committee will maintain concise but clear documentations of its views on the research proposal. The committee will review the progress of each research project at appropriate and specified intervals, but not less than once a year. The committee will review the qualifications of all investigators participating in the proposed research study.
V. Functions and Operations1. Guidelines
The guidelines for conducting a research project for Ethics Committee approval are as follows :
All prospective studies on drugs, investigational techniques as well as devices or any other procedure involving animals, to be conducted at Seth G.S. Medical College & K.E.M. Hospital, must have Animal Ethics Committee permission before commencing such a study.
Investigators and other personnel should treat animals with kindness and should proper care by avoiding or minimizing discomfort, distress or pain. Procedures that may cause more than momentary pain or distress should be performed with appropriate sedation, analgesia or anaesthesia in accordance with accepted veterinary practice. Surgical or other painful procedures should not be performed on unanaesthetized animals. At the end of the experiments or whenever appropriate during an experiment an animal that would otherwise suffer any pain distress or disable mint that can not be relieved or repaired should be painlessly killed under anaesthesia. The best possible living conditions should be provided to animals used for research purpose. It is a responsibility of an investigator to ensure that personnel conducting experiments on animals possess appropriate qualifications and / or experience for conducting the required procedure.
Each research proposal should be submitted along with a duly completed Animal Ethics Committee proforma, which is available at the office of the Animal Ethics Committee & also on intranet. The proforma should be typed and not hand written. It should have names and designation of Principal Investigator and co-investigators. The form should be forwarded through the Head of Department. The other details in the proforma such as type of animals, nature of the study, duration of study, rationale for study, whether survival surgery will be performed etc. must be completed.
A user fee of Rs. 1000/- will be charged for all sponsored projects. Academic projects, which are not sponsored, will be charged a nominal-processing fee
of Rs. 250/-. The fee will be collected at the time of submission of the project. The amount to be collected, as processing fee will be reviewed at the end of
one year.
Along with the AEC proforma, the project summary & the detailed study proposal, which includes background and rationale, objectives, study procedures, statistical methods should be submitted. AEC proforma, summary & study proposal should be submitted as one original copy & 2 photocopies.
2. Meetings
The committee will hold regular meeting once every four (4) weeks. When there are no research proposals to review, the meeting may be held less frequently. All regular members will receive notification of meeting schedules at least one week in advance. Meetings will be held as scheduled provided there is a quorum. A quorum is defined as half of the current regular members of the committee, rounded off to the next higher whole number (e.g. 4 out of 7). All projects will be reviewed by all members of the Animal Ethics Committee before the meeting. The review is both for scientific content and ethical principles.
If in the written review process no objection/queries are raised about the submitted projects then the projects will be passed even when less members than the
quorum are present [at least 3, with Member Secretary, Chairman (or nominated Acting Secretary of Chairman) and one member. Hierarchy
There is one Chairperson and one Member Secretary. The Chairman is the head of the committee. The Member Secretary is the guardian of all documents and funds in the committee’s possession. All other members are regular committee members with equal ranking. The proceedings of all meetings are recorded in English and in the form of minutes. The Member Secretary is responsible for coordination and recording of the minutes of the meeting which are recorded in English.
3. Majority Vote
A majority vote for approval, disapproval, request for modifications or information, suspension or termination of the research proposal or ongoing study is
defined as one-half of the members who have reviewed the project.
All voting members present at the review vote on the research proposal. If any member(s) of the committee is/are participating in the research project under discussion, they opt out from all deliberations on the project. No one may vote on a protocol in which he or she is listed as an investigator/sub-investigator. This is recorded in the minutes of the meeting. However, the investigator/sub-investigator may be called into provide clarifications on the study protocol.
4. Procedure
All communications with the committee are in writing. The completed proforma is accepted in office of the Animal Ethics Committee till the 5th of every month and are then circulated to all Animal Ethics Committee members. The meeting of all members is held in the first week of each month where each project is discussed and decisions arrived at. The CPCSEA comments are also discussed. The comments are sent to all investigators and approval is by the Member Secretary after receipt of revised documents/answers to queries. In case of major objections, revised protocol or clarifications are re-circulated and discussed again at next meeting. If necessary, the concerned investigator is invited to attend the meeting to provide clarifications on the queries raised.
5. Review Outcome
The committee documents its views in the following manner :
Permission to commence the study Study is passed in principle but clarification is required for technical queries. (Member Secretary is authorised to issue permission of commencement after appropriate clarifications are received). Study is passed in principle but permission of commencement is withheld till approval of CPCSEA is obtained to conduct clinical studies with new drugs. Clear disapproval giving reasons
6. Notification of Review Outcome
The outcome of committee’s review is recorded in writing within a week of the date of review and conveyed to the investigator within a further week.
7. Procedures for Appeal
For research proposals rejected by the committee, the applicant may appeal for a repeat review in within, within twelve (12) weeks of the receipt of the committee’s decision. While doing so, the applicant shall give justification relevant to the issues/objections raised by the committee. In such appeal cases, the committee considers inviting independent experts in the relevant field as special invitees who may give additional assessment of the research proposal.
8. Review of Amendments to the Approved Research Proposal
All amendments to the approved research proposal shall be submitted to the committee immediately after review of the original proposal.
9. Review of On-going Studies
The committee conducts a continuing review of each on-going study by obtaining the status report from the investigator at intervals appropriate to the degree or risk to the research animals, but at least once a year.
VI. Reports Required of Research Investigators
The research investigator should submit the following reports to the committee:
Annual Progress Reports Any changes or deviations in protocol which may increase the risk to animals involved in research. Any new information that may affect adversely the safety of the animals.
VII. Records Retention
The committee retains the following records for a period of at least 15 years after the completion of a study:
Standard operating procedures (SOPs) in effect at the time of review Membership list at the time of review Occupation/affiliations of the members at the time of review All documents pertinent to the research proposal Minutes of meetings All correspondence with the research investigator
VIII. Reports to the Institutional Authorities
The committee makes a yearly activity report for submission to the relevant institutional authorities, which includes the following elements:
A quantitative evaluation of the activities of the committee in a year The list of the proposals reviewed in a year Status of each study proposal IX Location and business address: The location and business address of the committee is as follows :
Address: Animal Ethics Committee Ayurveda Research Center 2nd Floor, Mortuary Building, Above CCBL, Seth GSMC & KEM Hospital, Parel, Mumbai – 400 012, Maharashtra Phone no: Direct: 022-24181744 Operator: 022-24136051 ext: 2046 Fax: 022-24121711 E-mail: kemarcATvsnl.com
XI. Amendments to the Standard Operating Procedures
a Amendments to the Standard Operating Procedures of the Animal Ethics Committee, Seth G.S. Medical College & K.E.M. Hospital (AEC) are proposed The proposal for amendment is submitted to the Member Secretary. The proposal for amendment is presented to the regular members at a scheduled committee meeting. Only regular members can vote to accept or reject the proposed amendment. A proposed amendment is approved by a vote of three-fourths of the members present in a quorum at a scheduled committee meeting, rounded to the next whole number |
Animal ethics committee |