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Presentation
at the Workshop on Research Ethics held at Jazan University 14-15th May 2012 by Professor Omar Hasan Kasule Sr.
MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman Institutional Review Board
and Department of Bioethics King Fahad
Medical City Riyadh EM: omarkasule@yahoo.com,
WEB: www.omarkasule-tib.blogspot.com
1.0 OVERVIEW
·
Ethics relate to morality = Islamic research
ethics relate to Islam's moral system
·
Morality in Islam is defined by the Law in most
cases
·
The Theory of maqasid al shariat provides an underlying basis for Islamic
research ethics
·
We have the theoretical basis we need to develop
the empirical experience
2.0 PURPOSES OF THE LAW IN HUMAN EXPERIMENTATION
·
Necessities, needs, and refinements, dharurat,
haajiyaat, tahsiinaat
·
Purpose of protection of religion, hifdh al din
·
The purpose of protection of life, hifdh al
nafs
·
The purpose of protection of progeny, hifdh
al nasl
·
The purpose of protection of the mind, hifdh
al ‘aql
·
The purpose of protection of wealth, hifdh al
mal
3.0 PRINCIPLES OF THE LAW IN HUMAN EXPERIMENTATION
·
The principle of intention, qaidat al maqsad
·
The principle of certainty, qaidat al yaqeen
·
The principle of injury, qaidat al dharar
·
Principle of hardship, qaidat al mashaqqat
·
The principle of
custom or precedent, qaidat al urf
4.0 NECESSITIES, NEEDS, and REFINEMENTS: dharuraat;
haajiyaat, & tahsiinaat
·
Normal human life cannot exist and continue
without dharuuraat.
·
Haajiyat
are for the proper functioning of life beyond the requirements of basic
survival.
·
Tahsinaat aim at achieving a higher level
of human dignity.
·
Human experimentation in order to fulfill
dharurat has priority over that research that aims at fulfilling hajiyat.
·
The Law will allow taking a higher risk for dharurat
than for hajiyat.
·
Experimentation for refinements may not be
considered at all if there is any risk.
·
The 5 dharurat recognized by the law are
preservation of religion, life, progeny, the mind, and wealth. An example of a dharurat
is a life-saving drug like insulin for the insulin-dependent diabetic.
·
An example of a haajat is a drug to treat
mild anxiety.
·
An example of a tahsin is a cosmetic
cream or female circumcision, al khafdh.
5.0 PURPOSE OF PROTECTION OF RELIGION, hifdh al din
·
Experiments
on humans become unethical when the scientists involved are not guided by
morality.
·
Thus
violation of the purpose of protecting religion brings cruelty and injustice in
its wake.
·
The great Islamic principle of jarh &
ta'adiil / ilm al rijaal does not exist in modern science
6.0 THE PURPOSE OF PROTECTION OF LIFE, hifdh
al nafs
·
Experiments
on humans for the purpose of finding new cures for disease fulfill the purpose
of protecting health and life. Often the benefit is general for the whole
society and not for subjects of the research. Phase 1 and phase 2 clinical
trials may have no direct benefit to the patient but they provide basic
scientific information. Phase 3 trials have potential benefit for the patient.
Phase 4 trials have a general societal benefit.
·
The
state has a responsibility for the life and health of its citizens. It
therefore must promulgate and enforce laws on the conduct of human experiments
in order to prevent abuses. It must be involved in the approval of drugs and
devices for experiments as well as ethical approval of protocols.
·
Death or
other forms of injury consequent from an experiment trigger a criminal charge
of unintended manslaughter for which compensatory and not punitive damages are
awarded, diyat. Informed consent of the victim or his written statement
relieving the physician or experimenter from liability is not admissible as
defense in this case. The strictness of the law on this matter is intended more
for societal benefit to put those engaged in experimentation on their toes so
that mistakes are not made.
·
The
risks involved in experimentation may appear to contradict the purpose of
preserving life. Injury or harm in an experiment is only a potential but not a
certainty. Any human experiment will be deemed illegal if there is a 100%
certainty of a hazard.
7.0 THE PURPOSE OF PROTECTION OF PROGENY, hifdh
al nasl
·
Research
on methods of curing infertility fulfils the purpose of protecting progeny.
·
The
whole of medicine especially pediatrics and obstetrics also fulfils this
purpose.
·
Good
health of potential parents ensures that they will be healthy enough to bear
the next generation.
·
Good
prenatal and obstetric care ensures delivery of a healthy baby who therefore
has more chances of growing into a healthy adult.
8.0 THE PURPOSE OF PROTECTION OF THE MIND, hifdh
al ‘aql
·
Research on cure of mental conditions fulfills
the purpose of protecting the mind.
·
Research on other somatic diseases fulfils the
same purpose because any disease will through pain, suffering, and loss of
function lead to mental symptoms of depression and anxiety.
·
Research on drugs and nutrients that alter the
mind is justified in order to protect humans from such deleterious effects.
9.0 THE PURPOSE OF PROTECTION OF WEALTH, hifdh
al mal
·
In general good health ensures a healthy
workforce that works to generate wealth for the community.
·
Human experimentation may lead to safer, more
effective, and cheaper methods of treating disease which saves wealth.
10.0 THE PRINCIPLE OF INTENTION, qaidat al maqsad
·
The basic principle is that each action is
judged by the intention behind it, al umuur bi maqasidiha. A research
protocol is judged by the underlying objectives of the researcher as manifest
in actual implementation and not the stated objectives that may be deceptive.
·
Means are judged with the same criteria as the
intentions, al wasail laha hukm al maqasid. If the intention, qasd,
is wrong the means, wasiilah, is wrong and vice versa. Under this
principle a research protocol with beneficial scientific results will be
rejected if the methods used are unethical.
11.0 THE PRINCIPLE OF CERTAINTY, qaidat al yaqeen
·
Human experimentation is carried out because of
uncertainty about what is the best treatment. If there is certainty that the
current treatment is the best that there can be, an unlikely practical
situation, then there is no legal justification for further research. Further
research cannot commence on the basis of some doubt about an existing treatment
method.
·
According to the principle that certainty cannot
be removed by doubt, al yaqeen la yazuulu bi al shakk, there must be
some empirical evidence of low efficacy in the current treatment or probable
efficacy in the new treatment before an experiment is authorized. Scientific
conclusions are relative, probabilistic, and never 100% certain.
·
The above principles can protect against
proliferation of human experiments that are unnecessary and are harmful but yet
leave room for those that have a good prospect of reaching a better treatment
modality.
12.0 THE PRINCIPLE OF INJURY, qaidat al dharar
·
Human experimentation has associated potential
hazards and risks. These risks have to be balanced against the injury by disease
and the potential benefit from the new treatment. The basic principle is that
injury, if it occurs, should be relieved, al dharar yuzaal. Thus a
clinical trial in search of an effective cure for a disease is an attempt to
remove an injury.
·
Preventive clinical trials are justified under
the principle that an injury should be prevented as much as is possible, al
dharar yudfau bi qadr al imkaan.
·
The new treatment being sought should not be as
harmful as the disease condition according to the principle that an injury is
not relieved inflicting or causing an injury of the same degree, al dharar
la yuzaal bi mithlihi.
·
Decisions to proceed with human experimentation
involve a careful balancing of benefits and risks. The easiest situation is
when the potential benefit far outweighs the potential risk, in which case the
research proceeds in pursuit of the benefit. If the risk is equal to the
benefit, we use the principle that prevention of a harm has priority over
pursuit of a benefit of equal worth, dariu an mafasid awla min jalbi al
masaalih.
·
If the risk is more than the benefit for the
individual research subject, but there is a larger societal benefit, we may
proceed with the research under the principle that public interest has priority
over individual interest, al maslahat al aamat muqaddamat ala al maslahat al
khaassat.
·
The individual may have to sustain a harm in
order to protect public interest, yatahammalu al dharar al khaas li dafiu al
dharar al aam.
·
In some situations benefits may not figure in
the equation; the consideration being the injury of the disease against the
potential risk of the experiment. The principle of the law used is to choose
the lesser of the two evils, ikhtiyaar ahwan al sharrain.
13.0 PRINCIPLE OF HARDSHIP, qaidat al mashaqqat
·
Hardship mitigates easing of the sharia rules
and obligations, al mashaqqa tajlibu al tayseer and necessity legalizes
the prohibited, al dharuraat tubiihu al mahdhuuraat. If any of the 5
necessities, al dharuraat al khamsat, is at risk permission is given to
undertake experiments that would otherwise be legally prohibited.
·
Committing the otherwise prohibited action
should not extend beyond the limits needed to preserve the purpose of the law
that is the basis for the legalization, al dharuraat tuqaddar bi qadriha.
·
Necessity however does not permanently abrogate
the patient’s right, al idhtiraar la yubtilu haqq al ghair.
·
The law asserts vicarious liability. It is
illegal to get out of a difficulty by delegating to someone else to undertake a
harmful act, ma haruma fi’iluhu, haruma talabuhu. Thus legal action will
be brought against all officials in the chain of command for negligence in
experiments in their institution even if they did not personally take part.
14.0 THE PRINCIPLE OF CUSTOM or PRECEDENT, qaidat al urf
·
The principle of custom is used to define
standards of good clinical practice. The basic principle is that custom or
precedent has legal effect, al aadat muhakkamat.
·
What is considered customary is what is uniform,
widespread, and predominant, innama tutabaru al aaadat idha atradat aw
ghalabat, or is predominant, widespread, and not what is rare, al ibrat
li al ghaalib al shaiu la al naadir.
·
Thus the standard of clinical care or
experimental procedure is what the majority of reasonable physicians consider
as reasonable care and which constitutes a professional standard.
·
An innovative therapy is departure from the
standard care. It is however allowed under the law but the physicians will be
held liable for any injuries to the patient. This liability also arises even if
standard care were used.
·
The Law recognizes that what is customary
changes with time, la yunkiru taghayyur al ahkaam bi taghayyuri al azmaan wa
al ahwaal wa al aadaat wa a’raaf.
15.0 THE DOCTRINE OF ISTISHAAB:
·
This is continuation of an existing ruling
either affirming, ithbaat, or
denying, dafau.
·
Matters are left as they are until there is
evidence to the contrary.
·
Recourse is made to istishaab if there is no evidence, daliil.
·
This
doctrine has the same impact as the principle of yaqeen discussed above.
16.0 THE DOCTRINE OF ISTIHSAAN:
·
The doctrine operates in a clinical situation in
which a physician obtains experimental evidence about the efficacy of a new
treatment but continues to use the old treatment because of some inclination in
his mind.
·
This problem does not arise if Bayesian
inference is used. The experimenter will have to state a probability of prior
belief in the efficacy of the new treatment. The results of the experiment are
then used to generate a posterior probability from the prior probability. The
posterior probability may reinforce or decrease the original assumption. In
this way prior clinical experience or judgment is combined with new
experimental evidence to reach a practical conclusion.
17.0 THE DOCTRINE OF BENEFIT, ISTISLAAH:
·
Istislah
is obtaining a benefit, jalb manufa'at,
and preventing a harm, dafiu mafsadat.
·
Consideration
of maslahat arises when we have to compare an existing to a new
innovative treatment. The potential benefit from the new treatment must be more
than the standard treatment for the experiment to be allowed to proceed.
·
Consideration
of maslahat also distinguishes a
patient as a subject from a healthy volunteer; the former may get some personal
benefit from the experiment since experimentation is combined with care whereas
the latter has no benefits at all but may be exposed to hazards.
·
Therapeutic
research has immediate benefits whereas the benefits of non-therapeutic
research are remote. In non-therapeutic research, the subjects are volunteers
who may be healthy with or patients.
·
In a randomized
trial, subjects who receive a placebo have no benefit and no hazard but of they
are patients they are missing the potential benefits of either the traditional
or the innovative treatment.