Institutional Human Ethics Committee (IHEC)
1. Aim
Following the National Ethical Guidelines of the Indian Council of Medical Research (ICMR) for Biomedical and Health Research involving Human Participants, the Institutional Human Ethics Committee (IHEC) of Vidyasagar University aims at safeguarding the dignity, rights, safety and well-being of the human participants involved in biomedical and health research.
2. Scope
The guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data. The purpose of such research should be:
(i). DIRECTED towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian cultural, social and natural environments.
(ii). CONDUCTED under conditions such that no person or persons become mere means for the betterment of others and that human beings who are subjected to any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency.
(iii). SUBJECTED to a regime of EVALUATION at all stages, i.e., design, conduct and reporting of the results thereof.
3. Principles
Every research has some inherent probabilities of harm or risk and thus, protection of research participants and/or communities should be built into the design of the study. The following principles are applicable to all biomedical and health research involving human participants or research using their biological material or data:
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1. Principle of Essentiality
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7. Principle of Professional Competence
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2. Principle of Voluntariness
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8. Principle of Maximization of Benefit
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3. Principle of Non-exploitation
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9. Principle of Institutional Arrangements
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4. Principle of Social Responsibility
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10. Principle of Transparency & accountability
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5. Principle of Ensuring Privacy & Confidentiality
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11. Principle of Totality of Responsibility
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6. Principle of Risk Minimization
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12. Principle of Environmental Protection
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4. Composition & affiliations of the IHEC members
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Sl. No.
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Position in the Committee
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Name
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1
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Chairperson
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Professor Debidas Ghosh
Emeritus Professor, D. T. S. K. S. Mahavidyalaya, NAAC – ‘A’ Graded Autonomous College, Debra, Paschim Medinipur – 721 124, West Bengal .
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2
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Member-Secretary
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Professor Dipak K. Midya
Department of Anthropology, Vidyasagar University, Midnapore -721 102
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3
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Member
(Basic Medical Scientist)
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Professor Sujata Maiti (Choudhury)
Department of Human Physiology, Vidyasagar University,
Midnapore -721102
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4
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Member
(Clinician)
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Dr. Jugal Kishore Kar
Professor & HOD, Department of General Medicine, Midnapore Medical College and Hospital, Midnapore- 721 101
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5
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Member
(Legal Expert)
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Mr. Sachindra Nath Mishra
Advocate, High Court, Kolkata - 700 001
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6
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Member
(NGO person))
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Mr. Amit Kumar Paul
Ashar Alo (NGO), Satyapur, Marotala, Paschim Medinipur - 721156
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7
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Member
(Philosopher)
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Professor Tapan Kumar De
Department of Philosophy, Vidyasagar University, Midnapore -721 102
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8
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Member
(Lay person)
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Mr. Manas Kumar Chakraborty
Pal Bari, Ganapatinagar, Midnapore, Paschim Medinipur – 721 101
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5. Documents required for IHEC review/clearance of a Research Proposal:
(i) An application seeking ethical clearance of the proposed research work by the PI (to be addressed to the Member-Secretary).
(ii) Filled-in Model Form in the given format
(iii) Research proposal
(iv) Informed Consent Form (ICF) in the given format in English and the local language(s). Translation and back translation certificates (if applicable)
(v) Questionnaire/Schedule/ Case record form
(vi) A certificate from a Medical person (clinician) confirming no perceived harm/risk to the study participants
(vii) Ph.D. Registration certificate/ Project offer letter
(viii) Intimation Form in the given format (Intimation Form)
Applicants are required to submit the HARD COPIES of all documents to the Member-Secretary. They are also requested to send the SOFT COPIES of all documents to the designated email ID of the IHEC).
6. Contact details (Member-Secretary):
Email ID: human_ethics_committee@mail.vidyasagar.ac.in