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.
Introduction
·
Medical research is a form of ijtihad
inspired by the teaching of the prophet that there is a cure for every
disease that must be searched for, li
kulli daai dawaau.
· Modern ethics arose as a reaction
to ethical violations by Nazi Germany and Japan who cruelly experimented on
prisoners of war without consent
·
Post World War Ethical Codes:
Nurenberg 1946, Helsinki 1964, Belmont Report 1979.
· The 4 Western principles of ethics
(autonomy, beneficence, nonmalefacence, and justice) are subsumed under just
one principle of fiqh, qa’idat al dharar.
·
The maqasid and qawa’id
provide a comprehensive guideline for research ethics
Research ethics from maqasid
al shari’at
·
The Islamic ethical theory on
research is based on the 5 purposes of the Law, maqasid al shari’at (hifdh al ddiin, hifdh al nafs, hifdh al
nasl, hifdh al aql, & hifdh al maal)
·
If any of the five is at risk
permission is given to undertake human experiments that would otherwise be
legally prohibited.
·
Therapeutic research fulfills the
purpose of protecting health and life. Infertility research fulfils the purpose
of protecting progeny.
·
Psychiatric research fulfills the
purpose of protecting the mind.
·
The search for cheaper treatments
fulfills the purpose of protecting wealth.
Research ethics from qawa”id
al fiqh.1
·
The 5 principles of the Law, qawa’id al shari’at, resolve conflicts
between and among the maqasid.
·
Under the principle of
intention, qa’idat al qasd, research is judged by its underlying and
not expressed intentions.
·
Under the principle of
certainty, qa’idat al yaqeen, research on new treatment modalities
is permitted if there are doubts about existing modalities.
·
Under the principle of injury,
qa’idat al dharar, research is allowed if benefit expected from the
experimental therapy outweighs the potential risks.
·
The principle of custom, qa’idat
al ‘aadat, is used to define standards of good clinical practice (GCP) as
what the majority of reasonable physicians consider as reasonable.
Research ethics from qawa”id
al fiqh.2
·
Under the doctrine of istishaab, an
existing treatment is continued until there is evidence to the contrary.
·
Under the doctrine of istihsaan a
physician can ignore results of a new experiment because of some inclination in
his mind based on clinical intuition.
·
Under the doctrine of istislaah medical research can be carried out in the public interest although it
causes inconvenience to individuals.
The shari’at basis for
informed consent
·
Informed consent by a legally
competent research subject is mandatory for research. Informed consent, an
expression of autonomy, is based on qa’idat
al dharar.
·
Of all the persons involved in
research, the research subject who consents has the purest intentions because
he is at risk. Others involved in the research may have selfish motives that
are not in the best interests of the research subject.
·
The doctrine of informed consent
is derived from the principle of preventing harm, qa’idat al dharar, already mentioned above.
·
Informed consent does not legalize
risky non-therapeutic research with no potential benefit.
·
It is illegal to force
participation of the weak (prisoners, children, the ignorant, mentally
incapacitated, and the poor) in research even if they sign informed consent
forms.
Research publication
·
Findings of research should be
widely disseminated either by teaching or by publication for universal benefit.
·
Islam enjoins dissemination of
knowledge and prohibits hiding or monopolizing knowledge, kitman al ‘ilm.
·
Violations / fraud in research
occur because of reputation, and the pressure to publish or perish
Research on animals…1
·
Islam enjoins kindness to animals
and prohibits any cruelty. Animal experimentation is therefore allowed only
under very strict conditions.
·
In general animal experimentation
is allowed under the doctrine of taskhiir.
·
Animal experiments are allowed if
a prima facie case can be established that the result of the research is
a necessity, dharuurat. Dharuurat under the Law is what is
necessary for human life. The regulations of necessity require that no more
than the absolute minimum necessary should be done.
·
Animal research has definite risks
for the animals that are not balanced by any benefits: pain, suffering,
permanent injury, inhumane treatment and operations, and being killed
(sacrificed). Thus use of animals in justifiable on the basis of benefiting
humans and not any benefits that accrue to the animals.
·
The risks to humans from animal
research are minimal in the short term; long-term effects are difficult to
fathom.
Research on animals…2
·
If the results of animal
experimentation will lead to protection of human life, then research is allowed
to proceed because then it is a necessity. This is similar to killing animals
for food, a necessity for human life.
·
Use of animals that are haram
like the pig should be avoided as much as possible and should be considered
only in cases of dharurat.
·
Animals, like humans, have rights
to enjoyment of life and good health. The researcher must therefore minimize
animal suffering. The animals must be shown kindness and respect. They should
not be subjected to the psychological pain of seeing other animals in pain or
being sacrificed. Pain must be minimized both during the experiment and when
the animal is being terminally sacrificed.