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Ethical Considerations in Human Research: Insights from Gulu University Workshop

This workshop, held from March 3-6, 2008, at Gulu University, delves into the ethical principles guiding research involving human subjects. Led by Jasper Ogwal-Okeng, the event addresses significant scandals and tragedies in research history, such as the Tuskegee Syphilis Study and unethical practices revealed in the Beecher publications. It emphasizes the importance of informed consent, ethical guidelines like the Nuremberg Code, and the Declaration of Helsinki. The workshop also highlights the complexities of conducting field trials in developing countries, advocating for collaborative and respectful research practices.

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Ethical Considerations in Human Research: Insights from Gulu University Workshop

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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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