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

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

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)

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)

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

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

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

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

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