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Research Ethics

Research Ethics. Gulu University Research Workshop 3 rd -6 th March 2008 Jasper Ogwal-Okeng. Scope. Introduction Scandals and Tragedies of Research with Human Participants Ethical and Regulatory Guidelines for Research in Humans

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Research Ethics

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  1. Research Ethics Gulu University Research Workshop 3rd-6th March 2008 Jasper Ogwal-Okeng

  2. Scope • Introduction • Scandals and Tragedies of Research with Human Participants • Ethical and Regulatory Guidelines for Research in Humans • Summary of accepted ethical principles of research on Human subjects • Field Trials in developing countries • Levels of Review

  3. Scandals and Tragedies • Nuremberg • Jewish Chronic Disease Hospital Research • Injecting liver cancer cells without consent • Beecher publications • Described many unethical practices • Tuskegee Syphilis Study (1932-1972)

  4. Ethical and Regulatory Guidelines • Followed the revelations of tragedies • To protect rights and integrity of participants • Emphasized Informed Consent • The Nuremberg Code • The Declaration of Helsinki (WMA) • The Belmont Report (Dept of Health Education and Welfare, USA) • Council for International Organizations of Medical Sciences (CIOMS)

  5. Guidelines (cont.) • CIOMS, in collaboration with WHO • “International Guidelines for Biomedical Research Involving Human Subjects” • Mainly for research in developing countries • In response to HIV/AIDS research • Takes into account Nuremberg and CIOMS NCST Guidelines for Research in Human subjects

  6. Accepted Ethical Principles (Summary) • Scientific merit • Equitable selection of subjects • Informed consent • Confidentiality • Coercion

  7. Field Trials in Developing countries • Communal consent • Potential benefits and risk of harm • Incentives • Feedback results • North-south Collaborative research • Material Transfer Agreement (MTA) • Respect for southern partners

  8. Levels of Review • Institutional Review Board/Committee (IRB/C) • NCST • NDA

  9. THANK YOU

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