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Adel F Almutairi,1 Ala’a BaniMustafa,1 Yousef M Alessa,1 Ghiath Alahmad2 1Science and Technology Unit, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; 2Biomedical Ethics, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaCorrespondence: Adel F AlmutairiScience and Technology Unit, King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaEmail almutairiad1@ngha.med.saBackground: The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. This pandemic is much more than a health crisis; it has also raised many ethical challenges. The large number of infected patients amid scarce resources has placed healthcare professionals in a critical situation in which they have to make difficult decisions about how to prioritize their patients. Therefore, the aim of this study is to explore the ethical challenges experienced and perceived by healthcare professionals working in healthcare institutions and research centers in Saudi Arabia.Methods: Semi-structured face-to-face interviews were conducted individually with frontline healthcare providers (physicians and nurses), researchers, and decision-makers involved in the management of COVID-19 cases. Each interview lasted up to 90 minutes. The thematic analysis technique was used to analyse the interview data.Findings: The participants’ rich experiences, which revealed a number of ethical challenges concerning the provision of medical care to infected patients, were framed around four main themes: treatment challenges related to COVID-19 patients, uncertainty of the medical outcome, medical care discrimination, and decision to discontinue medical treatment.Conclusion: The COVID-19 pandemic has posed huge ethical challenges for healthcare professionals that might lead to psychological issues given the emotional toll related to making life-and-death decisions.Recommendation: In a situation where no reliable and certain treatment is known or well tested, establishing centralized and responsive ethical committees could help reassure and guide practitioners and address their concerns.Keywords: coronavirus, COVID-19, ethics, medical discrimination, end of life, patients’ rights

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Abstract Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines.

There are a lot of efforts to promote ethics education and training at an undergraduate and postgraduate level around the world, including in Saudi Arabia. However, there is still a lack of structured ethics education curricula in obstetrics and gynecology residency programs in Saudi Arabia. In the current scenario, where new ethical dilemmas are emerging, an ethics education that only focuses on teaching the ethical principles does not enhance the competence to deal with the ethical challenges in daily practice. This study evaluates the lack of ethics education and training in obstetrics and gynecology residency programs in Saudi Arabia. A cross-sectional survey of working obstetricians and gynecologists in Saudi Arabia was conducted among all working levels of doctors (the residents, registrars, consultants, and program directors) from various hospitals of Saudi Arabia. 391 practitioners responded to the survey, representing a response rate of 39.1%, including 257 (66.4%) females and 130 (33.6%) males. 74 (23.0%) received formal education (medical school = 35%; residency programs = 11.8%; sub-specialty programs = 4.3%; postgraduate programs = 7.4%), 85 (26.4%) received informal education (online training = 12.8%; conferences = 18.9%; courses and workshops = 13.3%; self-learning = 31.7% and daily practices = 20.7%), and 78 (19.95%) received no ethics education. Almost all the respondents had a positive attitude towards ethical principles, but a least percent were competent to deal with the ethical challenges. The bottom line of this survey is the imperativeness of reinforcement of formal ethics education in obstetrics and gynecology postgraduate programs in Saudi Arabia., (© 2023. The Author(s).)

Background: Ethics is an essential component of human research, and knowledge and awareness of ethical guidelines are required to conduct research involving human subjects and ensure the participants' safety., Objectives: To investigate medical professionals' and researchers' knowledge of national and international research ethics guidelines, key principles in human research projects, ethical issues in different types of research, the importance of informed consent, and institutional review boards., Materials and Methods: A cross-sectional study with 251 participants, including physicians, nurses, and researchers from three different research centers and hospitals in Riyadh city, was carried out using an electronic self-structured questionnaire. The sample size was estimated using OpenEpi, Version 3. The questionnaire contained six different sets of questions to analyze knowledge about research ethics and guidelines. The results were analyzed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA)., Results: About 53.78% of the participants had received research ethics education, out of which 78.51% of the participants expressed the need for more training in research ethics education. The Belmont Report showed a high level of unawareness among nurses (88.3%), physicians (73.8%), and researchers (55.32%). Nurses had a high level of positive attitude about all the key principles of human research. The highest level of awareness of ethical issues in clinical trials and interventional studies was found among researchers (54%), and the lowest level of awareness was exhibited by nurses (19.32%). Nurses (74.34%) and physicians (62.79%) had the lowest positive attitudes about obtaining children's assent in pediatric research. Physicians and researchers had a higher awareness of the IRB than nurses., Conclusion: Researchers were well-versed in research ethics, regulatory guidelines, and ethical issues in various types of research, whereas nurses were enthusiastic about key principles in human research and the importance of informed consent. This study shows that a very low percentage of nurses have received research ethics education and emphasizes the critical importance of including research ethics education in nursing curricula, as the involvement of nurses in research is inevitable. This study also shows the lack of knowledge among nurses, researchers, and doctors about various international guidelines. It emphasizes the importance of adding regulatory guidelines to the curriculum and teaching them effectively to students. Also, periodic workshops should be conducted to enhance the practical knowledge of the professionals regarding the guidelines and guide them in overcoming the practical difficulties they encounter during their practice.

Ethics is an important aspect of medical care. The purpose of this study was to investigate the attitudes of obstetricians and gynecologists towards various ethical issues and ethical principles, and their satisfaction with their knowledge, understanding, and problem-solving skills regarding ethical issues. Methods: A cross-sectional survey was conducted among the working OB/GYNs in Saudi Arabia from various hospitals in Saudi Arabia between May 2020 and August 2020. A link to the three-point Likert scale questionnaire was mailed to 1000 OB/GYNs working in various hospitals. The data were analyzed using inferential statistics. The quantitative data were expressed as absolute numbers and percentages. Results: A total of 391 out of 1000 OB/GYNs responded. Most of the respondents were female OB/GYNs (65%), most of them were working in tertiary government hospitals (63%), and most were educated in bioethics (62%). About 80.3% of the respondents considered ethics important, and there was a low satisfaction rate with their knowledge (26%), understanding (38.6%), and problem-solving skills (35.8%) related to ethical issues. Conclusions: The obstetricians and gynecologists considered ethics an important aspect of daily practice but lacked the skills and knowledge to deal with ethical issues. The level of satisfaction with practice ethics was very low. Despite the fact that most of them had undergone bioethics education, most of them expressed the need for ethics training. Theoretical ethics education seemingly did not increase competence in resolving ethical issues, whereas experience did. The workplace had a strong correlation with the employee's attitude toward ethical issues, principles, and satisfaction with their knowledge and skills in resolving ethical issues. The ethics curriculum needs to be structured in a more effective way to improve competence in dealing with ethical challenges in daily practice.

The ethical challenges of pediatric cancer care across Arab countries are not well addressed, despite medical advancements and increased awareness of children's rights. The ethical challenges related to pediatric cancer in Saudi Arabia were investigated by surveying 400 respondents at King Abdulaziz Medical City in Riyadh, Jeddah, and Dammam, Saudi Arabia, from four groups: pediatricians, medical students, nurses, and parents of children with cancer. Respondents' characteristics were surveyed across three outcomes: awareness of care, knowledge, and parent consent/child assent, developed from a systematic review and a qualitative analysis. A majority of respondents (89.0%) considered pediatric cancer different from adult cancer. Families considered alternative treatment, according to 64.3% of respondents, while 88.0% emphasized understanding the family's needs and values. Furthermore, 95.8% of respondents believed physicians should offer time for pedagogy, 92.3% viewed parental consent as essential, and 94.5% thought that sufficient discussion about the plan and type of treatment should precede consent. However, child assent showed lower levels of agreement, with only 41.3% and 52.5% agreeing with getting child assent and having a discussion. Finally, 56% agreed that parents might refuse suggested treatment, while only 24.3% agreed that the child could refuse it. In all these ethical considerations, nurses and physicians showed significantly more positive results compared with other groups.

The new COVID-19 pandemic has affected day-to-day life, creating various ethical dilemmas. COVID-19 vaccination is seen as an effective way to halt the pandemic. Ethical challenges can arise when the vaccines are mandated for all ages, but more so when mandated for children. This systematic review discusses the pros and cons of the COVID-19 vaccine mandate for children. The primary objective of this study is to summarize exclusively the various ethical conflicts, impacts, and requirements that arise as a result of the COVID-19 vaccine mandate laws on children. The secondary objective is to analyze the reasons for parents refusing to allow their children to be given the COVID-19 vaccine sand the effective strategies to increase vaccine uptake among children. The study involved a systematic review, identification of relevant literature and reviews following the PRISMA-ScR recommendations. The keywords 'COVID-19 vaccine mandates on children' were used to mine the literature from PubMed and WHO COVID-19 Research Database. Limitations placed on the original searches were: English language, humans, ethics, and children. Out of 529 studies, only 13 satisfied the selection criteria. The sample included studies with a wide, diverse range of methods, settings, research, authors, and journals. COVID-19 vaccine mandates on children need to be scrutinized. Implementing the COVID-19 vaccination drive in a scientific way is acceptable. As children are the fastest-growing population and have the highest life expectancy, it is important to take into account that the vaccines do not disturb their growth and development.

Pediatric cancer is accompanied by many ethical challenges, particularly those related to respecting the child's opinion and parental responsibility and consent. Questionnaires were collected from 400 participants, from four equal groups: doctors, nurses, parents and medical students, from three cities in Saudi Arabia, about three problematic issues which revolve around the mandatory consent of one or both parents, the extent of a child's assent, and the acceptable form of consent and assent. Despite the diversity of the participants' cultural backgrounds, most preferred both parents to give consent, followed by either parent without differentiation between parents, which reinforced a trend towards more gender equality. The majority of participants preferred that parental consent forms be detailed enough to obtain the maximum information, while others chose medium-size consent forms; a large majority preferred that the form seeking to obtain the assent of the child with cancer be short, reflecting their desire not to increase the burden on the child, in addition to the fact that the final decision belongs to the parents rather than the child. Most participants preferred to rely on a child's level of maturity rather than having reached a certain age so that they could give assent, while the rest considered the age of 13-14 as a suitable age. These findings reflect an increasing ethical awareness regarding parental consent and child assent, and they can be formulated in a recommendation for a more ethical practice in the field of childhood cancer and pediatrics in general., (© 2021 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

The new and dangerous coronavirus disease (COVID-19) has posed a serious challenge to the ability of healthcare systems of many countries to contain the spread of the disease and to mitigate its various consequences. The disease posed many ethical challenges both in itself and in the methods used in its management. Although the ethical principles that healthcare operates under are universal, a thorough understanding of the ethical difficulties it poses necessitates consideration of contextual, societal, and cultural factors. This study provides an in-depth exploration of the ethical challenges related to the COVID-19 pandemic outbreak in relation to healthcare providers, medical researchers, and decision-makers in Saudi Arabia. Four themes were extracted from participants' responses, namely, ethical challenges about disease-control measures, challenges to actions in certain groups, challenges regarding software programs, and finally ethics in research practices. Each theme likewise contained sub-themes. The themes and sub-themes were discussed in light of the ethical principles: autonomy, beneficence, non-beneficence, and justice, as well as other principles, such as protecting confidentiality, privacy, and preventing stigma and discrimination., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Alahmad, Richi, BaniMustafa and Almutairi.)

Scientific medical research involving human samples often leads to improved diagnosis, the discovery of treatment modalities, or the identification of possible risk factors for many diseases. Some findings, including incidental findings, may be important to donors, and some may require intervention. This study aimed to explore the perspectives of health care professionals in their use of stored biological samples for biomedical research regarding the concept of the research results and the challenges of informing donors regarding the results. This qualitative study involved 19 medical researchers doing research with stored biological samples and biobanks. The data were gathered during face-to-face interviews in English using a semistructured interview technique. The participants provided rich and illuminating experiences, framed in the following themes: the professional duty of researchers to return the research results and the right of donors to know; factors affecting informing donors of results (e.g., severity of disease; impact of the provided information; reliability of the research results; and donor approval); challenges to physically returning the results; and the nature of the informed consent, as well as the elements required in the informed consent documentation. Although the majority of researchers agree on the importance of returning research results, some have contradictory views such as that returning research results is not the researcher's responsibility. The study results also support the view that a number of elements should be included in the informed consent, such as the intention of informing the donors of the results as well as the benefits and risks.

Background: With the huge number of patients who suffer from chronic and incurable diseases, medical scientists continue to search for new curative methods for patients in dire need of treatment. Interest in stem cells is growing, generating high expectations in terms of the possible benefits that could be derived from stem cell research and therapy. However, regardless of the hope of stem cells changing and improving lives, there are many ethical, religious, and political challenges and controversies that affect the research, and mandated to establish ethical guidelines and regulations. In Saudi Arabia, key stakeholders play an active role in discussing the ethics of stem cell research and therapy. The focus of the study was to explore professionals' perceptions related to the ethical challenges of using stem cells in research and treatment in Saudi Arabia., Results: A qualitative research study was conducted to explore and describe the perceptions of 25 professionals employed at different tertiary hospitals in the various regions of Saudi. A thematic analysis was performed to search for and identify the most significant perceptions shared by the participants. Four themes were generated based on the ethical challenges of four areas related to stem cell use, including (1) forbidden and permitted sources of stem cells, (2) informed consent, (3) beneficence, and (4) ethical regulations and guidelines., Conclusion: The study identified that there is a growing need to advance the knowledge, education, and awareness related to stem cell research and treatment in Saudi Arabia.

Despite rapid and successful development in pediatric cancer treatment, many ethical challenges remain. These challenges have been, and continue to be, the subject of much research, but few qualitative studies have explored the views of nurses, especially in the Middle East. This study, therefore, seeks to fill a knowledge gap in this area and to better understand the concerns of nurses-particularly those in Saudi Arabia and the Middle East. Face-to-face, in-depth interviews were conducted with 17 male and female nurses working in pediatric units at 2 hospitals in Saudi Arabia to explore their views on the ethical challenges in caring for children with cancer. All interviews were recorded and transcribed, then line-by-line encoded, merged, and categorized into themes. Our results show that pediatric cancer is perceived as being "different" from other diseases, and from cancer in adults. Nurses are an integral part of the medical care team and are aware of the importance of their role, as well as the special relationships that they develop with the children. Consent is mandatory and necessary and can be signed by any parent. Assent is important when children become able to give it. Pediatric cancer is seen as a different disease by nurses for various reasons. Their roles and relationships with children and families pose many challenges. Though parental consent and child assent are essential, nurses' collaboration is important for shared decision-making. Our study paves the way for broader studies to understand the concerns of nurses and other health-care providers about treating children with pediatric cancer.

Research biobanks can offer great benefits for science and healthcare. However, many ethical challenges arise from their use. These challenges have different perspectives in Muslim countries when research biobanks are created. We propose principles for good practice related to the research biobanks in Islamic countries, focusing on issues related to confidentiality, informed consent, children's participation, and others. These issues were explored according to Islamic fatwas and Usul Al Fiqh, and we provide principles for good practice for policy makers involved in the creation of research biobanks, researchers, and anyone who has to deal with stored tissue specimens taken from Muslims. The actual implementation of the principles will vary according to different jurisdictions.

Objective: Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic., Methods: A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis., Results: At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship., Conclusion: Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary consent. Researchers are encouraged to adopt a stepwise approach during the informed consent process.

The Kingdom of Saudi Arabia passed a Law and Implementing Regulations of Ethics of Research on Living Creatures in 14/09/1431 Hijri (24/08/2010). We have performed an ethical analysis of this law and, accordingly, this paper discusses the major components, key strengths, and weaknesses of this law. The Saudi system considers Islamic Shariah in addition to international research ethics guidelines. The Law and its Implementing Regulations contain all ethical requirements for research. We conclude that this law can serve as an example, not only for other Arab countries in the region that have similar values and social structure to the Kingdom of Saudi Arabia, but also for other Islamic countries., (© 2016 John Wiley & Sons Ltd.)

Background and Aims: There are many research biobanks in the world, including a small number in the Middle East. The Saudi biobank, one of the newly established biobanks, has just started to collect data and samples in 2016., Methods: A survey was conducted to assess the opinions of stakeholders regarding the return of individual research results. A total of 180 adults from three different groups (researchers, physicians, and laypeople) participated in this cross-sectional study., Results: There was strong agreement among all respondents that the biobank has the duty and donors have the right to be provided with important results that may have direct or indirect benefits. Moreover, there was strong support for the view that donors have the right to refuse to receive any research results., Conclusions: These results are compatible with many other studies and are in line with the governance of the Saudi biobank.

Purpose: The aim of this study was to investigate the ethical issues involved in children's participation in research biobanks in Saudi Arabia and the Middle East., Methods: A survey of 160 respondents from four groups (researchers, physicians, medical students, and laypersons) was conducted at King Abdulaziz Medical City in Riyadh, Saudi Arabia., Results: A clear and positive attitude toward pediatric clinical and genetic research inside and outside of Saudi Arabia was found. Parental consent is viewed as essential, with 60% saying parental consent is sufficient for children up to 12, and 40% saying it is sufficient for children 12-18 years old. More than 90% of respondents preferred to gain approval from any child with a decision-making capability; 58.2 and 38.6% of them believed that children between 12 and 18, and >18 years of age, respectively, can understand and thus give their approval for genetic research. Clear majorities in the study agreed with re-consenting children when they become adults, allowing them to withdraw at any time. A clear majority agreed that either parent could sign a consent form for their child to participate in a research biobank., Conclusion: All four groups believed, to varying degrees, that elements of ethical consideration were critical when involving children in research.Genet Med 18 8, 806-813.

Achieving a balance between giving access to information and respecting donors' confidentiality is a crucial issue for any biobank, with its large number of samples and associated information. Despite the existence of much empirical literature on confidentiality, there are too few surveys in the Middle East about the topic, particularly in the Saudi context. A survey was conducted of 200 respondents at King Abdulaziz Medical City in Riyadh, Saudi Arabia, among 5 groups of equal size, comprised of researchers, physicians, medical students, donors and laypersons, respectively. The majority of participants agreed that confidentiality is an important issue and that it is well protected in the Saudi biobank. All 5 groups showed different attitudes toward disclosing information to various third parties. They were in favor of allowing treating physicians, and to a certain extent family members, to have access to medical and genetic results from research. No significant differences were found between views on medical and genetic confidentiality. The majority of respondents agreed that confidentiality might be breached in cases with specific justified reasons. Even considering differences in religion, culture and other factors, the results of the study were consistent with those reported in the literature and research conducted in other countries. We therefore place emphasis on the importance of protecting and promoting patient/donor confidentiality and privacy., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam is the dominant religion in these countries, and it affects people's behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants' primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children's bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies.

Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.(1) Doctor-patient and researcher-participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.(2) However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.(3) Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research confidentiality have not been explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research. Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality. In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations. We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified., (© 2012 Blackwell Publishing Ltd.)

The notion of bodily integrity forms an important part of the value-structure of many religions and cultures. In this paper, we explore the notion of bodily integrity in Islam using male circumcision as the focus of the discussion. Our aim is to contribute to a better understanding of the Muslim perspective and of the differences and similarities between Western and Islamic ethical structures, in particular, regarding the concept of bodily integrity.