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Background material by Professor Omar Hasan Kasule Sr. for Year 1 Semester 1 PPSD session on 12th November 2008
1. Distinguish between therapeutic and non-therapeutic research.
2. Define the concept ‘good clinical practice’ and list its main principles.
3. Describe the composition of an institutional research ethics committee
4. Describe the functions of an institutional research ethics committee (emphasis on: scientific quality of the research, competence of the researchers, risks to research subjects, disclosures, compensation, payments to researchers and participants, confidentiality of the data).
5. Explain the application of the principle of autonomy in clinical research (emphasis on: informed consent, consent needed even for records based research that is published anonymously if non-health care workers have access before anonymizing).
6. Explain the application of confidentiality in clinical research (use anonymized data, no disclosure of subject details to researchers until after consent).
7. List information items that patients involved in clinical research must be told (emphasis on: what is the treatment, evidence about the treatment and missing information that necessitates research, how the treatment differs from the standard treatment, available alternatives treatments, likely risks and benefits, measures to ensure safety).
8. Explain why informed consent in clinical research is more important than in normal patient treatment.
9. Explain ethical guidelines on recruitment as research subjects of people in a dependent capacity such as prisoners, students, and employees.
10. Explain ethico-legal guidelines on material inducements for research subjects.
11. Discuss the obligation of members of the armed forces to be research subjects without consent.
12. Explain ethico-legal guidelines on withdrawal from research at any time.
13. Explain ethico-legal guidelines on consent to research by children (emphasis on: consent by competent children endorsed by parents, consent by parents, consider special vulnerability of children’s physiology, research in child’s interests so parents cannot consent to research that is against the child’s interests, benefits must outweigh the harm, extra precautions to prevent abuse, parental consent can be overridden by the child,).
14. Explain ethico-legal guidelines on consent to research by mentally incompetent persons (emphasis on: decision by proxy or advance consent or refusal, benefits must outweigh the harm, extra precautions to prevent abuse, parental consent can be overridden by the child, ).
15. Explain ethical guidelines for research in an emergency room.
16. Discuss issues relating to inclusiveness (emphasis on: include minorities and women in research).