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Presentation at a Research Methodology Course for Pediatrics Residency Program held via Zoom at Prince Sultan Military Medical City on 23 February 2021
1.0 GENERAL CONSIDERATIONS (A)
· What is the moral justification for non-therapeutic research
· Discuss issues relating to inclusiveness.
· Explain the concept of clinical equipoise
· Should hospitals reject all research sponsored by pharmaceutical companies?
· Is research based on putting fluorine or iodine in public water ethical?
· What are the duties and responsibilities of a patient in research?
· Is innovative surgery considered a form of research?
· 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)
· Describe various forms
of fraud in research
· Describe methods of
avoiding research malpractices
· Is it proper for a
physician to charge a finder's fee for suggesting his patients be invited as
research subjects? Is it proper for a physician to be paid to enroll patients?
Should researchers take the money and other benefits from pharmaceutical companies
that sponsor research?
· 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)
· Explain the
application of the principle of autonomy in clinical research
· List information items
that patients involved in clinical research must be told
· Explain how informed
consent helps protect the patient. Explain why informed consent in clinical
research is more important than in normal patient treatment.
· 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)
· 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.'
· Explain ethico-legal
guidelines on withdrawal from research at any time.
· Is it ethical to
undertake research in the emergency room without informed consent?
· Explain the
application of confidentiality in clinical research
· What do you do if, in
the course of your research, you discover a sexually transmitted disease
unrelated to the subject of your research?
· 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)
· 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).
· Describe ethico-legal
guidelines on research on material from living donors
· Describe ethico-legal
guidelines on research on material from deceased donors.
· Describe ethico-legal
issues in research on tissues from aborted fetuses.
· Discuss dissection of
cadavers for research or educational purposes
6.0 RESEARCH ON HUMAN TISSUES (B)
· Discuss what to do
when a pregnant woman dies with a dead fetus in utero
· Discuss ethico-legal issues
in embalming a dead body
· Discuss ethico-legal
issues in post-mortem examination for educational / research purposes
· Describe 2 sources of
embryos for research and explain the difference in ethical consideration
between them
· List research that
requires the use of embryos
· Explain ethical
guidelines for research on fetal tissue
· Discuss comparative
ethical issues in research on different types of stem: embryonal, fetal, cord,
and adult
· Discuss genetic
research involving genetic engineering
7.0 CONTROVERSIAL ISSUES IN HUMAN RESEARCH
· Discuss ethico-legal
issues of pharmacogenomic research
· Discuss ethico-legal
issues of research on aging, longevity, and immortality
· Discuss ethico-legal
issues of research on enhancement technologies,
· Discuss ethico-legal
issues of research on psychosurgery,
· Discuss ethico-legal
issues of research on neuro-transplantation,
· Discuss ethico-legal
issues of research on gonadal transplantation,
· Discuss ethico-legal
issues of research on xenotransplantation
8.0 RESEARCH ON THE VULNERABLE
· Explain ethico-legal
guidelines on consent to research by mentally incompetent persons
· Explain ethico-legal
guidelines on consent to research children
· Discuss ethico-legal
issues in research on women
· Discuss ethico-legal
issues in research on the elderly
· Research on
prisoners
· Research on
students
· Research on
employees
· Research on members of
uniformed services
· Discuss the obligation
of members of the armed forces to be research subjects without consent