0109-ETHICO-LEGAL ISSUES ON CLINICAL RESEARCH IN HUMANS
Paper presented at the PPIM Seminar in Kuala Terengannu on
15th September 2001 by Prof Omar Hasan Kasule, Sr. firstname.lastname@example.org
The Islamic ethical theory on research
is based on the 5 purposes of the Law, maqasid al shari’at,under which define the 5 necessities, dharurat, under
which human experimentation is allowed: preservation of religion, life, progeny, the mind, and wealth. 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. 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, hifdh al mal. The 5 principles of the Law (intention, certainty,
injury, hardship, and precedent) constitute the Islamic ethical guidelines. Research is judged by its underlying and not expressed
intentions. Research is prohibited certainty exists about beneficial existing treatment. Research is allowed if benefit outweighs
the risk or if public interest outweighs individual interest. If the risk is equal to the benefit, prevention of a harm has
priority over pursuit of a benefit of equal worth. The Law chooses the lesser of the two evils, injury due to disease or risk
of experimentation. The principle of custom is used to define standards of good clinical practice as what the majority of
reasonable physicians consider as reasonable. 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. Under the doctrine of istislaah preventing a harm has priority over obtaining a benefit. Informed consent by a
legally competent research subject is mandatory. Informed consent does not legalize risky non-therapeutic research with no
potential benefit. Informed consent is violated in community-based experimentation in which individuals are not consulted.
It is illegal to force participation of the weak (prisoners, children, the ignorant, mentally incapacitated, and the poor)
in clinical trials. Research on fetal human tissues may encourage abortion. Objection to dissection of cadavers for medical
education and post-mortem examination is on the basis of prohibition of mutilation but permission is given where necessity
can be established. Use of human bodies in auto crass experiments is an affront to human dignity. Genetic experiments on human
organisms, tissues, and cells give rise to many ethical problems. Transformed genes, molecules, and even microorganisms may
cause diseases hitherto unknown. They may lead to new forms of environmental pollution. The Law allows research on ageing
as long as the aim is not prolongation of life or preventing death because those aspects are under Allah’s control.
1.0 HISTORICAL BACKGROUND
Experiments on humans are as old
as history. Early humans experimented with several plants and by trial and error found some to be useful as medicines and
others to be poisonous. Such trials have continued throughout human history giving rise to a corpus of traditional medicine.
Many medical systems including tibb nabawi represent empirical knowledge accumulated over time by many informal and
often un recognized medical experiments. These early experiments were not planned in a systematic way neither were they documented.
Planned medical experiments are quite recent. Galen is credited with being the founder of experimental medicine before 200
CE. In 1747 CE James Lind found out by experimentation that lemon juice prevented scurvy. Dr Edward Jenner found in 1798 that
material from cowpox lesions prevented small pox. In 1914 Goldberger discovered the prevention of pellagra. Experiments were
sometimes carried out on whole communities such as the study of vitamin C in the prevention of the common cold, the Salk and
HBV vaccine trials, the multiple risk factor intervention trial (MRFIT) against cardiac disease, and fluoridation of community
water supplies to prevent dental caries. Some trials are therapeutic such as the randomized study of aspirin myocardial infarction
study. One of the earliest clinical trials was the use of streptomycin in the treatment of tuberculosis in 1948. Preventive
studies such as the women’s health study in which vitamin C and low dose aspirin were given to prevent cancer and cardiovascular
disease or the use of alpha-tocopherol and beta-carotene to prevent lung cancer among smokers. Modern sophisticated research
on humans in search of new drugs is an outgrowth of these early efforts. Modern medicine would not have progressed as it has
without some form of experimentation on humans. If a new drug is to be used on humans, it has to be tried on humans because
animal experiments are not adequate and may not be relevant to humans.
Humans are wont to transgress against
other humans. The angels questioned the creation of Adam on the basis of human aggression and spilling of blood (). The son
of Adam committed the first homicide in human history (KS41 Bukhari K60 B1, Bukhari K87 B2, Bukhari K96 B15, Muslim K28 H27,
Ibn Majah K21 B1, Ahmad 1:383, Ahmad 1:430, Ahmad 1:433). Daughters were buried alive in pre-Islamic Arabia
(81:8). Dhu Nuwaas a Jewish King in Yaman persecuted believers by burning them alive (85:4-8). The Pharaohs carried out a
systematic genocide of the Israelites (). King Nimrod carried out an experiment
to prove he could give and take life by ordering killing of one prisoner while sparing another one (2:258). King Muteesa I
tested the efficacy of a new gun presented to him by ordering its use on any person outside the palace. There is great suspicion
that nations that manufacture weapons encourage some low level conflicts for the purposes of testing their new weapons.
Human transgression has also manifested
in several forms of human experimentation. The search for new cures using human experimentation showed extreme forms of human
transgression and disrespect for human life in the Nazi and Japanese inhumane medical experiments on prisoners in the second
world war. These were extreme but not isolated incidents. Despite the horror of the details revealed at the Nuremberg
trials of Nazi medical experiments, unethical medical experiments without informing the subjects or getting their consent
continued after the second world war. In the 1950s LSD and other drugs were used in experiments to discover drugs that could
control human behavior. In 1953 a CIA employee used in an experiment on LSD without consent developed psychiatric symptoms
and committed suicide. In 1953 Harold Blauer, a hospitalized psychiatric patient in a research project funded by the US Army,
died after injection of mescaline. In the period 1940s to 1960s the US Atomic Energy Commission conducted experiments on unsuspecting
subjects including children to study the effect atomic weapon irradiation. In 1954-56 elderly patients at the Brooklyn Jewish
Chronic Diseases Hospital had cancer cells injected directly into their veins. In the period 1932-1972, 400 Black American
men with syphilis were deprived of any treatment in a study of the natural history of syphilis. In 1946-1956 retarded teenage
boys in Massachusetts had radioactive iron and calcium put in their breakfast
cereals. In the early 1950s in Massachusetts pregnant women had radioactive
iron injections to study fetal circulation. Some of the pregnant women involved in the thalidomide disaster were not informed
of the experimental nature of the drug.
NUREMBER CODE 1946
Twenty-five physicians were charged
at Nuremberg after World War II for Nazi inhuman experimentation on humans. Seven
were acquitted, 9 were imprisoned, and 9 were sentenced to death. The Nuremberg
code was laid down in 1946 in response to the criminal Nazi experiments on humans during the war. The main provisions of the
code were: (a) Voluntary informed consent (b) No random or unnecessary experiments (c) Animal experiments and survey of disease
natural history before subjecting humans to similar experiments (d) Avoiding unnecessary physical and mental suffering (e)
The researchers must be scientifically qualified (f) subjects can withdraw at any time (g) the investigation is stopped if
the patient is in danger. There was however no mention of experiments involving children.
The World Medical Association drew
up the Helsinki Declaration, incorporating the Nuremberg code, in 1964. The latest
version (1996) was approved by The 48th Assembly of the World Medical Association held in South
Africa in 1996 approved the latest version. The code is divided into three sections: Introduction,
Basic principles, clinical research, and non-clinical research.
The introduction asserted that the
primary duty of the physician was to act in the best interests of the patient. It pointed out the role of research in advancing
knowledge of diagnosis, therapy, or prophylaxis with the caution that such research always carries a risk to the subject.
A distinction was made between clinical research involving search for new treatment and diagnostic modalities and purely scientific
research that had no direct benefit to the patient. This distinction is however questionable because clinical research in
based on prior basic scientific research. The code also alluded to environmental concerns and the welfare of animals used
The following basic principles were
included in the code. Research on human subjects must conform to generally accepted scientific
principles and must be preceded by laboratory and animal experiments. A competent and independent committee must approve
the research protocol, setting out all details of the research and a statement of adherence to the Helsinki
declaration. The research is carried out by qualified researchers and under
the supervision of a medically qualified person who must assume full responsibility for the welfare of the research subjects.
The research must be preceded by careful risk-benefit assessment. The research
can be carried out only if its risks are predictable, the objectives are important when considered with the potential risks,
and the benefits outweigh the risks. Research subject integrity in the form
of privacy, physical, and mental welfare must be respected. Research subjects are entitled to full disclosure that covers the aims, methods, and potential hazards of the research before they give their voluntary
informed consent. They should be informed that they are free to abstain from
the study or to withdraw at any stage. Proxy consent is obtained for the legally incompetent, children or the mentally retarded.
Results of the research will be accepted for publication only if they are accurate and conform to the principles of the Helsinki
The declaration defined and approved
clinical research as medical research combined with medical care. The physician is free to use a new therapeutic or diagnostic
measure that in their judgment has hope of improving life and alleviating suffering. The potential benefits, hazards, and
discomfort of the new method must be weighed against the best current and available diagnostic and therapeutic methods. Use
of a placebo in a control group is allowed if no better method is available.
The declaration defined non-clinical
biomedical research as non-therapeutic research involving humans carried out only on volunteers either healthy volunteers
or patient volunteers. In case of patient volunteers the experimental design should not be related to their illness. The lead
physician in the research team retains responsibility for subject welfare. The research is terminated as soon as is judged
harmful to the research subjects. In any case the interests of science and society should never take precedence over the welfare
of the research subjects.
ISLAMIC CRITIQUE OF THE WESTERN ETHICAL CODES
and Helsinki codes on experimentation have not been successful in stopping unethical
research on research subjects who are weak members of society. As mentioned above, many unethical experiments were carried
out in the US soon after Nuremberg.
The basic failure is that these codes lack a clear identity. They are neither law that is enforceable using the normal legal
procedures nor are they moral standards that are enforced by the inner conscience of the experimenter. These codes are a reflection
of the secularization of western society in which morality was divorced from law and public affairs. Ethical codes are a bad
attempt to mitigate the bad effects of a divorce that should have never been allowed to occur in the first place.
Islam looks at problems of human
experimentation as purely legal issues. The Law provides adequate guidelines and safeguards. Islamic Law, unlike western law,
incorporates morality in its fabric. There is therefore no need to have special ethical codes outside the Law.
2.0 PURPOSES OF THE LAW IN HUMAN
NECESSITIES, NEEDS, and REFINMENTS
Ethical issues of human experimentation
can be discussed from the vantage point of the purposes of the law as set out by the lawgiver. The purposes can be divided
into three categories: necessities, dharuraat; needs, haajiyaat, and refinements, tahsiinaat. Normal
human life cannot exist and continue without dharuuraat. Haajiyat are
for the proper functioning of life beyond the requirements of basic survival. They serve the purpose of lifting difficulty,
haraj, from people that would arise of the law provided only for dharurat.
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.
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 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. The following
are considered before approving an experimental drug for experimentation: knowledge about the drug from previous studies,
consideration whether further research is needed, benefit and hazards to patients. Licensing a drug after for marketing is
a new experiment involving many humans with its benefits and hazards. Post-marketing surveillance, phase 4 of the clinical
study, is as important as the earlier phases
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. We may use the
analogy of jihad to understand the underlying legal issues. Jihad is a noble objective for which the purpose of preserving
life may be violated. The soldier in jihad knows that he has a high probability of being injured but cannot be 100% certain
that he will be injured. If there is certainty, yaqeen, in jihad that injury will occur then it is illegal to join
battle because there is a higher principle of never deliberately throwing oneself to destruction, la tulquu bi aydiikum
ila la tahaluka. 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.
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.
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.
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.
3.0 PRINCIPLES OF THE LAW IN HUMAN
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.
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 is 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 Law recognizes the following descending order of gradation: certainty,
yaqeen; predominant conjecture, ghalabat al dhann; conjecture, al dhann; and doubt, al shakk.Yaqeen, is a situation when there is no doubt. Dhann, is a situation in which there is some evidence in favor
of one option but that evidence is not strong enough to rule out the other alternatives. Shakk, is the opposite of
yaqeen and is a situation in which there are two or more competing options with no sufficient evidence to prove one
of them as the most valid. Since yaqeen is unattainable in science, we can make decisions based on ghalabat al dhann.
In the absence of ghalabat al dhann, existing treatments should continue in force until there is compelling evidence
to change them, al asl baqau ma kaana ala ma kaana. 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
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.
PRINCIPLE OF HARDSHIP, qaidat
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
THE PRINCIPLE OFCUSTOMor PRECEDENT, qaidat
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.
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.
THE DOCTRINE OF ISTIHSAAN
This is preference for one qiyaas over another because of evidence that the mujtahid feels more
comfortable with or which is stronger. The evidence or reasoning may not be obvious, qiyaas
khiffi. 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.
THE DOCTRINE OF BENEFIT, ISTISLAAH
Istislah is obtaining a benefit, jalb manufa'at, and preventing
a harm, dafiu mafsadat. Preventing a harm has priority over obtaining a benefit,
dafiu al mafsadat muqaddamu ala jalb al maslahat. Human interest or benefit is
the primary purpose of the law and is considered in three types. Recognized benefits, maslahat
mu'utabarat, are those related to the 5 purposes of the law: ddiin, nafs, nasl, ‘aql, & maal. Considerations
of most clinical trials fall under recognized benefits. Abrogated benefits, maslahat
mulghaat, are imaginary and are not real for example planning a clinical trial of medication to change the appearance
of normal males to females or drugs to increase liver metabolism of alcohol and thus enable addicts to take more alcohol with
delayed intoxication. Unclassified benefits, maslahat mursalat, are those for which the law did not mention any explicit text about their recognition or abrogation. Benefits
of human experimentation may be considered under maslahat mursalat following conditions laid down by the Malikis: conformity
to the purposes of the law, mulaimat li maqasid al shariat; being logical, ma'aquul;
being necessary, dharuuri; serving public and not personal or private interest; and being real and not imaginary
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.
4.0 INFORMED CONSENT
The commonest and most serious problem in human experiments is lack of proper informed consent. The following captive
populations may be used in research without their knowledge or consent: hospitalized patients, institutionalized children,
the mentally abnormal, army or police personnel, laboratory assistants or medical studemts. The process of full disclosure
that precedes patient consent usually creates enough transparency in the research process to prevent fraud and malpractice.
Consent to participation in an experiment does not void the duties and obligations of the traditional doctor-patient relationship.
Under the doctrine of sadd al dhari’at and in the interest of the public, the subject cannot consent to relieve
the physician from liability for negligent medical care or injury from the experimental procedures. The law on the basis that
a person with full legal competence would not give consent if all the implications and hazards of the experiment were explained
to him or her does not recognize consent to an experiment with a clear preponderance of harm. The Law as a contract under
which the patient expects reasonable care as well as expressed or implied warranties and guarantees recognizes the doctor-patient
relationship. In an experiment the research protocol is considered part of the contract and any protocol violations are considered
a breach of contract for which relief can be sought in a court of law under the doctrine that Muslims are bound by the conditions
of their agreement, al muslimuum ‘ala shurutihim.
Consent is allowed under the doctrine
of the human temporary custody of life. Life belongs to Allah but a human has temporary custody during his adult lifetime.
It is wring to argue that a human cannot make any decision to participate in an experiment with potential hazard to life because
he has no control over his life. He however is accountable for any decisions made such as consenting to a highly risky experiment
that has no potential benefits.
The Law is very explicit about the
need for consent by a patient. Nobody can be given any medicine or nutrition against his or her will ( ). Human autonomy or
privacy is respected even if the refusal of treatment is illogical or is based on false premises. Thus all subjects of a clinical
trial must give voluntary consent before being part of the experiment. Consent can be coupled with a contractual relation
in which specified conditions of treatment can be detailed and that contract is enforceable by the Law however any clause
that exempts the experimenter from liability for harm to the patient is null and void.
Consent is related to the fine balance
between benefit and risk in an experiment. It is only the subject of the experiment who has the most objective assessment
of risks because his welfare is at stake. Others may have other interests or pressures that color their judgment. The consent
of a minor raises serious problems. The Law allows a guardian to make decisions on behalf of the minor if they are clearly
beneficial to the minor. The Law frowns on any decisions that may be disadvantageous to the minor. Since a clinical trial
has both benefits and hazards, the decision is very difficult to make. A minor child with insight, mumayyiz, can be
allowed to express his or her views but the final decision rests with the guardian.
Consent can only be given by a person judged by the Law to be legally competent. Many experimental subjects in en-ethical
research are captive populations who cannot fulfill the conditions of legal competence. Hospitalized patients may not feel
free to refuse participation because they feel indebted or under the control of the physicians. Physicians are looked at as
authority figures expected not to do harm. Children and the mentally deficient may not have the intellectual competence to
evaluate the risks and benefits involved in an experiment in order to make an informed decision. Prisoners, armed forces and
police personnel, medical students may have undue pressure from superiors to consent to research that they would normally
5.0 OUTSTANDING ETHICO-LEGAL ISSUES
NON THERAPEUTIC EXPERIMENTS
Non-therapeutic experiments have no direct or immediate benefit to the subject of the study but may on the other hand
expose him or her to hazards. These experiments are however necessary to generate scientific data on which subsequent therapeutic
trials can be based. Phase 1 and phase 2 clinical trials are non-therapeutic trials on terminal patients who are not likely
to benefit from the treatment. They however provide pharmacodynamic, pharmacokinetic, and efficacy data used to design phase
Experiments in which whole communities andnot individuals are inducted
into an experiment such as fluoridation of drinking water raises an important issue of informed consent. Many individuals
either do not like to participate or are not in a position to give informed consent
THERAPEUTIC CLINICAL TRIALS ON HUMANS
Therapeutic trials involve clinical
trials of new drugs, clinical trials of new procedures, or clinical trials of new medical devices. Research subjects are either
patients (terminal or recovery possible) or healthy volunteers (paid or unpaid). The major ethical issues that arise are:
(a) forced participation of the weak (prisoners, children, the ignorant, mentally incapacitated, and the poor), risk to life
(short and long term), and lack of informed consent. The prophet forbade participating in jihad without the blessings of the
parents, la yaghzu illa bi ridha al waalidayn (KS174). Using the analogy of jihad, any person of whatever age must seek the
blessings of the parents before participation in a clinical trial. A wife can not participate in a clinical trial without
the husband’s permission.
RESEARCH ON HUMAN TISSUES
Human tissues used in research may
be from living persons, dead bodies, or aborted fetuses. The main ethical issue that arises is lack of proper informed consent
and the possible increase in abortions for the sake of obtaining fetal tissue for experimentation. A property and ethical
issue may arise over ownership of cell lines and other biological products developed from human tissues and patented for commercial
ANATOMY: DISSECTION OF CADAVERS
Dissection of cadavers is very importance
for medical education. There are really no alternatives to dissection. Cadavers may be abandoned persons or vagrants who have
no relatives to bury them. Cadevers may also be bought or donated. The main ethical issues that arise are: human dignity,
Informed consent, and final burial of all remains.
Post-mortem examination serves several
purposes. It can be done for scientific research to understand the natural history, complications, and treatment of a disease
condition. It can be done for further education of physicians and medical students especially when they compare their clinical
diagnosis with the evidence from autopsy. The lessons learned will improve their diagnostic and treatment skills in the future.
Post mortems are also undertaken for forensic purposes to provide evidence on the timing, manner, and cause of death. The
ethical issues that arise are: removal of parts of the body, dignity of dead, risk of disease spread, informed consent of
the deceased or the family, and delay of burial. Post mortem may be visualized as mutilation of the body that is forbidden.
The human has dignity in both life
and death. Respect for the dead body is the guidance of the prophet to stand up when a funeral procession passes by, al qiyaam
li al janaazat (KS160 Bukhari K23 B47, Bukhari K23 B48, Bukhari K23 B49, Bukhari K23 B50, Muslim K11 H73, Muslim K11 H74,
Muslim K11 H75, Muslim K11 H76, Muslim K11 H79, Muslim K11 H80, Abudaud K20 B42, Tirmidhi K8 B51, Nisai K21 B45, Ibn Majah
K6 B34, Muwatta K16 H33, Ahmad 1:60, Ahmad 1:64, Ahmad 1:68, Ahmad 1:72, Ahmad 1:82, Ahmad 2:265, Ahmad 2:287, Ahmad 3:25,
Ahmad 3:41, Ahmad 3:47, Ahmad 3:51, Ahmad 3:53, Ahmad 3:97, Ahmad 3:295, Ahmad 3:319, Ahmad 3:329, Ahmad 3:346, Ahmad 3:445,
Ahmad 3:446, Ahmad 3:447, Ahmad 4:164, Ahmad 4:346, Ahmad 4:388, Ahmad 4:391, Ahmad 4:413, Tayalisi H1803, Tayalisi H2184).
It is dignity to be buried whole. Surgical operations on the body are an affront to the dignity. The prophet forbade mutilation,
nahyu al muthla (KS175 Abudaud K15 B110, Tirmidhi K19 B48). Removal of some parts is looked at with disfavor. In cases in
which a body is buried without some of its parts, the parts when found later are washed, prayed for and buried in the same
grave.Post-mortem examination will lead to delay of burial when the sunnah is
to bury as soon as possible. Delay of the burial affects human dignity because of deteriorations in the body including a bad
smell. The balance of benefits and harms is difficult because intangibles like human dignity are involved. The benefit, maslahat,
of medical education vs the harm of body mutilation. muthlat. Where foul play is suspected, a post mortem examination
If a pregnant woman dies, attempts
should be made to remove the fetus if it is alive and viable. If the fetus is also dead, the issue is not clear. Removing
the fetus is mutilation of the body for no clear purpose.
CARCASSES IN AUTO CRASH EXPERIMENTS
Use of human bodies in auto crass
experiments is an affront to human dignity. It however provides valuable data that is used in improved auto engineering for
Genetic experiments on human organisms,
tissues, and cells give rise to many ethical problems. Transformed genes, molecules, and even microorganisms may cause diseases
hitherto unknown. They may lead to new forms of environmental pollution.
ALTERING HUMAN BEHAVIOUR
Drugs and surgical procedures that
alter human behavior violate the purpose of preservation of the mind, hifdh al ‘aql. Artificial alteration of
the mind may be voluntary (medical, social, perversion), or forced (abuse of prisoners and dissidents, experimentation on
humans, criminal purposes).
RESEARCH ON LONGEVITY
There is basically no ethical problem in the scientific research on cell aging as well as epidemiological studies
on risk factors of senescence. What matters is the intention behind the research and to what use that research will be put.
If the underlying intention is to prevent or delay death, the research is not ethical. The life span is fixed for each individual
and cannot be changed. If the intention of the research is to understand the aging process so that preventive measures can
be taken to maintain as high a quality of life as possible, then such research is ethical and is acceptable. Present epidemiological
and cell biological knowledge indicates that many measures can be taken to control the aging process. Better nutrition (especially
green vegetables and fruits), early detection and treatment of disease, sheltering from cosmic radiation and other environmental
exposures, can delay the aging process. This does not however delay the ajal because any other competing cause of death could
Early Human Experiments
Islamic Critique Of The Western Ethical Codes
PURPOSES OF THE LAW, maqasid al
Necessities, Needs, And Refinements
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