INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)

AND
INSTITUTIONAL ANIMAL ETHICS COMMITTEE
(IAEC)

Raja chakravarthi G
Contents
• INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)
• Responsibilities and functions of IBSC
• Registration of IBSC at IBKP
• Constitution of IBSC
• Confidentiality agreement
• Tenure and renewal of IBSC
• INSTITUTIONAL ANIMAL ETHICS COMMITTEE (IAEC)
• Functions of institutional animal ethics committee (IAEC)
• Composition and constitution of IAEC
• Membership duration & replacements in committee
• Rights and responsibility of members
• Conclusion
• Reference
LIST OF ABBREVIATIONS
• IBSC : Institutional biosafety committee
• IBKP : Indian Biosafety Knowledge Portal
• DBT : Department of biotechnology
• RCGM : Review Committee on Genetic Manipulation
• GE : Genetically engineered
• LMO : Living modified organisms
• GMO : genetically modified organisms
• GEAC : Genetic Engineering Appraisal Committee
• CPCSEA : Committee for the Purpose of Control and Supervision of
Experiments on Animals
INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)
 In compliance with Rules 1989, an Institutional Biosafety Committee (IBSC) is to be
constituted by every organization engaged in research, use & application activities related to
GE organisms (organisms include microorganisms, animals, plants, arthropods, aquatic
animals, etc.) and hazardous microorganisms ( "microorganisms" shall include all the
bacteria, viruses, fungi, mycoplasma, cells lines and algae).
 IBSC is the nodal agency within an organization for implementation of the biosafety
regulatory framework. DBT/Review Committee on Genetic Manipulation (RCGM) has been
entrusted with registration and monitoring of IBSCs.
Institutional Biosafety Committee (IBSC) is solely responsible for:
• To implement and respond to institutional biosafety & biosecurity at the institution level
• Evaluation of applications/ reports related to rDNA technology work involving the GE
organisms and non-GE hazardous microorganisms in an organization.
RESPONSIBILITIES AND FUNCTIONS OF IBSCs
• Assess and monitor the items of general consideration i.e. research facilities, procedures and experts involved in
GMOs/LMOs and GE research and ensure that the proposed risk assessment, risk management and emergency
plans are sufficient.
• Provide guidance to Principal Investigator on the issues related to biosafety while using GMOs/LMOs and GE
research including safety of the researcher(s) associated with the work.
• Inform the Principal Investigator about IBSC review, approval or rejection of applications.
• Copies of site emergency plan to be submitted to RCGM, GEAC, State Biotechnology Coordination Committee
(SBCC) or District Level Committee (DLC) as the case may be, as per Rules, 1989e).
• The IBSC shall inspect laboratories using checklists.
• IBSC shall apprise short coming measures (if necessary) under information to Head of Organization.
• Inspection reports should be maintained in the IBSC.
• Reporting for incidents and release : It is necessary that any incident within an organization such as non-
compliance of the biosafety guidelines, any biosecurity issues or any significant research-related accidents and
illnesses be reported to IBSC/ RCGM.
• The primary function of the IBSC is to implement and ensure compliance of
provisions of Rules 1989 at the Institutional level. These functions include
REGISTRATION OF IBSC AT IBKP
• Constitution of an IBSC and its registration in DBT through Indian Biosafety Knowledge Portal
(IBKP) is mandatory in India for every organization working with GE organisms, cells and
hazardous microorganisms under Rules 1989.
• Without registration/renewal of the IBSC, the institution/organization shall not be eligible to
conduct any rDNA activities and research on hazardous microorganisms that fall under the
purview of Rules 1989.
• Any modification/ update of information of a registered IBSC and renewal of IBSC shall also be
made through IBKP.
• Step 1 - Organization registration:
The organization seeking to constitute IBSC has to first register their organization online
at IBKP (https://ibkp.dbtindia.gov.in/content/ibscinfo).
• Step 2 - IBSC registration:
Using the Organization’s permanent login ID and a password generated by the
competent authority of the organization or his/her designate, the organization shall submit
form for registration of IBSC on the IBKP portal.
CONSTITUTION OF IBSC

IBSC
CONFIDENTIALITY AGREEMENT
• All IBSC members are expected to maintain confidentiality of the proposals and other related
information made available to them for review, reference or discussion and not divulge any
confidential or Intellectual Property (IP) or commercial business information (CBI) of an
applicant/organisation/institute acquired as a result of review of such proposals and
subsequent discussions.
• Each IBSC member including Chairperson, Biosafety Officer, DBT nominee, Member Secretary
and internal/external experts shall sign confidentiality agreement in the Performa available on
IBKP at the time of constituting IBSC or effecting changes in the composition of IBSC.
TENURE AND RENEWAL OF IBSC
• The tenure of the IBSC is for a period of 3 years from the date of issue of approval
letter. The institute has to renew IBSC registration after every three years. IBSC shall
process renewal request through portal at least 3 months before the expiry date of
the current validity period.
• Registered IBSCs requesting for major changes in the IBSC composition including the
change of DBT nominee may request for renewal of IBSC during the validity period.
• Renewal of the IBSC shall be made through the ‘Renew IBSC Registration’ module of
the IBKP.
• After verification of details in the registration renewal form, RCGM shall approve the
registration and communicate the same through the portal to the organization. In
case of any deficiencies/ clarifications, the same would be communicated to the
organization through the portal.
INSTITUTIONAL ANIMAL ETHICS COMMITTEE (IAEC)
• The use of animals in research is widely practiced in various laboratories across
the world.
• Animals have an intrinsic value and they have the sense organ to feel pain.
• Besides animals have a moral status, and that our treatment of them should be
subject to ethical considerations.
• Therefore, researchers must have respect for animals' worth, regardless of their
utility value, and for animals' interests as living, sentient creatures.
• Research and experimentation on animals are covered by provisions of the
Prevention of Cruelty to Animals Act, 1960 (amended in 1982) and Rules of
Breeding of and Experiments on Animals (Control & Supervision) 1998 (amended
in 2001 and 2006) framed under the PCA 1960.
• Government has constituted a Committee for the Purpose of Control and
Supervision of Experiments on Animals (CPCSEA) under the provision of Section
15 of PCA Act 1960.
Functions of Institutional Animal Ethics Committee (IAEC)
• IAEC accords quality and consistency in review of research proposals and to
prevent infliction of unnecessary pain & sufferings before, during and after
experiments on animals, to follow the CPCSEA guidelines.
• IAEC is providing independent, competent and timely review of the ethics of
proposed studies before the commencement of a study and regularly monitor the
ongoing studies.
• IAEC reviews and approves all research proposals involving small laboratory animal
experiments, up to phylogenetic level of rodents and lagomorphs only, with a view
to assure quality maintenance and welfare of animals used in pre‐clinical research.
• For experiments on higher animals, the IAEC will forward its recommendation to
the CPCSEA, New Delhi, for its approval process.
• IAEC reviews the proposals before start of the study as well as monitor the
research throughout the study and after completion of the study through annual
reports, final report.
Composition and Constitution of IAEC
• IAEC includes following members as described below:
• Chairman of the committee: Preferably Head of the Dept.
• A Biological Scientist
• Two Scientists from Different Biological Disciplines
• A Veterinarian Involved in The Care of Animal
• A Scientist in Charge of Animals Facility
• A CPCSEA Main Nominee & A CPCSEA Link Nominee
• A Scientist from Outside the Institute
• A Socially Aware Nominee
Membership Duration & Replacements in Committee
1. The duration of membership is 5 years or as per latest notification of CPCSEA
(coterminous with registration renewal).
2. At the time of renewal of registration new IAEC will be formed and at least
half of the members will be replaced.
3. Any replacement in IAEC members can be made only with the prior approval
of CPCSEA.
4. CPCSEA may be requested to replace a member in special cases viz. event of
death, long time non‐ availability or violation in responsibilities of IAEC. Long
time non‐availability is defined as absence in three consecutive meetings.
Rights and Responsibility of Members
• Every member of committee has equal rights to raise any relevant issue.
• Conflict of interest should be declared by members of the IAEC to the chair.
• It is cumulative responsibility of members to facilitate the smooth functioning of IAEC.
• Members should maintain confidentiality of all discussions during the meeting and sign a
secrecy undertaking 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 and after their membership period.
• Member can tender resignation from the committee with proper reasons to dose.
• Members should promote principle of 4Rs with active involvement, guidance and
suggestions.
• Any member who has any current information in field of animal welfare and ethics, during
his/her visit to any conference or during latest literature review, must share with other
members.
• Members should not raise any discussion on his/her gut feeling. Reference material, if any,
must be carried to meeting for easy sharing and decision making.
Conclusion
• An overview of the INSTITUTIONAL BIOSAFETY COMMITTEE
• An overview of the INSTITUTIONAL ANIMAL ETHICS COMMITTEE
Reference
• https://ibkp.dbtindia.gov.in/Registration/Index
• https
://ibkp.dbtindia.gov.in/Content/Commitee?AspxAutoDetectCookieSu
pport=1#:~:
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20and%20products%20thereof
.
• https://www.nou.nic.in/SOP_ANIMAL_ETHICS.pdf
Thank you