Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

Biobanks in the low- and middle-income countries of the Arab Middle East region: challenges, ethical issues, and governance arrangements-a qualitative study involving biobank managers.

BACKGROUND: Biobanks have recently been established in several low- and middle-income countries (LMICs) in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks. METHODS: In-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt (6), Jordan (1), and Sudan (1). Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45-75 min. After verbal consent, interviews were recorded and then transcribed. The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process. RESULTS: Biobank managers discussed the main challenges in establishing their biobanks. These included the staff's lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders. CONCLUSION: Managers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust.

Ethical decision-making climate, moral distress, and intention to leave among ICU professionals in a tertiary academic hospital center.

BACKGROUND: Commentators believe that the ethical decision-making climate is instrumental in enhancing interprofessional collaboration in intensive care units (ICUs). Our aim was twofold: (1) to determine the perception of the ethical climate, levels of moral distress, and intention to leave one's job among nurses and physicians, and between the different ICU types and (2) determine the association between the ethical climate, moral distress, and intention to leave. METHODS: We performed a cross-sectional questionnaire study between May 2021 and August 2021 involving 206 nurses and physicians in a large urban academic hospital. We used the validated Ethical Decision-Making Climate Questionnaire (EDMCQ) and the Measure of Moral Distress for Healthcare Professionals (MMD-HP) tools and asked respondents their intention to leave their jobs. We also made comparisons between the different ICU types. We used Pearson's correlation coefficient to identify statistically significant associations between the Ethical Climate, Moral Distress, and Intention to Leave. RESULTS: Nurses perceived the ethical climate for decision-making as less favorable than physicians (p < 0.05). They also had significantly greater levels of moral distress and higher intention to leave their job rates than physicians. Regarding the ICU types, the Neonatal/Pediatric unit had a significantly higher overall ethical climate score than the Medical and Surgical units (3.54 ± 0.66 vs. 3.43 ± 0.81 vs. 3.30 ± 0.69; respectively; both p ≤ 0.05) and also demonstrated lower moral distress scores (both p < 0.05) and lower "intention to leave" scores compared with both the Medical and Surgical units. The ethical climate and moral distress scores were negatively correlated (r = -0.58, p < 0.001); moral distress and "intention to leave" was positively correlated (r = 0.52, p < 0.001); and ethical climate and "intention to leave" were negatively correlated (r = -0.50, p < 0.001). CONCLUSIONS: Significant differences exist in the perception of the ethical climate, levels of moral distress, and intention to leave between nurses and physicians and between the different ICU types. Inspecting the individual factors of the ethical climate and moral distress tools can help hospital leadership target organizational factors that improve interprofessional collaboration, lessening moral distress, decreasing turnover, and improved patient care.

Perceptions, attitudes, and willingness of the public in low- and middle-income countries of the Arab region to participate in biobank research.

Population-based genomics studies have proven successful in identifying genetic variants associated with diseases. High-quality biospecimens linked with informative health data from diverse segments of the population have made such research possible. However, the success of biobank research depends on the willingness of the public to participate in this type of research. We aimed to explore the factors associated with the willingness of the public to participate in biobank research from four low- and middle-income countries in the Arab region (Egypt, Jordan, Morocco, and Sudan). We used a previously validated questionnaire to assess several constructs that included the public's perceptions, attitudes, and willingness to participate in biobank research. We recruited 967 participants. More than half did not have prior awareness of biobanks. Participants' willingness to donate biospecimens and health data was less than 10%. Our results also showed that participants harbored concerns with trust, privacy, and with data-sharing involving international researchers. Predictors of willingness to participate in biobank research included no previous involvement in research and positive attitudes toward biobanks. Finally, our study showed several differences between the four countries regarding several of the investigated constructs. We conclude there should be additional efforts to raise public awareness and enhance perceptions of the public in biobanking research to enhance trust. We further recommend qualitative research to explore the underlying factors that contribute to the public's concerns with international data sharing that would enhance global health.

Perceptions of medical students towards the practice of professionalism at the Arabian Gulf University.

BACKGROUND: To enhance the development of a curriculum in professionalism for medical students, the aim of this research was to evaluate medical students' responses regarding professionalism teaching and behaviors in their clinical experience at the Arabian Gulf University (AGU). METHODS: A retrospective cross-sectional, questionnaire-based study involving Year 5 medical students at the AGU. We used a "climate of professionalism" survey that consisted of two parts. The first part asked students to rate their perceptions of the frequency of professionalism practices of their peers (medical students), residents, and faculty. The response choices included: "mostly", "sometimes", and "rarely". The second part asked the students to assess their perceptions of the professionalism teaching and behaviors of the faculty. The response choices included: "mostly", "sometimes", and "rarely". We calculated an overall score for the responses in both parts of the questionnaire by assigning 3, 2, and 1 points to the response choices, respectively. We also calculated subscale scores reflecting different professionalism constructs. We used descriptive statistics and a one-way Analysis of Variance (ANOVA) followed by multiple testing comparisons with Bonferroni correction to examine pairwise comparisons. A p < 0.05 was considered statistically significant. RESULTS: The mean total scores of participants' ratings of professional behaviors of medical students, residents, and faculty for each academic year were approximately 60% of the total maximum score. The mean total scores of participants' rating of faculty's teaching and modeling behaviors concerning professionalism were approximately 58% of the maximum score. Compared with similar studies performed in the Arab Region, ratings regarding professional teaching and modeling of professionalism were lower. CONCLUSION: We recommend the further evaluation of professionalism teaching and behaviors at the AGU and further discussions regarding curriculum reform.

Moral distress in nurses caring for patients with Covid-19.

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.

Perspectives regarding privacy in clinical research among research professionals from the Arab region: an exploratory qualitative study.

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 (e.g., recruitment practices); during research (e.g., data collection and physical exams), and after the research (e.g., secondary use of data and data sharing). 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.

A Cross-Sectional Survey Study to Assess Prevalence and Attitudes Regarding Research Misconduct among Investigators in the Middle East.

BACKGROUND: 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. METHODS: 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. RESULTS: 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" (50.5%) followed by "fabrication and falsification" (28.6%). A significant predictor of misconduct included a lack of "prior ethics training". CONCLUSION: 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.

Patients' attitudes and perceptions regarding research and their rights: a pilot survey study from the Middle East.

Ethical and regulatory oversight of research may be suboptimal in low- and middle-income countries. To determine patients' attitudes and perceptions toward research participation and perceptions of their rights, we recruited 202 participants from hospitals in Egypt, Lebanon, Saudi Arabia and Sudan and asked them to complete a questionnaire assessing attitudes and perceptions. Around 20% believed that doctors sometimes perform research on patients without their knowledge and 35% believed that if participants withdrew from the research they would not receive good medical care. Over 85% believed that they should have rights regarding confidentiality of data, free medical care if injured during the research and asking questions. Almost half believed they have a right to withdraw without penalty and around 75% believed they could make complaints without fear of harm. Those who were illiterate or unemployed were less likely to appreciate their rights compared with their counterparts.

Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low- and middle-income countries.

PURPOSE: Many research ethics committees (RECs) have been established in low- and middle-income countries (LMICs) in response to increased research in these countries. How well these RECs are functioning remains largely unknown. Our objective was to assess the usefulness of a self-assessment tool in obtaining benchmarking data on the extent to which RECs are in compliance with recognised international standards. METHODS: REC chairs from several LMICs (Egypt, South Africa and India) were asked to complete an online self-assessment tool for RECs with a maximum score of 200. Individual responses were collected anonymously. RESULTS: The aggregate mean score was 137.4±35.8 (∼70% of maximum score); mean scores were significantly associated with the presence of a budget (p<0.001), but not with duration of existence, frequency of meetings, or the presence of national guidelines. As a group, RECs achieved more than 80% of the maximum score for the following domains: submission processes and documents received, recording of meeting minutes, criteria for ethical review and criteria for informed consent. RECs achieved less than 80% of the maximum score for the following domains: institutional commitment, policies and procedures of the REC, membership composition and training, policies and procedures for protocol review, elements of a decision letter and criteria for continuing review. CONCLUSIONS: This study highlights areas where RECs from LMICs can improve to be in compliance with recommended international standards for RECs. The self-assessment tool provides valuable benchmarking data for RECs and can serve as a quality improvement method to help RECs enhance their operations.

Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.

Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

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 (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). 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.

Consensus standards for introductory e-learning courses in human participants research ethics.

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.

Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.

Background: The recent expansion of genomic biobank research in the Arab region in the Middle East North Africa has raised complex ethical and regulatory issues. However, there is a lack of studies regarding the views of Arab researchers involved in such research. We aimed to assess the perceptions and attitudes of Arab researchers regarding these issues in biobank research. Methods: We developed a questionnaire to assess the perceptions and attitudes regarding genetic research of researchers from Egypt, Sudan, Morocco, and Jordan. The questionnaire requested demographic data, perceptions, and attitudes regarding the collection, storage, and use of biospecimens and data, the use of broad consent, data security, data sharing, and community engagement. We used multiple linear regressions to identify predictors of perceptions and attitudes. Results: We recruited 383 researchers. Researchers favored equally the use of broad and tiered consent (44.1% and 39.1%, respectively). Most respondents agreed with the importance of confidentiality protections to ensure data security (91.8%). However, lower percentages were seen regarding the importance of community engagement (64.5%), data sharing with national colleagues and international partners (60.9% and 41.1%, respectively), and biospecimen sharing with national colleagues and international partners (59.9% and 36.2%, respectively). Investigators were evenly split on whether the return of individual research results should depend on the availability or not of a medical intervention that can be offered to address the genetic anomaly (47.5% and 46.4%, respectively). Predictors of attitudes toward biospecimen research included serving on Research Ethics Committees, prior research ethics training, and affiliation with nonacademic institutions. Conclusions: We recommend further exploratory research with researchers regarding the importance of community engagement and to address their concerns about data sharing, with researchers within and outside their countries.

Perceived comfort level of medical students and residents in handling clinical ethics issues.

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.

Knowledge, attitudes, and practices regarding plagiarism of postgraduate students in Myanmar.

Information regarding the prevalence of plagiarism and its contributing factors are limited in Myanmar. We aimed to explore the knowledge, attitudes, and self-reported plagiarism practices of postgraduate students in Myanmar's universities and determine the factors associated with plagiarism. We conducted a cross-sectional questionnaire study during 2019-2020. The questionnaire contained: 1) demographics, 2) knowledge on plagiarism, 3) attitudes toward plagiarism, and 4) self-reported plagiarism practices. We calculated attitudes and plagiarism severity scores (PSS). We conducted multiple linear regression analyses and binary logistic regression analyses. A p-value <0.05 denoted statistical significance. We enrolled 217 participants. Of our participants, 37.6% self-reported at least one plagiarism act. The mean attitude score (S.D.) was 62.24 (10.44), (maximum score was 92, higher scores represent disapproval of plagiarism). This attitude score reflects only a moderate attitude toward disapproval of plagiarism. The attitude score was significantly higher for doctoral students (9.2%) than master students (90.8%); p = 0.003; and for participants with publications (13.4%) compared with those without publications (86.6%); p = 0.005. The attitude score was a significant predictor of the PSS. We conclude that there is evidence to suggest that plagiarism represents a significant ethical issue in Myanmar and recommend that Myanmar universities provide training in responsible conduct of research.

Challenges Facing Arab Researchers in Publishing Scientific Research: A Qualitative Interview Study.

Background: Studies have shown an underrepresentation of researchers from lower- and middle-income countries (LMICs) in the research literature compared with their counterparts in high-income countries. We aimed to explore Arab researchers' challenges regarding conducting and publishing research in peer-reviewed journals. Methods: We used a descriptive qualitative study design of semi-structured in-depth interviews. Using purposive sampling, we recruited participants from four Arab countries in the Middle East and North Africa. All interviews were recorded, transcribed, and translated to English if the original language was Arabic or French. We analyzed the transcripts using reflexive thematic analysis. Several authors independently coded the transcripts and agreed on the identified codes, themes, and subthemes. Results: We performed 17 interviews: three from Egypt, six from Jordan, four from Morocco, and four from Sudan. Our participants' comments were divided into three broad categories with associated themes and subthemes. The first regards the conduct of research (themes of inadequate quality of research, insufficient research resources, and nonsuppurative research environment). The second category involves the publishing process (themes of poor scientific writing skills and difficulties navigating the publishing and peer-reviewed system). The third regards international collaborations and the final category recommends methods to address the challenges. Our recommendations include: enhancing the institutional research culture, increasing funding mechanisms, establishing mentoring programs and workshops on research methodology and scientific writing, and increasing the representation of LMICs on the editorial staff. Conclusions: Identifying the challenges of Arab researchers in publishing original and quality research would guide programs tailored and targeted toward Arab scholars' needs.

Ethical Concerns of Patients and Family Members Arising During Illness or Medical Care.

Patients and family members (N = 671) were surveyed in five Mid-Atlantic U.S. hospitals to ascertain the number and kinds of ethical concerns they are presently experiencing or have previously experienced while being sick or receiving medical care. Seventy percent of participants had at least one (range 0-14) type of ethical concern or question. The most commonly experienced concerns pertained to being unsure how to plan ahead or complete an advance directive (29.4%), being unsure whether someone in the family was able to make their own decisions (29.2%), deciding about limiting life-sustaining treatments (28.6%), wondering about disclosing personal medical information to others in the family (26.4%) and not being sure whether to undergo treatment because of cost (26.2%). Most were interested to some degree in getting help from ethics consultants in the future (76.6%). Given this prevalence, common concerns might usefully be addressed systematically, rather than exclusively on a case-by-case basis.

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.