Ques 1: What are the requirements of IAEC?
- The duration of appointment is for a period of 5 years (coterminous with registration).
- The committee is required to be reconstituted at the time of renewal of registration, and at least half of the members will be replaced.
- A member can be replaced in the event of death or long-term non-availability or for any action not commensurate with the responsibilities laid down in the guidelines deemed unfit for a member.
- A member can tender resignation from the committee with proper reasons to do so.
- All members should maintain absolute confidentiality of all discussions during the meeting and sign a confidentiality form.
- Conflict of interest should be declared by members of the IAEC.
- IAEC is required to formulate a SOP for its working requirements and follow it in all the meetings.
Ques 2: What are the quorum requirements for IAEC meetings?
- The minimum of 6 members are required to compose a quorum.
- All decisions should be taken in meeting and not by circulation of project proposals.
- Presence of CPCSEA nominee is a must. Link nominee can attend in case main nominee conveys his unavailability in writing to the Chairman IAEC.
- Socially aware nominee presence is compulsory in cases when research protocols involving small animals and large animals will be considered and at least in one meeting in a calendar year.
Ques 3: What is the role of CPCSEA Nominees?
- Nominee should be familiar with the CPCSEA guidelines, the concept of 3 R’s and other animal welfare issues. He/She must keep update of information or draft guidelines or rules and regulations, placed for comment. He/She should be familiar with animal experimentation procedures, husbandry conditions, supplies, humane way of dealing with animals, handling procedures etc.
- Nominee attached to educational institution should be through with the syllabus prescribed by the University/ College for a particular course.
- Nominee attached with research establishments should learn about the overall goal/ mandate of the establishment and keep himself/ herself abreast with the current and past work done by the institute in animal studies and thus be able to link the new studies proposed.
- Nominee must read the proposal attached with Agenda thoroughly and come prepared to attend the IAEC meeting.
- For any clarifications on the protocols, methods, either they should see more details with the investigators when the agenda is circulated or seek comments from CPCSEA.
- He/She should aim for humane/ethical issues and compliance to GLP principles, avoid repetitions of animal studies, expected out come and it’s impact, number and sex of animals used, source, health status, alternatives, reduction without loosing scientific conclusions etc.
- Nominee should not to indulge in arguments and heated debate but understand the merit of a study based on above principles.
- Nominee is expected to sign the necessary forms of each protocol and maintain a copy/ list in his/ her records.
- In case of proposals dealing with large animal, nominees should note that IAEC is only a recommending authority for such studies. Nominee should ascertain the capability of institution to perform studies on large animals and make sure his/ her recommendations find place in the minutes attached to CPCSEA.
- Nominee should forward a copy of the minutes of the IAEC meetings to the CPCSEA office within 15 days from the date of meeting/ inspection of animal house.
- If no meetings are held for 6 months in a row because of lack of projects or due to other reasons, nominee should notify to the CPCSEA about “no meetings” after confirmation/ verification with the organization.
- Nominee should visit/inspect animal house atleast once in a calendar year and submit the inspection report in the prescribed format to the CPCSEA office within a month from the date of inspection.
- If nominee requires assistance of any other expert to review a protocol he/ she can do so by consulting CPCSEA.
- The nominee would be paid sitting fee and reimbursement of travel expenditure by the establishment / institute as decided by CPCSEA, from time to time.
Ques 4: How to Conduct IAEC Meeting?
- The meeting of the IAEC should be held on scheduled intervals as prescribed in the concerned SOP of the IAEC and additional meetings may be held if there are reasons to do expedited review.
- The proposals will be sent to members at least 15 days in advance.
- Decisions will be taken by consensus after discussions. Negative view points should be recorded in the minutes. In case consensus is not reached, the case should be referred to CPCSEA.
- Researchers will be invited to offer clarifications if need be.
- Independent consultants/Experts will be invited to offer their opinion on specific research proposals if needed.
- The decisions will be minuted and Chairperson’s approval taken in writing with signature of all the IAEC members present.
Ques 5: What are 3Rs in Animal Experimentation?
Answer: The Three Rs (3Rs) in relation to science are guiding principles for more ethical use of animals in testing. They were first described by W. M. S. Russell and R. L. Burch in 1959. The 3Rs are:
Replacement: Replace the use of animals with alternative techniques, or avoid the use of animals altogether
Reduction: Reduce the number of animals used to a minimum, to obtain information from fewer animals or more information from the same number of animals.
Refinement: Refine the way experiments are carried out, to make sure animals suffer as little as possible. This includes better housing and improvements to procedures which minimise pain and suffering and/or improve animal welfare.