1.1. This Committee shall be called the "Institutional Animal Ethics Committee" (hereinafter referred to as "IAEC" or "the Committee") of Netaji Subhas Medical College and Hospital, Amhara, Bihta, Bihar.
1.2. The Committee is established in accordance with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines issued under the Prevention of Cruelty to Animals Act, 1960 (Act 59 of 1960), and Rule 7 of the Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998.
1.3. The Committee shall function as the statutory body responsible for ensuring that animal experiments conducted in the medical college are performed humanely and in accordance with the principles of Replacement, Reduction, and Refinement (3Rs), and that animal welfare is given paramount consideration in all research and educational activities involving animals.
1.4. The Committee shall be registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forest and Climate Change, Government of India.
To ensure that all experiments on animals conducted in the institution are performed in accordance with the Prevention of Cruelty to Animals Act 1960, CPCSEA guidelines, and ethical principles of animal welfare.
To review and approve all research protocols involving animals from an ethical standpoint before commencement of experiments.
To ensure that animals used in experiments are treated humanely and that pain, suffering, distress, and discomfort are minimized through appropriate anesthesia, analgesia, and humane endpoints.
To promote the implementation of the 3Rs principles (Replacement, Reduction, and Refinement) in all animal-based research and teaching.
To ensure that all animal experiments are scientifically justified and that the expected benefits outweigh any harm to animals.
To monitor the conditions under which animals are bred, housed, maintained, transported, and used in the institution.
To ensure compliance with statutory requirements regarding registration, record-keeping, and reporting of animal experiments.
To provide guidance and training to researchers, students, and animal house staff on ethical and humane treatment of laboratory animals.
To ensure that adequate veterinary care is available for all animals used in experiments.
To conduct regular inspections of animal house facilities and experimental areas to ensure compliance with prescribed standards.
The Committee shall have the following functions and powers:
To review and evaluate all research proposals involving animals:
Assess scientific justification and merit of proposed experiments
Evaluate ethical aspects and potential impact on animal welfare
Ensure adherence to 3Rs principles (Replacement, Reduction, Refinement)
Verify qualifications and training of investigators and animal handlers
Review sample size justification and statistical methodology
Assess appropriateness of species, strain, age, and sex of animals
Evaluate anesthesia, analgesia, and post-operative care protocols
Review humane endpoints and euthanasia methods
Ensure availability of adequate facilities and resources
To grant approval, request modifications, or reject proposals based on ethical considerations:
Issue formal approval letters for ethically sound proposals
Request modifications when deficiencies are identified
Reject proposals that fail to meet ethical standards or lack scientific merit
Set conditions and monitoring requirements for approved projects
Specify reporting requirements for adverse events
To promote implementation of the 3Rs principles:
Replacement: Encourage use of non-animal alternatives (in vitro methods, computer simulations, cell cultures, human studies) wherever scientifically valid
Reduction: Promote optimal experimental design to minimize number of animals used while maintaining statistical validity
Refinement: Advocate for methods that minimize pain, suffering, distress, and improve animal welfare throughout the experimental process
Facilitate access to information on alternative methods
Encourage pilot studies and sharing of tissues/data between researchers
To ensure proper animal housing and husbandry:
Inspect animal house facilities regularly (at least once every six months)
Verify compliance with CPCSEA guidelines on housing, temperature, humidity, ventilation, lighting, and space requirements
Ensure availability of appropriate species-specific caging
Monitor provision of adequate food, water, and environmental enrichment
Assess cleanliness, sanitation, and pest control measures
Verify maintenance of appropriate temperature (22±3°C) and humidity (30-70%)
Ensure proper waste disposal and dead animal disposal procedures
To ensure availability of veterinary care:
Verify presence of qualified veterinary officer or consultant
Ensure availability of veterinary services during and after procedures
Monitor provision of pre-operative and post-operative care
Review protocols for pain assessment and management
Ensure availability of appropriate anesthetics, analgesics, and emergency drugs
Verify proper quarantine procedures for newly arrived animals
Monitor disease surveillance and outbreak management protocols
To oversee animal procurement and disposal:
Ensure animals are procured only from registered breeders/suppliers holding valid CPCSEA registration
Verify health certificates and transportation records
Monitor proper acclimatization period before use in experiments (minimum 7 days)
Ensure humane euthanasia methods as per CPCSEA guidelines
Monitor proper disposal of animal carcasses through incineration or deep burial
Maintain records of procurement and disposal
To maintain comprehensive records:
Minutes of all IAEC meetings with attendance, decisions, and rationale
All research proposals received, reviewed, and decisions taken
Approved protocols with modifications and conditions
Progress reports and completion reports from investigators
Adverse event reports and actions taken
Animal inventory records (species, strain, number, source)
Animal usage records (purpose, number used, procedures performed)
Inspection reports of animal house facilities
Training records of investigators and animal handlers
Correspondence with CPCSEA and other regulatory authorities
Annual reports submitted to CPCSEA
To prepare and submit annual reports to CPCSEA:
Summary of animal usage (species-wise, purpose-wise, severity classification)
Number of proposals received, approved, rejected, and pending
Details of major adverse events or animal welfare concerns
Training programs conducted
Facility inspection findings and improvements made
Implementation of 3Rs initiatives
Challenges faced and recommendations
Submit by 31st March every year for the preceding calendar year
To conduct regular monitoring of ongoing experiments:
Review progress reports from investigators (at least annually)
Conduct unannounced inspections of experimental areas
Investigate complaints or concerns regarding animal welfare
Monitor compliance with approved protocols
Verify implementation of humane endpoints
Assess post-procedure monitoring and animal recovery
Ensure proper documentation in animal experiment logbooks
To investigate adverse events and animal welfare concerns:
Establish procedures for reporting adverse events
Investigate all reported incidents involving unexpected animal deaths, severe suffering, or protocol deviations
Determine root causes and implement corrective actions
Suspend or terminate experiments if serious animal welfare concerns arise
Report serious violations to CPCSEA
Document investigations and outcomes
To organize training and capacity building programs:
Mandatory training for all personnel involved in animal experiments before project initiation
Training content to include:
Ethical principles of animal experimentation
CPCSEA guidelines and institutional policies
3Rs principles and implementation
Species-specific handling, restraint, and care
Recognition of pain, distress, and suffering in animals
Humane experimental techniques
Anesthesia and analgesia administration
Aseptic surgical techniques
Post-operative care and monitoring
Humane endpoints and euthanasia methods
Record-keeping requirements
Annual refresher training for all personnel
Specialized training for animal house staff
Maintain training records with certificates
To ensure compliance with statutory requirements:
Maintain institutional registration with CPCSEA
Ensure timely renewal of CPCSEA registration
Comply with conditions stipulated in CPCSEA registration certificate
Implement recommendations from CPCSEA inspections
Notify CPCSEA of changes in IAEC composition, infrastructure, or significant incidents
Display CPCSEA registration certificate prominently in animal house
Ensure no experiments are conducted without prior IAEC approval
To coordinate with other institutional committees:
Institutional Ethics Committee (Human): For projects involving both human and animal subjects
Institutional Biosafety Committee: For experiments involving genetically modified organisms or biohazardous agents
Research Committee: For overall research governance and prioritization
Bio-Medical Waste Management Committee: For disposal of animal carcasses and contaminated materials
Curriculum Committee: For ensuring ethical use of animals in teaching
To review use of animals in teaching:
Evaluate necessity of animal use in undergraduate and postgraduate teaching
Promote use of alternatives (models, videos, simulations, virtual dissection) where feasible
Ensure that live animal demonstrations are conducted humanely
Limit number of students per animal to minimize repetition
Ensure adequate supervision during student practicals
Prohibit use of animals for practicing surgical techniques without anesthesia and analgesia
Review teaching protocols annually
To establish Standard Operating Procedures (SOPs):
SOP for proposal submission and review process
SOP for animal procurement and quarantine
SOP for animal housing and husbandry
SOP for handling, restraint, and transport of animals
SOP for anesthesia and analgesia administration
SOP for surgical procedures and post-operative care
SOP for pain and distress assessment
SOP for humane endpoints
SOP for euthanasia methods (species-specific)
SOP for carcass disposal
SOP for adverse event reporting and investigation
SOP for emergency situations (disease outbreak, facility failure)
SOPs to be reviewed and updated annually
To ensure financial provisions for animal welfare:
Adequate budget for animal procurement from registered sources
Funds for appropriate species-specific housing and enrichment
Budget for veterinary care and medicines
Provision for anesthetics, analgesics, and euthanasia agents
Funds for animal house maintenance and upgradation
Budget for training programs and educational materials
Resources for emergency situations and contingencies
As per CPCSEA guidelines, the Institutional Animal Ethics Committee shall consist of the following members:
| S.No. | Member Category | Status in Committee |
|---|---|---|
| 1. | Principal cum Dean, NSMC | Chairperson (ex-officio) |
| 2. | Scientist In-charge of Animal House | Member Secretary |
| 3. | Main Nominee of CPCSEA (from outside institution) | Member |
| 4. | Nominee of CPCSEA (Scientist from outside institution) | Member |
| 5. | Veterinary Officer with degree in Veterinary Science | Member |
| 6. | Biologist from the institution | Member |
| 7. | Professor & Head, Department of Pharmacology | Member |
| 8. | Professor & Head, Department of Physiology | Member |
| 9. | Socially Aware Nominee (from outside institution) | Member |
| 10. | Scientist/NGO Representative working in animal welfare | Member |
Table 1: Composition of Institutional Animal Ethics Committee
The Committee composition must fulfill the following mandatory requirements:
Minimum 6 members, including:
At least one nominee of CPCSEA from outside the institution (Main Nominee)
Scientist In-charge of experimental animal facility as Member Secretary
At least one biologist
At least one qualified veterinarian (with degree in Veterinary Science)
At least one nominee from outside the institution representing socially aware persons
Scientist/NGO representative working in animal welfare
At least 3 members should be from outside the institution
No member should have any conflict of interest with the institution
Members should have knowledge, expertise, and commitment to animal welfare
The Principal cum Dean shall be the Chairperson of the Committee ex-officio.
The Chairperson shall provide overall supervision and ensure independence of the Committee.
In the absence of the Chairperson, the senior-most faculty member present shall preside over the meeting.
The Scientist In-charge of the Animal House/Experimental Animal Facility shall serve as Member Secretary.
The Member Secretary should preferably hold qualifications in life sciences with experience in laboratory animal science.
The Member Secretary shall be responsible for:
Convening meetings and preparing agenda
Receiving and processing research proposals
Maintaining all IAEC records and documentation
Coordinating facility inspections
Preparing annual reports to CPCSEA
Serving as nodal officer for all IAEC matters
Liaising with CPCSEA and other regulatory authorities
Monitoring compliance with approved protocols
Organizing training programs
Main Nominee: Appointed by CPCSEA from outside the institution, preferably a person with expertise in laboratory animal science, ethics, or animal welfare.
Scientist Nominee: Scientist from outside the institution nominated by CPCSEA.
CPCSEA nominees shall ensure independent oversight and represent broader scientific and ethical perspectives.
Institution shall request CPCSEA to nominate representatives while applying for registration or renewal.
Must hold a degree in Veterinary Science (B.V.Sc. & A.H. or equivalent).
May be employed by the institution or engaged as consultant.
Responsible for veterinary care, health monitoring, and welfare of all animals.
Shall advise on appropriate anesthesia, analgesia, surgical techniques, and euthanasia methods.
Scientist from biological sciences department within the institution (Anatomy, Physiology, Biochemistry, Microbiology, Pathology).
Should have understanding of animal biology and experimental design.
Provides scientific perspective on research protocols.
Person from outside the institution representing societal perspective on animal welfare.
Should not be affiliated with any animal facility or vivisection-related activity.
May be from civil society, NGO, or community representing public conscience.
Ensures that societal concerns about animal welfare are considered in decision-making.
Individual actively working in the field of animal welfare.
May represent animal welfare organizations, animal rights groups, or be an independent animal welfare advocate.
Brings perspective on humane treatment and alternatives to animal use.
No member shall participate in review or decision-making on any proposal in which they have personal or financial interest.
Members with conflict of interest shall declare the same and recuse themselves from discussion and voting on that particular proposal.
Declaration of conflict of interest shall be recorded in meeting minutes.
4.1. The term of office for all members shall be three years from the date of their nomination, except for ex-officio members who shall continue by virtue of holding their respective positions.
4.4. A member ceasing to hold the position by virtue of which they were appointed shall automatically cease to be a member.
4.5. The Principal may nominate substitute members in consultation with CPCSEA in case of death, retirement, resignation, or prolonged absence of any member.
The Committee shall meet as often as necessary, but at minimum once every three months (at least four meetings per year).
Additional meetings may be convened to review urgent proposals or address serious animal welfare concerns.
Special meetings may be called by the Chairperson or at the request of at least three members.
The Member Secretary shall issue notice at least 14 days prior to regular meetings.
Notice shall include date, time, venue, and detailed agenda.
Research proposals and relevant documents shall be circulated at least 7 days before the meeting to allow members adequate time for review.
In case of urgent meetings, shorter notice may be given with approval of the Chairperson.
The quorum for meetings shall be at least 50% of total members with a minimum of four members.
The Chairperson or presiding member must be present.
At least one CPCSEA nominee must be present.
At least one member from outside the institution (other than CPCSEA nominee) should be present.
If quorum is not present within 30 minutes, the meeting shall be adjourned to a date within 15 days.
Regular meetings shall include:
Confirmation of minutes of previous meeting
Action taken report on previous decisions
Review of new research proposals
Progress reports from ongoing projects
Adverse event reports and investigations
Inspection reports of animal house facilities
Compliance monitoring reports
Training programs conducted
Annual animal usage statistics (species-wise, purpose-wise)
Implementation of 3Rs initiatives
Review and updating of SOPs
Budget and resource requirements
Correspondence with CPCSEA
Annual report preparation
Any other matter with permission of Chair
Each proposal shall be reviewed thoroughly by the Committee.
Principal investigator may be invited to present the proposal and answer questions.
Committee shall assess:
Scientific justification and merit
Ethical justification for animal use
Implementation of 3Rs principles
Sample size justification
Appropriateness of species, procedures, and methods
Adequacy of anesthesia, analgesia, and post-operative care
Humane endpoints
Qualifications of investigators and handlers
Availability of facilities and resources
Committee may:
Grant full approval
Grant conditional approval with specified modifications
Request major revisions and resubmission
Reject the proposal with reasons
Decisions shall preferably be taken by consensus after thorough discussion.
Where consensus cannot be reached, decisions shall be made by majority vote.
Each member present shall have one vote.
In case of tie, the Chairperson shall have a casting vote.
Members with conflict of interest shall not participate in voting.
Dissenting opinions shall be recorded in minutes.
The Member Secretary shall prepare detailed minutes of each meeting within 15 days.
Minutes shall include:
Date, time, venue, and members present
Summary of discussions on each agenda item
Details of each proposal reviewed (title, investigator, decision)
Rationale for decisions taken
Conditions or modifications required
Inspection findings and recommendations
Action points with responsible persons and timelines
Any dissenting opinions
Draft minutes shall be approved by Chairperson and circulated to all members.
Confirmed minutes shall be maintained in permanent record book.
Minutes shall be made available to CPCSEA upon request.
All proposals involving animal experimentation must be submitted to the IAEC for ethical approval before commencement. Proposals shall include:
Title and objectives of the research
Name, qualifications, and experience of principal investigator and co-investigators
Training certificates in laboratory animal science
Scientific justification and expected outcomes
Literature review demonstrating necessity of animal use
Ethical justification for animal use
Implementation of 3Rs principles:
Replacement: Why non-animal alternatives cannot be used
Reduction: Sample size calculation and statistical justification
Refinement: Methods to minimize pain, suffering, and improve welfare
Species, strain, age, sex, and number of animals required
Justification for species and strain selection
Source of animals (registered breeder/supplier with CPCSEA registration number)
Detailed experimental methodology and timeline
Procedures to be performed on animals (surgical, non-surgical, repeated sampling, etc.)
Severity classification (mild, moderate, severe) of procedures
Anesthesia and analgesia protocols with doses and routes
Post-operative care and monitoring plan
Pain and distress assessment methods
Humane endpoints for terminating experiments
Euthanasia method (as per CPCSEA guidelines)
Disposal of carcasses
Qualifications and training of personnel handling animals
Facilities available for housing and experimentation
Funding source
Regulatory approvals (if involving GMOs, biohazards, drugs)
Declaration of no conflict of interest
Undertaking to comply with CPCSEA guidelines and IAEC decisions
Member Secretary shall acknowledge receipt of proposal within 3 days.
Proposal shall be circulated to all IAEC members at least 7 days before meeting.
Members shall review proposals independently before the meeting.
Proposals shall be discussed in detail in IAEC meeting.
Principal investigator may be invited to present and clarify.
Committee shall complete review within 45 days of receipt of complete proposal.
Full Approval: Proposal meets all ethical and scientific standards.
Conditional Approval: Approval subject to specified modifications or clarifications.
Major Revisions Required: Significant deficiencies requiring resubmission after modifications.
Rejection: Proposal does not meet ethical standards or lacks scientific merit.
Approved proposals shall receive formal approval letter stating:
Approval date and reference number
Approved number of animals (species-wise)
Validity period (typically 1-3 years depending on study duration)
Conditions and monitoring requirements
Requirement to report adverse events
Requirement to submit progress and completion reports
Requirement to seek re-approval for protocol modifications
Any significant changes to approved protocol require prior IAEC approval.
Significant changes include:
Increase in number of animals
Change in species or strain
Change in experimental procedures
Change in anesthesia/analgesia protocols
Change in investigators
Minor administrative changes may be approved by Chairperson and Member Secretary.
The Committee shall conduct comprehensive inspections of animal house facilities at least twice a year (once every six months).
Unannounced inspections may be conducted at any time.
Inspection team shall consist of at least three IAEC members including veterinary officer.
Inspections shall assess:
Compliance with CPCSEA housing standards
Temperature, humidity, ventilation, and lighting
Adequacy of cage space and environmental enrichment
Cleanliness and sanitation
Food and water quality
Pest control measures
Animal health status
Quarantine facilities
Emergency preparedness
Record-keeping
Staff training and competence
Inspection reports shall be documented with photographs.
Deficiencies shall be communicated to responsible authorities with timelines for corrective actions.
Follow-up inspections shall verify implementation of corrective actions.
Investigators shall submit annual progress reports to IAEC.
IAEC members may conduct announced or unannounced visits to experimental areas.
Monitor compliance with approved protocols.
Verify proper anesthesia and analgesia administration.
Assess post-procedure monitoring and care.
Review animal experiment logbooks.
Verify implementation of humane endpoints.
All unexpected animal deaths, severe suffering, or protocol deviations must be reported to IAEC within 24 hours.
Investigator shall submit detailed incident report.
IAEC shall investigate and determine:
Root cause of incident
Whether protocol violations occurred
Whether corrective actions are needed
Whether experiment should be suspended or terminated
Serious violations shall be reported to CPCSEA.
Investigators may be subject to suspension of privileges for serious or repeated violations.
Investigators shall submit completion report within 3 months of study completion.
Report shall include:
Total number of animals used
Procedures performed
Any deviations from approved protocol
Adverse events and how managed
Outcomes and findings
Publications or presentations resulting from the study
IAEC shall review completion reports and maintain records.
All personnel involved in animal experimentation must undergo training before handling animals:
Principal investigators and co-investigators
Research scholars and postgraduate students
Technical staff and animal handlers
Animal house staff
Ethical principles of animal experimentation (3Rs)
CPCSEA guidelines and institutional policies
Legal requirements under Prevention of Cruelty to Animals Act 1960
Species-specific biology, behavior, and handling techniques
Recognition of pain, distress, and suffering in animals
Humane experimental techniques
Anesthesia and analgesia administration
Aseptic surgical techniques
Post-operative care and monitoring
Humane endpoints
Euthanasia methods
Record-keeping and reporting requirements
Animal house biosecurity and disease prevention
Classroom lectures by experts
Practical demonstrations
Hands-on supervised practice
Video presentations
Assessment through written tests and practical evaluation
Certification upon successful completion
Maintain individual training records for all personnel
Training certificates to be submitted with research proposals
Periodic refresher training every 2-3 years
Specialized training for specific procedures (microsurgery, imaging techniques)
9.1. The Committee shall develop and maintain comprehensive Standard Operating Procedures (SOPs) covering all aspects of animal care and use:
Proposal submission and review process
Animal procurement and quarantine procedures
Species-specific housing and husbandry
Environmental monitoring and control
Sanitation and disinfection protocols
Handling, restraint, and transportation
Anesthesia and analgesia administration (species-specific)
Surgical procedures and aseptic techniques
Blood collection and sample collection methods
Post-operative care and monitoring
Pain and distress assessment
Humane endpoints
Euthanasia methods (species-specific, CPCSEA-compliant)
Carcass disposal procedures
Emergency response (disease outbreak, facility failure, natural disaster)
Adverse event reporting and investigation
Record-keeping and documentation
Breeding colony management (if applicable)
As per CPCSEA guidelines, animals shall be housed in appropriate facilities providing:
Space: Adequate floor area and cage height according to species and body weight
Temperature: 22±3°C (species-specific variations may apply)
Humidity: 30-70%
Ventilation: 15-20 air changes per hour
Lighting: 12-hour light/dark cycle, 300-400 lux at working plane
Caging: Species-appropriate, non-toxic materials, adequate drainage
Bedding: Appropriate, absorbent, dust-free, changed regularly
Environmental Enrichment: Species-specific enrichment to promote natural behaviors
Social Housing: Social species housed in compatible groups unless scientifically justified otherwise
Species-appropriate diet meeting nutritional requirements
Fresh, uncontaminated feed stored properly
Feed analyzed periodically for contaminants
Unlimited access to potable water unless restricted for scientific reasons
Water quality tested periodically
Special diets prepared under hygienic conditions
Qualified veterinary officer available
Daily health observations by trained staff
Quarantine period (minimum 7 days) for newly arrived animals
Prompt veterinary attention for sick or injured animals
Appropriate treatment with analgesics for pain relief
Isolation facilities for sick animals
Disease surveillance and outbreak management protocols
Euthanasia of animals with poor prognosis or severe suffering
Minimize number of animals used through proper experimental design
Use appropriate anesthesia for all painful procedures
Provide adequate analgesia during and after procedures
Monitor animals closely during and after procedures
Implement humane endpoints to terminate suffering
Use skilled personnel to minimize technical failures
Avoid repeated use of same animal unless scientifically justified and ethically acceptable
Performed only by trained personnel
Methods approved by CPCSEA and AVMA guidelines:
Rodents: CO2 inhalation (gradual fill), cervical dislocation, barbiturate overdose
Rabbits: Barbiturate overdose (IV), inhalant anesthetic overdose
Dogs/Large Animals: Barbiturate overdose (IV) preceded by sedation
Unacceptable methods: Drowning, burning, hypothermia, air embolism, use of neuromuscular blocking agents without anesthesia
Confirmation of death before disposal
Euthanasia performed in separate area away from other animals
Disposal through incineration or deep burial as per bio-medical waste rules
CPCSEA registration certificate
IAEC composition and member details
Minutes of all IAEC meetings
All research proposals received and reviewed
Approval letters issued
Progress reports and completion reports from investigators
Animal procurement records (source, date, number, species, health certificates)
Animal inventory records (daily census by species)
Animal usage records (purpose, procedure, investigator, date)
Animal experiment logbooks maintained by investigators
Veterinary care records
Breeding records (if applicable)
Euthanasia and disposal records
Adverse event reports and investigations
Facility inspection reports
Training records
SOPs with revision history
Correspondence with CPCSEA
Annual reports submitted to CPCSEA
All records shall be maintained for a minimum period of 3 years after completion of the study or as required by CPCSEA.
The Committee shall prepare and submit annual report to CPCSEA by 31st March every year covering the preceding calendar year (January to December), including:
Summary of animal usage:
Species-wise number of animals used
Purpose-wise classification (basic research, applied research, teaching, testing)
Severity classification (mild, moderate, severe)
Number of proposals received, approved, rejected, and pending
Details of training programs conducted
Facility inspection findings and improvements made
Implementation of 3Rs initiatives
Adverse events and investigations
Changes in IAEC composition
Challenges faced and recommendations
All records shall be made available to CPCSEA inspectors
Institution shall cooperate fully with CPCSEA inspections
Implement recommendations from CPCSEA inspection reports
Submit compliance reports within stipulated timelines
Institutional Ethics Committee (Human): For projects involving both human and animal research
Institutional Biosafety Committee: For experiments involving recombinant DNA, GMOs, or infectious agents
Research and Development Committee: For overall research governance
Bio-Medical Waste Management Committee: For proper disposal of animal carcasses and contaminated materials
Radiation Safety Committee: For experiments involving radioactive materials
Academic Council/Curriculum Committee: For ethical use of animals in teaching
Overview of animal research activities
IAEC functioning and decisions
Compliance with CPCSEA guidelines
Facility standards and improvements
Challenges and resource requirements
Suspension or cancellation of CPCSEA registration
Penalties under Prevention of Cruelty to Animals Act 1960
Legal action against responsible persons
Termination of research projects
Disciplinary action against investigators
14.1. This Constitution may be amended by a resolution passed by two-thirds majority of the total members of the Committee.
14.3. All amendments must be in conformity with CPCSEA guidelines, Prevention of Cruelty to Animals Act 1960, and Breeding of and Experiments on Animals (Control and Supervision) Rules 1998.
15.1. In case of doubt or dispute regarding interpretation of any provision of this Constitution, the decision of the Chairperson shall be final, subject to approval of the Managing Body and conformity with CPCSEA guidelines.
15.2. Matters not covered shall be governed by CPCSEA guidelines, Prevention of Cruelty to Animals Act 1960, and related rules and regulations.
16.1. This Constitution shall come into force from the date of its adoption by the Managing Committee of Sitwanto Devi Mahila Kalyan Sansthan and registration with CPCSEA.
| Position | Name | Designation |
|---|---|---|
| Chairperson | [To be filled] | Principal cum Dean |
| Member Secretary | [To be filled] | Scientist In-charge, Animal House |
| CPCSEA Main Nominee | [To be nominated by CPCSEA] | Expert from outside |
| CPCSEA Scientist Nominee | [To be nominated by CPCSEA] | Scientist from outside |
| Veterinary Officer | [To be filled] | Veterinarian (B.V.Sc.) |
| Biologist | [To be filled] | Faculty from Life Sciences |
| Socially Aware Nominee | [To be filled] | Representative from outside |
| Animal Welfare NGO Rep. | [To be filled] | Animal welfare advocate |
Table 2: Current Office Bearers
| Principle | Implementation Strategies |
|---|---|
| REPLACEMENT | Use non-animal methods: cell cultures, tissue cultures, computer simulations, mathematical models Use lower organisms (invertebrates, bacteria) where scientifically valid Use human-based research methods (clinical trials, epidemiological studies, human tissues) Use videos, models, and virtual dissection for teaching |
| REDUCTION | Optimize experimental design with proper statistical planning Share data and biological materials between researchers Use pilot studies to refine methodology Avoid unnecessary duplication of experiments Use appropriate statistical tests to minimize sample size Maximize information from each animal |
| REFINEMENT | Improve animal housing conditions and environmental enrichment Use appropriate anesthesia and analgesia Implement humane endpoints to minimize suffering Use less invasive techniques (imaging instead of terminal procedures) Provide post-operative care and monitoring Train personnel to improve technical competence Select appropriate species and strains |
Table 3: Implementation of 3Rs Principles
Research Proposal for Ethical Approval
Title: _______________________________________________________
Duration: __________________
Principal Investigator: _________________________________________
Qualifications: ______________________________________________
Training in Laboratory Animal Science: [ ] Yes [ ] No (Certificate attached)
__________________________________________________________
Replacement: Why cannot non-animal alternatives be used?
__________________________________________________________
Reduction: Sample size calculation and statistical justification:
__________________________________________________________
Refinement: Methods to minimize pain and improve welfare:
__________________________________________________________
| Species | Strain | Age | Sex | Number Required | Source |
|---|---|---|---|---|---|
Justification for species selection: _________________________________
Describe all procedures to be performed (attach detailed protocol):
__________________________________________________________
| Agent | Dose | Route | Frequency |
|---|---|---|---|
__________________________________________________________
__________________________________________________________
__________________________________________________________
I/We undertake to comply with all CPCSEA guidelines and IAEC decisions. I/We declare that I/we have no conflict of interest.
Signature of Principal Investigator: ________________________
Date: __________________
| Species | Body Weight | Floor Area per Animal | Cage Height |
|---|---|---|---|
| Mouse | Up to 25g | 60 cm² | 12 cm |
| >25g | 80 cm² | 12 cm | |
| Rat | Up to 200g | 200 cm² | 18 cm |
| 200-300g | 250 cm² | 18 cm | |
| 300-400g | 350 cm² | 18 cm | |
| >400g | 450 cm² | 18 cm | |
| Rabbit | Up to 3 kg | 3500 cm² | 45 cm |
| 3-5 kg | 4200 cm² | 45 cm | |
| >5 kg | 5400 cm² | 45 cm | |
| Guinea Pig | Up to 400g | 600 cm² | 18 cm |
| >400g | 800 cm² | 18 cm | |
| Dog | Up to 15 kg | 4 m² | 2 m |
| >15 kg | 8 m² | 2 m |
Table 4: Minimum Space Requirements (CPCSEA Guidelines)
