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
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).