A comparative ethical analysis of the Egyptian clinical research law.

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 selection of 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 selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than 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 critical need 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.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

BACKGROUND: Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations. METHODS: Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes. RESULTS: Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications. CONCLUSIONS: Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

A proposal for an international Code of Conduct for data sharing in genomics.

As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard to data sharing. One such way is an international code of conduct. In September 2020, an expert panel consisting of representatives from various fields convened to discuss a draft proposal formed via a synthesis of existing professional codes and other recommendations. This article presents an overview and analysis of the main issues related to international genomic research that were discussed by the expert panel, and the results of the discussion and follow up responses by the experts. As a result, the article presents as an annex a proposal for an international code of conduct for data sharing in genomics that is meant to establish best practices.

Autonomous decisions by couples in reproductive care.

BACKGROUND: Preconception Expanded Carrier Screening (ECS) is a genetic test offered to a general population or to couples who have no known risk of recessive and X-linked genetic diseases and are interested in becoming parents. A test may screen for carrier status of several autosomal recessive diseases at one go. Such a program has been piloted in the Netherlands and may become a reality in more European countries in the future. The ethical rationale for such tests is that they enhance reproductive autonomy. The dominant conception of autonomy is individual-based. However, at the clinic, people deciding on preconception ECS will be counselled together and are expected to make a joint decision, as a couple. The aim of the present study was to develop an understanding of autonomous decisions made by couples in the context of reproductive technologies in general and of preconception ECS in particular. Further, to shed light on what occurs in reproductive clinics and suggest concrete implications for healthcare professionals. MAIN TEXT: Based on the shift in emphasis from individual autonomy to relational autonomy, a notion of couple autonomy was suggested and some features of this concept were outlined. First, that both partners are individually autonomous and that the decision is reached through a communicative process. In this process each partner should feel free to express his or her concerns and preferences, so no one partner dominates the discussion. Further, there should be adequate time for the couple to negotiate possible differences and conclude that the decision is right for them. The final decision should be reached through consensus of both partners without coercion, manipulation or miscommunication. Through concrete examples, the suggested notion of couple autonomy was applied to diverse clinical situations. CONCLUSIONS: A notion of couple autonomy can be fruitful for healthcare professionals by structuring their attention to and support of a couple who is required to make an autonomous joint decision concerning preconception ECS. A normative implication for healthcare staff is to allow the necessary time for decision-making and to promote a dialogue that can increase the power of the weaker part in a relationship.

Values and value conflicts in implementation and use of preconception expanded carrier screening - an expert interview study.

BACKGROUND: Endeavors have been made to found and incorporate ethical values in most aspects of healthcare, including health technology assessment. Health technologies and their assessment are value-laden and could trigger problems with dissemination if they contradict societal norms. Per WHO definition, preconception expanded carrier screening is a new health technology that warrants assessment. It is a genetic test offered to couples who have no known risk of recessive genetic diseases and are interested pregnancy. A test may screen for carrier status of several autosomal recessive diseases and X-linked at one go. The technique has been piloted in the Netherlands and is discussed in other countries. The aim of the study was to examine values and value conflicts that healthcare experts recounted in relation to the discussion of implementation and use of preconception ECS in Sweden. METHODS: We interviewed ten experts, who were associated with influencing health policymaking in Sweden. We employed systematizing expert interviews, which endeavor to access experts' specialist knowledge. There were four female and six male informants, of which four were physicians, three bioethicists, one a legal expert, one a theologian and one a political party representative in the parliament. The participants functioned as members of two non-governmental bodies and three governmental organizations. We employed thematic analysis to identify themes, categories and subcategories. RESULTS: Two main themes surfaced: values and value conflicts. The main categories of Respect for persons, Solidarity, Human dignity, Do no harm, Health and Love formed the first theme, while values conflicting with autonomy and integrity respectively, constituted the second theme. Concepts relating to respect for persons were the most commonly mentioned among the participants, followed by notions alluding to solidarity. Furthermore, respondents discussed values conflicting with Swedish healthcare ones such as equality and solidarity. CONCLUSIONS: The experts highlighted values and concepts that are distinctive of welfare states such as Sweden and delineated how preconception ECS could challenge such values. Moreover, the analysis revealed that certain values were deemed more substantive than others, judging by the extent and detail of inference; for example, respect for persons and solidarity were on top of the list.

Frequency of pediatric migraine with aura in a clinic-based sample.

OBJECTIVE: To assess the prevalence and risk factors for pediatric migraine with aura (MWA) among patients presenting to pediatric neurology clinics. BACKGROUND: Headache is a common complaint among children, and the prevalence of migraine is about 8%. Up to one third of adults with migraine report experiencing aura; however, the exact percentage in children is unknown. METHODS: Medical records of children presenting with headache to three pediatric neurology clinics in Haifa in the last 5 years were retrospectively reviewed. Inclusion criteria were a diagnosis of migraine headache at 5-18 years of age. RESULTS: Of 260 children (140 female) who had migraine, 26.2% experienced aura. MWA was more common among females compared to males (32.6% vs 18.9%, P < .01) and among older children (OR: 2.50, 95% CI: 1.20-5.20; P < .01). Among those who experienced aura, visual aura was more common in females than males (66.7% vs 33.3%, P < .04). Family history of migraine was strongly related to MWA (P < .02): the odds of MWA were 2.46 times greater in children who had a family history of migraine. (OR: 2.46, 95% CI: 1.08-5.62; P < .03). CONCLUSIONS: MWA is as common in children as in adults. Aura is more common in older children. Children who have MWA are more likely to have a family history of migraine.

Pediatric mixed headache -The relationship between migraine, tension-type headache and learning disabilities - in a clinic-based sample.

BACKGROUND: Headache is a common complaint among children. The most common primary headache syndromes in childhood are migraine and TTH. However many times they seem to overlap. The purpose of our study was to assess the relationship between pediatric migraine, tension-type headache (TTH) and learning disabilities. METHODS: Children presenting with headache to three pediatric neurology clinics in the last 5 years were assessed. Two hundred sixty-two children, 5-18 years of age, who met the criteria for migraine were included. RESULTS: Of 262 children (54 % female) who had migraine, 26.2 % had migraine with aura. 59 children (22.5 % of the full sample) reported also having headaches that met the criteria for episodic TTH/mixed headaches. Females were more than 2.8 times more likely to experience mixed headaches than males (OR: 2.81, 95 % CI: 1.43-5.54; p <.003). Multiple logistic regression analysis revealed that older age (p <0.02), family history of aura (p <.02), and (lack of) TTH (p <.003) were significant predictors of aura, whereas gender was not significant (p >0.20). Children who had migraine with aura were less likely to have mixed headaches than children who did not have aura (OR: 0.26, 95 % CI: 0.11-0.63; p <.003). Children with mixed headaches were 2.7 times more likely to have a learning disability than children with migraine alone. CONCLUSIONS: Episodic TTH and migraine without aura (mixed headaches) in children might be part of a continuum, which can explain the high incidence of their co-occurrence as opposed to migraine with aura. Children with mixed headaches have a higher incidence of learning disability compare to those with migraine alone.

[PRIMARY HEADACHE IN CHILDREN AND ADOLESCENTS--DIAGNOSIS AND TREATMENT].

BACKGROUND: Primary headaches are one of the most common disorders of childhood, with migraine and tension type headaches (TTHs) being the most frequent ones. In spite of their prevalence, there is paucity of knowledge regarding the underlying pathophysiological mechanisms that cause headaches and regarding the unique aspects of headaches in children and adolescents. AIM: To review the literature and summarize the knowledge regarding clinical features, diagnosis and management of primary headache in children and adolescents, mainly migraine and TTH. RESULTS AND CONCLUSIONS: Most of our current knowledge regarding primary headaches in children and adolescents is driven from extrapolations from studies that were conducted with adult patients. Therefore, it needs to be validated for the different age groups. Migraines may be diagnosed effectively based on the 2nd edition of the International Classification of Headache Disorders (ICHD-II), however, TTH is diagnosed mainly by the absence of features found in other headache types. Treatment strategies for primary headaches vary according to patient's age, family structure, culture and beliefs, headache diagnosis, and based on the disability the headache imposes on the patient's daily living. It was shown that a multidisciplinary approach, that includes continuing counseling, education, and reassurance, in combination with pharmacological and non-pharmacological treatment, is an effective strategy for children and adolescents suffering from primary headaches. Further studies are needed to enrich our knowledge about the pathophysiological mechanisms that cause headaches in children and adolescents and to develop efficient strategies to alleviate their burden.

International survey on the implementation of the European and American guidelines on disorders of consciousness.

Diagnostic, prognostic, and therapeutic procedures for patients with prolonged disorders of consciousness (pDoCs) vary significantly across countries and clinical settings, likely due to organizational factors (e.g., research vs. non-academic hospitals), expertise and availability of resources (e.g., financial and human). Two international guidelines, one from the European Academy of Neurology (EAN) and one from the American Academy of Neurology (AAN) in collaboration with the American Congress of Rehabilitation Medicine (ACRM) and the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), were developed to facilitate consistent practice among professionals working with this challenging patient population. While the recommendations of both guidelines agree in principle, it remains an open issue how to implement them into clinical practice in the care pathway for patients with pDoCs. We conducted an online survey to explore health professional clinical practices related to the management of patients with pDoCs, and compare said practices with selected recommendations from both the guidelines. The survey revealed that while some recommendations are being followed, others are not and/or may require more honing/specificity to enhance their clinical utility. Particular attention should be given to the implementation of a multimodal assessment of residual consciousness, to the detection and treatment of pain, and to the impact of restrictions imposed by COVID-19 pandemics on the involvement of patients' families/representatives.

Ethical Analysis of Egypt's Law Regulating Clinical Research.

Lately, there has been increased research performed in Egypt. In response, the Egyptian Parliament published its first clinical research law in December 2020. The official version of the law was translated to English from Arabic and back by an accredited translation service. We performed an ethical analysis of the law based on the seven ethical requirements for clinical research proposed by Emanuel et al. and compared it with other regulations in the Arab region. The law contains provisions that fulfill all requirements for ethical research to varying degree. Provisions necessitating the sharing of participants' data and biospecimens by the Central Intelligence Agency requires further specifications to ensure privacy protection. Also, the law poses problematic liabilities that could hamper medical research. Egypt's law compares favorably with other laws in the region. Potential items that require further specification can be addressed in the executive regulations currently being drafted for the law.

Food-drug interactions: Knowledge among pharmacists in Jordan.

BACKGROUND: Pharmacists have crucial role in providing drug information and medication counseling to patients. This survey aimed to benchmark the current knowledge of the pharmacists concerning food-drug interactions (FDIs) in Jordan. METHODS: A cross-sectional study was conducted in Amman, the capital and largest city of Jordan, using a validated questionnaire. It was distributed to pharmacists working in community and hospital pharmacies using a convenience sampling technique. Descriptive and inferential statistics were performed in this study. RESULTS: A total of 340 questionnaires distributed, 300 (88%) pharmacists responded. Over 50% of pharmacists claimed that they have sufficient knowledge regarding FDI. Virtually, the overall median (interquartile range) knowledge score was 18 (15-21), approximately 60%. The highest knowledge scores were for alcohol-drug interactions section (66.6%) followed by both common food-drug interactions and the timing of drug intake to food consumption sections with a score of (58.3%) for each, reflecting a suboptimal knowledge of FDIs among the pharmacists. CONCLUSION: Pharmacists had unsatisfactory knowledge about common FDIs, with no significant difference between hospital and community pharmacists. Therefore, more attention and efforts should be played to improve awareness about potential food-drug interactions.

"A perfect society"- Swedish policymakers' ethical and social views on preconception expanded carrier screening.

To improve healthcare policymaking, commentators have recommended the use of evidence, health technology assessment, priority setting, and public engagement in the process of policymaking. Preconception expanded carrier screening, according to the World Health Organization's definition, is a novel health technology and therefore warrants assessment, part of which involves evaluating ethical and social implications. We examined ten Swedish policymakers' perspectives on ethical and social aspects of preconception expanded screening through in-depth expert interviewing, using a semi-structured questionnaire. Respondents were affiliated to governmental and non-governmental institutions that directly influence healthcare policymaking in Sweden. The interviews were recorded, transcribed verbatim, and analyzed via inductive thematic analysis method, which generated seven themes and several subthemes. Policymakers harbored concerns regarding the economics, Swedish and international political respects, implementation procedures, and societal effects, which included long-term ones. Moreover, participants detailed the role of public engagement, research, and responsibility in regard to preconception expanded carrier screening implementation. Since this is a qualitative study, with a small non-random sample, the results may not be generalizable to all policymakers in Sweden. However, the results give a profound insight into the process and interpretative knowledge of experts, in the Swedish milieu and the extent of readiness of Sweden to implement a preconception expanded carrier screening program.

Occipital Headaches in Children: Are They a Red Flag?

Occipital headache is considered a risk factor for serious secondary headache pathology. The purpose of our study was to assess the etiology of occipital headaches among children visiting the emergency department. Subjects were children aged 5 to 18 years who were referred to the emergency department due to headaches during the years 2013 to 2014. A total of 314 patients with headaches were seen at our emergency department. Thirty-nine patients had occipital headaches. Viral infections were the most prevalent final diagnosis (97; 31%), followed by migraine (37; 11.8%). None of our patients had a brain tumor. There was no difference in final diagnosis between the occipital and nonoccipital groups. The most common causes of occipital headaches are viral infections and primary headaches. Serious intracranial disorders presenting solely as occipital headaches and not accompanied by other neurologic signs are uncommon. Thus, occipital headaches should be evaluated in the same manner as other headache locations.

Curricular aspects of the Fogarty bioethics international training programs.

The curriculum design, faculty characteristics, and experience of implementing masters' level international research ethics training programs supported by the Fogarty International Center was investigated. Multiple pedagogical approaches were employed to adapt to the learning needs of the trainees. While no generally agreed set of core competencies exists for advanced research ethics training, more than 75% of the curricula examined included international issues in research ethics, responsible conduct of research, human rights, philosophical foundations of research ethics, and research regulation and ethical review process. Common skills taught included critical thinking, research methodology and statistics, writing, and presentation proficiency. Curricula also addressed the cultural, social, and religious context of the trainees related to research ethics. Programs surveyed noted trainee interest in Western concepts of research ethics and the value of the transnational exchange of ideas. Similar faculty expertise profiles existed in all programs. Approximately 40% of faculty were female. Collaboration between faculty from low- and middleincome countries (LMICs) and high-income countries (HICs) occurred in most programs and at least 50% of HIC faculty had previous LMIC experience. This paper is part of a collection of papers analyzing the Fogarty International Research Ethics Education and Curriculum Development program.

Perspectives of Egyptian research ethics committees regarding their effective functioning.

The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.

Enhancing research ethics capacity in the Middle East: experience and challenges of a Fogarty-sponsored training program.

We describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions' research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.