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Ethics, Medicine and Public Health 19 (2021) 100706

Available online at

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REVIEW

Challenges of the informed consent in some


countries of the MENA region: A Literature
Review
T. Habib a,∗, K. Richa a, F. Abou-Mrad b

a
Lebanese University, Faculty of Medical Sciences, Medical Ethics, Hadath, Lebanon
b
Lebanese University, Faculty of Medical Sciences, Saint Charles Hospital, Neurology,
Fyadieh, Lebanon

Received 10 March 2021; accepted 25 June 2021

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.

Abbreviation: MENA, Middle East and North Africa.


∗ Corresponding author.
E-mail addresses: tonihabib16@gmail.com (T. Habib), khalilwricha@gmail.com (K. Richa), fadiaboumrad@gmail.com (F. Abou-Mrad).

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

Purpose Table 1 Type of research in MENA region countries.


The evolution of medicine throughout the years led to the Countries Clinical Practice Clinical trials
fade away of the paternalism concept whether in clinical Algeria 0 0
practice or medical research. Bahrain 0 0
It was thought that the physician knows what’s best for his Egypt 0 3
patients, thus would take decisions related to their health Iran 10 3
without their consent, nor proper education regarding their Iraq 0 0
planned procedures. Several communities still feel more Jordan 0 2
comfortable this way [1]. Kuwait 1 0
Nonetheless, new guidelines emphasize the importance Lebanon 1 3
of the involvement of the patient in the decision-making Libya 0 0
concerning available therapeutic options, by that respect- Morocco 0 0
ing his preferences regardless of the desire of the physician Oman 1 1
[2,3]. This is called shared decision-making where the par- Palestine 0 0
ticipation of the patient is an indispensable determinant in Qatar 0 2
the quality care [4]. Saudi Arabia 6 0
Europe and the United States took the lead in this field. Syria 0 0
MENA region countries tried to import these norms and Tunisia 0 0
apply them locally. Many differences, mainly cultural, were UAE 2 2
a major challenge in following the same guidelines in the Yemen 0 0
Middle East and North Africa, which led to a certain devi-
ation from ethical standards [5]. Consent forms seemed to
be less about protecting the welfare of the participants and This study aims to define the concept of the informed
more about protecting the interests of the health care pro- consent, as well as to highlight the state of art of
fessional and research institutions [6]. informed consent applicability in clinical and research prac-
It was notable that most of the articles handling the issue tice conducted in some of the countries of the MENA
of informed consent in MENA region were conducted in the region, specifically in Algeria, Bahrain, Egypt, Iran, Iraq,
past 10 years which reflects the recent rise in the aware- Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Pales-
ness and the shift from the principle of paternalism to the tine, Qatar, Saudi Arabia, Syria, Tunisia, UAE, and Yemen
principle of autonomy, valuing the patient’s choice. [13]. Furthermore, we try to compare our findings with
That does not lower by any mean the importance of major international guidelines and discuss the challenges to
the physician’s opinion. In the contrary, it encourages the develop better informed consent forms.
physician to compare properly and clearly the different ther-
apeutic options available for the patient, and explains why
certain treatment options are better than others for exam- Methods
ple, by listing the most important benefits and risks of all
available options [7]. An IRB clear was secured for the good practice. A review of
Moreover, lack of clear application of the newest the literature was conducted on the Cochran library, Sco-
informed consent guidelines, in addition to low economic pus, EMBASE (Science direct), Medline (PubMed), WoS, and
level, have been a huge magnet for big pharmaceutical com- Google scholar. The search included, but was not limited
panies to conduct clinical trials in developing countries [8]. to the terms ‘‘informed, consent, consent form, paternal-
Thus it is extremely important to establish an appropriate ism, shared decision, research, medical research, human
consent form to protect participants enrolled in these stud- subject, IRB, REC, consentement, consentement éclairé,
ies. That is, since it is impossible to advance in medicine consentement libre, information médicale, paternalisme’’
and develop new therapeutic modalities and evaluate the
(French), (Arabic), and consecutively the name
present ones without conducting clinical trials [9,10].
of each country mentioned above, and was performed in var-
Obtaining informed consent appears to have mainly two
ious combinations. MESH terms relevant to each database
dimensions. The first one is clearly ethical and aims to pro-
were incorporated to improve the sensitivity and speci-
tect patients’ autonomy and their right to obtain proper
ficity of identifying relevant research works. We applied no
information about their health if they wish so. Second, in
language or date restrictions within the search. Available
the surge of medical suing, especially in the MENA region,
and relevant articles were all selected till the date of July
informed consent seems to be an ideal legal protection for
2019. All reports were obtained and reviewed. This review
practitioners and research institutions [11].
included 18 countries of which 36 articles and accepted
Finally, it is important to evaluate the information
manuscripts were collected from 9 countries, whereas the
acquired by the patient thus making sure that the latter
remaining 9 countries had no apparent study related to this
understood properly the message delivered by his physician.
topic (Table 1 and Fig. 1). Excluding criteria were studies
Several factors are to be taken into consideration in order
conducted in countries not considered to be part of the
to provide proper education such as the educational level of
MENA region [13] and articles not relevant to our objectives.
the patient, his culture, age, etc. [1,11,12].

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Ethics, Medicine and Public Health 19 (2021) 100706

Figure 1. Distribution of articles per country.

Findings and Discussion Cultural factors


Several cultural factors were shown to be very specific for
Findings were then divided into 2 major subgroups. The first some countries in this region, which led to the alteration of
group of articles discusses mainly informed consent in clini- the informed consent process within this society.
cal trials. The second group handles informed consent in the In general, Nakkash et al. described the Lebanese and
clinical practice in different scenarios, such as in emergen- Qatari population as ‘non-research cultures’ because of
cies, surgeries, invasive procedures, etc. the lack of interest they have towards research despite
its necessity in this region [6], while Ahram et al. showed
Medical research that other populations such as Jordanians have realized the
importance of medical research and would agree to par-
MENA region has witnessed a surge in clinical trials,
ticipate in it regardless of the existence of an appropriate
especially genetic based, which created several ethical chal-
consent form [21].
lenges because of lack of experience in this field [12,14].
Physicians were shown to have a very high social status
Available data on informed consent form components in the
among Arabs particularly [1]. Patients consider it offensive
MENA region showed lack of compliance and adherence with
to object a physician’s order or to refuse to participate in a
International conference on Harmonisation—Good clinical
study he suggested [3]. They were often worried that some
practice ICH-GCP guidelines [3,12,14—18].
decisions might affect their relationship with their doctors
Industry-sponsored studies in the UAE has been reported
[22]. In addition, with this respect comes trust, as several
to be > 80% compliant to Good Clinical Practice GCP con-
studies have shown that patients did not prefer to be part
sent forms, much more than non-industry-sponsored in 2013
in the decision making process and would rather leave this
[19,20].
decision for the doctor along with the most powerful fig-
The type of study has a large impact on the enthusi-
ure in the context (father, employer, Behvarze. . .), whether
asm of the participants. For example, genetic testing was
it concerns their participation in a study or a treatment
stigmatized because it contains individual information and
modality. They consider any physician as a person that is try-
could reveal disease predisposition that the patient might
ing to help them and improve their health outcome. Such a
not want to know [12]. Other studies showed that partici-
culture might question the investigator’s conflict of interest
pants do not mind blood testing for example but when it
and emphasizes the importance of research ethical frame
comes to drug trials they may be scared to participate [3].
[1,5,18].
Debates were held about the components of the consent
Furthermore, the act of signing papers, whether in
form. For instance, some thought that participants with-
research or clinical practice, was not very welcome among
drawal from their study will cost them a lot, thus they did
all populations, especially illiterate, as many preferred oral
not mention their right to do so in their consent form or only
consenting [3,6,11]. A signature request may be perceived
allowed partial withdrawal [17].
as a lack of trust and considered as an insult. Also, that is
Most of the MENA region countries share a lot of cultu-
because signing has a unique value especially in the Arab
ral and religious similarities, which have the most apparent
societies as it is used in occasions such as marriage, finan-
effect on the informed consent process in this region.
cial and juridical procedures, and some people may have had

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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

Table 2 Type of scenarios studied in each country.


Settings Critical situation Surgery patients Aesthetic Psychiatric
surgeries patients
Country Iran Iran Iran Lebanon
Lebanon Kuwait
Oman
Saudi Arabia
UAE

Literacy Children research


To achieve its objectives, the consent form has to be well In case of children research, in addition to the consent of
informed, which implicates a complete comprehension by the parents, assent must be obtained from children who
the patient. Consequently, many factors conditioning the are mature enough to take decisions but not old enough to
patient’s level of understanding must be taken into consid- consent legally according to their local law.
eration. For instance, it is pointless to elaborate a written Several opinions were shared about who should consent
consent for an illiterate patient. for the child, whether it’s the mother or the father or both,
The average literacy rate has been rapidly increasing in depending on the cultural background. The major ethical
this region. That is thought to be because the level was challenge faced was parents forcing their kids to participate
already low in the last decade in comparison with devel- in studies [26]. A significant number of children had no idea
oped countries. Also, male population still enjoys a higher what was the purpose of their visit when coming to assent
level of education [39—41]. [24]. This clearly disrupts the freedom and autonomy of the
Several studies showed moderate level of comprehension child.
after consenting. A study in Egypt for example, found that
100% of participants in a pharmaceutical trial thought that Clinical scenarios
this study will be surely beneficial for them just because it
was suggested by their physician [3]. The countries that handled these different topics are repre-
In fact, the information acquisition was influenced sented in Table 2.
essentially by socio-economic factors, age, gender, resi-
dence, language, culture, perception of risk, personality and Critical situations
mainly, level of education [2,7,11,27,30,37,42].
The quality of obtaining informed consent was higher In clinical practice, informed consent rules and princi-
in patients with higher education, younger patients (that ples are often altered in emergency situations; even the
generally have a higher educational level), and women. Par- law in some countries can exclude emergency situations.
ticipants of low educational level were marginalized and This allowed physicians to act in a paternalistic approach,
given less importance [30]. which can sometimes be aggressive and tough, neglecting
The majority of patients did not know their rights of patient’s value, but lifesaving. Nevertheless, some pre-
asking questions, taking decisions and refusing a treatment ferred to obtain the consent of the patient or his legal
modality or participating in a study [2,43]. representative in such situations in order to protect them-
Participants in clinical trials might find the informed selves.
consent a difficult document to understand particularly However, patients were shown to express frustration
if they have a low level of education [5,16]. Nair et al. when asked to sign papers in emergencies as they were
stated that the informed consent in UAE was written at already nervous, in an uncomfortable situation, in an
a 12th grade level when US guidelines suggests using 8th unusual location, and in a state of illness, which makes them
grade level [44]. Besides, although ethical, a very thor- vulnerable [25].
ough information release with use of medical jargon to Patients in the emergency ward and critical care units
patients mainly with low literacy often complicated the were also less likely to participate in studies [42,46].
informed consent process and rose suspicions on the motives
of the research [6,16,24,45]. Therefore, a consent form Surgery patients
must be adapted to each and every individual before being Surgeries are a regular daily act for surgeons, but it is a
adopted [5,27,28,43]. Participants appeared to show more major life event and novel experience for patients [7].
trust when the investigator respects their language and Several studies revealed that surgeons’ busy schedule
cultural beliefs, but translation of the consent may add refrained them from giving enough time for the informed
another layer of complexity [11]. Thus, oral consent can consent process and explain it properly to patients using
be used for patient with low literacy, as well for children, terms adequate to their educational level [7,25]. In addi-
elderly, mentally ill participants, and refugees and it has tion, the timing of the consent form signing was not
shown to increase response rate [6]. However, Nakkash et al. appropriate in the majority of cases, as it was done on
did not discuss vulnerability in their study and the need for a admission prior to surgery, in an inappropriate place, where
surrogate in certain situation, as well as lack of traceability patients were under pressure and felt obligated to sign
in case of oral consent. because of all the preparations that were made and by fear

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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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