(2024) 25:48
Martin et al. BMC Medical Ethics
https://doi.org/10.1186/s12910-024-01040-0

BMC Medical Ethics

Open Access

RESEARCH

A comparative ethical analysisof the Egyptian clinical research law
Sylvia Martin1*, Mirko Ancillotti1, Santa Slokenberga2 and Amal Matar1,3

Abstract
Background In this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis
is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country
with a robust healthcare infrastructure and predominantly treatment-naïve patients.
Methods We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed
approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer
scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise
to ensure rigorous analysis and interpretation of the laws.
Results On the rating of the seven different principles (social and scientific values, scientific validity, fair selectionof participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France,and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selectionof participants) were challenging to directly identify due to certain regulations embodying ’implicit’ principles morethan explicitly stated ones.
Conclusion The analysis underscores Egypt’s alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the criticalneed for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity.
Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda
for enhancing research ethics in Egypt and beyond.
Keywords Biomedical laws, Ethical principles, Egypt, Clinical trials, Social value*Correspondence:
Sylvia Martin
sylvia.martin@crb.uu.se
1
Center for Research and Bioethics, Uppsala University, Uppsala, Sweden
2
Department of Law, Uppsala University, Uppsala, Sweden
3
Clinical Immunology and Transfusion Medicine Department, Uppsala
University Hospital, Uppsala, Sweden© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to theoriginal author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images orother third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line
to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of thislicence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Martin et al. BMC Medical Ethics(2024) 25:48

Introduction
Science relies on research to move forward and enhanceknowledge. Different research areas deploy at different
levels of human subjects’ involvement, from qualitativeand non-interventional research methods to biomedical
research and medical validation procedures. While virtually
all research has ethical implications, clinical research calls
for special attention, and it is widely agreed that it should
be conducted according to more stringent ethical principles than other types of research [1]. To facilitate appropriate ethical implementation of research, it is imperative for
ethical regulations to be receptive to the advancements inthe field. The well-being of participants is a fundamental
condition of research emphasized by the principles outlined worldwide in renowned ethical texts like the Belmont
Report (cited in [2]1), and the Helsinki Declaration (see[3]2). These core principles include ensuring participants’entitlement to minimize harm and discomfort [2], as well
as safeguarding their rights against exploitation [4].
For assessing whether the ethical requirements are
fulfilled, and to ensure that international standards arerespected, as it has been proposed by Artal & Rubenfeld[5], 2017, it is essential account for specific principles
developed in the field. Research conduct that seemed
legitimate to the men of science in the past is abhorrent
to the contemporary conscience [6]. Ethical standards
also depend on where they apply. Different societies,
with their specific traditions and cultures, have systemsof values and norms that may only partly coincide withresearch ethics principles informing international standards. Hence, there could be a gap between what is culturally acceptable and what is compliant with international
ethics standards. However, the risk of ethical colonialism
and its biases, may be difficult to avoid, as it can be considered factual that many international documents heavily rely on the Western perspective [7].
While cognizant of this, a few documents can be considered ethical reference points, such as the above-mentioned Belmont Report and the Helsinki Declaration forthe protection of human participants in medical research[8]. Another influential example is the Ethical Frameworkfor Biomedical Research from Emanuel et al. [9, 10]. The
1

US Department of Health and Human Services. (1979). The Belmont
Report: Office of the Secretary, Ethical Principles and Guidelines for theProtection of Human Subjects of Research, the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research.

Page 2 of 14

Ethical Framework for Biomedical Research has heavily
influenced the ethics work of leading institutions such as
the Department of Health (DoH, South Africa3) and Council for International Organizations of Medical Sciences(CIOMS). In research ethics, the framework has often beenused to assess the functioning of ethical review committees
and the ethical adequacy of legal regulations of research
involving human subjects (see [11–13]). This ethical framework, rooted in major Western philosophical traditions but
not explicitly aligned with any specific school of thought,
enables the authors to formulate a set of principles that
resonates with a broad consensus, accommodating diverse
moral intuitions and beliefs.
Regulatory framework implementation in the new settings offers a great chance to explore what the most recent
bioethical laws are (like for the BRICS countries in [14]).
In this regard, the Egyptian Bioethical law from 2020 can
be considered as an innovative example for other countries
in the process of implementing bioethical regulations andimproved bioethical education across the world [15–17].
As Egypt is considered an LMIC by the World Bank [18],yet a “high growth pharmaceutical market”, the country
has become one of the most attractive locations for pharmaceutical companies to outsource their clinical trials.
The country, with over 100 million inhabitants, provides anoteworthy example of implementing bioethical laws in acontext with predominantly treatment-naive patients and arobust medical infrastructure encompassing public hospitals and healthcare professional representation.
The aim of the present paper is to analyze and discussfrom an ethical perspective the new Egyptian clinical trial
law. The Egyptian law is analyzed and discussed in relation to the Ethical Framework for Biomedical Research by
Emanuel et al. [9, 10], and in comparison to selected othernational and supranational laws.
Egypt

One of the recent countries adopting bioethical law toregulate clinical human subject research is Egypt, which
enforced its first law on clinical trials in the official journal
on December 23rd, 2020. The issuance of the law, which
has long been in the making, was hastened by the COVID19 pandemic and the urgency to carry out vaccine trials
among the Egyptian population [19]. This regulation is partof a broader effort to enhance the respect for civil/humanrights in the country. In 2022, the recent reports from the2« World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects », JAMA, vol. 310, ­no 20,‎ 27 novembre 2013, p. 2191–2194

3

Department of Health. (2015). Ethics in health research: Principles, processes and structures.

Martin et al. BMC Medical Ethics(2024) 25:48

US Embassy still pointed out some issues [20], raising concern about fairness and equity in the whole society, andimpacting ethical procedures in health and research. However, Egypt -as a United Nations member since 1945- hasbeen participating in the global initiative to enhance humanrights application [21]. Like other Arabic countries (Jordan, Saudi Arabia) registered in the UN Watch Database,it needed to justify their application of human rights [22].
Efforts are made to improve ethical skills among health caregivers in Egypt. For example, EL-Khadry et al. [23], assessed
the effect of educational intervention on knowledge and attitude towards research, research ethics, and biobanks among
Egyptian paramedical and administrative teams. Egypt has
witnessed exponential growth in medical research like inmany developing countries, driven by the pressing need to
improve healthcare [24]. Egypt held the 37th position interms of publication volume in 2023 [25]. It is worth noting that in 2020, Egypt had only 838 researchers per million
inhabitants, in stark contrast to the USA’s 4,821 researchers
per million inhabitants (in 2019) and the United Arab Emirates’ 2,443 researchers per million inhabitants (Researchers
in R&D (per million people) [26] representing the medium
position compared to of BRICS countries like South Africa(484 researcher per million habitants) or China (1,585).
National examples: France and Sweden

On the national level, France and Sweden hold a long
tradition of ethical regulation. French law influenced thestructuring of the Egyptian legal system in 1875. Later,reforms were made to the Egyptian civil law under theguidance of a French legal expert Édouard Lambert in the
1930-the 1940s [27]. We selected France as a study focus
due to its historical ties and influence on Egypt’s regulatory framework. Additionally, for comparative analysis
with another high-income Western nation, Sweden waschosen for its renowned status as a research leader, distinct from any historical connections with Egypt.
Northern European countries are still considered to beleading countries in research (Sweden is the ­3rd country
in terms of research and development expenditures (%of GDP) after Israel and Korea in 2020 – [28] and have along tradition of bioethics practices and reflections (e.g.,
Helsinki’s declaration in 2000 [29]). Specifically, Sweden is included in the study as an example of a Nordic
country with an evidence-based culture of health policymaking [30] and constant interest for ethical inquiry inunder-researched vulnerable populations [31–33]. In
2004, Sweden enforced “The Act concerning the Ethical
Review of Research Involving Humans” (SFS nr: 2003:460)
that sharpened ethical review procedures for biomedical research way earlier than other countries (e.g. Loi
Jardé in France from 2012, and the Egyptian law 2020),
introducing a reference that showcased innovative law inPage 3 of 14

the early 2004 that remains in effect. In 2020, France had4926 researchers per million inhabitants, quite comparable to the USA’s 4,821 researchers per million inhabitants (in 2019) and representing a European example of a“medium” score of researchers per million inhabitants. In
comparison, Sweden counts for 7,930 researcher per a million inhabitant, Norway 6,699, Finland 7,527 or Denmarkwith 7,692 (Researchers in R&D (per million people) [34].
At the international level, France ranked at the ­6th position
for publication volume, while Sweden ranked the ­18th [35].
Supra‑national entity: the EU regulations to consider
when considering France and Sweden

Supra-national European regulations play an importantrole in the legal system of EU countries even if such a
supra-national level does not exist in Egypt. At the EU level,
the EU Regulation on clinical trials on medicinal products
for human use (CTR) governs the ethical review of clinical
trials, however detailed aspects of ethics committees andethical review depend on further regulation at Member
State level. This means that even though the EU regulates
ethical review of clinical trials in the CTR, there could beconsiderable divergences across Europe in how the committees are set up and perform their tasks. To begin with,
the CTR requires that a clinical trial be subject to ethicalreview (Article 4), and it outlines several relevant aspects ofthe process of carrying out that review. However, modalities regarding ethical committee and its work are a questionof the Member States’ regulation. Generally, the application
for authorisation to conduct a clinical trial is divided into
two parts. Part I focuses on the technical-scientific dimension, and part II on the ethical aspects which are reviewed
by each member state concerned. An ethics committee,
within the meaning of the CTR, is an independent bodyestablished in a Member State in accordance with the lawof that Member State4. Under the national law, this bodyneeds to be empowered to give opinions for the purposesof the CTR, considering the views of laypersons, in particular patients or patients’ organizations (Art. 2(2)(11)). The
CTR prescribes in Recital 18 merely a guiding requirementthat the member state needs to ensure that “the necessary
expertise is available”. Member States should have a mechanism in place to ensure the involvement of laypersons, inparticular patients or patients’ organisations. However, theeffect of this involvement that the CTR requires is that theirviews are taken into account in the review (Art. 2(2)(11)).
It is not uncommon that several ethics committees exist ina member state. How the involvement of an ethics committee is organized for the purposes of the tasks specified

4
The composition of the ethics committees remains to be decided by amember state.

Martin et al. BMC Medical Ethics(2024) 25:48

in the CTR is a question for the Member States to decide(recital 18). However, the process needs to be organized sothat the relevant timelines of the clinical trials approvals set
out in the CTR are met (Art. 4).

Methods
Design and data analysis

We examine the Egyptian law vis-à-vis France’s andSweden’s framework, considering the obligations thatstem in regards to clinical trials from the CTR. Furthermore, we examine these regulations in light of the Ethical Framework for Biomedical Research by Emanuelet al. [9, 10]. Indeed, we will consider the EU implication into France and Sweden’s regulations.
A directed approach to qualitative content analysis was
adopted using the seven principles informing the Ethical
Framework for Biomedical Research as predeterminedthemes [36]. Two independent coders examined eachselected regulation in their original version for French(MA, SM), Swedish (MA, AM), EU (MA, AM), and in
an English translation for the Egyptian law (AM, SM).
The coders discussed the results critically in debriefing
sessions and their coding was discussed until consensus
with a legal expert working with ethical regulations at theinternational level (SS) contributing the clarification of EU
and both Swedish and French framework.
Theoretical framework

The seven principles that will serve as comparison criteria for our analysis are the following: “(1) (Social) value- enhancements of health or knowledge must be derived
from the research; (2) scientific validity- the research must
be methodologically rigorous; (3) fair subject selection - scientific objectives, not vulnerability or privilege, and thepotential for and distribution of risks and benefits, should
determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit
ratio-within the context of standard clinical practice andthe research protocol, risks must be minimized, potential
benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh therisks; (5) independent review - unaffiliated individuals must
review the research and approve, amend, or terminate it; (6)informed consent - individuals should be informed about
the research and provide their voluntary consent; and (7)respect for enrolled subjects -subjects should have their privacy protected, the opportunity to withdraw, and their wellbeing monitored.” (Emanuel et al., 2000, p2701 [9]).
Material

For a thorough assessment, we exclusively examined theprimary text of each law, excluding connections to other

Page 4 of 14

regulations (e.g., the "Code de la Santé" and "Code Penal"
for French regulation or to “Law No. 151 of 2019, theEgyptian Medicines Authority” for the Egyptian text).
Our analysis utilized the latest version of the law, including any amendments. These are:1) Egypt’s law – no amendments December 2­ 3rd, 2020,
Law No. 214 of 2020 Regulating Clinical Medical
Research.
2) French law: the “Loi Jardé” (LOI n° 2012-300 du 5mars 2012 relative aux recherches impliquant lapersonne humaine) amended with the “Décret n°
2016-1537 du 16 novembre 2016 ”. We will consider
the latest 2022 amendment for reference in our
analysis.
3) Swedish law: Lag (2003:460) om etikprövning av
forskning som avser människor with the following amendments: 2018:147, 2018:1092, 2019:1144,
2021:611, 2022:48.
4) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, andrepealing Directive 2001/20/EC Text with EEA relevance OJ L 158, 27.5.2014, p. 1–76.
These laws have been identified for being the main relevant legal texts for biomedical research regulations andmore specifically research involving human subjects.
The selection of national and international regulations
to assess was based on their presence within international pharmacological and biomedical research industry. Moreover, the EU regulation will be considered as
an adjunct line of analysis to complement Swedish andFrench regulation examination as both countries arepart of EU.

Results
The full overview of coding procedure for all regulation isavailable as supplementary material (see Tables 1, 2 andAppendix 1). A summary of this assessment is presented
in Table 1 with a score system showing the complianceor absence of compliance to each principle. A score of 0means there is little to no compliance with the criteria,
while an X indicates satisfactory or complete compliancewith the criteria.
Social value
Egypt

Egyptian law does not overtly address the social valueof the research proposal. However this may be implied

Martin et al. BMC Medical Ethics(2024) 25:48

Page 5 of 14

Table 1 Comparative coding summary
Emanuel’s criteria

EgyptFranceSwedenEU

1 Social values and scientific value

0

0

0

0

2. Scientific validity

x

x

x

x

3. Fair selection

x

x

0

x

4. Favorable Risk-benefit ratio

x

x

x

x

5. Independent review

x

x

x

x

6. Informed consent

x

x

x

x

7. Respect for participants

x

x

x

x

0= partial or no compliance with the criteria, X=satisfactory or full compliancewith the criteria

as the national Research Ethics Committee (REC5)(Supreme Council) will take into account “national
interest” when evaluating research protocols (Chapter(ch) 3, article (art) 7(2)).
SwedenSimilarly, the Ethical Review Act, has no clauses thatare focused on assessing the social value of research.
However, the notion of research serving a social interest is implicitly demonstrated by the composition of thedepartmental REC, where five members out of 15 represent society’s interests (Section 25). In Section 8, it isindeed stated that the welfare of research participants
must be prioritized over the needs of society.

and prevail over all other interests; and (b) it is designed togenerate reliable and robust data for example. Moreover,member state and Union inspections are envisaged (taking compliance with the EU regulation as a token of good
research for society and for science). See Art. 78 and 79.
Scientific validity
Egypt

Regarding Scientific validity, Egyptian law set up the
responsibility of REC to ensure ethical quality (Art. 1,
Art. 2, Art. 24) of the accepted protocols, but also set
up standards for scientific quality (Art. 7; 2; Ch. 2 Art.
10) making sure that principal investigators have therequired scientific competences (Ch. 5 Art. 22; Ch. 3 Art.
6 provided a detailed list of required competences §2, Ch.
4 Art. 9.).
SwedenThe Swedish law emphasizes the importance of soundresearch. In Section 11, it is stated that research may only
be approved if it is carried out by/under the supervision of a
researcher with the necessary scientific competence. In Section 9, where the scientific value of the proposed researchis weighed against, and if proportionate justifies, the risks
to the health, safety, and personal integrity of research
participants.
FranceFranceFrance also lacks a clear statement on the social value. The
law relates to “social” level as it often refers to the “Code dela santé” (CS) and to the “social security” system, but noclear points about social values per se. Social and scientificvalue is stated in the “Research organized and carried out
on human beings to develop biological or medical knowledge shall be authorized“ (Art. L1121-1 CS).
EU

Under the CTR, social value – enhancement of health – isthe whole purpose, even if not expressis verbis stated, Art.
3 and Art. 6 ensure that as a general principle, (a) the rights,
safety, dignity, and well-being of subjects are protected

5
In France, the REC acronym coul refer more to the High National EthicalCommittee, which issues recommendations on a societal scale. It is important to note that this committee is distinct from the day-to-day oversightof research ethical applications or clinical trials. The latter responsibility
primarily falls within the purview of internal ethical committees situatedwithin hospitals or universities, which have the authority to grant approvals.
Externally, the (Comité de Protection des Personnes or CPP) serves as themost pertinent entity, akin to a Research Ethical Committee (REC); hence,
we have opted to utilize the acronym REC for clarity.

Article L1121_2 expresses the need for social and scientific validity. Art. L 1121-3 refers to “qualified personnel” for scientific validity and after the approval has been
given by a REC. RECs have a regional organization andcan be involved together with Commission nationale del’informatique et des libertés (CNIL) for data security
issues, and Committee of Experts for Research Study and
Evaluation in Health domain. Any research is also regulated by EU rules (Article L1121-1 CS). Specific regulations for certain disciplines are stated in the CS (L1121-3)
but not in the Loi Jardé.
EU

At the EU level, Art. 4 requires prior authorization. In
particular, a clinical trial shall be subject to scientificand ethical review and shall be authorized in accordancewith the rules set out in the CTR. Under Article 6(1)(b)(i) the reliability and robustness of the data generated in
the clinical trial, taking account of statistical approaches,
design of the clinical trial and methodology, including sample size and randomization, comparator, andendpoints.

Respect for recruited participants art L 209–5,. art. L.1122-1 PHC, art.
and study communities
L.1122-1 HPC, art L1126-1 PHC
Concerning interventional researches(category 1): art. L.1122-1-1 PHC, art. L.
1122-1-1 PHC, art. L.1122-1-1, §2, PHC.

Article L1121-2, Article L1121-14,
Chapter II: Informing and obtaining
the consent of persons undergoing
research involving the human person(Articles L1122-1 to L1122-2).
Chapitre V : Dispositions particulières
applicables aux investigations cliniquesde dispositifs mentionnés à l’article
premier du règlement (UE) 2017/745
du Parlement européen et du Conseil
du 5 avril 2017 (Articles L1125-1 àL1125-31)

Informed consent

Article 28 General rules, Article 29(2)Article 29(1), (7) and (8), Chapter 5

Article 7, Article 29, Informed consent,
Article 76(1); Article 81 (the ‘EU database’), Article 37(4), Article 30 Informed
consent in cluster trials

Article 4, Article 9

L. 1114-1, Art. L1123-1

Independent review

8 §, 9 §, 10 §!6 §, 14 §, 17 §, 18 §, 20 §, 21 §, 22 § All
the sections in the law from 13, 14, 15,
16, 17, 18, 19, 20, 21 and 22.

Art 12; 2., Art, 15; 2.Chap 5, Art 15;3, Art 1§, 7 §, 19 §, 8 §
12 (1), art 18:5, Art 20:9, 10, Art 14

Art 1; 21, Art 12; 3 Chap.5 arti 12 § 3,
law Art 3, Chap 7 art 17 § 2: obtaining IC is mandatory, Chap 10, art 23§2 Informed consent for data usage
for further research- YesArt1; 24, law art 8., Chap 2 article 4: 6 §, 25 § SFS 2018:1091 Act with supREC, Chap 3 artile 1 to 4 about setting plementary provisions on ethical review
up protocols
to the EU regulation on clinical trialsof human medicinal products Ethicalreview of the application for permission
for clinical drug trials § 2 The ethicalreview must be carried out by the Ethics
Review Authority.

Art 18; 6 (PI duties), Chap 5 art 10,
Chap 7 art 18 §9, Chap 11 : requirements of research organization

Article 6

article L1123-10 (R. 1123-46),Article
L1121-2)

Favorable risk-benefit ratio

14 §Art 17; 7 (PI resp), art 3, Chap 5 art
13.14:

Article 10 Specific considerations
for vulnerable populations, Article 35,
Article 31 Clinical trials on incapacitated subjects, Article 28 Article 29(2),Article 32 Clinical trials on minors,
Article 33 Clinical trials on pregnant
or breastfeeding women, Article 34.

Fair selection of study population Articles L. 1121-5 to (Articles L. 1121-5
to L. 1121-8 of the Code de la santé
Code – CSP. article L. 1122-2, article L.
1122-2 of the CSP, article L. 1122-1-2of the CSP, art. L. 1122-2 II, §3, art.
L.1122-2 PHC, Art. L. 1121-6 PHC, art.
L.1121-8-1 PHC, art. L.1122-1-2 PHC, art.
L.1122-1-3 PHC, art L.1131-1-1 PHC, art.
L1131-1-1 PHC, art. L.1122-2 II PHC, art.
L. 1122-2 II PHC.

No provisions..

Swedenarticle 1, #2, art 1, #24, Art 7; 2, Ch 2 Art 11 §, Verksamhetsregioner och avdeln10 Ch 5 art 22. Chap 3 art 6, §2
ingar av Etikprövning 25§, Beslutsförhet
Chap 4 art 9.
26 §Art. L 1121-3, Article L.1121-8-1, Arti.
L1123-7

Scientific validity

Art 10, Chapitre 5, art 18. Chapitre 8
art 20. Art 7; 2 - Ch 2 Art 10. Executive
regulations art 24

Egypt

Article 4 Prior authorization, Article 6

Article L1121-2 Modifié par LOI n°2012- Article 3 General principle, Article 6,
300 du 5 mars 2012 - art. 1 (V)See art.78 and 79.
Article L1121-16

Social and scientific value

EU regulation

French Law

Emanuel et al., 2000 [9]Table 2 Coding table short form

Martin et al. BMC Medical Ethics(2024) 25:48
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Martin et al. BMC Medical Ethics(2024) 25:48

Fair selection of study population
Egypt

The Egyptian law ensures the impartial selection of an
appropriate number of research participants. There are
specific recommendations for REC in regards to recruitment of specific sub-groups or vulnerable population.
For example, prohibit research participants to enroll in
simultaneous medical research and prohibit induced participation (Ch. 5 Art. 13; 14).
SwedenThere are no definite clauses in the considered law thatemphasize the requirement for fair selection of the study
population. Nonetheless, protection of minors and individuals who cannot consent to research participation is
described in Sections 18, 20, 21, and 22 (see Informed
consent section).
FranceFrench regulation requires that study participants bebeneficiaries of the Social Security system (and if not,they will be considered as if they are). Fair selection of
the participants is ensured by the CS (Articles L. 1121-5
to L. 1121-8). The main categories with stated protection are adults in coma, with dementia or for psychiatric conditions, or enfeebled patient, people deprived of
their freedom, foreigners, minors, pregnant and nursing
women. Moreover, situations such as “urgency” that may
override any consent needed.
EU

Art. 10 offers “specific considerations for vulnerable populations”, in particular, minors (see Art. 32), incapacitatedsubjects (see more Art. 31, 28, 29), pregnant or breastfeeding women (see Art. 33), the participation of specificgroups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of theapplication for authorization of that clinical trial on thebasis of expertise in the population represented by the
subjects concerned. Art. 34 also covers national measuresfor participants performing mandatory military service,persons deprived of liberty, persons who, due to a judicial
decision, cannot take part in clinical trials, or persons inresidential care institutions.
Favorable risk‑benefit ratio
Egypt

Clear specifications of the Principal investigator requires
all the consideration about risk-benefit ratio (both at thephysical and psychological level), ensuring dignity andhealth, adding a note for specific attention to reducing
side effects (Art. 18; 6). Another layer of risk reduction

Page 7 of 14

is the provision to evaluate preclinical medical research(Ch. 5 Art. 10), the provision of health insurance coverage of any research participant (Ch. 7 Art. 18 §9), andensuring that the research organization will be able toattend properly to research participants’ health needs incase adverse effects or health risks ensuing from the clinical trial (Ch. 11).
SwedenAccording to the Swedish legislation, the necessary condition for approving research is that fundamental personal freedoms, and human rights are respected. While
Section 9 states that research may be approved if its scientific value outweighs the risks to research participants,
Section 8 specifies that their welfare must be prioritizedover the needs of society and science. Section 10 statesthat research should be conducted only if its expected
result cannot be achieved in another way that involves
less risk to the health, safety, and personal integrity of
research participants.
FranceFavorable benefit-risk ratio was refined with the inclusion of “new facts” issues that appeared with Loi Jardé.
The most important point to emphasize is that thesponsor will be responsible for the care and necessary
costs ensued from severe side effects, if they occur.
These include both biomedical research (R1) as well asinterventional minimal risk research (R2).
EU

Art. 6 ensures that risks (minimization, safety measures) and inconveniences for the subject are considered
and reduced for medicinal products and interventions
compared to normal clinical practice. Suspected unexpected serious adverse reactions and annual reportingare strictly regulated at the EU level. Under the CTR,
the committees are informed regarding suspected unexpected serious adverse reactions that are reported pursuant to the CTR as well as the annual report submitted to
the European Medical Agency (Art. 44.3).
Independent review
Egypt

Independent review will be implemented by a REC(Art. 1, 24), and it will protect the rights of participants, review the research protocol, decide on approval,
amendments or renewal of the research, and lastly monitor the research (All this is in accordance to the executive regulations of law art 8). The specifics of the review
process are detailed in several articles (Ch. 2 Art. 4:
REC; Ch. 3 Art 1 to 4).

Martin et al. BMC Medical Ethics(2024) 25:48

SwedenAccording to Section 6, independent review is mandatory whenever the research involves a physical intervention or involves affecting or risk harming the research
participant physically or psychologically. Independent
review is also required in the case of studies involving
biological material taken from a living person and canbe traced to that person. The same article emphasizes
the principal investigator’s responsibility, who must takemeasures to prevent research from being carried out inviolation of the law. Section 25 sets out the organizationof the authority providing an independent review, i.e., theEthics Review Authority. This is divided into operational
regions, each composed of one or more departments
according to their areas of expertise. Departments consist of a chairman, who is or has been an ordinary judge,
and fifteen other members, of whom ten have scientificcompetence and five represent public interests, including
at least one member who represents one or more patientorganizations. The government appoints the chairman
and its deputy, while the Ethics Review Authority chooses
the other members and their deputies.
France

The independent review component is well establishedwith the composition of the Committee for the Protection of Persons and the presence of 39 RECs acrossthe 7 inter-regions committees. The repartition of
REC into 2 colleges, one more scientific and the second more patient-related, support independent review,
but the designation and recruitment of different REC
members (depending on the national or local level, forexample) is not clear. For the local levels (Art L1123-1),
the text state that the Health Minister CPP for a fixedor undetermined duration and according to the needs.
Their members are appointed by the Director Generalof the regional health agency in which the committee has its headquarters. The committees are completely independent in the performance of their duties.
They have legal entity under public law. Committee
resources are provided by the State. However, ethicalapproval can be obtained via institutional committees(in house at some hospitals and universities). Member of the National commission for research involving
human need to declare their conflicts of interest (Art.
L1123-1-1) which is not clarified for CPP (promotorsof the same institution are – per definition- applying
to their “in house” ethical committee).
EU

Art. 4 refers to the need for prior authorization in accordance with the law of the Member State concerned6. The
review by the ethics committee may encompass aspects

Page 8 of 14

addressed in Part I of the assessment report for theauthorization of a clinical trial as referred to in Article
6 and in Part II of that assessment report as referred toin Article 7 as appropriate for each Member State concerned. Article 9 should ensure that the persons validating and assessing the application do not have conflicts ofinterest, are independent of the sponsor, of the clinical
trial site and the investigators involved and of persons
financing the clinical trial, as well as free of any other
undue influence. A special mention explains that at least
one layperson shall participate in the assessment.
Informed consent (IC)EgyptAmong the very first articles (Art. 1; 21), Egypt’s law provides a definition of IC, promoting its engagement into
this ethical procedure “the written expression based oncomplete voluntary freewill of the person with full legal
capacity, and it includes his explicit consent as a signature and a fingerprint to participate in clinical medical
research, after all aspects of the research are explained
to him, and in particular the potential effects or harmsthat may impact his/her decision to participate[…]”. The
exception of obtaining IC is detailed in executive regulations (Ch. 5, Art. 12; 3). More specific considerationis also represented in other sections of the law: in Ch. 7
Art. 17 § 2: obtaining IC is mandatory. In Ch. 10, Art. 23§2, IC is required for data usage and for further research.
Furthermore it provides specification for consent of data
usage.
SwedenSection 17 states that, in line of principle, research can
only be performed if the research participant has voluntarily and explicitly consented in a documented way
after receiving adequate and specific information. Section 16 describes what the fundamental pieces of information are. In cases where a research participant is in adependent relationship with components of the researchteam or if the research participant has difficulties asserting their right, Section 14 states that issues of information and consent must be given special attention. Specificrecommendations are provided in the case of minors or
if the research participants turned 15 years (Section. 18).
Sections 20, 21, and 22 list under what circumstances
research can be performed without consent (illness,mental disorder, a weakened state of health, or any other6
The effect of the decision is, nonetheless, strong. Where an ethics committee has issued a negative opinion, on the condition that rules that are
valid for the entire Member State apply, that Member State has a duty torefuse to authorise a clinical trial (Article 8.4, for extended authorisations
see Article 14.10, for substantial modifications for the assessment report,
see Articles 19, 20 and 23).

Martin et al. BMC Medical Ethics(2024) 25:48

similar condition of the research participant prevents
their consent from being obtained).
FranceIC regulations state that “Consent is free, informed and(voluntary) emphasizing the importance of individuals
providing explicit agreement in various legal situations. It
must be written for category 1 studies and may be oral
for category 2 studies (but must be recorded in the medical file). For category 3 research and for studies on datacollected in the course of normal care, the rule is that thepatient “must not object.” No research mentioned in 1° ofArt. L. 1121-1 may be carried out on a person without
his or her free IC, given in writing after the person has
been provided with the relevant information. Where it
is impossible for the person concerned to express his or
her consent in writing, it may be attested by the trusted
support person provided for in Art. L. 1111-6, by a family member, or, failing this, by one of the person’s close
relations, provided that this trusted person, family member or close relation is independent of the investigatorand the sponsor. Specific recommendations are provided
for minors (under 18 solely). Article 4 is also providing details about the case where the participant cannot
express consent and is not under guardianship. There
are also options for “collective consent,” but they are only
available for interventional research with minimal risk
(epidemiologic search).
EU

Art. 7 mentions the need for compliance with therequirements for IC as set out in Art. 29, explicating
the regulations about written IC. A specific regulation
has also been dedicated in Art. 30 for cluster trials. This
specification states that “Where a clinical trial is to be
conducted exclusively in one Member State, that Member State may, without prejudice to Art. 35, and by way of
derogation from points (b), (c), and (g) of Art. 28(1), Art.
29(1), point (c) of Art. 29(2), 29(3), (4) and (5), points (a),(b) and (c) of Art. 31(1) and points (a), (b) and (c) of Art.
32(1), allow the investigator to obtain IC by the simplified means set out in paragraph 2 of this Article, provided
that all of the conditions set out in paragraph 3 of this
Article are fulfilled.”
Respect for participants
Egypt

Egyptian law provides protection of privacy and data
(Art. 12; 2), adequate information of researcher participants (Art,.15; 2. Ch. 5; Art 18:5), protection from publicity (Art. 15;3) together with a straightforward explanationof requirements to respect withdrawal of consent (Art. 2,1) and compensation aspects (Art. 20:9, 10). The details

Page 9 of 14

of non-induced participation (for money or reward)
could also be understood as a measure of respect forrecruited participants (Art. 14).
SwedenSection 1 states that its purpose is to protect the individual and respect human dignity in research. This isreaffirmed under Section 7. Noteworthy, according to
Section 40, some exceptions can be made with regards
to requiring consent or processing of data if this isrequested by the government or another authority. This is
only possible if it is clear that the research does not entail
any appreciable risk to an individual’s health or safety orpose an infringement on an individual’s integrity.
FranceThe respect for study participants was unclear in the text
and focuses more on fair selection and risk protection ofresearch participants. One specific element regarding theparticipant protection of “a deceased person, in a state ofbrain death, without his or her consent expressed during
his or her lifetime or through the testimony of his or her
family” (Art. L1125-13).
EU

Article 28 prescribes general rules that must be met for aclinical trial to be lawfully conducted. This article clarifies
that benefit to the participants, IC, right to mental andphysical integrity, minimal pain or risk, guaranteed medical care, and no undue influence (including financial) are
the basis for any medical research. EU regulation Article 28 of Regulation (EU) No 536/2014 of the European
Parliament and of the Council, Article 2 make sure thatwithdrawal is free of constraints and will not have repercussions nor affect the participants’ rights and care, butalso makes sure that the withdrawal of consent does notaffect the data collected prior to withdrawal.

Discussion
Our results show that the Egyptian law fulfills the ethicalrequirements for human subject research and is comparable to the French, Swedish and EU regulations.
Detailing the results, we also observed that all regulations tended to have a very vague approach to “social
values and scientific values” (principle 1). In terms of
the fair selection of participants, the Swedish text wasprobably the vaguest (principle 3), but in general, thisprinciple appeared to be well integrated. All other principles also were well represented in Egyptian law as in the
French, Swedish, and EU’s laws (principles 4, 5, 6, 7). We
explore in two separate points the results :1) Value andvalidity (in which principles 1, 2 and 5, with 5 as the way/Martin et al. BMC Medical Ethics(2024) 25:48

procedure to reach value and validity), 2) Participant’s
protection (principles 3, 4, 6, and 7).
Values and scientific validity
Principle 1, Social values and scientific value

Egyptian regulation suffers from the same issues in clarifying the social value aspect as French, Swedish, and EU
regulation. The results from the assessment of social values reveal that most of the regulations struggle to clearly
define under what specifications research should serve asocial purpose. Social value is often envisioned at the levelof cost-effectiveness measurements, and its definition
may be difficult to normalize across states and cultures as
it refers to “the general concept and practice of measuringsocial impacts, outcomes, and outputs through the lens ofcost” [37]. In Emanuel et al’s vision, it is composed of thea) ensured benefit b) value for the prospective beneficiaries, c) dissemination of the results via long-term collaborative strategy d) avoiding to undermine the community’s
existing healthcare [38]. Furthermore, these results question the importance of social value in research per se, forexample, in specific areas where the social value aspect
cannot be considered as an overarching guide. Recent
debates questioned, for example, the justice and egalitarian arguments that can arise from questioning the social
value of research [39, 40] depending on how innovativeand impactful on a societal level the research is.
Principle 2, Scientific validity

Egyptian law, French, Swedish, and EU regulation, tries
to specify the scientific validity mostly via their REC
members selection. The general implementation of a control mechanism and ethical review board’s competences
question the real level of expertise or education that thesemembers do have in order to review research protocols
or scientific methods. For example, there is not a clear
consensus about the need for specific competencies inorder to have balanced and non-biased decisions in ethical vetting because [41] as different ethical reviewers willraise different concerns. In their results, they confirmedthat the main influencing factor in readers-queries was
the profession, with scientific validity issues being more
frequently asked by scientific reviewers, whereas ethicalissues were more frequently pointed out by ethicists.
Depending on the system and general community
functioning, the selection of research ethics committees members can put into question the non-biased
nature of assessment of scientific validity. For instance,in France, the members of the Nation Ethical Committee, who are responsible for offering direction to
all REC, are "selected" or "designated" by the Presidentof France. The same question could also be raised in
Egypt were Central intelligence members are sitting at

Page 10 of 14

the National REC (the Supreme Council). The impact
of politics and social politics in presumably non biased
procedure is also rising with the use of preference studies to inform policy making and including patient’s
advocacy in decisions boards as it can have a role indecision makings [42] providing advances in shareddecision making but also leveraging non-biased decisions making as there is still not a unified definition ofsuch processes [43] and for example, research showsthat methodological standards are often downgraded toprovide access to the co-researchers [44].
As it is sometimes defined in science in general, validity should be assessed in an adequate manner acrossmedical field. Scientists refer to scientific quality measures (like in systematic literature review assessements
scales for scientific quality) but validity interpretation canbe difficult to apprenhend for an heterogeneous groupof experts (like an REC). In its very classical definition“The validity of a research study refers to how well the
results among the study participants represent true findings among similar individuals outside the study. This
concept of validity applies to all types of clinical studies,including those about prevalence, associations, interventions, and diagnosis”, scientific validity could look easy toapprehend but even then, just having the precision “Thevalidity of a research study includes two domains: internaland external validity” explain the layer of complexity that
may not be represented in Emanuel’s principles definition[45]. Going further into the validity explanation and use
in ethical consideration in biomedical research should be
warranted. For example, some research look at different
levels of validity to clarify what one considers as validity (scientific validity may be too vague to refer to permit
clear assessment): congruence validity, criterion validities,
etc [46]). Wages et al. in 2021 [47], showed the potential for using operating characteristics to inform design’s
safety and accuracy in phase I clinical trials that could
open the debate around a better definition of scientificvalidity checks in biomedical research. One part of theissue comes from scientific communities but the scientificvalidity should be also a matter of concerns for all REC
members. The competencies of any participants should
be addressed in the REC reviewer’s selection as somequestions also arise from the medical field where shareddecision-making has been implemented before and somedebate remains about the representativeness of patientsthat do get involved in the medical decision-making [48,49].
Principle 5, Independent review

All ethical regulations, including Egypt’s, ensure thatthe review system is independent and thus RECs haveMartin et al. BMC Medical Ethics(2024) 25:48

Page 11 of 14

the power to authorize, follow up and end any research
to protect participants [29]. One of the major concerns
still not addressed in the regulations is the difficulty toguarantee REC effectiveness in regards to some deficiencies in REC theory and structure [50]. The opportunities
to enhance EC efficiency and effectiveness could also
depend more on the researcher and the scientific community as Hickey et al., 2022 suggested [51]. Clarifying
the collaborative approach across ethics committees andresearch can be the path to increased medical researchefficiency.

Principle 7, Respect for recruited participants and study
communities

Participant’s protection
Principle 3, Fair selection

Limitations

In the Egyptian regulation, the fair selection of participants is pursued, which can be considered a positive
development with respect to the previous regulation
proposal, where protection of the rights and welfare ofvulnerable subjects were not adequately considered [52].
Generally, one can wonder about the impact of fairness
when recruiting for clinical trials. Ongoing discussions
emphasize that the fair selection of participants could
be a very ethically challenging issue as it is a ground for
dilemmas [53], including the levels of “(1) fair inclusion;(2) fair burden sharing; (3) fair opportunity; and (4) fair
distribution of third-party risks”. The equal opportunity
issue also arose for example in 2022 when French law
integrated EU requirements and shifted toward allowing
research participants with no access to social security to
be part of research [54], offering extended opportunities
for participation but putting the question of fairness of
selection into question.
Principle 4, Favorable risk‑benefit ratio

Egyptian regulation, like the four other comparatives,
consider “Risk-benefit” as a sine qua none principle andthe clarity of Helsinki’s declaration [55]. However, noregulation mentioned the potential for under-reporting
harms depending on what one considers to be “harm”.
One of the aspects that are often under-considered is
psychological harm, as even clinical trials in the field tend
not to report psychological harm (compared to physicaladverse effects of drugs in clinical trials) as can be noted
in research by [56, 57].
Principle 6, Informed consent

Informed consent is implemented overall, and as forprinciple 5, Egypt complies, like all comparatives to thisstandard practice. Even if a variety of informed consent
exists, the law sticks to written consent without specifying the potential for renewed consent, broad consent,
or other approaches [58] and the “blanket consent”
potential.

Respect for participants reflects respecting autonomy
across health care and research systems that appear to beconsistent across the 4 regulations. Egyptian law places
an equivalent emphasis on this principle as French law
and is comparable to Swedish and EU regulation. All
these regulatory frameworks effectively incorporate thisprinciple into their bioethical laws. Heightened attention
still needs to be paid to respect at different levels, such as
for gender issues [59], or/and ethnicity [60, 61].
Our study contains limitations. The first one is that we
looked for expressis verbis statements that limit theapprehension of the full corpus of laws application in a
specific context. Indeed, some implicit references could
counterbalance our conclusions. For instance, the CTR
underscores the overarching objective of promoting thesocial value by enhancing health, even if not explicitly
stated. Nevertheless, at the clinical level, practitioners
may not have comprehensive access to all regulations andare likely to rely on referenced texts in the ethical application specific to their country. The lack of clarity (orcomplex implicit references) may hinder comprehension
and result in a complex implementation process. Utilizing the principles proposed by Emanuel et al. may also
be presented as a limitation as this analytical foundation
may not comprehensively encapsulate the nuances inherent in the examined legal frameworks. Another limitation could be posited in the fact that the analysis may not
fully reflect the influence of cultural and social variations
among the three countries. Further research would needto also assess the overall structure of ethical procedurein each country and their organization (from Supreme
councils, regional entities, national unified procedures,
etc).

Conclusion
In conclusion, the Egyptian law in comparison to French,
Swedish, and the connected EU regulations reveals itsalignment with Emanuel et al.’s principles. However, several common challenges and areas of improvement canbe sought with regards to each of the ethical principles
and thus open the way for further research. The main
topic identified via our analysis is the need to clarify
and standardize the concept of social value of research,which often focuses on cost-effectiveness measurements
and implicitly -not always directly- refers to a very difficult concept to apply [62]. Our second main discussion
point highlights concern about the expertise and unbiased decision-making of ethical review boards. Further
research is warranted to explore in more detail’s otherMartin et al. BMC Medical Ethics(2024) 25:48

principles. Overall, these findings highlight the need forcontinuous improvement and refinement of ethical regulations to ensure the protection of participants and theintegrity of research in Egypt and other jurisdictions.
Based on the discussion, the following recommendations can be made for improving research ethics regulations in the countries in our analysis:
1. Clarify and Standardize Social Value: Develop clear
guidelines and standards to define and measure thesocial value of research across different states andcultures. This should include a detailed framework
for assessing research’s contribution to societal benefits, cost-effectiveness, and its alignment with thelong-term healthcare goals of the community.
2. Enhance Scientific Validity: Strengthen the criteria for the selection of Research Ethics Committee(REC) members to ensure they possess the necessary
expertise and education to review research protocols and scientific methods effectively. This includes
establishing more rigorous competency requirements
and providing ongoing training to ensure balanced
and non-biased decision-making in ethical approvals.
3. Improve Participant Protection: Emphasize the fair
selection of participants by addressing ethical challenges and ensuring equitable opportunities for participation. This involves revising existing regulations
to better protect the rights and welfare of vulnerable
subjects and to promote fairness in participant selection.
4. Increase REC Effectiveness: Address deficiencies
in REC theory and structure to enhance the effectiveness of research ethics committees. This could
involve adopting more collaborative approaches
between review boards and researchers, and ensuring that ethics committees have the authority, independence, competences and resources needed tooversee research effectively.
5. Promote Respect for Participants: Ensure that all
research activities respect the autonomy and dignityof participants. This entails paying heightened attention to issues of gender, ethnicity, and other factorsthat may affect participants’ experiences in researchsettings.
6. Further Research: Encourage further research into
the nuances of ethical principles beyond those identified by Emanuel et al., to better understand thecultural and social variations that may affect theimplementation of ethical guidelines in different
jurisdictions and cultural contexts.
Abbreviations
CS	Code de la santé / Health code

Page 12 of 14REC	Research Ethics Committee
CTR​	Clinical trial regulations
Art.	Article
Ch.	Chapter§	Paragraph
LMIC	Low to medium income countryEU	Europe
CNIL	Commission nationale de l’informatique et des libertés / national
commission for computer science and freedomsREC	French specific will stand for
CPP	Comité de Protection des personnes / person’s protection committee
IC	Informed consent

Supplementary Information
The online version contains supplementary material available at https://​doi.​
org/​10.​1186/​s12910-​024-​01040-0.
Additional file 1: Appendix 1. Comparative table with references to law
texts.
Acknowledgements
Sylvia Martin (SM) and Amal Matar (AM) conceived of the presented idea.
SM, AM and Mirko Ancillotti (MA) developed the theory and performed thecomputations. SM, AM, MA, and Santa Slokenberga (SS) verified the analyticalmethods and discussed the results. All authors provided critical feedback andhelped shape the research, final analysis and manuscript. None of the authors
have competing interest to declare.
Authors’ contributions
Sylvia Martin (SM) and Amal Matar (AM) conceived of the presented idea.
SM, AM and Mirko Ancillotti (MA) developed the theory and performed thecomputations. SM, AM, MA, and Santa Slokenberga (SS) verified the analyticalmethods and discussed the results. All authors provided critical feedback andhelped shape the research, final analysis and manuscript.
Funding
Open access funding provided by Uppsala University.
Availability of data and materials
All data generated or analyzed during this study are included in this publishedarticle [and its supplementary information files].

Declarations
Ethics approval and consent to participate
Not applicable.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Received: 15 November 2023 Accepted: 26 March 2024

References
1. Dooly M, Moore E, Vallejo C. Research ethics. Research-publishing net.
2017.
2. Miracle VA. The Belmont Report: the triple crown of research ethics.
Dimens Crit Care Nurs. 2016;35(4):223–8.
3. Halonen JI, Erhola M, Furman E, Haahtela T, Jousilahti P, Barouki R, et al.
The helsinki declaration 2020: Europe that protects. Lancet Planetary
Health. 2020;4(11):e503–5.

Martin et al. BMC Medical Ethics

4.
5.
6.
7.

8.
9.
10.
11.
12.
13.

14.
15.
16.
17.
18.
19.

20.
21.
22.
23.

24.
25.
26.
27.
28.
29.
30.

(2024) 25:48

Johansen MV, Aagaard-Hansen J, Riis P. Benefit–a neglected aspect ofhealth research ethics. Dan Med Bull. 2008;55(4):216–8.
Artal R, Rubenfeld S. Ethical issues in research. Best Pract Re Clin Obstet
Gynaecol. 2017;43:107–14.
Paul H. The scientific self: reclaiming its place in the history of research
ethics. Sci Eng Ethics. 2018;24(5):1379–92.
Thaldar D, Shozi B, Kamwendo T. Culture and context: Why the global
discourse on heritable genome editing should be broadened fromthe South African perspective. BioLaw Journal-Rivista Di BioDiritto.
2021;4:409–16.
World Medical Association Declaration of Helsinki: ethical principles for
medical research involving human subjects. Jama. 2013;310(20):2191-4.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?
Jama. 2000;283(20):2701–11.
Emanuel EJ, Wendler D, Grady C. An ethical framework for biomedical
research. The Oxford textbook of clinical research ethics. 2008. p. 123–35.
Rid A, Emanuel EJ. Ethical considerations of experimental interventions in
the Ebola outbreak. Lancet. 2014;384(9957):1896–9.
Tsoka-Gwegweni JM, Wassenaar DR, Using the Emanuel, et al. framework
to assess ethical issues raised by a biomedical research ethics committee
in South Africa. J Empir Res Hum Res Ethics. 2014;9(5):36–45.
Mutenherwa F, Wassenaar DR, de Oliveira T. Ethical issues associatedwith HIV phylogenetics in HIV transmission dynamics research: a reviewof the literature using the Emanuel Framework. Dev World Bioeth.
2019;19(1):25–35.
Mantzaris E. Regulatory frameworks as a tool for ethical governance:
drawing comparisons amongst the BRICS (Brazil, Russia, India, China andSouth Africa) countries. Afr J Public Affairs. 2017;9(8):91–104.
Sim JH, Ngan OMY, Ng HK. Bioethics education in the medical programme among Malaysian medical schools: where are we now? J Med
Educ Curric Dev. 2019;6:2382120519883887.
de Lemos Tavares ACAL, Travassos AGA, Rego F, Nunes R. Bioethics curriculum in medical schools in Portuguese-speaking countries. BMC Med
Educ. 2022;22(1):199.
Mukhamedzhanovna MZ, Akmalovna U, Nugmanovna M. The Uzbek
Model of Bioethics: History and Modernity. Malim: jurnal pengajian
umum asia tenggara (SEA Journal of General Studies). 2020;21.
Bank W. 2023a [Available from: https://​datah​elpde​sk.​world​bank.​org/​knowl​edgeb​ase/​artic​les/​906519.
Marzouk D, Sharawy I, Nakhla I, El Hodhod M, Gadallah H, El-Shalakany
A, et al. Challenges during review of COVID-19 research proposals:
experience of faculty of medicine, Ain Shams university research ethics
committee, Egypt. Front Med. 2021;8:715796.
State USDo. 2022 [Available from: https://​www.​state.​gov/​repor​ts/​2022-​
count​ry-​repor​ts-​on-​human-​rights-​pract​ices/.
Migiro. [Available from: https://​www.​world​atlas.​com/​artic​les/​when-​did-​egypt-​gain-​itsin​depen​dence.​html.
H S. United Nations Human Rights Council and Israel: Comparative Analysis with Egypt, Jordan, and Saudi Arabia (Doctoral dissertation, University
Honors College Middle Tennessee State University). 2021.
EL-Khadry SW, Abdallah AR, Yousef MF, M. abdeldayem H, Ezzat S,
Dorgham LS. Effect of educational intervention on knowledge and attitude towards research, research ethics, and biobanks among paramedical
and administrative teams in the National Liver Institute, Egypt. Egyptian
Liver Journal. 2020;10:1-8.
Normile D. The promise and pitfalls of clinical trials overseas. Science.
2008;322(5899):214–6.
SJR [Available from: https://​www.​scima​gojr.​com/​count​ryrank.​php.
Bank W. 2023b [Available from: https://​data.​world​bank.​org/​indic​ator/​SP.​
POP.​SCIE.​RD.​P6?​end=​2017&​locat​ions=​EG&​start=​2007.
Chaaban Y. Comparative law as a critical tool for legal research in Arabcountries: a comparative study on contractual balance. Akkad J Law
Public Policy. 2021;1(3):123–34.
Bank W. 2023c [Available from: https://​data.​world​bank.​org/​indic​ator/​GB.​
XPD.​RSDV.​GD.​ZS?​locat​ions=​SE&​most_​recent_​value_​desc=​true.
Guraya SY, London N, Guraya SS. Ethics in medical research. J Microscopy
Ultrastructure. 2014;2(3):121–6.
Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should
donors be allowed to give broad consent to future biobank research?
Lancet Oncol. 2006;7(3):266–9.

Page 13 of 14

31. Norberg Wieslander K, Höglund AT, Frygner-Holm S, Godskesen T.
Research ethics committee members’ perspectives on paediatricresearch: a qualitative interview study. Res Ethics. 2023;19(4):494–518.
32. Gallagher B, Berman AH, Bieganski J, Jones AD, Foca L, Raikes B, et al.
National human research ethics: a preliminary comparative case studyof Germany, Great Britain, Romania, and Sweden. Ethics Behavior.
2016;26(7):586–606.
33. Harcourt D, Quennerstedt A. Ethical guardrails when children participate in research: risk and practice in Sweden and Australia. Sage Open.
2014;4(3):2158244014543782.
34. Bank W. 2023d [Available from: https://​data.​world​bank.​org/​indic​ator/​
SP.​POP.​SCIE.​RD.​P6?​end=​2017&​locat​ions=​EG&​start=​2007.
35. Scimago Journal and Country Rank [Available from: https://​www.​scima​
gojr.​com/​count​r yrank.​php.
36. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277-88.
37. Tuan MT. Measuring and/or estimating social value creation: Insights
into eight integrated cost approaches: Bill & Melinda Gates Foundation
Seattle, WA; 2008.
38. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical researchin developing countries ethical? The benchmarks of ethical research. J
Infect Dis. 2004;189(5):930–7. https://​doi.​org/​10.​1086/​381709.
39. Juth N. For the sake of justice: should we prioritize rare diseases?
Health Care Analysis. 2017;25:1–20.
40. Juth N, Henriksson M, Gustavsson E, Sandman L. Should we accept ahigher cost per health improvement for orphan drugs? A review andanalysis of egalitarian arguments. Bioethics. 2021;35(4):307–14.
41. Haaser T, Bouteloup V, Berdaï D, Saux M-C. The multidimensional natureof research ethics: letters issued by a French research ethics committee
included similar proportions of ethical and scientific queries. J Empirical Res Hum Res Ethics. 2022;17(3):242–53.
42. Groot BC, Vink M, Haveman A, Huberts M, Schout G, Abma TA. Ethics ofcare in participatory health research: mutual responsibility in collaboration with co-researchers. Educ Action Res. 2019;27(2):286–302.
43. Bomhof-Roordink H, Gärtner FR, Stiggelbout AM, Pieterse AH. Key
components of shared decision making models: a systematic review.
BMJ Open. 2019;9(12):e031763.
44. Malterud K, Elvbakken KT. Patients participating as co-researchers inhealth research: a systematic review of outcomes and experiences.
Scandinavian J Public Health. 2020;48(6):617–28.
45. Patino CM, Ferreira JC. Internal and external validity: can you apply
research study results to your patients? Jornal brasileiro de pneumologia. 2018;44:183.
46. Larsen KR, Lukyanenko R, Mueller RM, Storey VC, VanderMeer D, Parsons J, et al., editors. Validity in design science research. Designing for
Digital Transformation Co-Creating Services with Citizens and Industry:
15th International Conference on Design Science Research in Information Systems and Technology, DESRIST 2020, Kristiansand, Norway,
December 2–4, 2020, Proceedings 15; 2020: Springer.
47. Wages NA, Horton BJ, Conaway MR, Petroni GR. Operating characteristics are needed to properly evaluate the scientific validity of phase I
protocols. Contemp Clin Trials. 2021;108:106517.
48. Arora NK, McHorney CA. Patient preferences for medical decision making: who really wants to participate? Medical Care. 2000:335-41.
49. Lindsay SE, Alokozai A, Eppler SL, Fox P, Curtin C, Gardner M, et al.
Patient preferences for shared decision making: not all decisions
should be shared. J Am Acad Orthopaedic Surgeons. 2020;28(10):419.
50. Whitney SN. Institutional review boards: a flawed system of risk management. Res Ethics. 2016;12(4):182–200.
51. Hickey A, Davis S, Farmer W, Dawidowicz J, Moloney C, Lamont-Mills A,
et al. Beyond criticism of ethics review boards: strategies for engaging
research communities and enhancing ethical review processes. J Acad
Ethics. 2021:1-19.
52. Silverman H, Edwards H, Shamoo A, Matar A. Enhancing research
ethics capacity in the Middle East: experience and challenges of a
Fogarty-sponsored training program. J Empir Res Hum Res Ethics.
2013;8(5):40–51.
53. MacKay D, Saylor KW. Four faces of fair subject selection. Am J Bioeth.
2020;20(2):5–19.
54. Pace C, Miller FG, Danis M. Enrolling the uninsured in clinical trials: an
ethical perspective. Crit Care Med. 2003;31(3):S121–5.

Martin et al. BMC Medical Ethics(2024) 25:48

55. Association WM. World Medical Association Declaration of Helsinki:
ethical principles for medical research involving human subjects. Jama.
2013;310(20):2191–4.
56. Duggan C, Parry G, McMurran M, Davidson K, Dennis J. The recording of adverse events from psychological treatments in clinical trials:
evidence from a review of NIHR-funded trials. Trials. 2014;15(1):1–9.
57. Jonsson U, Alaie I, Parling T, Arnberg FK. Reporting of harms in randomized controlled trials of psychological interventions for mental andbehavioral disorders: a review of current practice. Contemp Clin Trials.
2014;38(1):1–8.
58. Hansson SO, Björkman B. Bioethics in Sweden. Cambridge Quarterly of
Healthcare Ethics. 2006;15(3):285–93.
59. Cameron JJ, Stinson DA. Gender (mis) measurement: Guidelines forrespecting gender diversity in psychological research. Soc Personal
Psychol Compass. 2019;13(11):e12506.
60. Braddock CH III. Racism and bioethics: the myth of color blindness. Am J
Bioeth. 2021;21(2):28–32.
61. Truong M, Sharif MZ. We’re in this together: a reflection on how bioethics
and public health can collectively advance scientific efforts towards
addressing racism. J Bioeth Inq. 2021;18(1):113–6.
62. Habets MG, van Delden JJ, Bredenoord AL. The social value of clinicalresearch. BMC Med Ethics. 2014;15(1):1–7.

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