1. Ethics in Research and International Cooperation
Dany Hilmanto

2. Developing Countries Continuous(ongoing) Emerging Economy Countries Major Problem Ethic problems in research project

3. Main problem : Vulnerability of the people in the country
1. Participant Affect the ability to give Informed Consent
(Participation to a Study without Prejudice/PSP)
• Right to deny participation in study research
• Lack of access to healthcare services
• Low level of education
• Limited Knowledge
2. Research Team/Local Ethic Commitee:
• Study design /research methodologies :
difficult to do (from ethic view)
• Conflict of interest improve the local research
infrastructure

4. Fundamental Ethical Considerations
1. Be responsive to the needs of the country where
research is carried out
 added value for the health
 welfare of the intended participants/community/
country
2. Scientific Value
3. Abide by the relevant international guidelines.

5. Specific Issues Related to Ethical Review Process
1. Sponsors &Researchers
 must comply with the relevant EU/ national
legislation (Declaration of Helsinki) & Host and
Funding countries
2. Benefit
Provide Benefit for :
Stakeholders
Participant
Community
Local Researcher
Local Health System Impact

6. Vulnerable specific attention To ensure Informed Consent understanding
3. Healthy Volunteers
Vulnerable specific attention
To ensure Informed Consent understanding
To ensure their safety
To inform risk and benefit completely during
informed consent
4. Standard of Care
Declaration of Helsinki (Revision)
“ The benefits, risks, burdens and effectiveness of a new
intervention must be tested against those of the best current
proven intervention”
Standard of care provided to the research participants
comply with the relevant international rules &
recommendations

7. 5. Ethical review process
Ethical Review Commitee (ERCs) must be identified in the submitted document
International Guideline : require approval by two ERCs
Local ( where the study is being held)
Sponsorship Country
6. Informed consent / Assent
Developing Countries Environment & Culture factor
involve other community figures and/or family members
Will not face any risk that relates to their refusal to participate in the planned study

8. 7. Data Protection and Privacy The research must describe in detail how, for how long and by whom study data will be handled, protected, stored Cross-country data transmission between countries Material Transfer Agreement (MTA)/Memorandum of Understanding (MOU) (recommended) 8. Animal Welfare  Research projects must comply with the applicable EU/national legislation governing animal experimentation  To building of capacity (e.g. in terms of training on animal experiments and/or facilities).

9. Thank you for your cooperation