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AN OVERVIEW OF HEALTH RESEARCH ETHICS IN INDONESIA. By : SURIADI GUNAWAN. Background Information INDONESIA. Over 17.000 islands Over 215 million population Over 250 ethnic groups Major religions : Islam (85%), Christianity, Buddhism, Hinduism, and Confucianism.

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by suriadi gunawan

AN OVERVIEW OF

HEALTH RESEARCH ETHICS

IN INDONESIA

By :

SURIADI GUNAWAN

slide2

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

slide3

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%)

research areas 1999

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%

slide5

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

slide6

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
slide7

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
slide8

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
development of research ethics in indonesia
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

development of research ethics in indonesia1
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)

national commission of ethics in health research

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

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 committees

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

clinical trial of drugs according to decree of fda on gcp 2001

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

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

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