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Paper written by Professor Omar Hasan Kasule Sr.
1.0 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.
2.0 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.
3.0 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.
4.0 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.
5.0 OTHER
CONSODERATIONS
·
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