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Indian Council of Medical ResearchBioethics Activities
Dr. Vijay KumarScientist F
Indian Council of Medical ResearchNew Delhi
Indian Council of Medical Research (ICMR)
• The apex body in India for the formulation, coordination and promotion of biomedical research under Department of Health Research, Ministry of Health and Family Welfare, Government of India
• Established in 1911, as Indian Research Fund Association (IRFA)
• Redesignated in 1949 as the Indian Council of Medical Research (ICMR) with considerably expanded scope of functions.
• Intramural research is carried out through the Council's theme oriented 21 permanent research institutes/centers and 6 regional centers addressing to regional health problems
Network of ICMR Institutes
ICMR Field stations network
Malaria Field stations
Human Reproduction Research Centres
National Nutrition Monitoring Bureaux
VCRC Field stations
NIV Field stations
Cancer registries
NIOH Field stations
Bioethics Cell at ICMR Headquarters Office, New Delhi
Bioethics Cell • Secretariat of the Central Ethics Committee on Human
Research (CECHR) – a National Ethics Committee and a referral body for the Ministry of Health and Family Welfare as well as other Ministries under Govt. of India for all Bioethics related activities.
• Secretariat for Institutional Ethics Committee for reviewing the projects generated by ICMR Headquarters scientists and also proposed to review proposals from WHO-SEARO.
• Coordinates all activities related to ethical issues pertaining to medical research on humans and animals in India.
Bioethics Cell of ICMRActivities
• Opinions on bioethics issues at national level• Formulating Policy Statements, Ethical Guidelines and
Guidance Documents• Education / Training in bioethics• Consultation on issues related to Bioethics and functioning
of Institutional Ethics Committees• Maintaining database for Bioethics Resources• Co-coordinating International Collaboration on bioethics• Organizing workshop/Seminars/Symposia related to Bioethics• Conducting research in the area of Bioethics.
Documents prepared• Policy Statement on Ethical Considerations involved
in Research on Human Subjects’ in 1980• Ethical Guidelines for Biomedical Research on
Human Subjects’ “ in 2000• Revised version of ‘Ethical Guidelines for Biomedical
Research on Human Participants’ in 2006• Legislation of the ‘Ethical Guidelines for Biomedical
Research on Human Participants’ submitted to Ministry of Health & Family Welfare
• Guidelines on Stem cell Research & Therapy (DHR-ICMR-DBT)
• Draft Guidelines on Safety assessment of derived GM foods derived from r-DNA plants
Documents prepared• Draft Ethical Guidelines for Bio-banking in India• National Guidelines for Accreditation, Supervision &
Regulation of ART Clinics in India (2005) issued by division of Reproductive, Health & Nutrition (RHN), ICMR
• Guidance Document on Animal Experimentation, 2006• Model Standard Operating Procedures for IEC in India• Standard Operating Procedure for Ethics Committees
prepared under ICMR-FERCAP joint initiative. • WHO sponsored textbook on “Contemporary Issues in
Biomedical and Health Research” as resource material for teaching Bioethics in India.
Ethical Guidelines for Biomedical Research
The BillThe BillTHE BIOMEDICAL THE BIOMEDICAL
RESEARCH ON HUMAN RESEARCH ON HUMAN SUBJECTS (REGULATION, SUBJECTS (REGULATION,
CONTROL AND CONTROL AND SAFEGUARDS) BILL, SAFEGUARDS) BILL,
20072007
Other Guidelines
Humane Animal Use
Genetically Modified Foods
Stem Cell Research
Biobanking
Assisted Reproductive Techniques
HIV / AIDS Research
Text Book in Bioethics
1. Bioethics - Background, History and Evolution of Guidelines
2. Role and responsibilities of ethics committees
3. Ethical Considerations in Clinical Trial 4. Ethical Issues in Genetics with Focus on
Genetic Testing and Screening 5. Ethical considerations in transplantation and
stem cell research 6. Ethical issues in Assisted Reproductive
Technologies (ARTs) 7. Ethical issues in epidemiological research 8. Ethics of international collaboration in
biomedical & health research - an Indian perspective
9. Ethics in social science research10. Ethical practices in publication in biomedical
sciences 11. Ethical issues in Traditional Medicine
Research 12. Ethical practices and guidelines in animal
experimentation 13. Twin Pillars of Biomedical Research Ethics -
tackling the challenges 14. Case Studies
Bioethics TrainingsICMR-WHO-FERCAP
• Human Subject Protection Course (HSPC), from 2nd- 4th August, 2006 at Mumbai
• Standard Operating Procedures (SOP) Training Course from 30th Aug-1st Sep, 2006, Mumbai.
• Members of 6 Institutional Ethics Committee participated (n=70)
– Tata Memorial Hospital– NIRRH– NIIH– Independent EC– KEM Hospital– TN Medical College
UGs & PGs600 511
Ethics Sensitisation & Training
Researchers and
IEC members424 633
Researchers and
Faculty400
Trainers12
NIH WHO
• Quality of Informed Consent in Clinical trials and Clinical Research funded by the Council– Questionnaire based
study completed to see the content of Informed consent forms
– 4 site visits planned to witness actual Informed consent process
THANK YOU