Displaying publications 1 - 20 of 38 in total

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  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. Lantos JD, Saleem S, Raza F, Syltern J, Khoo EJ, Iyengar A, et al.
    J Clin Ethics, 2019 3 22;30(1):35-45.
    PMID: 30896442
    In this article, we first review the development of clinical ethics in pediatrics in the United States. We report that, over the last 40 years, most children's hospitals have ethics committees but that those committees are rarely consulted. We speculate that the reasons for the paucity of ethics consults might be because ethical dilemmas are aired in other venues. The role of the ethics consultant, then, might be to shape the institutional climate and create safe spaces for the discussion of difficult and sometimes contentious issues. Finally, we report how pediatric clinical ethics has evolved differently in a number of other countries around the world.
    Matched MeSH terms: Ethics Committees; Ethics Committees, Clinical
  3. Devaraj TP
    Med J Malaysia, 2000 Aug;55 Suppl B:38-42.
    PMID: 11125520
    To answer the question posed the terms of reference of local ethical committees as well as a few from overseas were reviewed. It was noted that these committees were established by various professional bodies and functioned independently. Guidelines for ethical practice and conduct were made available to the profession with compliance left to the individual doctor. Amongst the many ethical issues of concern both to the public and the profession was that of self regulation. It is being suggested that these concerns be addressed rather then set up a national body.
    Matched MeSH terms: Ethics Committees*
  4. Tackett S, Ng CJ, Sugarman J, Daniel EGS, Gopalan N, Tivyashinee T, et al.
    Dev World Bioeth, 2024 Jun;24(2):74-83.
    PMID: 36861660 DOI: 10.1111/dewb.12396
    The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; non-institution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity.
    Matched MeSH terms: Ethics Committees, Research*
  5. Mak, Joon-Wah
    MyJurnal
    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
  6. Zee TW, Abdul Aziz MFB, Wei PC
    Dev World Bioeth, 2024 Dec;24(4):331-341.
    PMID: 37997006 DOI: 10.1111/dewb.12435
    Even though there is a significant amount of scholarly work examining the ethical issues surrounding human genomics research, little is known about its footing in Malaysia. This study aims to explore the experience of local researchers and research ethics committee (REC) members in developing it in Malaysia. In-depth interviews were conducted from April to May 2021, and the data were thematically analysed. In advancing this technology, both genomics researchers and REC members have concerns over how this research is being developed in the country especially the absence of a clear ethical and regulatory framework at the national level as a guidance. However, this study argues that it is not a salient issue as there are international guidelines in existence and both researchers and RECs will benefit from a training on the guidelines to ensure genomics research can be developed in an ethical manner.
    Matched MeSH terms: Ethics Committees, Research*
  7. Karbwang J, Torres CE, Navarro AM, Wongwai P, Jimenez EB, Shetty Y, et al.
    F1000Res, 2024;13:19.
    PMID: 39165349 DOI: 10.12688/f1000research.143138.1
    BACKGROUND: COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active.

    METHODS: The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test.

    RESULTS: A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs.

    CONCLUSIONS: Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

    Matched MeSH terms: Ethics Committees, Research*
  8. Hashim HA, Abidin AFZ, Salleh Z, Devi SS
    Data Brief, 2020 Jun;30:105624.
    PMID: 32395587 DOI: 10.1016/j.dib.2020.105624
    Panel dataset in this article contains information on the ethical commitment disclosures of Malaysian publicly listed companies. The data presented is related to the research article entitled "Ethical Practice Disclosure of Malaysian Public Listed Companies" [1]. In examining the level of ethical commitment disclosures, content analysis is performed involving 1,115 annual reports for five year periods (2012 - 2016). The annual reports are gathered from Main Market of Bursa Malaysia website. Information on ethical commitment disclosures are extracted from the annual reports. The data are collected using Ethical Commitment Index (ECI) comprising six themes; corporate ethics values, action to promote ethics, whistle-blowing policy, code of ethics, sustainability practices, and ethics committee. This dataset is useful as an indicator of the companies' ethical commitment reflecting ethical climate in Malaysian public listed companies.
    Matched MeSH terms: Ethics Committees
  9. Ting CY, Adruce SAZ, Hassali MA, Ting H, Lim CJ, Ting RS, et al.
    Trials, 2019 05 10;20(1):267.
    PMID: 31077233 DOI: 10.1186/s13063-019-3348-x
    After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject's inclusion criteria, the funding and acknowledgements. These changes were made during the recruitment of participants and after approved by the Medical Research and Ethics Committee (MREC), National Institutes of Health Malaysia, on 16th November 2018.
    Matched MeSH terms: Ethics Committees, Research
  10. Abusafia AH, Roslan NS, Mohd Yusoff D, Mat Nor MZ
    J Taibah Univ Med Sci, 2018 Aug;13(4):370-376.
    PMID: 31435349 DOI: 10.1016/j.jtumed.2018.04.003
    Objective: The aim of this study was to evaluate academic dishonesty among nursing students at a public university in Malaysia.

    Methods: This study utilized a descriptive and cross-sectional design to evaluate academic dishonesty among nursing students using a purposive sampling method. The participants of this study consisted of 201 students from diploma (Year 2 and 3) and degree (Year 2 to Year 4) nursing programmes. A self-administered, validated questionnaire was used for data collection. Institutional ethics committee clearance was obtained prior to commencement of the study.

    Results: The results of this study showed that 82.1% and 74.6% of nursing students had engaged at least once in an act of academic dishonesty in an academic or clinical setting, respectively. The most frequent form of academic dishonesty in an academic setting was plagiarism (77.1%). There was a significant association between gender and academic dishonesty in a clinical setting (p 

    Matched MeSH terms: Ethics Committees
  11. Noordin, M.I., Chung, L.Y.
    JUMMEC, 2007;10(2):43-50.
    MyJurnal
    Rectal delivery of drugs has been proven to be effective in terms of drug absorption and distribution comparable with other routes such as oral, buccal, sublingual or even nasal. In this study, two new suppository bases were developed using combinations of locally sourced hydrogenated palm kernel oil, hydrogenated palm kernel stearin and hydrogenated palm kernel olein with mixtures of stearic acid and glyceryl monostearate. When formulated with aspirin, these bases produced suppositories with acceptable characteristics. These aspirin suppositories were tested on twelve healthy subjects after an approval from the Medical Ethics Committee, University of Malaya had been procured. We quantified aspirin from the urine samples of the subjects to determine the relative availability of the different suppository preparations relative to an oral dose. The excretion of salicylic acid, one of the metabolite of aspirin in human urine taking aspirin was quantified. The F value was found to range from 1.16 to 1.38. Hence, the excretion results showed that these palm kernel oil blends are suitable suppository bases.
    Matched MeSH terms: Ethics Committees
  12. See HY, Mohamed MS, Nor SNM, Low WY
    J Empir Res Hum Res Ethics, 2021 12;16(5):487-500.
    PMID: 34292842 DOI: 10.1177/15562646211033191
    Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.
    Matched MeSH terms: Ethics Committees, Research
  13. Mohd Said Nurumal, Mohammad Syafiq Mohamad Azizi, Muhammad Kamil Che Hasan
    MyJurnal
    Introduction: Simulation is widely practiced as learning strategies in many disciplines including nursing. It is con- sidered an updated technological approach towards providing safe and sound patients care. Thus, this study was conducted to assess the level of knowledge among nursing students using a simulated mannequin for cardiovascular assessment. Methods: This is a cross-sectional study design focusing Year 4 nursing students at Kulliyyah of Nurs- ing, International Islamic University Malaysia (IIUM). A simulation mannequin was used for students performing a cardiovascular assessment. Level of knowledge was tested using an adapted questionnaire. The study was approved by the Kulliyyah of Nursing Postgraduate Research Committee (Ref: IIUM/313/DDAA/20/4/10) and IIUM Research Ethics Committee (Ref: IREC 2018-024). Results: A total of 57 nursing students involved in this study revealing good cardiovascular assessment knowledge. Majority of them reported that simulation exercise is one of the good learning strategies to enhance their capabilities and increase their confidence level. Conclusions: The results from this study could indicate that using technological simulation approach could provide a similar effect in performing cardiovas- cular assessment among nursing student IIUM. Future larger scale is needed including for any other disciplines in nursing to facilitate students’ preparation towards the real clinical setting.

    Matched MeSH terms: Ethics Committees, Research
  14. 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*
  15. Kaur S
    J Med Ethics, 2013 Apr;39(4):230.
    PMID: 23077337 DOI: 10.1136/medethics-2012-100965
    Matched MeSH terms: Ethics Committees, Research*
  16. Yoshizawa G, Sasongko TH, Ho CH, Kato K
    Front Genet, 2017;8:99.
    PMID: 28775738 DOI: 10.3389/fgene.2017.00099
    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.
    Matched MeSH terms: Ethics Committees, Research
  17. Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, et al.
    Am J Gastroenterol, 2019 01;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
  18. Bicchierai G, Nori J, De Benedetto D, Boeri C, Vanzi E, Bianchi S, et al.
    Tumori, 2019 Oct;105(5):378-387.
    PMID: 30558495 DOI: 10.1177/0300891618816212
    PURPOSE: To evaluate the role of contrast-enhanced spectral mammography (CESM) in the post biopsy management of breast lesions classified as lesions of uncertain malignant potential (B3) by core needle biopsy and vacuum-assisted biopsy (VAB).

    METHODS: The local ethics committee approved this retrospective study and for this type of study formal consent is not required. A total of 42 B3 lesions in 40 women aged 41-77 years were included in our study. All patients underwent CESM 2-3 weeks after the biopsy procedure and surgical excision was subsequently performed within 60 days of the CESM procedure. Three radiologists reviewed the images independently. The results were then compared with histologic findings.

    RESULTS: The sensitivity, specificity, and positive and negative predictive values for confirmed demonstration of malignancy at CESM were 33.3%, 87.2%, 16.7%, and 94.4% for reader 1; 66.7%, 76.9%, 18.2%, and 96.7% for reader 2; 66.7%, 74.4%, 16.7%, and 96.7% for reader 3. Overall agreement on detection of malignant lesions using CESM among readers ranged from moderate to substantial (κ = .451-.696), for categorization of BPE from moderate to substantial (κ = .562-.711), and for evaluation of lesion intensity enhancement from fair to moderate (κ = .346-.459).

    CONCLUSION: In cases of Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or BI-RADS 3 results at CESM, follow-up or VAB rather than surgical biopsy might be performed.

    Matched MeSH terms: Ethics Committees
  19. Tan, Mark Kiak Min
    MyJurnal
    Prematurity is the leading cause of infant mortality and one of the main reasons for newborn infants to be admitted to the Neonatal Intensive Care Unit (NICU). Advancements in medicine has made the NICU a maze of sophisticated modern technology and expensive to run. These advances in technology have also resulted in an added layer of complexity to many ethical dilemmas that are encountered in the NICU. In 1977, Beauchamp and Childress introduced the principles of biomedical ethics. These four principles of (1)respect for autonomy, (2)nonmaleficence, (3)beneficence and (4)justice, form a suitable starting point for the analysis of the moral challenges of medical innovation. This article explores how the four ethical principles relate to decision-making in the NICU, and how they can be applied to the treatment of sick newborn infants in clinical practice. It also highlights the reasons why healthcare personnel need to equip themselves with good communication skills and up to date knowledge of ethical considerations in the NICU in order to make quality decisions about care for their patients. This article also suggests that a Clinical Ethics Committee can play a vital role in ensuring that the best decisions are achieved for these patients.
    Matched MeSH terms: Ethics Committees, Clinical
  20. Huh JW, Maeda K, Liu Z, Wang X, Roslani AC, Lee WY
    Ann Coloproctol, 2020 Apr;36(2):70-77.
    PMID: 32054250 DOI: 10.3393/ac.2020.01.19
    PURPOSE: Current acceptance of the watch-and-wait (W&W) approach by surgeons in Asia-Pacific countries is unknown. An international survey was performed to determine status of the W&W approach on behalf of the Asia-Pacific Federation of Coloproctology (APFCP).

    METHODS: Surgeons in the APFCP completed an Institutional Review Board-approved anonymous e-survey and/or printed letters (for China) containing 19 questions regarding nonsurgical close observation in patients who achieved clinical complete response (cCR) to neoadjuvant chemoradiotherapy (nCRT).

    RESULTS: Of the 417 responses, 80.8% (n = 337) supported the W&W approach and 65.5% (n = 273) treated patients who achieved cCR after nCRT. Importantly, 78% of participants (n = 326) preferred a selective W&W approach in patients with old age and medical comorbidities who achieved cCR. In regard to restaging methods after nCRT, the majority of respondents based their decision to use W&W on a combination of magnetic resonance imaging results (94.5%, n = 394) with other test results. For interval between nCRT completion and tumor response assessment, most participants used 8 weeks (n = 154, 36.9%), followed by 6 weeks (n = 127, 30.5%) and 4 weeks (n = 102, 24.5%). In response to the question of how often responders followed-up after W&W, the predominant period was every 3 months (209 participants, 50.1%) followed by every 2 months (75 participants, 18.0%). If local regrowth was found during follow-up, most participants (79.9%, n = 333) recommended radical surgery as an initial management.

    CONCLUSION: The W&W approach is supported by 80% of Asia-Pacific surgeons and is practiced at 65%, although heterogeneous hospital or society protocols are also observed. These results inform oncologists of future clinical study participation.

    Matched MeSH terms: Ethics Committees, Research
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