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SOP for Institutional Animal Ethical Committee

Objectives of IAEC (Institutional Animal Ethical Committee)

  • Supervision by qualified person
  • Due care and humanity to avoid pain
  • If recovery of Experimented animals involve serious suffering, should be destroyed while still insensible
  • Use of animals avoided where it is possible to do with other teaching
  • Experiments on larger animals avoided
  • Experiments not performed merely for the purpose of acquiring manual skill
  • Animals properly looked after before and after experiments
  • Suitable records are maintained with respect to experiments performed on animals

Functions of IAEC

  • To work for achievement of the objectives.
  • Review and approve all types of research proposals involving small animal experimentation before the start of the study.
  • Monitor the research throughout the study and after completion of study through periodic reports.
  • Visit to animal house and laboratory where the experiments are conducted.

Composition of IAEC

Rule 13 of the Breeding of and Experiments on Animals (Control and Supervision) Rules 1998, as amended, every IAEC shall include

  1. A biological scientist
  2. Two scientists from different biological disciplines
  3. A veterinarian involved in the care of animal
  4. Scientists in the charge of animals facility of the establishment concerned
  5. A scientist from outside the institute
  6. A non scientific socially aware member and
  7. A nominee of CPCSEA

Specialist may be co-opted while reviewing projects using biohazards

Chairperson and Member Secretary nominated by the Institution from amongst the eight members. Members against 5, 6, 7 will be nominated by CPCSEA, with a provision of a Link nominee for CPCSEA nominee.

IAEC Constitution and duration

  • CPCSEA constitutes IAEC on receipt of five names against sr. no. 1-4 from the institute.
  • Duration is for a period of 3 years.
  • Reconstituted at the time of renewal of registration
  • Changes made with the approval of CPCSEA

IAEC requirements

  • Appointment is for a period of 3 years (coterminous with registration)
  • Committee to be reconstituted at the time of renewal, at least half of the members to be replaced
  • 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 and follow it in all meetings

Quorum requirements

  • Minimum 6 members required to compose a quorum
  • All decisions should be taken in meetings
  • Presence of CPCSEA nominee is a must
  • Link nominee can attend in case main nominee conveys unavailability in writing to chairman
  • Socially aware member’s presence compulsory in cases referred to CPCSEA and at least in one meeting in  a calendar year

Conduct of business

  • Chairperson will conduct all meetings
  • Member Secretary is responsible for organizing the meetings, record maintenance and communication
  • Member Secretary will prepare minutes of the meeting, get it approved by the Chairman before communicating to researchers.
  • A copy of minutes to be sent to Member Secretary CPCSEA within 15 days of the meeting, otherwise meeting is considered invalid

Participation by Investigators / experts in IAEC

  • Subject experts may be called upon for review of selected research protocols
  • They give specialized views but decision making done by members only
  • Investigators may be called to present their case

Application Procedure

  • All proposals submitted in prescribed form.
  • All relevant documents with checklist should be enclosed.
  • Required no. of copies of the proposal along with the application and documents duly signed by Principal Investigator (PI) and Co-investigators / Collaborators submitted to IAEC

Review procedures

  • Meeting of the IAEC held on scheduled intervals as per SOP
  • Proposals sent to members at least 15 days in advance.
  • Decision taken by consensus. Negative view point’s recorded in minutes. If consensus not reached referred to CPCSEA
  • Researchers invited to offer clarification if needed
  • Independent Experts invited in specific research proposals
  • Decisions minute and Chairperson’s approval taken in writing with signature of all IAEC members present.

Decision-making

  • Discuss various issues before arriving consensus
  • Member should withdraw during decision procedure where conflict of interest arises
  • Only members can take decision
  • Decision may be to approve, reject or review the proposals
  • Suggestions for revision and the procedure for having the application re-viewed to be specified
  • Modified proposals reviewed through identified members
  • Procedures for appeal by the researchers to be clearly defined

Communicating the decision

  • Commmunicated by Member Secretary in writing.
  • Suggestions for modifications, if any, sent by IAEC.
  • Reasons for rejection to be informed to researcher
  • Scheduled plan of ongoing review by the IAEC to be communicated to PI (Principal Investigator)

Follow up procedure

  • Reports submitted at prescribed intervals for review.
  • Report submitted at the end of the study.
  • Serious Adverse Events (SAEs) and interventions undertaken to be intimated.
  • Protocol deviation informed with adequate justification.
  • Any amendment to protocol resubmitted to IAEC for renewed approval.
  • Any new information related to study communicated.
  • Premature termination of study notified with reasons along summary of the data obtained so far.
  • Change of investigator / sites should be informed and approval of IAEC taken.

Record keeping and Archiving

  1. Curriculum Vitae of all IAEC members including training programs in animal ethics attended.
  2. Copy of all study protocols with enclosed documents, progress reports.
  3. Minutes of all meetings.
  4. Copy of all existing relevant national and international guidelines on animal ethics and laws with amendments.
  5. Copy of all correspondence with members, researchers and other regulatory bodies.
  6. Final report of approved projects.
  7. Record of breeding of animals, supply etc.
  8. Record of import of animals with species, source, quantity, usage etc.
  9. Record of all Contract research, if conducted at the institute.
  10. Record of rehabilitation of large animals if done.
  11. All documents archived for a period as prescribed in SOP and not less than one year.

Updating IAEC members

  • All relevant new guidelines and amendments to the Rules and Act brought to the attention of the members
  • Members encouraged to attend national and international training programs/workshops/conferences in research ethics.

Reporting to CPCSEA

  • IAEC to send a copy of minutes to CPCSEA within 15 days.
  • Inspection report of animal house with photographs by IAEC members to be sent once in one calendar year.

Fees Payable to CPCSEA

Registration fee of Rs. 1000/- and renewal fee of Rs. 500/- is to be paid by Demand Draft in favor of CPCSEA payable at New Delhi (as applicable)

1 responses on "SOP for Institutional Animal Ethical Committee"

  1. a good job…..well presented the data and i must also say it is very informative..best wishes…to pharmacrunch..!!!

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