By : SURIADI GUNAWAN

1. AN OVERVIEW OF HEALTH RESEARCH ETHICS IN INDONESIA By : SURIADI GUNAWAN

2. Background Information INDONESIA Over 17.000 islands Over 215 million population Over 250 ethnic groups Major religions : Islam (85%), Christianity, Buddhism, Hinduism, and Confucianism. 32 provinces and over 350 districts / municipalities GDP ± US $1000 per cap/year Health Expenditure US $15 per cap/year 45 medical schools and 30 schools of P.H. 85 institutions doing health research

3. Health Research 1999 Around 1500 research projects / year Budget US $5 Million / year (0.5% of national health budget) Main sources : Ministry of Health(30%), Ministry of Education / Universities(40%), International agencies(10%), Ministry of Science and Technology (5%)

4. Research Areas (1999) Health Systems Research 25% Biomedical / Epidemiological 22% Pharmaceutical (drugs) 20% Nutrition 8% Socio-behavioural 6% Environmental / Occup. 5% Demographic 5% High technology 4% Clinical 3% Other 2%

5. Survey / Mapping of ECs (2001) 180 questionnaires 75 returned 26 ECs identified : 10 in teaching hospitals 8 in medical schools 6 in research institutes 1 in provincial health service 4 ECs in stage of formation

6. Survey / Mapping of ECs (2001) • 50% have Operational Guidelines • Average number of members : 10 • Only 20% have lay representation • Average protocols reviewed : 15 per year (range 10-100) • Total 5 00 protocols reviewed per year • Problems : - Low awareness • - Lack of National Guidelines • - Poor documentation • - Lack of funding / facilities • - Poor monitoring

7. Development of Research Ethics in Indonesia • 1982 “Ethical Guidelines for Medical Research” • Published by University of Indonesia (UI) • Medical School • E.C. of UI Med.School established • 1985 E.C. of National Family Planning Coordinating Board established • National workshop organized by UI Medical • School and Consortium of Medical Sciences • “Ethical guidelines for Medical Research” • adopted

8. Development of Research Ethics in Indonesia • E.C. of National Institute of Health Research and Development established • 1992 Law No.23/1992 on Health (includes • stipulations on Health Research) • - Values and norms of the community, health & • safety of subjects should be taken into • account • - Sanctions for violators • 1995 Government Regulation No.39/1995 on Health Research and Development : • - MOH to regulate use of human subject • - Informed consent requirements • - Sanctions for violators • - Compensation for research subject

9. Development of Research Ethics in Indonesia 2000 Guidelines on clinical trial of traditional drugs (MOH Decree no.56) • - Research Ethics Work Group established at NIHRD - National workshop on research ethics - National course on research ethics - Survey / mapping of ECs - ”Guidelines for Good Clinical Practice” issued by Indonesian FDA - WHO operational guidelines for ethics committees translated

10. Development of Research Ethics in Indonesia 2002 - Second National Workshop on research ethics : prepared draft national guidelines on ethics of health research and proposed establishment of a National Commission on Health Research Ethics - Decree no. 1333/2002 on informed consent in health research • - Inauguration of National Commission on Ethics of Health Research - National guidelines on ethics in health research - Modules for training in ethics of health research (12 modules)

11. National Commission of Ethics in Health Research Established by Decree of MOH No 1334 / 2002 20 members (physicians, biomedical scientists, public health experts, lawyer, sociologist, philosopher / ethicist, agriculturalist, pharmacist) Tasks :- promote ethics in health research - prepare national guidelines - develop networking of ECs - review special protocols - monitor institutional ECs - report to MOH annually Secretariat : NIHRD in Jakarta

12. Research by Foreigners * Regulated by Presidential Decree No 100 / 1993 * Protocol to be submitted to Indonesian Institute of Science (LIPI) for approval * A multi-departmental team advises LIPI * Local sponsor & counterpart required * Final report to be submitted to LIPI * A new government regulation will be issued

13. Ethics Review Committees • ERCs to be established at institutional, regional/ provincial, and national levels according to need • ERCs should be independent and free of political, institutional, professional and commercial interests • - Composition should be multidisciplinary with lay representation, consisting of 5 – 10 members according to National Guidelines on ethics on Health Research 2003

14. Clinical Trial of Drugsaccording to Decree of FDA on GCP 2001 All clinical trials to be registered and approved by FDA ERC approval required for all clinical trials Drugs to undergo trial should be approved by FDA National Clinical Trial Consultant Team advises FDA Inspections to be carried out by FDA

15. Clinical Trial of Traditional Drugs Regulated by MOH Decree No 56/2000 Traditional drugs used in formal health services should undergo clinical trials GCP to be used as guidance Traditional drugs with empirical evidence of efficacy and safety can go into phase III clinical trial directly

16. Main Challenges To establish National Network of ERCs To socialize National Guidelines/ create awareness among researches To increase capacity in ethics review To start surveying, registration and accreditation of ERCs To develop policies/legislation on bioethics and protection of human research subjects

17. Thank You