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Lecture
by Prof Omar Hasan Kasule Sr. for 4th
year medical students at the Faculty of Medicine KFMC Riyadh on April 30, 2012
1.0 GENERAL
CONSIDERATIONS (A)
1. What
is the moral justification for non-therapeutic research
2. Discuss
issues relating to inclusiveness.
3. Explain
the concept of clinical equipoise
4. Should
hospitals reject all research sponsored by pharmaceutical companies?
5. Is
research based on putting fluorine or iodine in public water ethical?
6. What
are the duties and responsibilities of a patient in research?
7. Is
innovative surgery considered a form of research?
8. Is
it proper to include a placebo group in a drug trial in the third for a drug
licensed in the rich countries?
2.0 GENERAL
CONSIDERATIONS (B)
9. Describe
various forms of fraud in research
10. Describe
methods of avoiding research malpractices
11. Is it
proper for a physician to charge a finder's fee for suggesting his patients to
be invited as research subjects? Is it proper for a physician to be paid to
enroll patients? Should researchers take money and other benefits from
pharmaceutical companies that sponsor research?
12. Is research
ethical in poor countries for the benefit of rich countries? Discuss the 10/90
gap: 10% of research money is spent on 90% of the world's health problems.
Explain how patenting restricts access to drugs by poor countries
3.0 INFORMED CONSENT and CONFIDENTIALITY (A)
1. Explain
the application of the principle of autonomy in clinical research
2. List
information items that patients involved in clinical research must be told
3. Explain
how informed consent helps protect the patient. Explain why informed consent in
clinical research is more important than in normal patient treatment.
4. Is
self interest a valid reason for patient consent to participate in research? Is
a patient obliged to participate in clinical research in the public
interest? Can the patient be forced to
be part of the research if the research drug s the same as the drug he takes
normally for his disease? Why should a terminal patient participate in a drug
toxicity study? Is it proper to offer poor patients participation in research
so that they can have access to expensive drugs?
4.0 INFORMED CONSENT and CONFIDENTIALITY (B)
5. What
measures would you take if a research subject says 'I do not understand this
research but I will sign anyway because I trust you'
6. Explain
ethico-legal guidelines on withdrawal from research at any time.
7. Is
it ethical to undertake research in the
emergency room without informed consent
8. Explain
the application of confidentiality in clinical research
9. What
do you do if in the course of your research you discover a sexually transmitted
disease unrelated to the subject of your research?
10. What do you
do if the course of your questionnaire research on cardiovascular disease you
discover severe mental disease in an airline pilot?
5.0 RESEARCH ON HUMAN
TISSUES (A)
1. Describe
ethico-legal guidelines on genetic testing of biological samples obtained from
individuals (hint: informed consent must be obtained if the test is not
anonymized).
2. Describe
ethico-legal guidelines on research on material from living donors
3. Describe
ethico-legal guidelines on research on material from deceased donors.
4. Describe
ethico-legal issues in research on tissues from aborted fetuses.
5. Discuss
dissection of cadavers for research or educational purposes
6.0 RESEARCH ON HUMAN
TISSUES (B)
6. Discuss
what to do when a pregnant woman dies with a dead fetus in utero
7. Discuss
ethico-legal issues in embalming a dead body
8. Discuss
ethico-legal issues in post mortem examination for educational / research
purposes
9. Describe
2 sources of embryos for research and explain the difference in ethical
consideration between them
10. List
research that requires use of embryos
11. Explain
ethical guidelines on research on fetal tissue
12. Discuss
comparative ethical issues in research on different types of stem: embryonal,
fetal, cord, and adult
13. Discuss
genetic research involving genetic engineering
7.0 CONTROVERSIAL
ISSUES IN HUMAN RESEARCH
1.
Discuss ethico-legal issues of pharmacogenomc research
2.
Discuss ethico-legal issues of research on ageing,
longevity, and immortality
3.
Discuss ethico-legal issues of research on enhancement
technologies,
4.
Discuss ethico-legal issues of research on
psychosurgery,
5.
Discuss ethico-legal issues of research on
neuro-transplantation,
6.
Discuss ethico-legal issues of research on gonadal
transplantation,
7.
Discuss ethico-legal issues of research on
xenotransplantation
8.0 RESEARCH ON THE
VULNERABLE
1.
Explain ethico-legal guidelines on consent to research
by mentally incompetent persons
2.
Explain ethico-legal guidelines on consent to research
on children
3.
Discuss ethico-legal issues in research on women
4.
Discuss ethico-legal issues in research on the elderly
5.
Research on prisoners
6.
Research on students
7.
Research on employees
8.
Research on members of uniformed services
9. Discuss
the obligation of members of the armed forces to be research subjects without
consent