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.

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.

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.

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.

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.

Reevaluating the Ethical Issues in Porcine-to-Human Heart Xenotransplantation.

A major limiting factor with heart allotransplantation remains the availability of organs from deceased donors. Porcine heart xenotransplantation could serve as an alternative source of organs for patients with terminal heart failure. A first-in-human porcine xenotransplantation that occurred in January 2022 at the University of Maryland Medical Center provided an opportunity to examine several ethical issues to guide selection criteria for future xenotransplantation clinical trials. In this article, the authors, who are clinicians at UMMC, discuss the appropriate balancing of risks and benefits and the significance, if any, of clinical equipoise. The authors also review the alleged role of the psychosocial evaluation in identifying patients at an elevated risk of posttransplant noncompliance, and they consider how the evaluation's implementation might enhance inequities among diverse populations. The authors argue that, based on the principle of reciprocity, psychosocial criteria should be used, not to exclude patients, but instead to identify patients who need additional support. Finally, the authors discuss the requirements for and the proper assessment of informed and voluntary consent from patients being considered for xenotransplantation.

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 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.

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.

Reliability and validation of an attitude scale regarding responsible conduct in research.

BACKGROUND: Several studies reveal a problematic prevalence of research misbehaviors. There are several potential causes of research misconduct but ensuring that scientists hold attitudes that reflect norms of acceptable behaviors is fundamental. AIM: Our aim was to evaluate the psychometric properties (factor structure and reliability) of an "attitude" scale that we adopted from a questionnaire we previously used to investigate the prevalence of research misbehaviors in the Middle East. METHODS: We used data from participants (n = 254) who were involved in our prior questionnaire study to determine the validity of an attitude scale that we adapted from this previous study. We performed exploratory factor analysis (EFA) to determine the factor structure of the attitude scale followed by measures of convergent and concurrent validity. We assessed reliability by computing the Cronbach's alphas of each construct of the attitude scale. RESULTS: EFA indicated that the attitude scale consists of two factors (constructs). Convergent validity was demonstrated by significant correlations of item-item and item-total. Correlation analysis revealed that the attitude constructs were significantly correlated with the Research Misbehavior Severity Score, thereby demonstrating concurrent validity. Cronbach's alphas were greater than 0.75 for both constructs. CONCLUSION: We demonstrated a valid and reliable 20-item attitude scale with two factors related to "acceptability of practices in responsible conduct in research" and "general attitudes regarding scientific misconduct". The use of a validated attitude scale can help assess the effectiveness of educational programs that focus on participants acquiring attitudes that are instrumental in responsible conduct in research.

Development and Validation of a Biobank Questionnaire Intended for the Public in the Arab Region.

Background: Assessing the public perspectives regarding donation of biospecimens to biobanks would be helpful with the establishment of biobanks in the Arab region. Objective: To develop a biobanking questionnaire in Arabic and assess its psychometric properties. Design: Multicenter cross-sectional study. Methods: We used a two-step process for questionnaire development. First, we decided on the important constructs for a questionnaire followed by development of an item pool through review of the scientific literature and published questionnaires. The questionnaire was refined through cognitive interviews and translation. An expert panel assessed content validity. The final questionnaire included five domains: perceptions; aspects important to participation in biobank research; preferences for type of biobank; attitudes toward biobanking; and willingness to participate in biobank research. Second, we distributed the questionnaire to 250 members of the public from Egypt, Jordan, Sudan, and Morocco to assess the questionnaire's psychometric properties, including reliability (internal consistency and Cronbach's alpha) and construct validity (convergent and divergent validity and exploratory factor analysis [EFA]). Results: Internal consistency yielded a range of Cronbach's alpha for the five domains from 0.62 to 0.80. EFA showed a 12-factorial solution. Kaiser-Meyer-Olkin measure of sampling adequacy was 0.907 and Bartlett's test of sphericity was significant (p < 0.005). Attitudes were positively correlated with willingness to donate (r = 0.30; p < 0.001). Conclusions: The final biobank Arabic language questionnaire showed excellent reliability and acceptable validity parameters. The newly developed Arabic questionnaire is the first psychometrically tested tool that can be used in the Arab region to assess the public perspectives on participation in biobanking research.

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.

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.

Medical costs of Alpha-1 antitrypsin deficiency-associated COPD in the United States.

BACKGROUND: There are limited data on economic aspects of the genetic variant of chronic obstructive pulmonary disease (COPD) in the context of the more prevalent form of COPD. The objective of this study was to isolate the healthcare resource utilization and economic burden attributable to the presence of a genetic factor among COPD patients with and without Alpha-1 Antitrypsin Deficiency (AATD), twelve months before and after their initial COPD diagnosis. METHODS: Retrospective analysis of OptumLabs® Data Warehouse claims (OLDW; 2000-2017). The OLDW is a comprehensive, longitudinal real-world data asset with de-identified lives across claims and clinical information. AATD-associated COPD cases were matched with up to 10 unique non-AATD-associated COPD controls. Healthcare resource use and costs were assigned into the following categories: office (OV), outpatient (OP), and emergency room visits (ER), inpatients stays (IP), prescription drugs (RX), and other services (OTH). A generalized linear model was used to estimate total pre- and post-index (initial COPD diagnosis) costs from a third-party payer's perspective (2018 USD) controlling for confounders. Healthcare resource utilization was estimated using a negative binomial regression. RESULTS: The study population consisted of 8881 patients (953 cases matched with 7928 controls). The AATD-associated COPD cohort had higher expenditures and use of office visits (OV) and other (OTH) services, as well as OV, outpatient (OP), emergency room (ER), and prescription drugs (RX) before and after the index date, respectively. Adjusted total all-healthcare cost ratios for AATD-associated COPD patients as compared to controls were 2.04 [95% CI: 1.60-2.59] and 1.98 [95% CI: 1.55-2.52] while the incremental cost difference totaled $6861 [95% CI: $3025 - $10,698] and $5772 [95% CI: $1940 - $9604] per patient before and after the index date, respectively. CONCLUSIONS: Twelve months before and after their initial COPD diagnosis, patients with AATD incur higher healthcare utilization costs that are double the cost of similar COPD patients without AATD. This study also suggests that increased costs of AATD-associated COPD are not solely attributable to augmentation therapy use. Future studies should further explore the relationship between augmentation therapy, healthcare resource use, and other AATD-associated COPD expenditures.

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.

Strengths of the French end-of-life Law as Well as its Shortcomings in Handling Intractable Disputes Between Physicians and Families.

French end-of-life law aims at protecting patients from unreasonable treatments, but has been used to force caregivers to prolong treatments deemed unreasonable. We describe six cases (five intensive care unit patients including two children) where families disagreed with a decision to withdraw treatments and sued medical teams. An emergent inquiry was instigated by the families. In two cases, the court rejected the families' inquiries. In two cases, the families appealed the decision, and in both the first jurisdiction decision was confirmed, compelling caregivers to pursue treatments, even though they deemed them unreasonable. We discuss how this law may be perverted. Legal procedures may result in the units' disorganisation and give rise to caregivers' stress. Families' requests may be subtended by religious beliefs. French end-of-life law has benefits in theoretically constraining physicians to withhold or withdraw disproportionate therapies. These cases underline some caveats and the perverse effects of its literal reading.

Knowledge, Awareness, Attitudes, and Practices towards Research Ethics and Research Ethics Committees among Myanmar Post-graduate Students.

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.

Assessing Research Ethics Committees in Myanmar: Results of a Self-Assessment Tool.

BACKGROUND: Human subject research has increased in Myanmar since 2010 and accordingly, the establishment of research ethics committees (RECs) have increased to review these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. OBJECTIVES: To assess the structures and processes of RECs at Medical Institutions in Myanmar. METHODS: 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. RESULTS: Out of maximum 200 points, the total mean score for Myanmar Medical Institutions was 112.6 ± 12.77, which is lower compared to 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. CONCLUSION: The results show that for Myanmar RECs there is significant room for improvement in their "structures and processes" as well as the extent of institutionl commitment. The self-assessment tool proved to be valuable method to assess the quality of RECs.