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.

A multicenter study of the awareness and attitudes of Egyptian faculty towards research ethics: a pilot study.

The awareness and attitudes of faculty towards research ethics committees (RECs) and research ethics practices are largely unknown. Accordingly, we conducted a cross-sectional survey study involving various faculties (Medicine, Nursing, Pharmacy, and Dentistry) from four universities in Egypt. A large majority (> 85%) held positive attitudes towards RECs, but almost a third thought that RECs would delay research. More than half had not received prior training in research or medical ethics, but more than 90% thought that this subject matter should be taught to postgraduates. A large majority recognized the need for informed consent and confidentiality protections in research, but some held attitudes regarding certain research ethics practices that were questionable. We conclude that a curriculum in research ethics should be developed for university faculty and that further qualitative studies should explore the basis of several of the attitudes regarding practices in research ethics.

Identifying structures, processes, resources and needs of research ethics committees in Egypt.

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.

Capacity mapping of national ethics committees in the Eastern Mediterranean Region.

BACKGROUND: 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. METHODS: We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. RESULTS: We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. CONCLUSION: While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

BACKGROUND: Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. OBJECTIVE: To develop a framework for analyzing control group selection for critical care trials. METHOD: Ethical analysis. RESULTS: A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. CONCLUSION: Weighing and balancing the competing ethical objectives of trial design should be done for each trial.