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