Abstract
Medical research has a crucial role in the development of medical knowledge. Ethical behavior is essential
within the sphere of human medical research. Numerous regulations about research involving human subjects
have been issued, such as the Helsinki Declaration and the Belmont Report. Despite these guidelines, significant
abuse of human subjects and a profound violation of the standards of medical ethics were encountered. Most of
the currently accepted Western principles of ethics in research are consistent with the instructions of Islam
known to us more than 14 centuries ago. Islamic law automatically bans all immoral actions. A researcher who pursues scientific knowledge to cause harm is subject to God’s rage. In Islam, injustice is forbidden. Coercing
and exploiting vulnerable groups to participate in medical research is incompatible with Islamic law.
Researchers should be equipped with knowledge and comprehension of religious perspectives related to human research.
Introduction
Islam opens the door to research. In many verses of the
Glorious Quran, God encourages people to learn and look
for wisdom to build the earth (Only those fear Allah,
from among His servants, who have knowledge(Qur’an
35:28).God states in the Holy Quran.“..And follow not
(i.e., say not, or do not or witness not) that of which you
do not know..” (17; 36).Islam encourages the use of
science, medicine, and biotechnology as solutions to
human suffering. Thus, Muslims throughout the world
may be eager to make use of the latest medical
developments.1 Islam forces the dissemination of
knowledge and prohibits hiding it; as the Prophet (peace
be upon him) (PBUH) said: “Whoever conceals
knowledge which Allah has made beneficial for
mankind’s affairs of religion, Allah will bridle him with
reins of fire on the Day of Resurrection.”.
In the golden Islamic era from the 9th to the 11th
century, many discoveries and huge advances in science
and medicine were revealed. For example, Mohammed
Zakariya AlRazi (born in 854 CE) was the first to
conduct clinical trials comparing two identical groups of
monkeys and humans.3
Muslim countries with common backgrounds and ethical
concerns should involve themselves in research that suits
the local situation. Many underdeveloped countries need
research to provide affordable medicines to the low
socioeconomic classes, and many researchers feel the
deficit in the contributions of Muslims in the medical
field.4
Clinical research requires that it conforms to
internationally recognized ethical guidelines. For Muslim
physicians, conforming to Islamic ethical guidelines is an
added requirement. Muslim physicians and scientists
should monitor externally sponsored research in their
own countries to ensure that these guidelines are
followed.5
Ethical Codes and Unethical practice
The Nuremberg Code, established in 1948, was the first
international document that emphasized voluntary
participation and informed consent. It appeared after the
Nuremberg Trials of the Nazi Physicians (World War II)
who experimented with prisoners of war, gave them
lethal drugs, caused pain and suffering to all of them, and ended in the death of many. All the experiments were not
serving any benefit to those researched and of course,
were done without any consent. The Nazi physicians had
abandoned the traditional ethical commitment of the
physician to individual patient welfare. They were
committed and found guilty. The Nuremberg trials of the
Nazi Physicians opened the eyes to what was happening
both in the democratic countries of the West and the
heinous experiments of Nazi Germany.6
Japanese physicians during World War II undertook
biological warfare research on military and civilian
prisoners, often causing terrible suffering. Subjects died
either because of experiments or were put to death when
no longer useful. These crimes were not publicized as
were those by Nazi physicians, nor were Japanese
physicians tried in the Tokyo War Crimes trials
The World Medical Association issued guidance in 1964
to help physicians while conducting biomedical research
on humans. The Declaration of Helsinki regulates
worldwide research ethics and establishes standards for
“non-therapeutic research”. The Declaration of Helsinki
is the foundation for current Good Clinical Practices
(GCP). Later, in 1979, the Belmont Report was
published, emphasizing basic ethical principles and
guidelines for conducting research with human
subjects.8Many other international laws and regulations
were established.
Despite these international ethical codes, there were
many irregularities, deceits, and unethical practices that
were exposed by Western physicians, moralists, and the
media. The occurrence of blatant unethical procedures is
disappearing in the West. The drug companies pushed
their experiments and unethical procedures in third-world
countries. But even there, the international codes are
exposing them.6
In the 1950s, American prisons hosted an increasing
variety of non-therapeutic medical experiments some of
which were risky such as injecting live cancer cells to
study the natural killing-off process of the human
body.9The Willowbrook hepatitis study (From 1956
through 1971) involved intentionally infecting healthy
but mentally challenged children with hepatitis by
feeding them a solution made from the feces of those
with activehepatitis.10
In a hospice in Massachusettsin the 1950s, handicapped
children were told that they would go on an enjoyable
trip and would be given lots of delicious food. The
children were unknowingly being used in anon-therapeutic experiment whereby they were given
radioactive food to examine the effect of radioactive
materials on human beings. Much later, each of them was
given US$ 60,000 as reparation. This incident remained
unknown until eventually, it came to the attention of a
journalist, who wrote a book about it which was
published in 2004.11,12
Post Awareness Research
In the Cincinnati Radiation Experiment (1960-1972)
Eugene Saenger, a cancer researcher at the University of
Cincinnati School of Medicine began one of the most
notorious human radiation experiments of the postwar
era. Over more than ten years, Saenger and his research
team exposed approximately 80 patients with terminal
cancer to potentially lethal doses of radiation; at least
eight of them have died from radiation poisoning.
In Jewish Chronic Disease Hospital (1963), twenty-two
chronically ill and debilitated noncancer patients were
injected with live human cancer cells. Patients were not
told of the cancer injection. The hospital covered up the
lack of consent and tried to fraudulently obtain consent.
Two years after the investigation, the American Cancer
Society appointed the principal investigator as a Vice
President.
The Tuskegee Syphilis Experiment (1932-1972) targeted
600 poor and illiterate African American males (399 with
syphilis and 201 without). They were told that they were
being treated for “bad blood”. The study was originally
designed to last for 6 to 8 months, but it turned into a
long-term study that continued for 40 years. Researchers
followed their progress without providing penicillin,
which was a known antidote as of 1943. Twenty-nine
men died directly from syphilis and 100 others died of
illnesses related to syphilis.15
Learning from these traumatic and often cruel moments
in history gave impetus to developing international
ethical guidelines, driving research conduct, and
protecting the rights and safety of those participating in
studies today.16
Islam and Medical Research
Islam is not only a religion; it is a way of life. The
Shari’a controls the everyday activities of Muslims. Once
an individual freely joins Islam, he is bound by Islamic
rules and hence he is obliged to follow instructions and
rules in the Quran and Hadith. The rejection of secularization within Muslim communities does not
affect the relationship between Muslim countries and
secular states as Islam respects others’ beliefs and
choices.17
Islamic bioethics is an extension of Shari’ah (Islamic
law), which is itself based on two foundations: The
Qur’an (the holy book of all Muslims and the Sunna
(based on the Prophet Muhammad’s words or acts).
Development of Shari’ah in the Sunni branch of Islam
also required ijma (consensus of jurists after the death of
the prophet) and qiyas (analogy) using human reason
when no clear rule is found in the Quran or Sunna,
resulting in 4 major Sunni schools of jurisprudence.
In Islamic communities, religion greatly influences
behavior and practice. Teaching human research ethics to
researchers in Islamic communities will not be
meaningful and effective if resources heavily rely on
foreign, word-to-word translated guidelines that do not
address the Islamic cultural dimension of ethical human
subjects research.18Ethical principles and guidelines have
been developed by international organizations such as the
World Medical Association (WMA) and the Council for
International Organizations of Medical Sciences
(CIOMS). The Islamic Organization for Medical
Sciences (IOMS) in Kuwait convened a meeting in Cairo,
Egypt, in 2004 and produced a document advancing an
Islamic viewpoint on these principles and guidelines. Dr.
Husam Fadel elaborated in depth on these principles
outlined in the “International Ethical Guidelines for
Biomedical Research (An Islamic Perspective).”
While researchers involved in the design or conduct of
research with human subjects are typically familiar with
international ethical guidelines, religion’s impact on
participants’ perceptions of human research should not be
underestimated.18Medical research in the Islamic
community should conform to and not violate the 5
maqasidal-shari’ah which are the preservation of religion
life, and health, progeny (curing infertility), intellect, and
wealth. If any of the five purposes is at risk, permission is
considered to undertake human experiments that would
be otherwise morally unacceptable in Islam.
Ethics of Medical Research
Respect for Persons
This principle “incorporates at least two ethical
convictions: first, that individuals should be treated as
autonomous agents, and second, that persons with
diminished autonomy are entitled to protection.” Islam
respects autonomy even on the issue of belief. The Qur’an declares that “there is no compulsion in religion”
(Quran 18:29) and that each person has the full will to
accept Islam or refuse it.
In Islam, a similar principle applies, that is, “no one is
entitled to dispose of the rights of a human being without
his [her] permission”. In the human subjects’ research
context, this implies that “no one should be involved in a
research project without his[/her] free and voluntary
consent”.21This is stipulated in the fiqh rule: “No one is
entitled to dispose of the rights of a human being without
his permission” and “No right of a human being can be
canceled without his consent.”This statement is arguably
in conformity with the Belmont principle of respect for
persons.5,18, 21
If a participant may be concerned about the presence of a
religiously prohibited ingredient in a trial medication or
placebo, the medical researcher should disclose the
ingredients to him/her during the process of informed
consent.18
In Islam, consent is allowed under the doctrine of the
‘‘human temporary custody of life’’. This means that the
subject and physician or researcher are accountable
before God for any decision made, such as consenting to
a highly risky experiment that has no potential direct
benefit. This is why Islam would object to phase I trials
in healthy subjects unless under unique and compelling
circumstances with every effort made to protect the
participants, detect complications as early as possible,
and take the necessary steps to treat them.
Informed Consent
The research should be fully explained to the participants
in simple language, that they could fully comprehend.
Any questions should be answered. A written document
in simple language should be given to the participant
He/she should be given enough time to review it, ask
questions, and have free choice to accept or refuse
participation; alternatives (in case of refusal) should be
explained. Refusal of participation will not in any way
affect his/her right to full treatment and management.
The participant can withdraw at any time. The researched
person even then, will not affect his right to full treatment
and management.6
The foreseeable risks, discomforts, and hazards should be
explained, indicating the probability, magnitude and
duration. The risks should include physical,
psychological, social, legal, and economic risks. If any
hazard occurs during research, the research should be
stopped immediately and the participants should be informed, treated for any injury, and compensated duly.
Many consent documents declare that no compensation
will be paid in case of injury or even death. This should
be changed, and the Institution Review Board
(IRB)should not accept the research until the sponsors
agree to treatment and compensation. The subject’s
confidentiality should be always protected.
Beneficence:
The first main principle of Islamic Medicine is the
emphasis on the sanctity of human life which derives
from the Qur’an:“If anyone saved a life, it would be as if
he saved the life of all mankind” (Quran 5:32.). The
verse says: The person who helps to preserve the life of
even one person is the protector of the whole of
humanity, for he possesses a quality which
isindispensable to the survival of mankind. It is reported
that Prophet Mohammed (PBUH) said, “There should be
neither harming nor reciprocating harm”. He also said
“Allah likes when anyone does a work, to do it with
perfection”.23
Based on sound logic and clear Islamic teachings, the
physician has no right to recommend or administer any
harmful material to his patients. The Qur’an says: “And
He makes for them good things lawful, and bad things
are forbidden”(Quran 7:157).A person who pursues
scientific knowledge to cause harm is subject to God’s
wrath. God says: “And they learn what causes them harm
and brings them no benefit, and they already know that
whoever purchases it has no share in the
hereafter(Qur’an2:102).
Human experimentation can be associated with potential
hazards and risks. These risks have to be balanced
against the harm caused by the disease and the potential
benefit of the proposed new treatment (risk/benefit ratio)
When balancing possible harms against benefits, human
subjects researchers can apply Islamic rules such as
public interest overrides individual interest; accepting the
lesser of two harms; necessity overrides prohibition;
harm has to be removed at any cost if possible (IMANA
Ethics Committee 2005); and “if a less substantial
instance of harm and an outweighing benefit conflict, the
harm is forgiven for the sake of the benefit”. An example
of “Necessity legalizes the prohibited” is participation in
a phase I trial. When there is an endemic disease with no
available successful standard of care, and there is a
promising new drug as proven by experimental studies, it
would be permissible to expose healthy volunteers to the
potential harm of participation in such trials for the
benefit of the community if they receive no payment for
such a utilitarianattitude.19
Islamic law automatically bans all immoral actions as
‘‘Haram’’ and automatically permits all that is moral as
Mubaah. Walton et al.24 explored the health beliefs of
practicing Muslim women and found that all research
participants (100%) strongly agreed that smoking,
alcohol, and overeating were harmful to the body. So,
while consuming alcohol is a harmful action, and is thus
prohibited by Islam, and is even illegal in some Islamic
communities, it may be considered beneficial in other
cultures.18
Justice
The principle of justice is an established principle in
Islamic law, and it calls for fairness in all affairs of life,
including the context of human subject research. Justice
is often regarded as synonymous with fairness and can be
summarized as the moral obligation to act based on the fair
adjudication between competing claims. The Qur’an
says: “Indeed We have sent Our Messengers with clear
proofs and revealed with them the Scripture and the
Balance (justice) that mankind may keep up justice.”
(Quran 57:25). Researchers should not offer potentially
beneficial research only to some patients who are in their
favor or select only ‘undesirable’ persons for risky
research. In Islam, injustice is forbidden. Coercing and
exploiting vulnerable groups to participate in research is
incompatible with Islamic law, as is excluding women of
reproductive age from biomedical research.
The Prophet Mohammed (PBUH)said: “There is no
special merit of an Arab over a non-Arab except by
righteousness and piety”.25
The Prophet (PBUH) stated: “Ihsan is to worship Allah
as if you see Him, and if you cannot achieve this state of
devotion then you must consider that He is looking at
you.”26Ihsan which has no equivalent in English means to
be good, generous, sympathetic, tolerant, forgiving,
polite, cooperative, selfless, etc., In life, this is even more
important than justice; for justice is the foundation of a
sound society but Ihsan is its perfection. Justice protects
society from bitterness and violation of rights, while
Ihsan makes it sweet and joyful and worth living.
To apply Ihsan in the research context some points must
be considered; investigators are required to be qualified
and committed to conducting the research; safeguards for
the well-being of the participants should be in place, the
data should be accurate and transparent; and the
methodology must be correct.
Medical Research in Vulnerable Subjects
Vulnerability in research occurs when the participant is
incapable of protecting his or her interests and therefore,
has an increased probability of being intentionally or
unintentionally harmed. The vulnerability can be due
either to an inability to understand and give informed
consent or to unequal power relationships that hinder
basic rights. Excluding subjects from research for the
only reason of belonging to a vulnerable group is
unethical and will bias the results of the investigation. To
consider a subject or group as vulnerable depends on the
context, and the investigator should evaluate each case
individually.28
Incompetent adults should not be exposed to any
nontherapeutic research. The consent of the guardian is
imperative. The research should be useful to the
person(patient) or his group. There should be no other
alternative to obtain that information. Prisoners and
incarcerated persons should not be exposed to research
unless it is going to help the person or group. The
consent of the prisoner is legally invalid; however, it
should be obtained without coercion.6
Volunteers, or so-called volunteers, are easily
forthcoming from the poorer, more vulnerable sections of
the population who would even risk suffering pain or
bearable damage for small payments. This is true of
many kinds of research, in addition to research on issues
such as organ
transplantation and the like. It is unethical to exploit a
subject’s poverty and vulnerability in this manner.
Medical students, prison inmates, and other such groups
have frequently been used for medical experiments in
exchange for different favors and advantages.
Research on Children
The participation of children in clinical research is
essential because children develop different diseases and
respond to treatment in a different way than adults.
Nevertheless, many drugs have inadequate information
on toxicity and administration regimens for children
Medical research on children has increased in the last 20
years. International ethical regulations for conducting
clinical research on children may not pertain to Muslim
communities where religious beliefs play a big role in the
decision-making process.3
Few regulations released details about the participation of
children in clinical research.30Among the reviewed
documents, the guidelines by the Islamic Organization of
Medical Sciences—released in 2005 from Kuwait (IOMS, 2005) and updated in 2016 were the most
balanced and included all key points of research ethics.
The latter from Kuwait documents stated that “Children
and adolescents must not be included in health-related
research unless a good scientific reason justifies their
exclusion.”3
Among Muslims, three items might add to the inherent
difficulties in children’s participation: the right
knowledge, the uncertainty about religious judgment, and
the cultural barriers in the relationship between parents
and children.31In pediatrics, the research questions should
be scientifically sound and lead to the understanding,
advancement, or improvement of a medical issue for a
larger population.3
Children should not be exposed to nontherapeutic clinical
research. The consent of the minor is invalid and hence it
is obligatory to obtain the consent of the guardian. The
assent is the agreement of the child to participate in
research when he/she is not competent to provide legally
valid informed consent.
Children under seven cannot comprehend the intricacies
of medical research. However, children who can
comprehend and understand should be informed in
simple language and their consent obtained. If they
refuse, no research should be done on them, despite the
guardian’s consent.6
Women in research
Those who call for equality between men and women
falsely accuse Islam of not giving womentheir rights.
Islam protects women’s dignity and rights more than any
other regulation, or laws currently used in Western
countries. Women are different biologically,
physiologically, and psychologically from men. Islam
1400 years ago realized this and looked at women and
men equally in issues related to general legal rights and
differentiated between them in their financial
responsibilities, heritage, family responsibilities
testimonies, and the right to divorce. The Prophet
Muhammad (PBUH) in his last speech at Arafat
Mountain instructed Muslims to take care of women. He
stated:”Show fear towards God regarding women, for
you have got them under God’s security.
The woman in Islam represents the cornerstone of the
family, and it is the responsibility of a man to ensure her
protection and welfare. Two prerequisites are needed for
a female to participate in research: the first is the
approval of the family and the second is that the women must consent to the proposed research project. The
approval of the husband is an important pre-requisite
because he is the protector of the family, and her
protection against any harm is a crucial issue. If she
refuses, the husband has no right to force her
toparticipate.33
If participation may be hazardous in case a woman
conceives, the investigator should offer her pregnancy
testing and provide her with access to effective
contraception before the research. The participation is
conditional on voluntary informed consent, including
information on the precautions taken to spare her and her
fetus if she becomes pregnant from any hazards.
Research on pregnant and lactating Ladies
Islamically, there is no objection to the participation of
pregnant women in biomedical research because of the
potential benefit of the research to them and their fetuses.
There will always be some risk. Islamically, accepting
the possibility of such harm would nevertheless be
permissible if the mother or the fetus is likely to gain an
absolute or outweighing benefit. When there are potential
risks for the fetus, even when they are minor or
outweighed, the investigator should also obtain the
consent of the father. Ethically and Islamically, the
investigators should make an extra effort to explain the
trial, the potential benefit to the fetus, and the potential
complications before she agrees to participate in the
trial.5
The research should benefit the pregnant lady, her fetus,
or the group. Clinical research should in no way expose
the pregnant lady, nursing mother, fetus, or baby to any
harm.The lady should avoid pregnancy if the research
period is prolonged, and contraception should be used.
The consent of the husband or any other member of the
family is not enough. The consent of the husband may be
essential in research involving reproduction.
Conclusion
Research is a potential engine for the development of any
nation. Despite the presence of many international
regulations, medical research on human subjects is
replete with horrendous stories of cheating, maiming and
even killing many innocent persons.
Islam emphasizes seeking and disseminating knowledge.
Morality and ethics in Islam are of divine origin. Medical
research in the Islamic community should conform to and
not violate the 5 maqasid al-shari’ah which are the
preservation of religion, life, progeny, intellect, and
wealth. For Muslim physicians, conforming to Islamic ethical guidelines is an added requirement. Muslims
should be the first to broadcast those ideals since saving a
life, for a Muslim, would be as if he saved the life of all
mankind.
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