Institutional Ethics Committee

The need for Institutional Ethics Committee (IECs) in medical and research establishments resulted from the realization that affirms human rights as a prerogative of all members of society. Individual physicians and research workers may not be able to do what is right in all instances as evidenced by the number of cases on record.

One should not think that this morally and ethically driven persuasion is a recent phenomenon. Infact, most of the medical writings available from ancient civilizations like Mesopotamia, Egypt, China, India and Greece, describe very precisely the code of conduct to be followed by medical practioners .One is struck by the tremendous respect shown for the preservation of the rights of the patient and more importantly the accountability of the treating physician. In other words, the medical and research community of today is the proud possessor of a rich ethical inheritance.

Institutional ethics committees vary widely in their composition, usually in an attempt to assure a broad based multi-disciplinary membership. In addition to those with research and clinical experience, many committees include representation from Pastoral Care, Social Work, and Law backgrounds, and often a member with a more academic orientation. Moreover, most committees find it important to include individuals from the lay community to help provide a patient's and public perspective.

The present medical and research scene in India is rather chaotic and irregular and therefore vulnerable to unethical practices. With globalization and shift of research focus from the developed countries to developing countries, the protection of vulnerable populations in countries like India is of utmost importance and urgency. The apex medical and research bodies at best have played a passive role till recently on ethical issues by not making a strong enough stand in public and not being persuasive enough to motivate all institutions to establish ethics committees. There has been no concerted move to either educate the public on ethical issues confronting medical practice and research or importantly, to incorporate bioethics as a subject in the medical, nursing, paramedical and biotechnology courses.

The Indian Council of Medical Research (ICMR) has published detailed guidelines on the composition and responsibilities of IECs and established ethical guidelines for biomedical research on human subjects (Published in 2006). A survey of existing IECs of various institutions in the country was initiated recently by the ICMR. Unfortunately this effort received a very unenthusiastic response. This sorry situation reflects an inadequate form of control and governance in the practice of medicine and research because the overseeing institutions are not given the necessary authority to take action against offenders, and society as a whole has not established a sensitive and interactive approach to the whole question of unethical practices.

What should be our perception of IIT-IEC?

When an ethical dilemma occurs, it is not so much a question of "shall I do the wrong thing or the right thing", it is, "which good that I am trying to achieve is the better good?"

An IEC is not a scientific review board - working as a gatekeeper and a regulator for experimental research and clinical trials. An IEC does not have that kind of a mandate - nor does it wish to.

It is not a morals police force going around looking for research workers doing something unethical.

It is not a quality review board or risk management committee who is supposed to cover the institution's legal situation.

Then what should it be?

The IIT-IEC should function like a preventive medicine department (preventing problems from arising) and concentrate its efforts on conflict resolution.

IIT-IEC must bear in mind that it is a porous bi-layered membrane facing creative research on one side and maintaining society's human rights on the other.

Composition of IEC

IEC will have a chairman, the member secretary and members nominated by the Director.

IEC will have minimum eight (8) members including

  • 2 medical/ non medical scientists
  • All members of the IEC should be non-institutional except the member secretary
  • The chair should be an outsider
  • The secretary should be a staff of this institution
  • There should be at least 2 lady members in the committee
  • There should be at least 5 members for a quorum
  • No senior administrative officer of the institution should be a member
  • An office and office staff should be available for the secretary of the IEC
  • No outside member of the IEC should be connected with the institution or research project in any way


 

Some Specific roles the IIT- IECs can play are the following

  1. Be available through the member secretary for clarifying ethical problems that may arise from the project and detail the ethical problem for the IEC to debate.
  2. Make sure that "informed consent "has been properly obtained. There is a general belief among doctors and research workers that patients belonging to the lower socio-economic group are pretty illiterate about medical matters and therefore need not be told much about their diagnosis, management or prognosis or why a certain quantity of blood or other specimens are being collected.The findings of a survey are totally at variance with this observation.
  3. Multi-center trials require a uniform protocol and a unified assessment system. There should be unlimited cross talk between IECs of institutions involved.
  4. Periodic follow up should be made by the IEC after an institutional project has been sanctioned.
  5. Use of laboratory animals in research - additional inputs from physiologist, pharmacologists and pathologists should be sought by the IEC or a separate committee should be available.
  6. Informed consent obtained from volunteers who are to participate in a field trial must be meticulously executed. The dangers if any spelt out, what legitimate safeguards as opposed to enticements can be offered ?what sort of compensation will be offered if something goes wrong, how will confidentially be maintained , can be biological samples obtained from the person be sent to other laboratories in india and abroad? And the proper disposal of biological samples.
  7. Clinical trials of drugs or therapy conducted by clinicians /research workers attached to this institution and a collaborating one, should not only be assessed by the IEC ,but it should have a say in the quantum of largesse offered for the person's services and the final report should be made available to the IEC before it is submitted to the sponsoring agency. The ethics committee minutes of the collaborating institution should be available with the institutional PI.
  8. Stem cell research. Experts and details mandatory.

Procedure for Ethical Clearance for Projects

  1. Clearance by the 'Technical Committee' is needed. In case of experiments involving animals, clearance from the Animal Experimentation Committee is required.
  2. Submission of the proposal highlighting the Ethical aspects have to be submitted to the IEC office. Form 1 - must be filled up and attached to the submitted proposal. Clearance(s) as mentioned in (1) must also accompany the proposal. This must be submitted to the Member Secretary at least a month before the next meeting of the Ethics committee.
  3. The PI will be informed of the date and time of the IEC meeting when the presentation has to be made to the IEC.
  4. The IEC will issue the clearance certificate subject to all the criteria being met by the PI for the submitted proposal.
  5. Submit 8 hard copies of your proposal to the IEC office with the prescribed forms.


 

Note: A copy of the ICMR guidelines [2006] is available at the IEC office for reference. A model "Informed Consent Form" is also available for reference.

Ongoing Protocol Review Submission Form 2


 



 

For more details contact

Institutional Ethics Committee
IC& SR Building 2nd Floor,
IIT Madras, Chennai 600 036
Phone: +91 (44) 2257 4929
EMail: iec@iitm.ac.in

Dr. Anju Chadha
Member Secretary, IEC
Professor, Laboratory of Bioorganic Chemistry
Department of Biotechnology and National Center for Catalysis Research
IIT Madras, Chennai 600 036
Phone: +91 (44) 2257 4106; Fax 4102

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