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