Displaying publications 1 - 20 of 85 in total

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  1. Yusof MYPM, Teo CH, Ng CJ
    BMC Med Ethics, 2022 Nov 21;23(1):117.
    PMID: 36414962 DOI: 10.1186/s12910-022-00849-x
    BACKGROUND: The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.

    METHODS: The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.

    RESULTS: Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.

    CONCLUSION: The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

    Matched MeSH terms: Informed Consent*
  2. Yuhanif Yusof, Anisah Che Ngah, Zaki Morad Mohamad Zaher
    Int J Public Health Res, 2014;4(1):384-390.
    MyJurnal
    Introduction The aim of this study was to examine the aspect of information disclosure by doctor-investigator during the process of obtaining informed consent in clinical trials.
    Methods This research employed a mixed-method data collection that is library research and interview. A qualitative methodology and analysis were used in an open-ended, face-to-face interviews with 17 patient-subjects. The interview questions were based on information that needed to be disclosed to patient-subjects during the process of obtaining informed consent. Each interview took place in Kajang Hospital and National Heart Institute and lasted 25-30 minutes. Interviews were conducted in Bahasa Melayu and English. The interviews were tape-recorded, and the main points from the interviews were jotted down to ensure that all information was adequately gathered. Interviewed occurred in Kajang Hospital and National Heart Institute. The participants were patients who had been referred to the Kajang Hospital and National Heart Institute. They were recruited (8 from Kajang Hospital and 9 from National Heart Institute) by their own doctors to participate in a study to evaluate the safety and effectiveness of the investigational stent after been diagnosed with coronary artery disease and also in a study to investigate drug for antidepressant. respectively.
    Results The study revealed that doctor-investigators fail to disclose full information to patient-subjects. Instead, doctor-investigators only disclosed information which they thought were necessary for the patient-subjects to know. The study also showed that there were doctor-investigators who did not disclose information at all to the patient-subjects.
    Conclusions This study implies that the aspect of information disclosure in the process of obtaining informed consent in clinical trials is rather poor and did not fulfill the criterion of good medical practice. A random monitoring task to be conducted by the research ethics commitees during the informed consent process is suggested.
    Matched MeSH terms: Informed Consent
  3. Yousuf RM, Fauzi AR, How SH, Akter SF, Shah A
    Singapore Med J, 2009 May;50(5):494-9.
    PMID: 19495519
    Optimal patient care varies considerably from place to place and is influenced by scientific as well as social developments. The purpose of this study was to investigate awareness and pertinent issues regarding informed consent among hospitalised patients and to determine lapses, in order to improve the standard of care.
    Matched MeSH terms: Informed Consent/legislation & jurisprudence*
  4. Yousuf RM, Fauzi AR, How SH, Rasool AG, Rehana K
    Singapore Med J, 2007 Jun;48(6):559-65.
    PMID: 17538757
    Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals.
    Matched MeSH terms: Informed Consent*
  5. 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: Informed Consent
  6. Vollrath J
    Bioethics, 1989 Apr;3(2):93-105.
    PMID: 11649247 DOI: 10.1111/j.1467-8519.1989.tb00331.x
    Matched MeSH terms: Informed Consent
  7. Victor Lim
    MyJurnal
    Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decision making. The paternalistic approach by doctors is no longer acceptable. Today the patient has the right to receive and the doctor the obligation to give sufficient and appropriate information so that the patient can make an informed decision to accept or refuse a treatment option. This has led to higher standards of practice in the process of informed consent taking. Consent taking is both a legal and moral requirement. Failure to comply with standards of practice can result in criminal prosecution, civil litigation or disciplinary action by the relevant professional authority. Consent taking is a process and not merely a one-off affixation of the patient’s signature on consent form. It involves a continuous discussion to reflect the evolving nature of treatment from before the treatment is given to the post-operative or discharge period. The regulatory authorities in many countries have established standards for consent taking which would include the capacity of the patient, the person who should seek consent, the information to be provided and the necessary documentation.
    Matched MeSH terms: Informed Consent
  8. Vaithilingam RD, Safii SH, Baharuddin NA, Karen-Ng LP, Saub R, Ariffin F, et al.
    Oral Dis, 2015 Jan;21(1):e62-9.
    PMID: 24930489 DOI: 10.1111/odi.12267
    Periodontal bio-repositories, which allow banking of clinically validated human data and biological samples, provide an opportunity to derive biomarkers for periodontal diagnosis, prognosis and therapeutic activities which are expected to improve patient management. This article presents the establishing of the Malaysian Periodontal Database and Biobank System (MPDBS) which was initiated in 2011 with the aim to facilitate periodontal research. Partnerships were established with collaborating centres. Policies on specimen access, authorship and acknowledgement policies were agreed upon by all participating centres before the initiation of the periodontal biobank. Ethical approval for the collection of samples and data were obtained from institutional ethics review boards. A broad-based approach for informed consent was used, which covered areas related to quality of life impacts, genetics and molecular aspects of periodontal disease. Sample collection and processing was performed using a standardized protocol. Biobanking resources such as equipment and freezers were shared with the Malaysian Oral Cancer Database and Tissue Bank System (MOCDTBS). In the development of the MPDBS, challenges that were previously faced by the MOCDTBS were considered. Future challenges in terms of ethical and legal issues will be faced when international collaborations necessitate the transportation of specimens across borders.
    Matched MeSH terms: Informed Consent
  9. Urban John Arnold D’Souza, Vinod Kumar S., Nagesh Chodankar
    MyJurnal
    Introduction: Regular physical activity and VO2 max are correlated directly. Physical anthropometry physical ac-tivity, lung function and cardiac parameters such as systolic, diastolic blood pressure and resting heart rate are the important baseline parameters in relation to the a healthy life. In this study, a comprehensive determination of these parameters were planned among the common ethnicities of Sabah. This study in turn aims at making the sedentary people to make physically active and implicate a possible relationship between cardio-respiratory parameters with the physical activity levels. Methods: A total of 385 young adult Sabah, Malaysia college students with n=148 males and n= 237 females were randomly selected from the different colleges in Kota Kinabalu. Ethical clearance was received from Faculty of Medicine & Health Sciences UMS, and the participants were briefed on the procedures with their voluntary consent. IPAQ-Score/Met-Min/Week, BMI, resting heart rate, blood pressure, lung function parameters – forced vital capacity, peak expiratory flow rate etc were estimated by standard techniques. Data was analyzed, a regression analysis and ANOVA was performed to assess the relationship between independent and dependent variables. Results: Physical activity level has a significant correlation with the dependent variables of this study. VO2max is significantly and inversely related to body weight, BMI, blood pressure and pulse rate, whereas physical activity level is directly correlated. A weak positive correlation for VO2 max with lung function parameters.Conclusion: Physical activity, VO2 max and cardio-respiratory parameters; interdependently correlated and regular activity contributed to the rate of oxygen consumption.
    Matched MeSH terms: Informed Consent
  10. Tumin M, Abdul Talib Abdul Mutalib M, Mohd Satar N, Abdullah N, Chong CS, Ng KP, et al.
    Ann. Transplant., 2014;19:112-8.
    PMID: 24584108 DOI: 10.12659/AOT.889490
    Informed consent of prospective donors should include information about the quality of life (QoL) of existing donors, especially those within the relevant country. This study aimed to provide information on Malaysian organ donors' QoL relative to a control group.
    Matched MeSH terms: Informed Consent/psychology*
  11. Talib N
    Med Law, 2010 Sep;29(3):433-42.
    PMID: 22145562
    The doctrine of informed consent has the effect of allowing the mentally competent adult patient to exercise individual choice in any proposed medical treatment. The ethical principles primarily inherent in this doctrine would be the principles of autonomy and beneficence. However, it is argued in this essay that the concept and meaning of autonomy might be vastly different between western and eastern communities. Consequently the doctrine of informed consent will lead to a different meaning in these different societies. The essay also raises the implication of transplanting legal doctrines into societies which might not be fully prepared to implement the ideal contained in the doctrine of informed consent.
    Matched MeSH terms: Informed Consent/legislation & jurisprudence*
  12. Soong Shui Fun, Segaran Ramodran, Chyretta Burno, Mohd Ishkandar Nazlan, Wihelmina Michael
    MyJurnal

    Introduction: The Ministry of Health Malaysia over the last 20 years has initiated healthy lifestyle campaign to curb obesity but the issue has remained an escalating problem affecting Malaysians. Obesity among students in higher institute is a concern. Undergraduate student nurses as role-model advocating health, being overweight can be a problem. This study is to identify BMI status and determine associated lifestyle factors among undergraduate nurses in UMS. Methods: The study deployed a cross-sectional descriptive survey using a questionnaire to empirically asses BMI status and associated dietary and exercise practice among student nurses. Ethical clearance for the study was ob- tained from UMS`s REC and as well as respondents` consent. A total of 100(N) nursing students were selected through stratified sampling by year of study (year 1, n=35; year 2 n=35; and year 3 n=30). Random sampling for each year of study was done using full name list generated using Microsoft excel. The study tool consists of a validated instrument which captured the respondent’s demographics, BMI index, Healthy Eating Practice Index, and Exercise Practice Inventory. Results: Among the 100 student nurses in this study, 28 students had BMI index of more than 24.9 (either being overweight, obesity Type I or Type II). Students from finalYear 3are significantly overweight(p=0.03) compared to Year 1 or Year 2 students. Comparing respondents with optimum BMI and non-optimum BMI, students who are overweight had significantly poorer Healthy Eating Practice scores and poorer Exercise practice scores. Conclusion: Findings from this study imply that 1 in 4 nursing students are overweight mostly related to poor lifestyle habits. These findings raise the rhetoric and implication of overweight nurses as health care role -models and this paper will discuss some suggestions to address the issue.

    Matched MeSH terms: Informed Consent
  13. Soegiarto G, Abdullah MS, Damayanti LA, Suseno A, Effendi C
    Asia Pac Allergy, 2019 Apr;9(2):e17.
    PMID: 31089459 DOI: 10.5415/apallergy.2019.9.e17
    Background: The prevalence of allergy among Surabaya school children is currently unknown.

    Objective: To identify the prevalence of the common allergic sensitization and allergic diseases among school children and undergraduate students in suburban of Surabaya by epidemiologic data collection.

    Methods: A multistage simple random sampling was done to select 5 primary schools, 8 secondary schools (4 of junior high schools and senior high schools, respectively), and 1 university from 5 districts in Surabaya city. Out of 550 invited respondents, 499 (128 primary school, 221 secondary school, and 150 undergraduate) respondents gave their consent. A complete personal history, allergic symptoms, environmental exposure of common allergens was obtained from interview and the physical examinations were performed. Skin prick test (SPT) was done using 45 different allergen extracts. Total serum IgE and specific IgE radioallergosorbent test levels were measured for respondents with allergic manifestations.

    Results: There was an increasing SPT positivity among study respondents, from primary school, secondary school, to undergraduate students (21.90%, 28.95%, to 45.30% respectively). Cockroach (42.85%) and fungi/mold spore (42.85%) were the most common allergens in primary school children. House dust mites was the most common allergen in secondary school (63.16%) and undergraduate students (58.82%). Urticaria and rhinitis were the commonest allergic diseases manifestation. History of atopy was positive in 60.79% of the allergic respondents.

    Conclusion: The prevalence of allergic sensitization among school children and undergraduate students in Surabaya suburb areas were increased compared to previous estimates in 1998. While house dust mites are known as important allergens, surprisingly cockroach was the common allergen among the younger school children.

    Matched MeSH terms: Informed Consent
  14. Sivalingam N
    Med J Malaysia, 2011 Dec;66(5):421-2.
    PMID: 22390093 MyJurnal
    Matched MeSH terms: Informed Consent*
  15. Sia, B.T., Low, S.Y., Foong, W.C., Prmasivah, M., Khor, C.Z., Say, Y.H.
    MyJurnal
    As the sugar intake of Malaysians is one of the highest in the Asia Pacific region, we wanted to investigate how this high prevalence of ‘sweet tooth’ is influenced by biological determinants like age, gender, ethnicity and Body Mass Index (BMI). Therefore, this study was to determine the demographic and BMI differences of preference, intake frequency and craving of a list of sweet beverages and food among Malaysian subjects. Convenience sampling was performed around Kuala Lumpur, with informed consents, involving 367 multi-ethnic subjects (163 males, 204 females; 83 Malays, 201 Chinese, 83 Indians; 209 lean, 158 overweight). Demographics and anthropometric measurements were taken and questionnaire on the preference/frequency/craving of a list of 22 sweet food and beverages with a 7 point hedonic scale (from 1= very unpleasant/never/never crave to 7 = very pleasant/at least once a day/ always crave) was performed. Females significantly preferred more, took less frequently but had equal craving of sweet foods compared to males. Lean subjects and those
    Matched MeSH terms: Informed Consent
  16. Shakeel S, Nesar S, Rahim N, Iffat W, Ahmed HF, Rizvi M, et al.
    J Pharm Bioallied Sci, 2017 Oct-Dec;9(4):266-271.
    PMID: 29456378 DOI: 10.4103/jpbs.JPBS_327_16
    Aims: Despite an increased popularity of print and electronic media applications, there is a paucity of data reflecting doctors' opinions regarding efficient utilization of these resources for the betterment of public health. Hence, this study aimed to investigate the perception of physicians toward the effect of electronic and print media on the health status of patients.
    Setting and Design: The current research is a cross-sectional study conducted from January 2015 to July 2015. The study population comprised physicians rendering their services in different hospitals of Karachi, Pakistan, selected by the nonprobability convenience sampling technique. In this study, 500 questionnaires were distributed through email or direct correspondence.
    Methods and Materials: Physicians' perception toward the impact of electronic and print media on the health status of patients was assessed with a 20-item questionnaire. Different demographic characteristics, such as age, gender, institution, position, and experience of respondents, were recorded. Quantitative data were analyzed with the use of Statistical Package for Social Sciences, version 20.0 (SPSS, Chicago, IL). The association of the demographic characteristics of the responses of physicians was determined by one-way ANOVA using 0.05 level of significance.
    Results: In this study, 254 physicians provided consent to show their responses for research purposes. A response rate of 50.8% was obtained. Nearly one-third of the respondents negated that patients get health benefit using electronic and print media. The majority did not consider electronic and print media as lifestyle-modifying factors. Physicians thought that patients particularly do not rely on mass media for acquiring health information and consider healthcare professionals as unswerving information resource.
    Conclusions: Mass media can be productive resources to augment awareness among patients, although physicians seem unconvinced about the extended usage of print/electronic media.
    Matched MeSH terms: Informed Consent
  17. Segaran Ramodran, Billy Bryan Jafrin, Mellonna Ignatia Jeffrey Liew, Nurul MadihahMohd Raeh, Juecella Joyce Jalius
    MyJurnal
    Introduction: EC1773 is a community outreach program conducted annually by Universiti Malaysia Sabah (UMS). It serves as a platform for nursing and medical students to collaborate hands-on health promotion for rural commu- nities. As of date, there has been no empirical study to gauge student`s post-program satisfaction. This study aims to evaluate satisfaction among students who have undergone the UMS-led community out-reach program and identify gaps for improvement. Methods: The study entailed a cross-sectional design involving 165 (N) nursing(n=65) and medical students (n=100) who had completed a 10-day rural outreach program. Ethical approval was obtained from the Research Ethics Committee of UMS as well-informed consent from respondents. A 25- item questionnaire requir- ing Likert-scale responsewas used to evaluatethe level of satisfaction across 5 sub-categories namely; pre-departure preparation & briefing;onsite facilities and logistics; teamwork; community participation and learning achievements. Results: Among 165 nursing -medical students in the study, 88% (n=146) were satisfied and 12% (n=19) were dis- satisfied with the UMS-led outreach program. Sub-category items rated as satisfactory were community participation 96% and learning achievements 91%. Poor satisfaction highlighted by respondents regarding the out-reach program were inadequacy of facilities and poor logistics 62% and quality of pre-departure preparation and briefing 66%. Nursing students reported significantly higher dissatisfaction (p=0.04) regarding teamwork and adequacy of onsite facilities and logistics. Conclusion: Findings from this study infers that student’s post-evaluation towards the UMS-led outreach is generally satisfactory but has specific shortfalls that need to be addressed.
    Matched MeSH terms: Informed Consent
  18. Segaran Ramodran, Lenny Seputri Masse, Nurul Hanis Syazwan Irawan, Suhailah Saniman
    MyJurnal
    Introduction: Smartphone has become an essential Smart-tool for IT-based learning among university students. How- ever, excessive use of smartphones can be addictive leading to psychological distress, poor academic performance, social isolation and depression. In the context of University Malaysia Sabah (UMS), the issue of contention is whether smartphone addiction is a problem among nursing undergraduate students and thus the justification for this study. This study evaluated the pattern of usage smartphone and addiction among nursing students in UMS. Methods: The study deployed a cross-sectional survey design involving 100 (N) respondents selected through clustered convenient sampling from year 1(n=35), year 2 (n=35) and year 3 (n=30) nursing students who are currently pursuing their di- ploma study in UMS. Ethical approval was obtained from the Research Ethics Committee of UMS as well-informed consent from respondents. The study tool consisted of a well-establish validated questionnaire benchmarked from a previous study (reliability Cronbach α= 0.78) which captured respondents’ socio-demographics, smartphone us- age characteristic proforma and Smart Addiction Scale (SAS). Results: Among 100 nursing students in this study, 78% (n=78) of them had high smartphone usageaveraging 4.3 hours daily. The overall prevalence of smartphone addiction among nursing students in this study was 25% (n=25). Male student nurses significantly had higher smart- phone addiction scores compared to female students (p=0.01). Likewise, year 3 students had higher addiction scores compared to their peers in year 2 or year 1 (p=0.002). Conclusion: findings from this study imply that smartphone addiction affects 1 in 4 nursing students in UMS and there is a need to develop ‘digital detox” strategies to address the issue.
    Matched MeSH terms: Informed Consent
  19. Salauddin SA, Ghazali H
    Malays J Med Sci, 2019 Nov;26(6):137-142.
    PMID: 31908595 MyJurnal DOI: 10.21315/mjms2019.26.6.14
    Background: Penile augmentation using injection of a foreign body into penile skin was mainly performed by non-medical personnel. Majority of these patients end up with complication of an abnormal mass formation known as penile paraffinoma.

    Methods: We described three different surgical techniques for correction of penile paraffinoma based on our single-centre experience. Informed consents were obtained from patients whose photographs were taken during the operation step.

    Results: In general, three patients had simple excision biopsy with primary suturing, four patients underwent single stage excision of circumferential granuloma with bilateral scrotal skin flap reconstruction and one patient experienced dual stage procedure. Three of them were injected with paraffin, one with silicone and the remaining four were unable to identify the substance used. All patients successfully underwent the surgical procedure and four of them had minor post-operative surgical site infection and wound gapping.

    Conclusion: All patients recovered well and the mean International Index of Erectile Function (IIEF-5) score obtained was 24.25. In our experience, excision biopsy was adequate for focal mass and reconstructive surgery using bilateral scrotal flap was suitable for circumferential mass.

    Matched MeSH terms: Informed Consent
  20. Safurah Khairul Fadzil, Marhanis Salihah Omar, Noorlaili Mohd Tohit
    Int J Public Health Res, 2018;8(2):998-105.
    MyJurnal
    Introduction The use of dietary supplements had risen over the years among chronic
    disease patients with most of it were of patients' own initiative. This study
    aimed to describe the supplements use, assess the knowledge and attitude
    towards supplements and its interaction with prescribed medication, and
    determine whether knowledge and attitude towards supplements could
    influence treatment adherence in chronic disease patients.
    Methods A cross-sectional study was conducted among chronic disease patients in
    Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpur from
    September to November 2016 upon their written informed consent. This
    study consists of a collection of validated instruments that measured the use
    of dietary supplements and its reason; the knowledge and attitude on dietary
    supplements and supplements-drug interaction and medication adherence.
    Results A total number of 250 respondents were interviewed and 72.4% was found to
    use supplements of own initiatives. Most of the respondents were using
    supplements to maintain health (78.8%), prevent health problems (72.4%)
    and improve overall health (63.2%). It was found that respondents'
    knowledge on supplement-drug interactions were not at the satisfactory level.
    The treatment adherence was found not to be associated with knowledge and
    attitude towards supplements nor numbers of supplements use.
    Conclusions Chronic disease patients mainly knew on the purpose of supplements for
    health and wellness, but had less knowledge on supplement-drug interactions,
    warranting patients' education on that particular field.
    Matched MeSH terms: Informed Consent
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