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Presentation at a training program ‘Applying the
Principles of Ethics to Clinical Practice:’ held at Aramco Dhahran April 6,
2015 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH
(Harvard) Chairman of the Ethics Committee King Fahad Medical City.
Ethical obligation to do research
·
The medical profession is obliged
to seek better ways of treating disease which justifies human experimentation.
Inaction by the medical profession would be considered un-ethical.
·
Treatments, even those widely used
and widely accepted, must be continually re-evaluated for example high-dose
estrogen for prostate cancer and clofibrate were widely used but later were
found dangerous.
Risk vs benefit consideration in searching
for new treatments
·
It is justifiable to subject a
patient to experimentation if he can see hope in the trial: (a) present
treatment is not effective (b) patient not responding to the standard
treatment.
·
The situation in which a superior
treatment is sought when the current treatment is effective is more complicated
ethically.
·
Use of a placebo raises ethical
issues because those in the control group are not deriving any benefit. It is
probably acceptable in diseases like headache where it may have an effect or in
adjuvant therapy.
·
There must be sufficient evidence
of usefulness of the test material to justify subjecting half of the study
population to its potential risks.
·
The new treatment must be compared
with the best available so far.
·
It is unethical to compare the new
treatment against an inferior existing treatment.
·
An ethical issue also arises when
a potentially useful treatment is withheld from one half of the study
population.
·
Clinical research can be ethical
only if it is scientific.
Informed consent
·
Informed consent interferes with
the doctor-patient relation.
·
It is difficult for a physician to
tell a patient that he does not know which of the two treatments is better and
at the same time warn against all the side effects expected.
·
Informed consent does not however
legalize a trial that is of no benefit to the patient.
Information given for informed consent
·
Study aims, methodology, duration,
benefits, and foreseeable risks of the research.
·
Possible costs should be explained
to the subject.
·
The treatment of research-related
harms as well as compensation for that harm must be explained.
·
The subject must be informed about
possible advantageous alternatives so that they can choose to undergo treatment
in the knowledge that they have the choice to choose the alternative.
·
The subjects must be informed that
they have the freedom to refuse participation and to withdraw at any stage of
the research.
·
The subjects should be aware of
the consequences of their decision to withdraw.
·
Details about maintenance of
confidentiality must also be explained.
·
The subject should know how and
when research findings will be communicated to him or her.
·
The total number of research
subjects must also be revealed.
Other considerations
·
Randomization when there is prior
knowledge that one treatment is better than another one
·
Patients under the stress of
disease may not fully understand the study and therefore their consent is not
free
·
Failure to stop the study when
harmful/beneficial effects appear
Case Scenario 1:
The commander of an army brigade
asked the brigade physician to undertake research on causes of very high sick
leaves. The physician took blood from all soldiers to look for their immune
profiles. When some soldiers protested that they were not asked for consent he
told him he was following military orders.
Case Scenario 2:
A physician was recruiting
patients for a large multi-center study of myocardial infarction. The informed
consent sheet was 10 pages long because there were many procedural details and
adverse effects to disclose. Most of the
subjects were bored reading through or listening to the details and were ready
to sign because they trusted the physicians doing the study.
Case Scenario 3:
A new drug that had proved
efficacy against leukemia in invitro, animal and phase 2 trials was
submitted for human trials. Its risk profile was not well understood from
earlier studies. It was to be tested against a placebo. There was no known
effective treatment for this disease.
Case Scenario 5:
A multi-center trial of a new
medication was carried out at a local hospital; the hospital was among the last
to join the 5-year trial. Local results showed that the drug was effective and
patients were satisfied. Interim analysis of the data by the sponsor showed the
superiority of the new drug. The sponsor also noticed that if the results of
the local hospital were eliminated, the sample size of the remaining sites
would be adequate. He therefore decided to terminate the study at the hospital
prematurely and cut off the supply of the drug.