An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done.
The purpose of the review process is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. A key goal of IECs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), and seeks to maximize the safety of subjects.
The Institutional Ethics Committee (IEC) for KIIT is constituted at Kalinga Institute of Medical Sciences (KIMS). The goal of the IEC is to protect the rights and welfare of those individuals who agree to participate in research. The review and approval of proposals and activities by the IRB are meant to assist the researchers by having a review that will objectively analyze the potential risk involved to research participants, as well as ways to minimize that risk. As part of the process, the College IRB will evaluate the aforementioned ethical practices in determining risk.
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals. The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them. For this purpose, the Government has made “Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998” as amended during 2001 and 2006, to regulate the experimentation on animals. The objective of this SOP is to contribute to the effective functioning of the Institutional Animal Ethics Committee (IAEC) so that a quality and consistent ethical review mechanism for research on animals is put in place for all proposals dealt by the Committee as prescribed by the CPCSEA under PCA Act 1960 and Breeding and Experimentation Rules 1998.
IAEC has been designed to secure the following objectives:
- Experiments shall be performed in every case by or under the supervision of a person duly qualified in that behalf, that is, Degree or Diploma holders in Veterinary Science or Medicine or Laboratory Animal Science of a University or an Institution recognized by the Government for the purpose and under the responsibility of the person performing the experiment;
- That experiments are performed with due care and humanity and that as far as possible experiments involving operations are performed under the influence of some anesthetic of sufficient power to prevent the animals feeling pain;
- That animals which, in the course of experiments under the influence of anesthetics, are so injured that their recovery would involve serious suffering, are ordinarily destroyed while still insensible;
- That experiments on animals are avoided wherever it is possible to do so; as for example; in medical schools, hospitals, colleges and the like, if other teaching devices such as books, models, films and the like, may equally suffice;
- 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, mice, rats etc;
- That, as far as possible, experiments are not performed merely for the purpose of acquiring manual skill;
- That animals intended for the performance of experiments are properly looked after both before and after experiments;
- That suitable records are maintained with respect to experiments performed on animals
Functions of IAEC
IAEC was constituted in KIIT School of Biotechnology on 09.05.2013 vide CPCSEA memorandum No-1577/PO/ac/11/CPCSEA. As defined in “Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998” “Institutional Animals Ethics Committee” means a body comprising of a group of persons recognized and registered by the Committee for the purpose of control and supervision of experiments on animals performed in an establishment which is constituted and operated in accordance with procedures specified for the purpose by the Committee;
The primary duty of IAEC is to work for achievement of the objectives as mentioned above.
IAEC will review and approve all types of research proposals involving small animal experimentation before the start of the study. For experimentation on large animals, the case is required to be forwarded to CPCSEA in prescribed manner with recommendation of IAEC.
IAEC is required to monitor the research throughout the study and after completion of study through periodic reports and visit to animal house and laboratory where the experiments are conducted. The committee has to ensure compliance with all regulatory requirements, applicable rules, guidelines and laws.
Indian regulations require that every organization intending to conduct research on genetically modified organisms (GMOs) should constitute an Institutional Biosafety Committee (IBSC) to approve and periodically review the biosafety aspects of the research projects.
IBSC was constituted in KIIT School of Biotechnology on 30.07.2012 vide DBT memorandum No-BT/BS/17/493/2012-PID. Each IBSC has to meet at least twice a year to review the status of rDNA projects in the institution. It is important that the Chairman and Member Secretary ensure that regular meetings take place. More than two meetings may be held as per requirement of the projects. The IBSC members are expected to look into the following during the meetings:
- Action taken on the decisions of earlier IBSC meetings.
- Characterization of work and approval as per risk category.
- Evaluation of projects and direction to submission for appropriate agencies for approvals
- Inspection of containment facilities and greenhouses etc.
- Review the medical reports of employees
- Maintaining procedures and other approval requirements.
IBSC has to furnish half yearly reports on the ongoing projects in the organization to RCGM regarding the observance of the safety guidelines including accidents, risks and deviations, if any. The role of IBSCs assumes major importance in the regulatory framework since it is a Statutory Committee that operates from the premises of the institution and hence is in a position to conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines. The decisions taken by the next higher committee i.e., Review Committee on Genetic Manipulation (RCGM), which operates from DBT are based on the applications submitted by the investigators with the approval of IBSC. Therefore, it is pertinent that the members of the IBSCs and DBT nominees to the IBSCs have expertise in evaluation, assessment and monitoring of projects as per the rDNA guidelines.