establishment of an intersystem ethics committee & capacity building of ec members & of...
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Establishment of an Intersystem Ethics Committee & Capacity Building
of EC members & of applicants
Intersystem Biomedica Ethics Committee , Mumbai
Dr Jayashree Joshi, Member Secretary
FERCI Conference, TMC, Mumnbai, Mumbai,2011
FERCI, Mumbai,2011
Late Dr Arun SanghaniFounder Chairman
FERCI, Mumbai,2011
ALLOPATHY
UNANIHOMEOPATHY
YOGANUTRITION
AYURVED
SIDDHA
ISBEC
Mission• To function as an independent ethics committee for
encouraging scientific progress of various systems of medicine
• To inter exchange ethical values amongst various systems
• To collaborate with the ICMR, CSIR, AYUSH, CCRAS
FERCI, Mumbai,2011
Objectives
• To formulate guidelines for research in inter system research
• To guide the industry in clinical trials
• To undertake training in Research Ethics in clinical medicine
Highlights of ISBEC SOPsIntersystem Biomedica Ethics Committee
• ICH GCP Guidelines• ICMR guidelines• FERCI Guidelines• WHO Guidelines• FDA• DCGI Guidelines
• Charaka Samhita• Sushruta Samhita• Ashtanga Hridaya• Sharangdhar Samhita• Vaidyak- Sadvritta-
Sadachar
Homeopathy UnaniFERCI, Mumbai,2011
ISBEC –categories of applicants:
1) Multinational companies 2) Governmental Research Organisations like ICMR,
DBT, CCRAS, CSIR 3) Postgraduate students’ dissertations for MSc or
PhD 4) Clinical trials by Clinical Research Organisations 5) Projects from Ayurvedic CROs 6) Questionnaire surveys by voluntary organisations, national professional bodies or Pharmaceuticals
FERCI, Mumbai,2011
Review ProcessApplication from Investigator, CRO, Student
1 st wk
Primary reviewer + Other members
ISBEC Meeting Suggestions / Rejection
Modified protocol submittedApproval letter issued with a validity date
Expedited review
Special Meeting Suggestions / Rejection
FERCI, Mumbai,2011
4th wk
Primary reviewer + Other members
• Asthma – Phase II-Comparative with placebo
• DM- Phase I – antisecretory compound- use of placeboPhase Phase IV-multicountry; Ayurvedic - for multicentric
studies• TB –Existing approved product-Multinational Co
• I H D- Homeopathy- Total revision of protocol
• Malaria
• Leucorrhoea, Menorrhagia
• Neurogenic painFERCI, Mumbai,2011
Types of Diseases
Range of Topics for studiesMore than 80 projects evaluated
• New molecules for DM, BPH - NCE- Phase 1, 2
• PKPD studies• Phase 3 studies- DM, Arthritis• New indications for a drug or vitamin• Pilot studies- Ayurved based• Questionnaire surveys• Nutrition- analysis of foodgrains• Nutrition- anthropometry• Nutrition education• Herbal/ Ayurveda based• Dietary interventions- genetically
selected foodgrainsFERCI, Mumbai,2011
Review of ADRs & Action Taken
• Hepatotoxicity in CSIR-NMITLI project- wrongly attributed to the herbal product
• Gastrointestinal side effects – wrongly attributed to herbal product
• Injectable product for neurological pain relief- multinational study - consent form modified as per the recommendation
Dissemination of Intersystem values & principles
• Full Day ICMR supported Seminar - proceedings- published- ISBEC, ICMR, Industry, academia
• Half Day- Seminar – FERCI President ,ISBEC, MRC-KHS participation
• ICMR Reverse Pharmacology Training Workshop- session on ethics in research- Ayurvedic, allopathic, basic scientists-delegates from all over India
• Chapter on clinical trials in pregnant & lactating womenFERCI, Mumbai,2011
Future Plans
• Training• Seminars• Workshops• Monitoring
FERCI, Mumbai,2011
Thank You !
FERCI, Mumbai,2011