AN OVERVIEW OF

HEALTH RESEARCH ETHICS

IN INDONESIA

By :

SURIADI GUNAWAN

• 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

Background Information

INDONESIA

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%)

1. Health Systems Research 25%2. Biomedical / Epidemiological 22%3. Pharmaceutical (drugs) 20%4. Nutrition 8%5. Socio-behavioural 6%6. Environmental / Occup. 5%7. Demographic 5%8. High technology 4%9. Clinical 3%10. Other 2%

Research Areas (1999)Research Areas (1999)

• 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

Survey / Mapping of ECs (2001)Survey / Mapping of ECs (2001)

Survey / Mapping of ECs (2001)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

1982 “Ethical Guidelines for Medical Research” Published by University of Indonesia (UI)

Medical School

1984 E.C. of UI Med.School established

1985 E.C. of National Family Planning Coordinating Board established

1986 National workshop organized by UI Medical School and Consortium of Medical Sciences

“Ethical guidelines for Medical Research” adopted

Development of Research Ethics in Indonesia

1989 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 violators1995 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

Development of Research Ethics in Indonesia

Development of Research Ethics in Indonesia

2000 Guidelines on clinical trial of traditional drugs (MOH Decree no.56)

2001 - 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

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 2003 - 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)

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

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

Ethics Review Committeesaccording to National Guidelines on ethics on

Health Research 2003

- 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

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

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

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

Thank You