Henry Silverman

Disparities in research publications persist between low- and middle-income countries (LMICs) and high-income countries, with Arab researchers from LMICs in the Middle East facing significant barriers including the potential impact of linguistic biases. These disparities are reflected in the lower acceptance rates and underrepresentation in high-impact journals. This study aimed to quantitatively identify the specific shortcomings of manuscript submission that contribute to publication inequities. We categorized reviewers’ critiques into predefined areas of manuscript deficiencies, such as lack of novelty, methodological flaws, poor language quality, and misalignment with journal scope, and rated each item as significant (1), moderate (2), or minor (3). Among the 60 letters analyzed, the most common deficiencies were a lack of novelty (51.7%), flawed methodology (40.0%), misalignment with the journal’s scope (22.3%), and poor English language quality (18.3%). These results highlight the key areas for improvement: identifying novel research questions, using sound methodologies, choosing appropriate journals, and strengthening scientific writing skills. These challenges might disproportionately affect researchers of LMICs, reinforcing global disparities in research visibility. To address these disparities, institutions in LMICs must provide researchers with robust training on research methods and academic writing. Simultaneously, journals have an ethical responsibility to ensure an equitable and unbiased evaluation of submissions across diverse global contexts. These combined efforts are essential to fostering a more inclusive and representative academic publishing landscape.

Disparities in research publications persist between low- and middle-income countries (LMICs) and high-income countries, with Arab researchers from LMICs in the Middle East facing significant barriers including the potential impact of linguistic biases. These disparities are reflected in the lower acceptance rates and underrepresentation in high-impact journals. This study aimed to quantitatively identify the specific shortcomings of manuscript submission that contribute to publication inequities. We categorized reviewers’ critiques into predefined areas of manuscript deficiencies, such as lack of novelty, methodological flaws, poor language quality, and misalignment with journal scope, and rated each item as significant (1), moderate (2), or minor (3). Among the 60 letters analyzed, the most common deficiencies were a lack of novelty (51.7%), flawed methodology (40.0%), misalignment with the journal’s scope (22.3%), and poor English language quality (18.3%). These results highlight the key areas for improvement: identifying novel research questions, using sound methodologies, choosing appropriate journals, and strengthening scientific writing skills. These challenges might disproportionately affect researchers of LMICs, reinforcing global disparities in research visibility. To address these disparities, institutions in LMICs must provide researchers with robust training on research methods and academic writing. Simultaneously, journals have an ethical responsibility to ensure an equitable and unbiased evaluation of submissions across diverse global contexts. These combined efforts are essential to fostering a more inclusive and representative academic publishing landscape.

Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive thematic analysis. Our findings revealed several key challenges. First, Arab researchers struggle to conduct high-quality research due to limited resources, inadequate funding, and a lack of a supportive research infrastructure. Furthermore, a shortage of teamwork and mentoring diminishes research productivity. Perverse promotion policies, heavy teaching loads, and low salaries force many researchers to seek external income sources, leaving them with insufficient time for research. Regarding publishing in high-impact journals, Arab researchers confront challenges existing of insufficient scientific writing skills, underrepresentation on editorial boards, and unconscious biases against researchers from economically challenged areas. Finally, achieving research integrity is closely tied to lack of access to essential resources. To address these issues, our participants proposed targeted interventions at the institutional and external levels. For example, universities can implement mentoring programs, offer workshops on scientific writing and publishing, and foster a supportive institutional culture for research. Addressing the underrepresentation of Arabic researchers on editorial boards is crucial for equity in global scientific publishing. In conclusion, acknowledging and addressing these challenges will empower Arab researchers, elevate research quality, and promote equitable global scientific collaboration. Our findings provide guidance for universities, governments, and international donors seeking to enhance research and publication practices in the Arab Middle East.

Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self‐Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare.To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences.We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.

To enhance efforts against plagiarism, a deeper understanding of its various aspects is essential. This cross-sectional questionnaire study assessed the knowledge, attitudes, subjective norms, and self-reported plagiarism practices among health researchers in Egypt and Lebanon. A validated questionnaire was distributed to postgraduate students and faculty members across 15 universities through personal emails and health researcher-specific social media platforms. Out of 283 respondents, the mean knowledge score was 14.8 ± 3.7 out of a possible 27.0, indicating moderate knowledge of plagiarism. Attitudes toward plagiarism were moderately permissive, with an average score of 62.2 ± 10.9, out of a maximum of 90.0. Subjective norms received a moderate score of 33.6 ± 6.7, where a favorable score should be low (10–23) suggesting that participants perceive society as disapproving of plagiarism and believe its prevalence is low. The mean self-reported Plagiarism Severity Score (PSS) was 4.1 ± 3.6, reflecting a low level of self-reported plagiarism, with a maximum possible score of 18. Multivariable analysis revealed a negative correlation between subjective norms and the PSS (β = −0.194, CI [−0.196: −0.010]). This finding is counterintuitive, as one would typically expect that a lower subjective norms score (indicating stronger disapproval of plagiarism), would correlate with fewer acts of plagiarism. One possible explanation for this result is the presence of negative perceptions of organizational justice—such as feelings of being unfairly treated—which might lead to higher rates of self-reported research misconduct. We recommend that universities in the Arab Middle East region develop research ethics training programs that include responsible conduct in research. However, it is essential for academic leaders to assess and address the research integrity climate within their institutions, as organizational injustice could undermine the effectiveness of these educational efforts.

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.

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.

Objective To determine the attitudes of Egyptian patients regarding their participation in research and with the collection, storage and future use of blood samples for research purposes. Design Cross-sectional survey. Study population Adult Egyptian patients (n=600) at rural and urban hospitals and clinics. Results Less than half of the study population (44.3%) felt that informed consent forms should provide research participants the option to have their blood samples stored for future research. Of these participants, 39.9% thought that consent forms should include the option that future research be restricted to the illness being studied. A slight majority (66.2%) would donate their samples for future genetic research. Respondents were more favourable towards having their blood samples exported to other Arab countries (62.0%) compared with countries in Europe (41.8%, p<0.001) and to the USA (37.2%, p<0.001). Conclusions This study shows that many individuals do not favour the donation of a blood sample for future research. Of those who do approve of such future research, many favour a consent model that includes an option restricting the future research to the illness being studied. Also, many Egyptians were hesitant to have their blood samples donated for genetic research or exported out of the Arab region to the USA and European countries. Further qualitative research should be performed to determine the underlying reasons for many of our results.

Background: Moral distress occurs when constraints prevent healthcare providers from acting in accordance with their core moral values to provide good patient care. The experience of moral distress in nurses might be magnified during the current Covid-19 pandemic. Objective: To explore causes of moral distress in nurses caring for Covid-19 patients and identify strategies to enhance their moral resiliency. Research design: A qualitative study using a qualitative content analysis of focus group discussions and in-depth interviews. We purposively sampled 31 nurses caring for Covid-19 patients in the acute care units within large academic medical systems in Maryland and New York City during April to June 2020. Ethical considerations: We obtained approval from the Institutional Review Board at the University of Maryland, Baltimore. Results: We identified themes and sub-themes representative of major causes of moral distress in nurses caring Covid-19 patients. These included (a) lack of knowledge and uncertainty regarding how to treat a new illness; (b) being overwhelmed by the depth and breadth of the Covid-19 illness; (c) fear of exposure to the virus leading to suboptimal care; (d) adopting a team model of nursing care that caused intra-professional tensions and miscommunications; (e) policies to reduce viral transmission (visitation policy and PPE policy) that prevented nurses to assume their caring role; (f) practicing within crisis standards of care; and (g) dealing with medical resource scarcity. Participants discussed their coping mechanisms and suggested future strategies. Discussion/Conclusion: Our study affirms new causes of moral distress related to the Covid-19 pandemic. Institutions need to develop a supportive ethical climate that can restore nurses’ moral resiliency. Such a climate should include non-hierarchical interdisciplinary spaces where all providers can meet together as moral peers to discuss their experiences.

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar.

Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinical research. It is unknown, however, how research professionals regard concepts of privacy as well as the situations in the research setting that require privacy protections. The aim of this study was to explore the views of research professionals from Arab countries regarding concepts and scope of privacy that occur in clinical research. Methods We adopted an exploratory qualitative approach by the use of focus group discussions. We recruited individuals involved in research from Egypt and Morocco. We analyzed focus group data via a constant comparison approach, which consisted of close reading of the transcribed interviews followed by coding and then determining themes and subthemes. Results Between August 2016 and July 2018, we conducted nine focus group discussions. Respondents discussed several privacy issues that occurred before the research began ; during research, and after the research. Respondents revealed their perspectives of patients towards privacy in the clinical and research settings and mentioned that patients are more likely to permit access to their privacy in the clinical setting compared with research setting due to the existence of benefits and trust in clinical care. Respondents also recommended training regarding data protections for individuals involved in research. Conclusions Our study shows that research professionals discussed a range of privacy issues that are present during the different stages of research. We recommend 1) development of standards regarding privacy protections during recruitment efforts; 2) additional training for individuals involved in research regarding best practices with data security in secondary research; 3) a quantitative study involving investigators and REC members to determine their knowledge, attitudes and practices regarding privacy issues that occur in research; and 4) a quantitative study involving patients to elicit their views regarding their privacy concerns in research.

Human subjects research has increased in Myanmar since 2010 and, accordingly, the establishment of research ethics committees has increased review of these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at medical institutions in Myanmar, we used a self-assessment tool for RECs operating in low- and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 medical institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate and multivariate statistics to analyse the data. Out of a maximum 200 points, the total mean score for Myanmar medical institutions was 112.6 ± 12.77, which is lower compared with the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but lacked essential policies. The results show that for Myanmar RECs, there is significant room for improvement in their “structures and processes” as well as the extent of institutional commitment. The self-assessment tool proved to be a valuable method to assess the quality of RECs.

Background Studies have shown that medical students and residents believe that their ethics preparation has been inadequate for handling ethical conflicts. The objective of this study was to determine the self-perceived comfort level of medical students and residents in confronting clinical ethics issues. Methods Clinical medical students and residents at the University of Maryland School of Medicine completed a web-based survey between September 2009 and February 2010. The survey consisted of a demographic section, questions regarding the respondents’ sense of comfort in handling a variety of clinical ethics issues, and a set of knowledge-type questions in ethics. Results Survey respondents included 129 medical students (response rate of 40.7%) and 207 residents (response rate of 52.7%). There were only a few clinical ethics issues with which more than 70% of the respondents felt comfortable in addressing. Only a slight majority (60.8%) felt prepared, in general, to handle clinical situations involving ethics issues, and only 44.1% and 53.2% agreed that medical school and residency training, respectively, helped prepare them to handle such issues. Prior ethics training was not associated with these responses, but there was an association between the level of training (medical students vs residents) and the comfort level with many of the clinical ethics issues. Conclusions Medical educators should include ethics educational methods within the context of real-time exposure to medical ethics dilemmas experienced by physicians-in-training

Recent studies from Western countries indicate significant levels of questionable research practices, but similar data from low and middle-income countries are limited. Our aims were to assess the prevalence of and attitudes regarding research misconduct among researchers in several universities in the Middle East and to identify factors that might account for our findings. We distributed an anonymous questionnaire to a convenience sample of investigators at several universities in Egypt, Lebanon, and Bahrain. Participants were asked to a) self-report their extent of research misconducts, as well as their knowledge of colleagues engaging in similar research misconducts and b) provide their extent of agreement with certain attitudes about research misconduct. We used descriptive, bivariate, and multivariate logistic regression statistics to analyze the data. Data from 278 participants showed a high prevalence of misconduct, as 59.4% of our respondents self-reported to committing at least one misbehaviors and 74.5% reported having knowledge of any misbehaviors among any of their colleagues. The most common type of self-report misconduct was “circumventing research ethics regulations” followed by “fabrication and falsification”. A significant predictor of misconduct included a lack of “prior ethics training”. Scientific misconduct represents a significant issue in several universities in the Middle East. The demonstration that a lack of “prior ethics training” was a significant predictor of misconduct should lead to educational initiatives in research integrity. Further studies are needed to confirm whether our results can be generalized to other universities in the Middle East.

BackgroundStudies have shown that research participants fail to appreciate the difference between research and medical care, labeling such phenomenon as a "therapeutic misconception" (TM). Since research activity involving human participants is increasing in the Middle East, qualitative research investigating aspects of TM is warranted. Our objective was to assess for the existence of therapeutic misconception amongst Egyptians.MethodsStudy Tool: We developed a semi-structured interview guide to elicit the knowledge, attitudes, and perspectives of Egyptians regarding medical research.Setting: We recruited individuals from the outpatient settings (public and private) at Ain Shams University in Cairo, Egypt.Analysis: Interviews were taped, transcribed, and translated. We analyzed the content of the transcribed text to identify the presence of a TM, defined in one of two ways: TM1 = inaccurate beliefs about how individualized care can be compromised by the procedures in the research and TM2 = inaccurate appraisal of benefit obtained from the research study.ResultsOur findings showed that a majority of participants (11/15) expressed inaccurate beliefs regarding the degree with which individualized care will be maintained in the research setting (TM1) and a smaller number of participants (5/15) manifested an unreasonable belief in the likelihood of benefits to be obtained from a research study (TM2). A total of 12 of the 15 participants were judged to have expressed a TM on either one of these bases.ConclusionThe presence of TM is not uncommon amongst Egyptian individuals. We recommend further qualitative studies investigating aspects of TM involving a larger sample size distinguished by different types of illnesses and socio-economic variables, as well as those who have and have not participated in clinical research

SUPPORT, a study involving approximately 1,300 premature infants who were randomly assigned to treatment protocols that differed in whether they offered higher or lower levels of oxygen saturation, was purportedly an example of comparative effectiveness research performed in the intensive care unit. However, SUPPORT became highly controversial. One source of controversy involved the proper determination of “reasonably foreseeable risks.” Commentators debated whether randomization to contrasting restrictive strategies that are within existing standard‐of‐care treatments imposed additional “reasonably foreseeable risks” greater than what study participants would have received outside of the research. A second controversial issue had to do with disclosures in informed consent documents. This article explores these issues.We argue that randomization to contrasting restrictive interventions lying at the outer ends of “standard‐of‐care” practices differs in important ways from unrestricted “standard‐of‐care” practices available outside of a proposed study; that research involving such randomization might pose additional “reasonably foreseeable risks” from what occurs in “standard‐of‐care” practices; and that for trials whose study designs are similar to the SUPPORT study, respect for persons requires the disclosure of information about the nature of the experimental procedures and their risks.

ABSTRACT An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan.

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions, which are in turn influenced by developmental conditions. Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities

Medical research must involve the participation of human subjects. Knowledge of patients' perspectives and concerns with their involvement in research would enhance recruitment efforts, improve the informed consent process, and enhance the overall trust between patients and investigators. Several studies have examined the views of patients from Western countries. There is limited empirical research involving the perspectives of individuals from developing countries. The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research. Such information would help clarify the type and extent of concerns regarding research participation of individuals from cultural, economic, and political backgrounds that differ from those in developed countries

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi-day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active-learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East

Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region.

Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs