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Intersyste m Bio m edica Ethics Co mm ittee , Mu m bai Dr Jayashree Joshi, Member Secretary

Establishment of an Intersystem Ethics Committee & Capacity Building of EC members & of applicants. Intersyste m Bio m edica Ethics Co mm ittee , Mu m bai Dr Jayashree Joshi, Member Secretary. FERCI Conference, TMC, Mumnbai , Mu m bai,2011. Late Dr Arun Sanghani

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Intersyste m Bio m edica Ethics Co mm ittee , Mu m bai Dr Jayashree Joshi, Member Secretary

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  1. 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

  2. Late Dr ArunSanghani Founder Chairman FERCI, Mumbai,2011

  3. AYURVED ALLOPATHY SIDDHA ISBEC HOMEOPATHY UNANI YOGA NUTRITION FERCI, Mumbai,2011

  4. 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

  5. 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

  6. Highlights of ISBEC SOPsIntersystem Biomedica Ethics Committee • ICH GCP Guidelines • ICMR guidelines • FERCI Guidelines • WHO Guidelines • FDA • DCGI Guidelines • CharakaSamhita • SushrutaSamhita • AshtangaHridaya • SharangdharSamhita • Vaidyak- Sadvritta-Sadachar Homeopathy Unani FERCI, Mumbai,2011

  7. 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

  8. Review Process Application from Investigator, CRO, Student Expedited review 1 stwk Primary reviewer + Other members Primary reviewer + Other members Special Meeting Suggestions / Rejection ISBEC Meeting Suggestions / Rejection 4th wk Modified protocol submitted Approval letter issued with a validity date FERCI, Mumbai,2011

  9. Types of Diseases • 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 pain FERCI, Mumbai,2011

  10. 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 foodgrains FERCI, Mumbai,2011

  11. 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

  12. 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 women FERCI, Mumbai,2011

  13. Future Plans • Training • Seminars • Workshops • Monitoring FERCI, Mumbai,2011

  14. Thank You ! FERCI, Mumbai,2011

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