Ethics in Research and International Cooperation Dany Hilmanto

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

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

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.

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

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

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

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).

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