Workshop Overview

Currently growing knowledge and technology in the field of health is supported by various number of health research, both interventional and observational, involving one or many research centers (multi-center). Some researchers have also started examining human genetics or genomes or carrying out further research of stored biologic materials. Sensitive ethical issues may arise before, during, or after research. Storage of human biological materials or the use of left-over specimens for future follow-up studies also requires deep ethical considerations, particularly concerning informed consent and confidentiality.

One of the main tasks of health research ethics committee is to ensure that research ethics are conducted in accordance with nationally and internationally accepted standards of health research ethics, ensuring the safety and well-being of humans that are the source of research subjects, considering the privacy and dignity of the study participants. Implementation of these ethical obligations is at the core of health research ethics. To avoid violations, a deep understanding of the ethics of health research is required. Dengvaxia vaccine case can be a lesson learner for us together in re-evaluating the application and use of ethical principles in conducting the study and monitoring a study.

The World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) In line with the guidelines and ethical standards of national health research and development have developed a guide that encourages researchers and members of HREC to obtain both basic and advanced training courses on research ethics guidelines involving human participants. Training in health research for members of the ethics committee is a key element to strengthen the capacity of research institutions. With the support from multi-sector partnerships and national or international networks, capacity building can lead to better ethical review mechanisms. By studying the development of health research ethics in the world from the beginning to the present, we can obtain a comprehensive picture of health research ethics in its effort to protect humans who become the subject of a research.

As a follow up, the National Institute of Health Research and Development (NIHRD / Badan Litbangkes) through the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) and the United Stated – National Institutes of Health (US-NIH Department of Bioethics) will organize an International Standard of Health Research Ethics Training. This training will be very useful for health research institutions to improve the ability in the study or ethical review of a research protocol. The training will use an international module developed by US-NIH that has been done in several countries to increase multinational capacity Building.

Schedule

Time Topic Trainer
09.00 – 09.30 Opening remark:

  1. Directorate General of National Institute of Health Research and Development MoH Indonesia : dr. Siswanto, MHP., DTM
  2. Secretary General of National Institute of Health Research and Development MoH Indonesia : Dr. Nana Mulyana
  3. Director of center for Health Resources and Services Research and Development MoH Indonesia : Dr. dr. Irmansyah, SpKJ(K)
09.30 – 10.00 The Ethics of Research in Infectious Disease

 

Background Reading

 

Presentation
Prof. dr. Moh. Hakimi, Sp.OG(K)., Ph.D
10.00 – 10.30 Clinical research ethics: Current challenges in Indonesia

 

Presentation
Prof. dr. M. Sudomo
10.30 – 11.00 Break
11.00 – 11.30 Code of conduct for Biosecurity

 

Background Reading

 

Presentation
Prof. R. Sjamsuhidajat Ronokusumo, dr., Sp.B., KBD
11.30 – 12.00 Ethics review of clinical research

 

Presentation

 

Background Reading

 

 NIH Policy on Single-IRB Review — A New Era in Multicenter Studies

 

 Evidence gaps and ethical review of multicenter studies

 

Reidar Lie
12.00 – 12.20 Case presentation Reidar Lie
12.20 – 12.45 Discussion Reidar Lie
12.45 – 13.45 Lunch
13.45 – 14.15

 

Ethics lecture: Responsiveness to host country needs and reasonable availability of interventions in clinical trials

 

Background Reading

 

Presentation
Joe Millum
14.15 – 14.30 Case presentation: reasonable availability concerns surrounding a clinical trial Joe Millum
14.30 – 14.45 Discussion of reasonable availability case Joe Millum
14.45 – 15.15 Break
15.15 – 15.45 Ethics lecture: responsibility of care for participants in trials, including ancillary care and post-trial benefits

 

Presentation

 

Background Reading

 

ANNIVERSARY ESSAY: The Challenge of Assuring Continued Post-Trial Access to Beneficial Treatment

 

The Ancillary-Care Responsibilities of Medical Researchers
Liza Dawson
15.45 – 16.00 Case presentation Liza Dawson
16.00 – 16.30 Discussion Liza Dawson
16.30 – 16.45 Closing

 

Time Topic Trainer
09.00 – 09.30 Ethics lecture: Standard of care and placebo controlled trials

 

Presentation

 

Background Reading

 

The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?

 

The Ethics of Clinical Research in Third World

 

The use of placebo in a trial of rectal artesunate as initial treatment for severe malaria patients en route to referral clinics: ethical issues
David Wendler
09.30 – 09.45 Case presentation: standard of care and choice of control group in a clinical trial David Wendler
09.45 – 10.15 Discussion of case study David Wendler
10.45 – 11.15 Break
11.15 – 11.40 Case study: Dengvaxia clinical trial

 

Presentation
Reidar Lie
11.40 – 12.00 Discussion Reidar Lie
12.00 – 13.00 Lunch
13.00 – 13.30 Biobanking, stored specimens and data: Consent

 

Background Reading

 

Presentation
Joe Millum
13.30 – 14.00 Discussion Joe Millum
14.00 – 14.30 Biobanking, stored specimens,  and data: risks, benefits and custodianship

 

Presentation
Joe Millum
14.30 – 14.45 Case study: specimen research in an international collaborative study Joe Millum
14.45 – 15.00 Discussion of case study Joe Millum
15.00 – 15.30 Break
15.30 – 16.00 Community engagement in clinical research

 

Background Reading

 

Presentation
Liza Dawson
16.00 – 16.30 Case study on community engagement Liza Dawson
16.30 – 17.00 Discussion Liza Dawson
17.00 – 17.15 Closing
Time Topic Trainer
09.00 – 09.30 Experience sharing: Obtaining Ethical clearance Prof. Dr. dr. Suryani As’ad, M.Sc., Sp.GK(K)
09.30 – 10.00 Discussion
10.00 – 10.30 Coffee Break
10.30 – 11.00 Key Ethical Issues in Research with Children

 

Presentation

 

Background Reading

 

Making a difference: the clinical research programme for children

 

A Standard for Assessing the Risks of Pediatric Research: Pro and Con
David Wendler
11.00 – 11.45 Research involving vulnerable groups, reduced capacity to consent

 

Presentation

 

Background Reading

 

Using Data to Improve Surrogate Consent for Clinical Research with Incapacitated Adults

 

Ethics Issues for Canadian HIV/AIDS Researchers in International Settings
David Wendler
11.45 – 12.00 Discussion David Wendler
12.00 – 12.30 Closing

Event Speakers

David S Wendler, PhD

Senior Investigator, Head Section on Research Ethics
NIH Clinical Center Department of Bioethics

Liza Dawson, PhD

Research Ethics Team Leader
Division of AIDS, NIAID / NIH / DHHS

Reidar K. Lie, MD, PhD

Head and Professor of Department of Philosophy
University of Bergen, Norway; Bioethicist, Clinical Center Department of Bioethics & Fogarty International Center, NIH

Joseph R. Millum

Bioethicist
Clinical Center Department of Bioethics & Fogarty International Center, NIH

Prof. R. Sjamsuhidajat Ronokusumo, dr., Sp.B., KBD

Department of Surgery Faculty of Medicine University of Indonesia

Prof. Dr. M. Sudomo

Chairman of NIHRD Ethics Committee

Prof. Dr. dr. Suryani As’ad, M.Sc., Sp.GK (K)

Chairman of Medical Research Ethics Committee
Faculty of Medicine, Hasanuddin University of Makassar

dr. Moh. Hakimi, Sp.OG (K), Ph.D

Chairman of Medical Research Ethics Committee
Faculty of Medicine, Gadjah Mada University – Dr. Sardjito Hospital