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