Bioethics Activities in India under ICMR

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1 Bioethics Activities in India under ICMR Dr. Nandini K. Kumar Deputy Director General Indian Council of Medical Research New Delhi

2 Indian Council of Medical Research Founded in Indian Research Fund Association Renamed as ICMR in 1949 Apex organization to formulate, conduct, coordinate and promote biomedical research

3 Mandate To undertake and support basic, epidemiological, applied and operational research in the areas of national public health importance using tools including those of modern biology.

4 ICMR INSTITUTES MRC IOP HQRS IRMS CJIL ICPO RMRI NIOH NICED IIH NIN NIRRH FDTRC EVRC NCLAS GRC VCRC NIV TRC NARI NIE RMRC RMRC RMRC RMRC RMRC CRME

5 Ethics Committees

6 Survey of Institutional Ethics Committees and Ethical Review practices Understand the actual manner in which the Ethics Committees are functioning in different parts of the country In 2001-questionaire Medical Colleges/ ICMR instt- 32 responded

7 Survey on Ethics Committee Review in India No Legal expert in most of the committees Appointment procedures / lobbying Decision making by consensus / majority approach No. of proposals variable 2-60 / meeting Minutes/ record keeping poor No charge for review Independence / Competence??

8 Survey of Institutional Ethics Committees In > 1200 questionaires circulated, replies from about 223 received and analysed To develop various training & capacity building through corrective measures To plan Accreditation of IECs

9 Survey of Institutional Ethics Committees In point questionnaire circulated to 1200 institutions public and private based on WHO operational guidelines for ethics committees Biomedical Research Reviewing ICMR guidelines for research human subjects responses Colleges under Indian Systems of Medicine & Homeopathy (12.6 %) Research Institutes (53.6% ) Allopathic Medical Colleges (24.5%) Dental colleges (3 %) Voluntary Agencies (7. 3% ) First survey to develop various training modules & capacity building through corrective measures proposed 40 ethics committees chosen Accreditation of IECs planned

10 Preparation of SOPs for Ethics Committees An ICMR-FERCAP workshop on Development of Standard Operating Procedures (SOPs) for Institutional Ethics Committees Guidelines for preparing Standard Operating Procedures for Institutional Ethics Committees for Human Research

11 Independent Ethics Committees in India Mumbai Ahmedabad Delhi Bangalore

12 Need of the Hour Strategies to be developed for sensitisation through Workshops Update guidelines & formulate new ones Seek international collaboration for capacity building in bioethics Regional Initiatives WHO, various Fora Global Initiatives NIH, Wellcome Trust, Melinda & Bill Gates Foundation, Ford Foundation

13 Guidelines

14 Ethical Guidelines for Biomedical Research The Bill THE BIOMEDICAL RESEARCH ON HUMAN SUBJECTS (Promotion and REGULATION) BILL, 2006

15 Other ICMR Guidelines

16 Draft Guidelines Stem Cell Research Genetically Modified Foods Biobanking

17 The National Ethical Guidelines

18 OHRP Website for FWA : Compliance with the following procedural standards: 45 CFR 46 and all of its subparts (A,B,C,D) 45 CFR 46, subpart A (Common Rule) 21 CFR 50 and 21 CFR 56 CIOMS International Ethical Guidelines ICH-GCP-E6 Sections 1 through 4 Canadian Tri-Council Policy Indian Council of Medical Research Other (please submit copy to OHRP with this Assurance)

19 Bioethics Website IEC survey Questionnaire is available on ICMR website A model format for submission of research proposal for review by IEC to help the EC members review the proposal Guidelines for preparing Standard Operating Procedures for Institutional Ethics Committees for Human Research

20 Teaching Resources under preparation on culturally relevant Indian topics A Textbook comprising 12 Chapters is under preparation for distribution during training programs and workshops Chapter 1 Animal Experimentation Chapter 2 Clinical trials and GCP Chapter 3 Transplantation Chapter 4 Epidemiology Chapter 5 International Collaboration Chapter 6 Publication Ethics Chapter 7 History and Background of ethics Chapter 8 Ethics Committees Chapter 9 Genetics and Genomics Chapter 10 Social Science Research Chapter 11 Traditional Medicine Chapter 12 Assisted Reproductive Techniques Case Study Compilation

21 Preparation of curriculum for Medical Colleges and Universities Preparation of syllabus for teaching Bioethics in various Health Universities NIH Sponsored Planning Grant for developing curriculum on Bioethics NIH Training grant for 4 years Resource persons identified to carry out country wide training exercises for students, faculty, researcher, Ethics Committee members etc.

22 Training Workshops conducted ICMR, WHO, NIH sponsored modules : 1 day, 3 days common Participants - medical professionals, nonmedical, nurses, social workers, followers of traditional systems of medicine etc.

23 FERCAP (Forum for Ethical Review Committee in Asia Pacific) Set up on 12th January, 2000 at Bangkok SEARO and WPRO countries To educate Ethics Committee members Networking of member countries & support other Fora of Latin America, Russia, Africa, Mediterranean, Caribbean, US & Canada Translation of Operational Guidelines of WHO for IECs

24 Distribution in FERCAP Region Singapore Samoa Taiwan Australia Japan FERCIT Thailand Lao Vietnam Bangladesh FERCAP Cambodia China Bhuthan Indonesia Sri Lanka Myanmar FERCAP Philippines Malaysia KAIRB Korea FERCIN Nepal

25 FERCI (Forum for Ethical Review Committee in India) National Chapter of FERCAP in India Steering Committee constituted in Dec 2002 Registered

26 Objectives of FERCI Establish & foster communication between ethics committees in India Act as national collaborating agency for ethics reviews Organize meetings & symposia on ethical review processes Assist in the development& implementation of SOPs for ethical review in the region, taking into consideration the WHO Operation Guidelines for Ethics Committees Reviewing Biomedical Research Facilitate training opportunities for members of ECs in the country Co-ordinate national communications & issues with other global bodies.

27 Private Sectors - IFPMA - Phrma - WIRB Public sectors TDR, OHRP, ICMR SIDCER NGOs - EFGCP - IOWH FERCAP FLACIES FECCIS PABIN FOCUS National Chapters National Chapters National Chapters National Chapters National Chapters Strategic Initiative for Developing Capacity in Ethical Review

28 Sensitisation & Training Ethics committee survey SOPs & Training FERCAP Curriculum Bioethics Activity FERCI South East Asia Central Ethics Committee International collaboration Funding for workshops Guidelines

29 Collaboration in Bioethics Bangladesh China Cambodia Indonesia Japan Lao PDR Malaysia Nepal Pakistan Philippines Sri Lanka Singapore Taiwan Thailand Brazil Canada Germany France Switzerland South Africa South America USA

30 NIH Sponsored Bioethics Program Planning Grant Training Grant Sensitisation programs of different durations like 1-5 days Undergraduates students Postgraduates students IEC members Researchers and Faculty members national & international Distance Education programme in association with Indira Gandhi National Open University Training for trainers - 8 weeks, 6 months

31 NIH Sponsored Bioethics Training program Syllabus prepared for 4 different levels Undergraduates students Postgraduates students IEC members Faculty members Distance Education programme in association with Indira Gandhi Open University Sensitisation / training programs of different durations like 3 days, 5 days, 8 weeks, 6 months

32 NIH Training Grant Centrally Co-ordinated Bioethics Education for India Nandini K. Kumar Program Director Vasantha Muthuswamy Co-Program Director

33 Time Line Structure of Training Program Workshop/WS Participants No of WS x No of participants Training Prog Year- wise trainee Total Short term 1 st 2 nd 3 rd 4 th 2-day workshop UGs, PGs 2x100 2 x x day workshop Researchers, 3 x 30 3 x 30 4 x Trainers, IEC members 5-day International workshop with 12 Foreign participants 1 x 42 1 X day workshop Trainers 1 x 20 1 x (Adv training) Long term (Adv training) 8-wk program Trainers 1 x 10 1 x mo program Trainers 1 x 6 1 x 6 12 Total trainees: 1056 Distance education

34 Symposium

35 Program

36 Total no of Trainees Trained in 1 st & 2 nd year Total proposed (4 year period) UGs/PGs International Researchers/IEC members Long-term training In 3 rd - 4 th year 32 Total trained

37 THANK YOU

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