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Indian Council of Medical Research
Bioethics Activities
Dr. Vijay Kumar
Scientist F
Indian Council of Medical Research
New...
Indian Council of Medical Research
(ICMR)
• The apex body in India for the formulation, coordination and promotion of
biom...
Network of ICMR Institutes
ICMR Field stations
network
Malaria Field stations
Human Reproduction
Research Centres
National Nutrition
Monitoring Burea...
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...
Bioethics Cell of ICMR
Activities
• Opinions on bioethics issues at national level
• Formulating Policy Statements, Ethica...
Documents prepared
• Policy Statement on Ethical Considerations involved
in Research on Human Subjects’ in 1980
• Ethical ...
Documents prepared
• Draft Ethical Guidelines for Bio-banking in India
• National Guidelines for Accreditation, Supervisio...
Ethical Guidelines for Biomedical
Research
The BillThe Bill
THE BIOMEDICALTHE BIOMEDICAL
RESEARCH ON HUMANRESEARCH ON HUMA...
Other
Guidelines
Humane Animal
Use
Genetically
Modified Foods
Stem Cell
Research
Biobanking
Assisted
Reproductive
Techniqu...
Text Book in Bioethics
1. Bioethics - Background, History and
Evolution of Guidelines
2. Role and responsibilities of ethi...
Bioethics Trainings
ICMR-WHO-FERCAP
• Human Subject Protection Course (HSPC),
from 2nd- 4th August, 2006 at Mumbai
• Stand...
UGs & PGs
600 511
Ethics Sensitisation & Training
Researchers
and
IEC members
424 633
Researchers
and
Faculty
400
Trainers...
• Quality of Informed
Consent in Clinical
trials and Clinical
Research funded by
the Council
– Questionnaire based
study c...
THANK YOU
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Indian Council of Medical Research Bioethics Activities

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Indian Council of Medical Research Bioethics Activities

  1. 1. Indian Council of Medical Research Bioethics Activities Dr. Vijay Kumar Scientist F Indian Council of Medical Research New Delhi
  2. 2. 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
  3. 3. Network of ICMR Institutes
  4. 4. 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
  5. 5. Bioethics Cell at ICMR Headquarters Office, New Delhi
  6. 6. 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.
  7. 7. Bioethics Cell of ICMR Activities • 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.
  8. 8. 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
  9. 9. 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.
  10. 10. Ethical Guidelines for Biomedical Research The BillThe Bill THE BIOMEDICALTHE BIOMEDICAL RESEARCH ON HUMANRESEARCH ON HUMAN SUBJECTS (REGULATION,SUBJECTS (REGULATION, CONTROL ANDCONTROL AND SAFEGUARDS) BILL,SAFEGUARDS) BILL, 20072007
  11. 11. Other Guidelines Humane Animal Use Genetically Modified Foods Stem Cell Research Biobanking Assisted Reproductive Techniques HIV / AIDS Research
  12. 12. 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 research 10. 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
  13. 13. Bioethics Trainings ICMR-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
  14. 14. UGs & PGs 600 511 Ethics Sensitisation & Training Researchers and IEC members 424 633 Researchers and Faculty 400 Trainers 12 NIH WHO
  15. 15. • 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
  16. 16. THANK YOU

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