Zaw Zaw Oo1, Min Wun2, Yin Thet Nu Oo2, Kyaw Swa Mya3, Henry J Silverman4. 1. University of Medicine 2, Yangon, Ministry of Health and Sports, Yangon, Myanmar. 2. Department of Medical Research, Myanmar Ministry of Health and Sports, Yangon, Myanmar. 3. University of Public Health, Ministry of Health and Sports, Yangon, Myanmar. 4. Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
Abstract
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.
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.
Entities:
Keywords:
Institutional Review Committees; Myanmar; Research; Research Ethics; Research Ethics Committees
Authors: Hany Sleem; Rehab Abdelhai Ahmed Abdelhai; Imad Al-Abdallat; Mohammed Al-Naif; Hala Mansour Gabr; Et-Taher Kehil; Bakr Bin Sadiq; Reham Yousri; Dyaeldin Elsayed; Suad Sulaiman; Henry Silverman Journal: J Empir Res Hum Res Ethics Date: 2010-09 Impact factor: 1.742