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 IssuesRelated to EthicalReviewProcess 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
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 andeffectiveness of a new intervention must be tested against those of the best current proven intervention” Standard of care provided to the research participants complywith 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 theirrefusal to participate in the planned study
7. Data Protection and Privacy The research must describe in detail how, for how long and by whomstudy 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 governinganimal experimentation To buildingof capacity (e.g. in terms of training on animal experiments and/or facilities).