Apollo Hospitals is committed to bring health care of international standards within the reach of every individual. It undertakes bio-medical research and scientific experimentation on human subjects in the premises of the hospital to discover better medical and therapeutic modalities for the benefit of mankind. In order to see that due care and caution is taken at all stages of the research and to ensure that the research subject(s) and those affected by it are put to minimum risk from and by the research, the institution has constituted an Ethics Committee. It is an independent body governed by the policies and procedures as per the regulatory requirements. The committee is reconstituted from time to time as per the standard operating procedures
The Institutional Ethics Committee of Apollo Hospitals is named as “Institutional Ethics Committee - Clinical Studies” (“IEC-CS”). The research activities of Institution shall be overseen by the IEC-CS. It is designed in accordance with Declaration of Helsinki and also the applicable guidelines formulated by Indian Council of Medical Research (ICMR), New Delhi and Central Drugs Standards Control Organization (CDSCO). This committee shall evaluate, scrutinize and monitor all clinical research. The role of the IEC-CS is “to protect and maintain the dignity, rights, safety and well being of all research participants”. It will:
1. Provide independent, competent and timely review of the ethics of proposed research studies
undertaken by researchers/clinicians from the Institution.
2. Review and approve the proposed research before the commencement of the research.
3. Ensure regular evaluation of the ethics of ongoing research studies.
4. Review, scrutinize and decide upon any ethical issue(s) relating to the research study.
The functions and activities of Institutional Ethics Committee shall be performed in accordance with ICH-GCP guidelines, Indian GCP Guidelines of the CDSCO, the ICMR guidelines, Drugs and Cosmetics Rules and Schedule Y (amended 2013) of Drugs and Cosmetics Act of India and all other applicable national and international regulations and guidelines. In the event of any conflict between the regulations/guidelines, the requirements specified in Indian regulations/guidelines shall prevail.
The management of Apollo Hospitals supports the formation and activities of IEC-CS in each of its centers doing human research namely Ahmadabad, Chennai, Hyderabad, Madurai, New Delhi, Bilaspur and Bhubaneswar, Mysore and Bangalore. EC is constituted and authorized by centre-specific Head of the Institution of Apollo Hospitals. The Chairperson of the Committee shall be independent and thus not associated with any activities of the Institution, as in accordance with Schedule Y. The chairman shall enter into an MOU with the head of the institution that necessary support, facilities and independence will be provided to ethics committee and the records will be maintained as long as required. This will ensure adequate finance, human resource allocation, a secretariat for administrative work and record keeping with due care and confidentiality. 5 of our ECs (Ahmedabad, Chennai, Hyderabad, Madurai and New Delhi) are AAHRPP accredited.
To Understand the Working Procedure Manual Please click the below link
INSTITUTIONAL ETHICS COMMITTEE-CLINICAL STUDIES -WPM
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