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REVIEW
a
Lebanese University, Faculty of Medical Sciences, Medical Ethics, Hadath, Lebanon
b
Lebanese University, Faculty of Medical Sciences, Saint Charles Hospital, Neurology,
Fyadieh, Lebanon
KEYWORDS Summary
Autonomy; Background. — The world of medicine has seen a shift from a paternalistic to a patient-centred
Clinical trials; approach along with a surge in medical research in the MENA region. This medical revolution is
Consent form; accompanied by ethical challenges, most importantly concerning the informed consent. Coun-
Ethics; tries in the MENA region have become aware of this, as several studies aim to study these
Evidence based challenges, their cause, and their solution. This article summarizes all the major findings of
medicine; these studies.
Informed consent; Methods. — A total of 36 articles were reviewed in order to form a proper idea about the
MENA region; importance of informed consent and its applicability in some countries of the MENA region.
Paternalism Literature review included the following countries: Algeria, Bahrain, Egypt, Iran, Iraq, Jordan,
Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, UAE,
and Yemen. Excluding criteria were studies conducted in a country not considered to be part
of the MENA region and articles not relevant to our objectives.
Results. — Challenges of the informed consent in the MENA region are the result of several
interrelated factors unique to this region including cultural, religious, and legislative factors.
Conclusion. — Efforts have been made to improve the ethical behaviour of physicians in the
MENA region, however we are still far behind as several undeniable factors play a significant
role, thus forcing an adapted informed consent form and procedure to every country and every
population.
© 2021 Elsevier Masson SAS. All rights reserved.
https://doi.org/10.1016/j.jemep.2021.100706
2352-5525/© 2021 Elsevier Masson SAS. All rights reserved.
T. Habib, K. Richa and F. Abou-Mrad
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Ethics, Medicine and Public Health 19 (2021) 100706
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T. Habib, K. Richa and F. Abou-Mrad
bad experiences when signing papers. Not to mention the Further, Al Quran encourages shared decision making with
state of some participants involved in illegal actions such as the family and the physician and forbids suspicion [28].
refugees [1,5,6]. Some regions such as some areas in Saudi Arabia, accord-
Moreover, a gender inequality was remarkable in certain ing to Islamic jurisprudence, asked women to have the
countries like Egypt, where there is a male predominance, consent of their male guardian in some cases like hospital
and women were not allowed to consent without the pres- admissions, however both males and females had the right
ence and the approval of the husband or father; which may to sign consent documents for clinical research, with some
disrupt the autonomy of the female participant [1]. Taking limitations (e.g. pregnancy) [17].
the corresponding male’s consent seems to be a conven- Furthermore, concerning minors’ involvement in
tional unwritten law. This is also because in case of any research, Islamic Fatwas require obtaining the informed
inconvenience, it’s the male that can press charges and not consent of the child’s guardian; and children are asked to
the woman [23]. Rules differ among countries and depend on respect and obey the parents’ decision if it goes by Sharia
the case, e.g. in Iran, women could consent independently [26].
in therapeutic researches, however when a non-therapeutic
research might affect marital life, the consent of both part-
ners was ethically preferable [18]. While this inequality was
Legislative factors
remarkably present in other countries too, some of them The legal frame of informed consent differs between MENA
have managed to separate medical actions from others such region countries.
as marriage and hospital admission, e.g. Saudi Arabia [17]. Arabic and Islamic societies in the MENA region are still
What is also worth mentioning is the tight relationship influenced by Islamic ethics, and thereby founded deonto-
eastern families have [5,24], where they form a huge impact logical rules based on religious teachings [28].
on personal decisions to the extent that it was often impos- Practically, laws concerning informed consent need gen-
sible to sign a paper before consulting the whole family, erally further development [28,31,32]. For example, in the
especially in critical situations like illness [11,25]. In MENA context of medical research, some laws did not have patient
region, children generally live with their parents until mar- data protection legislations [1], neither protected parti-
riage [23]. In such a culture, a person learns to respect cipants against coercive efforts, which led to physicians
his parents at all ages, and would consider it inappropri- including their patients in their trials with no respect to
ate to disagree with them [26]. Therefore the freedom and their feelings or rights [33]. Also, vulnerable patients, such
autonomy of the participants, females in particular, are not as in psychiatry, were not protected in some countries like
respected by their own relatives [6,12]. Several cases have Lebanon [31]. However, other governments have regulations
been reported [23]. for clinical trials, but ignore the guardian consent, the legal
Clinically, Hammami et al. stated that when the decision rights and welfare of children [26]. The consent form was
making is a collective practice, similar to the one in the Arab signed on several occasion by a person other than the patient
world for example, extended information was required to be or his legal guardian. [30].
disclosed, and participants seemed to be more interested in Moreover, some MENA countries such as Lebanon and
details concerning benefits and post-procedure issues rather Qatar have research regulations that require consent of the
than risks and available alternatives [27]. participant or his legal representative as well as ethical
clears from institutional review boards (IRBs) based mainly
on academic institutional policies and international guide-
lines, whereas according to Nakkash et al., 22 out of 26
Religious factors universities that conduct researches in Lebanon do not have
Most of the countries in this region are religious, and laws IRBs [6]. However, new ministerial guidelines presented in
mainly in Islamic countries are concordant with religion 2014 could potentially change the figure [34].
[5,17]. The ethical virtues and principles such as freedom, When the IRBs are absent, such as in Egypt, the research
beneficence, non-maleficence and the importance of their supervision was done by institutions and faculties [1], which
improvement are noteworthy in Islam [1,18], although they may be inappropriate as these committees may be less
are not always respected in research practice conducted in interested in the patient’s benefits and rights, and more
the MENA region [1]. concerned by protecting the research institution [6].
Muslims for instance come from several schools, thus Concerning clinical practice, most countries of the MENA
there are no clear statements concerning health issues region such as Iran, Kuwait, Lebanon and Saudi Arabia con-
[28]. According to Shia Islamic jurisprudence, humans have sider the informed consent as a legal document and as the
authority on their body, and therefore should be asked for patient’s right, but they also state that the consent should
permission before getting involved in research or undergoing be, not only signed, but properly explained, and in the right
any procedure, regardless of its intentions [23]. It is neces- time, so the patient’s decision can be free [28,31,35—37].
sary for the Muslim to take real care of his health since it is For instance, Iran, according to the Islamic penal code and
considered as a gift from God [29]. Nonetheless, preserva- based on ethical coding, considers any medical or surgical
tion of religion remains more important than preservation of intervention, outside emergencies, a threat to the patient
life. Thus, in addition to the trust granted for the physician and sometimes a potential crime, if consent was not elabo-
due to his high social status, Muslims should not question rated in optimal conditions [23,25,38].
the decisions of their surgeon because he is considered as Although legal, the informed consent can be misapplied,
an instrument of God, and thereby, they believe that their as it is routinely signed rather than being a pedagogical tool
faith is finally God’s will [30]. involving the patient in the decision [30,31].
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Ethics, Medicine and Public Health 19 (2021) 100706
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T. Habib, K. Richa and F. Abou-Mrad
of interrupting routine hospital work. This led to the fact time of discussion with the patient, treatment, benefits,
that a significant number of patients did not even read the risks, complications, follow-up consents, reassessment of
consent form before signing [30]. competence etc. Moreover the majority of Lebanese psy-
Also, surgeons failed to give enough details on the sur- chiatrists knew about the presence of a special psychiatric
gical procedure, type of anaesthesia, potential adverse informed consent, but only the generalized form, if used,
effects of the surgery, potential risks, other alternative ther- was found, and was presented by the administration, not the
apies, length of hospital stay, postsurgical follow-up, costs physician. The oral consent form was used in 22% of cases,
of therapy, and information about the surgeon himself, and leaving no traceability of a good communication between
were limited to explaining the type, benefits, importance the psychiatrist and the patient. Although all psychiatrists
of the surgery, and the consequences of rejecting it. Sur- found the family participation mandatory in the decision
geons avoided giving too much information and thought it with the patient, a surrogate, not a legal representative
may cause unnecessary stress and patient would not mem- or a person of trust, was generally leading a paternalistic
orize any of the information given, whereas studies have care, with disrespect to patient’s confidentiality, privacy
shown 97.3% of patients wished to learn more about their and mainly autonomy (taking decisions, signing the consent,
disease and the therapy options [7,27,29,33]. In addition, etc.) [31,46].
it was notable that despite poor understanding, the overall
attitude was positive after consenting, and that is thought
to be because of the patient’s appreciation of free medical
attention [43]. Implications
It has been suggested that risk of death and any other
It is important to understand differences among populations
risk with higher than 5% chance of occurrence should be
to be able to adapt a special consenting process and form for
disclosed [29,36].
each and every individual. Westernized consent forms have
The quality of obtaining informed consent was higher
suffered to do their job of being informative and protect
in patients undergoing special surgeries, which can be
patient’s right and autonomy because of the aforementioned
explained by the fact that surgeries with higher risks demand
differences [6,18,27].
more support by the healthcare provider and demands a
The five elements of informed consent are disclosure;
better protection for the latter and for the hospital [30].
comprehension; capacity; voluntariness and consent [24].
While Ghiyasvandian et al. showed that the majority
In the absence of respect of these elements, an ethical
of information related to surgeries were provided to the
question is to be asked.
patient by the physician, Joolaee et al. clearly stated that in
In the progress of medicine and the shift from paternal-
his study in Iran, only in 2.3% of cases the form was provided
ism to patient-centred approach, MENA region countries and
by a physician, therefore in the majority of cases, patients
populations seem to be still far from the norms and inter-
could not ask technical questions related to the procedure.
national guidelines. Patient autonomy and freedom is being
Informed consent process can differ between private and
disrupted in a direct and indirect way. Direct factors are the
public surgeons within the same country. A study in Kuwait
patient’s close relationship with his family and his environ-
stated that private surgeons tend to think more of the
ment, and the male dominant culture. The participation of
informed consent as a benefit for the patient rather than
the family and the husband or the father in the concept
just a legal paper [36].
process violates the freedom of the participant. Cultural
For this reason, surgeons and medicine students in gen-
differences were known to form an obstacle for informed
eral agreed that they would benefit from a formal training
consent worldwide and not only in the MENA region [51,52].
on informed consent based on intercultural differences
Indirectly, the physician’s social status, religious princi-
[29,36,47].
ples, absence of strictly applied rules, and the ignorance
of the participant’s rights leaves the patient exposed to the
Aesthetic surgeries physician. This raises the call for ethics in everyday practice
Patients who desire to have aesthetic surgeries must be and in researches where the practitioner has a responsibility
carefully evaluated for psychiatric disorders before any pro- to protect the vulnerable patient due to its cultural beliefs.
cedure. Therefore, the informed consent process must be However, cultural factors do not only reach patients,
held perfectly and procedures’ risks and benefits must be but also affect practitioner’s behaviour. Physicians in MENA
thoroughly explained, so the patient can have a complete region, especially older ones, are still used to the pater-
idea about the procedure and have a free decision. It is nalistic approach and think the patient should not know
important to mention that any malpractice in informed con- everything.
sent in such situations can be more penalized than in the
case of other procedures [48]. That is thought to be because
of the optionality of performing most of aesthetic proce- Suggestions
dures.
In order to overcome these challenges, several solutions
have been proposed by the literature.
Psychiatry patients As studies have shown, the use of a standardized pre-
Abou Mrad et al. showed in a Lebanese study, analyzing the prepared checklist which while being brief, contains all the
ethical frame of psychiatric informed consent, deficiencies important information for the patient in a non-technical lan-
in the care quality process. In fact, most of the patients’ guage, led to better understanding [6,7,30,38]. In addition,
medical records lacked essential information such as the the patient should be allowed to keep a copy of the consent
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Ethics, Medicine and Public Health 19 (2021) 100706
[43]. These forms should be written using the local language, Disclosure of interest
and taking into consideration the local culture.
In case of research, forms should be re-evaluated by The authors declare that they have no competing interest.
the local IRBs or research ethics committees that can make
sure patient’s beliefs and culture are respected; which also
implies a better development of these structures [5,6]. References
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