Displaying all 9 publications

  1. Kaur S, Balan S
    Theor Med Bioeth, 2015 Oct;36(5):341-61.
    PMID: 26438122 DOI: 10.1007/s11017-015-9339-3
    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.
    Matched MeSH terms: Ethics Committees, Research/standards; Ethics Committees, Research/trends; Ethics Committees, Research/ethics*
  2. Mak, Joon-Wah
    The International Medical University (IMU) has encouraged and facilitated research activities since 2001. Research activities by undergraduates, postgraduates, and faculty members have increased substantially since then. The governance aspects of research activities are closely monitored by the Institutional Review Board which is the IMU-Joint Committee on Research and Ethics. (Copied from article)
    Matched MeSH terms: Ethics Committees, Research
  3. Kaur S, Choy CY
    Dev World Bioeth, 2014 Apr;14(1):20-8.
    PMID: 23170779 DOI: 10.1111/dewb.12004
    This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form.
    Matched MeSH terms: Ethics Committees, Research*
  4. Kaur S
    J Med Ethics, 2013 Apr;39(4):230.
    PMID: 23077337 DOI: 10.1136/medethics-2012-100965
    Matched MeSH terms: Ethics Committees, Research*
  5. Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, et al.
    Am. J. Gastroenterol., 2019 Jan;114(1):107-115.
    PMID: 30177785 DOI: 10.1038/s41395-018-0233-2
    INTRODUCTION: Living in an urban environment may increase the risk of developing inflammatory bowel disease (IBD). It is unclear if this observation is seen globally. We conducted a population-based study to assess the relationship between urbanization and incidence of IBD in the Asia-Pacific region.

    METHODS: Newly diagnosed IBD cases between 2011 and 2013 from 13 countries or regions in Asia-Pacific were included. Incidence was calculated with 95% confidence interval (CI) and pooled using random-effects model. Meta-regression analysis was used to assess incidence rates and their association with population density, latitude, and longitude.

    RESULTS: We identified 1175 ulcerative colitis (UC), 656 Crohn's disease (CD), and 37 IBD undetermined (IBD-U). Mean annual IBD incidence per 100 000 was 1.50 (95% CI: 1.43-1.57). India (9.31; 95% CI: 8.38-10.31) and China (3.64; 95% CI, 2.97-4.42) had the highest IBD incidence in Asia. Incidence of overall IBD (incidence rate ratio [IRR]: 2.19; 95% CI: 1.01-4.76]) and CD (IRR: 3.28; 95% CI: 1.83-9.12) was higher across 19 areas of Asia with a higher population density. In China, incidence of IBD (IRR: 2.37; 95% CI: 1.10-5.16) and UC (IRR: 2.63; 95% CI: 1.2-5.8) was positively associated with gross domestic product. A south-to-north disease gradient (IRR: 0.94; 95% CI: 0.91-0.98) was observed for IBD incidence and a west-to-east gradient (IRR: 1.14; 95% CI: 1.05-1.24) was observed for CD incidence in China. This study received IRB approval.

    CONCLUSIONS: Regions in Asia with a high population density had a higher CD and UC incidence. Coastal areas within China had higher IBD incidence. With increasing urbanization and a shift from rural areas to cities, disease incidence may continue to climb in Asia.

    Matched MeSH terms: Ethics Committees, Research
  6. Ri Wei Andrew Chin, Yun, Yuan Chua, Min, Ning Chu, Nur Farhanie Mahadi, Muhammad Saiful Bahri Yusof, Mung, Seong Wong, et al.
    The academic life of medical students can be considered as psychological toxic. About
    half of United States medical students experience burnout and more than 25% experience depression.
    This study aimed to determine the prevalence of burnout among medical students in a Malaysian
    medical school and its associated factors. Methods: This is a cross sectional study of 452 medical
    students from Universiti Sains Malaysia (USM). Copenhagen Burnout Inventory was distributed
    via Google Forms through Facebook Messenger. Ethical approval was obtained from the Human
    Research Ethics Committee USM. Data were collected via Google Sheets. Each respondent only
    submitted one Google Form as no resubmission link was provided once completed Google Form was
    submitted. Result: The prevalence of burnout among USM medical students was 67.9%. Personal
    burnout was the highest (81.6%), followed by work-related burnout (73.7%) and client-related
    burnout (68.6%). The analysis showed that regardless of year of study, gender and ethnicity (all P >
    0.05), USM medical students were vulnerable to burnout. Conclusion: The prevalence of burnout
    among USM medical students was high and the most prevalent type of burnout was personal burnout.
    Therefore, burnout among medical students should be a concern and must be addressed to prevent
    subsequent unwanted consequences.
    Matched MeSH terms: Ethics Committees, Research
  7. Palafox B, Seguin ML, McKee M, Dans AL, Yusoff K, Candari CJ, et al.
    BMJ Open, 2018 Jul 30;8(7):e024000.
    PMID: 30061449 DOI: 10.1136/bmjopen-2018-024000
    INTRODUCTION: Hypertension is a leading contributor to the global burden of disease. While safe and effective treatment exists, blood pressure control is poor in many countries, often reflecting barriers at the levels of health systems and services as well as at the broader level of patients' sociocultural contexts. This study examines how these interact to facilitate or hinder hypertension control, taking into account characteristics of service provision components and social contexts.

    METHODS AND ANALYSIS: The study, set in Malaysia and the Philippines, builds on two systematic reviews of barriers to effective hypertension management. People with hypertension (pre-existing and newly diagnosed) will be identified in poor households in 24-30 communities per country. Quantitative and qualitative methods will be used to examine their experiences of and pathways into seeking and obtaining care. These include two waves of household surveys of 20-25 participants per community 12-18 months apart, microcosting exercises to assess the cost of illness (including costs due to health seeking activities and inability to work (5 per community)), preliminary and follow-up in-depth interviews and digital diaries with hypertensive adults over the course of a year (40 per country, employing an innovative mobile phone technology), focus group discussions with study participants and structured assessments of health facilities (including formal and informal providers).

    ETHICS AND DISSEMINATION: Ethical approval has been granted by the Observational Research Ethics Committee at the London School of Hygiene and Tropical Medicine and the Research Ethics Boards at the Universiti Putra Malaysia and the University of the Philippines Manila. The project team will disseminate findings and engage with a wide range of stakeholders to promote uptake and impact. Alongside publications in high-impact journals, dissemination activities include a comprehensive stakeholder analysis, engagement with traditional and social media and 'digital stories' coproduced with research participants.

    Matched MeSH terms: Ethics Committees, Research
  8. Nor Dalila Marican, Rozita Hod, Nadiah Wan-Arfah, Azmi Hassan
    Int J Public Health Res, 2018;8(1):933-938.
    Introduction Non-specific low back pain is one of the most common physical ailments
    affecting millions of people worldwide. This condition constitutes a
    significant public health problem and was listed as a prevalent health
    complaint in most societies. Even though there are many anecdotal claims
    for reflexology in the treatment of various conditions such as a migraine,
    arthritis and multiple sclerosis, but very little clinical evidence exists for
    reflexology on the management of low back pain per se. This study aims to
    evaluate the effects of foot reflexology therapy as an adjunctive treatment to
    the Malaysian low back pain standard care in relieving pain and promoting
    health-related quality of life among people with non-specific low back pain.
    Methods This is a parallel randomized controlled trial with pre and post-treatment
    study design. The study setting for the intervention located at Penawar
    Reflexology Center, Kuala Terengganu, Malaysia. A total of 100
    participants with non-specific low back pain will be allocated to one of two
    groups, using a randomization computer program of Research Randomizer.
    The control group will receive low back pain standard care, while the
    intervention group will receive standard care plus eight sessions of foot
    reflexology therapy. The pain intensity and health-related quality of life
    scores will be measured using Visual Analogue Scale and Euro-quality of
    life scale respectively in both groups. The study was approved by the
    Human Research Ethics Committee of University Sultan Zainal Abidin
    (UHREC/2016/2/011). The study protocol was registered at
    ClinicalTrials.gov, with the ID number of NCT02887430.
    Measurements Outcome measures will be undertaken at pre-intervention (week 1), postintervention
    (week 6) and follow-up (week 10).
    Conclusions This will be the first trial to compare the foot reflexology therapy with
    control group among people who medically diagnosed with non-specific low
    back pain in Malaysia. The result of this study will contribute to better
    management of this population, especially for Malaysia healthcare setting.
    Matched MeSH terms: Ethics Committees, Research
  9. Sazlina SG, Browning CJ, Yasin S
    BMJ Open, 2012;2(6).
    PMID: 23161092 DOI: 10.1136/bmjopen-2012-002119
    INTRODUCTION: Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care.
    METHODS AND ANALYSIS: A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals.
    TRIAL REGISTRATION: This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).
    Matched MeSH terms: Ethics Committees, Research
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