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Global Forum for Bioethics in Research VI: What happens when research is over – obligation
Joint Clinical Research Centre, Kampala - Uganda
”Beneficent gifts will assuage the ills of the poor from which enlightenment will result for the preservation of the rich. Yes, rich benefactors, generous men, this sick man laying in the bed that you have subcribed is now experiencing the disease that will be attacking you; he will be cured or perish; but in either event, his fate may enlighten your physician and save your life”
(In S.F Spicker, et. Al., 1988: The use of human Being in Research)
1947 - The Nuremberg Code
1948 - Universal Declaration of Human Rights
WMA Declaration of Helsinki, 2000
Principle 30: ”At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”
Council for International Organisations of Medical Sciences (CIOMS), 2002
Guideline 10: ” Before undertaking research in a population or community with limited resources, the sponsor and investigator must make every ffort possible to ensure that: any intervention or product developed, or knowdge generated, will be made reasonably available fo the benefit of that population.... In geneal, if the there is good reason to believe that a product developed or knowledge gernerated by rsearch is unlikely to be reasonably available or applied to the benefit of the population of the host country or community after the conclusion of the research, it is unethical to conduct the research in that community”
The Sponsor: An individual, company or insititution taking responsibility for the initiation, management and financing the research.
The Investigator/Researcher: A person responsible for the conduct of the clinical at a trial site.
Research Participants: These a sample of the population - that justifies the research. The participants are a means to the anticipated results of the research. They are the primary benefactors of the beneficial results of the research by default. They continue to be part of the population and sieze to be participants after the research is terminated.