1.0 OBJECTIVE
1.1 To lay down a standard procedure to be followed for Institutional Animal Ethics Committee meeting and obtaining protocol approval for Experimentation on Animals.
2.0 SCOPE
2.1 This Standard Operating Procedure (SOP) shall be applicable for Institutional Animal Ethics Committee meeting and obtaining protocol approval for Experimentation on Animals.
3.0 RESPONSIBILITY
3.1 Head- Animal House Facility / Study Director
3.2 All members involve in-activity
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
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5.1 Functions of Institutional Animal Ethics Committee (IAEC)
5.1.1 IAEC should
provide an independent, competent, and timely review of the ethics of proposed studies
before the commencement of a study and regularly monitor the ongoing studies.
5.1.2 IAEC will review
and approve all research proposals involving animal experiments up to the physiological level only with a view to assure quality maintenance and welfare
of animals used in laboratory studies while conducting biomedical and
behavioral research and testing of products.
5.1.3 For experiments
on higher animals, the IAEC will forward its recommendation to the CCSEA (CPCSEA), New
Delhi, for its approval.
5.1.4 Monitor and
inspect the housing of animals of breeders/establishments and ensure that it is
as per specified standards.
5.1.5 Grant permission
for conducting experiments on animals. Regulate experiments on animals as per
stipulated conditions and standards.
5.1.6 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.
5.1.7 Ensure that
experiments on animals are avoided whenever it is possible to do so and propagate
the principles of 3Rs (Reduce, Refine & Replace the use of animals in experiments).
5.1.8 Ensure that
experiments on larger animals are avoided when it is possible to achieve the same
results by experiments upon small laboratory animals like guinea-pigs, rabbits,
frogs, rats, mice, and pottery.
5.1.9 Ensure that
required records are maintained with respect to experiments performed on animals.
5.1.10 Ensure that as
far as possible experiments are not performed merely for the purpose of
acquiring manual skills.
5.1.11 Ensure that animals intended for the performance of experiments are properly looked after both before and after experiments.
5.2 Composition of IAEC
5.2.1 The committee
will be nominated by the management & will be approved by COMPANY/INSTITUTE.
The composition of the committee will be as follows and will fulfill the
CPCSEA norms vide gazette Rule 13 of Breeding of and Experiments on Animals
(Control and Supervision) Rules 1998.
5.2.2 The composition
maybe as follows:
1.
Chairperson
2.
Two faculty
members of the institute, preferably involved in animal experiments, out of two one from the
non-clinical discipline.
3.
One
veterinarian involved in the care of animals
4.
In-charge
Animal House
5.
A scientist
from outside the institute
6.
One non-scientific
socially aware person
7.
One
representative or nominee of CCSEA (CPCSEA)
8.
One specialist
may be co-opted while reviewing special projects using hazardous agents such as
radio-active substances and deadly microorganisms.
9. Member-Secretary
5.3 Membership duration and responsibilities
5.3.1
The duration of
membership will be 5 years.
5.3.2 There will be no
bar on the members serving for more than one term but it is desirable to have
around one-third of fresh members.
5.3.3 A member can be
replaced in the event of long-term non-availability (three consecutive
meetings). The authority to replace the member shall be with the Director.
5.3.4 Members should
maintain the 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.
5.3.5 No Institutional
Animal Ethics Committee meeting can be held in the absence of the nominee of
CPCSEA. No decision pertaining to animal allotment and projects on the approval
of projects can take place in the absence of the nominee.
5.3.6 A minimum of 6 members, including at least two outside members, is required for a quorum. The presence of a CPCSEA member or nominee is mandatory for every meeting. The proposals of emergent need may be considered through circulation which will be decided by the TFM.
5.4 Offices/conduct of the meeting
5.4.1 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 CPSEA before communicating to the
PI. In any case, the meeting should not be held without the presence of a CCSEA
member or nominee.
5.4.2 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 a checklist of each protocol dealing with large animals must be sent
to CCSEA, New Delhi Office, for scrutiny by the Sub-committee members.
Clearance of large animal projects will be subject to the approval received from
the Sub-Committee for Large Animal Projects.
5.4.3 The CCSEA 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.
5.5 Application procedure
5.5.1
All proposals
should be submitted in the prescribed application form, copies of which will be
available with the Member Secretary.
5.5.2 All relevant
documents should be enclosed with the application.
5.5.3 The required
number of copies of the proposal along with the application and documents in the prescribed
format duly signed by the PI and Co-investigators/Collaborators should be forwarded
by the Head of the Department.
5.5.4 The Member
Secretary will acknowledge the receipt and indicate any lacunae. Missing
information should be supplied within two weeks.
5.5.5 The date of the meeting will be intimated to the PI who should be available to offer clarifications
if necessary.
5.5.6 The decision of IAEC will be communicated in writing. If a revision is to be made, the revised document in the required number of copies should be submitted within a stipulated period of time as specified in the communication.
5.6 Documentation
5.6.1 All research
proposals should be submitted with the following documents:
·
Title of the project
·
Names of the PI and Co-investigators with
designation.
·
Name of any other Institute/Hospital/Field area
where research will be conducted.
·
Endorsement of the Head of the Department.
·
Protocol of the proposed research.
·
Ethical issues in the study and plans to address
these issues.
·
Proposal should be submitted with all relevant
annexures like proforma, CV of outside members, undertaking, etc. to be used in
the study.
·
Any other information relevant to the study.
·
Agreement to submit six monthly progress report
and final report at the end of study.
· The PI 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).
5.7 Review procedure
5.7.1 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 the previous meeting). Additional meetings
will be held as and when necessary.
5.7.2 The proposals
will be sent to members at least 2 weeks in advance.
5.7.3 PI/Co-investigator
should be available during the meeting and may be invited to offer
clarifications.
5.7.4 Independent
consultants/Experts may be invited to offer their opinion on specific research
proposals.
5.7.5 The decisions of
the meeting shall be recorded in the minutes’ book and shall be confirmed
during the next meeting with the signature of the Chairperson on each page.
5.7.6 The minutes of each meeting will be signed by Chairperson and member Secretary, within 15 days of the meeting.
5.8 Element of review
·
Scientific design and conduct of the study.
·
Approval of the scientific review committee and
regulatory agencies.
·
Assessment of predictable risks/harms to the
animals.
·
Protocol and proforma of the study.
·
Plans for data analysis and reporting.
·
Adherence to all regulatory requirements and
applicable guidelines.
·
Competence of investigators, research, and
supporting staff.
·
Facilities and infrastructure in the animal
house.
5.9
Decisions making
5.9.1
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 the understanding of the Chair.
5.9.2
A member shall
withdraw from the meeting during the decision procedure concerning the 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.
5.9.3 Only members of
IAEC will make the decision. The decisions shall be taken in the absence of the study director/study personnel.
5.9.4 Decision may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection should be given.
5.10 Communicating the decision
5.10.1
Decision will be
communicated to PI by the Member Secretary in writing.
5.10.2 Suggestions for modifications and reasons for rejection shall be communicated to the PI.
5.11 Follow up procedures
5.11.1
Any new
information related to the study should be communicated to IAEC.
5.11.2
Premature
termination of study should be notified with reasons along with the summary of the
data obtained so far. The un-used animals may be surrendered to Animal House.
5.11.3
Change of
investigators should be done with the approval of IAEC.
5.11.4
Record keeping
and archiving Curriculum Vitae (CV) of all members of IAEC.
5.11.5
Minutes of all
meetings duly signed by the Chairperson & CCSEA nominee. Copy of all
correspondence with members, researchers, and other regulatory bodies.
5.11.6
Copy of existing
relevant national and international guidelines on research ethics and laws
along with amendments.
5.11.7 All study-related documents (study projects with enclosed documents) should be archived for minimum of five years after the completion of the study. A copy of the filled proforma related to the projects shall remain with the PI for a minimum of five years.
5.12 Updating IAEC members
5.12.1 All relevant information on Animal ethics will be brought to the attention of the members of IAEC by the Member Secretary.
5.13 Performance of experiments
5.13.1
Experiments shall
be performed under the supervision of a qualified person (Veterinary/ Medicine/Post
graduate above in life sciences/Pharmaceutical sciences/Lab animal
science/study director/study personnel) and under the responsibility of the person performing the experiment.
5.13.2
Experiment shall
be performed with due care and humanity.
5.13.3
Animals intended
for the performance of experiments shall be properly looked after both before
and after experiments by following the current running version of SOP/AH/004.
5.13.4
Study director
using experimental animal(s) shall be responsible for the welfare of the animal(s)
during their use in experiments.
5.13.5
Experiments
involving operative procedures shall be performed under anesthesia to be
administered by a veterinary surgeon/scientist/study director/study personnel
so trained for the purpose.
5.13.6
Animals which in a course of experiments under the influence of anesthesia are so injured that
their recovery would involve pain or suffering shall be euthanized by CO2
method.
5.13.7
Experiments shall
not be performed as a public demonstration.
5.13.8 No experiment the result of which is already conclusively known shall be repeated without justification.
5.14 Laboratory animal ethics
5.14.1
All scientists
working with laboratory animals must have a deep ethical consideration for the
animals they are dealing with. From the ethical point of view it is important
that such considerations are taken care at the individual level, at
institutional level and finally at the national level.
6.0 ENCLOSURES
6.1 Nil
7.0 ABBREVIATIONS
7.1
SOP : Standard Operating Procedure
7.2
QA : Quality Assurance Facility
7.3 AHF : Animal House Facility
8.0 REFERENCES
8.1
In-house
8.2 CCSEA (CPCSEA) guidelines.
9.0 REVISION HISTORY
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END OF THE DOCUMENT
You may like to read these links:
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the Animal House Facility
4. List of All SOPs and Documents for Invivo Laboratory
5. List of SOPs and Documents for CCSEA (CPCSEA)
6. BIOCHEMICAL DATA OF COMMON LABORATORY ANIMALS
7. HAEMATOLOGICAL DATA OF COMMON LABORATORY ANIMALS
8. COMMONLY USED ANAESTHETIC AGENTS FOR LABORATORY ANIMALS
9. MINIMUM SPACE RECOMMENDATIONS FOR LABORATORY ANIMALS
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