1. Gulu University Research Workshop
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 ( )

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