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

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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)

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Research Areas (1999)

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

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

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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

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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

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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)

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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

• according 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

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

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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

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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

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Thank You