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  1. Dal-Ré R, Voo TC, Holm S
    J Glob Health, 2023 Jan 20;13:04012.
    PMID: 36655916 DOI: 10.7189/jogh.13.04012
    BACKGROUND: It is unknown if changes have been made to the original participant's information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when it was transferred to participating countries.

    METHODS: National principal investigators from 30 countries were asked if the original PIS/ICF was edited in their countries and, if so, to share with us the one used to recruit participants. We assessed whether the 25 different elements of information from the good clinical practice guidelines and the Declaration of Helsinki were present in, deficiently described, or absent from the PIS/ICFs.

    RESULTS: Nineteen national principal investigators responded: eight (Argentina, Brazil, Ethiopia, Georgia, Iran, Lebanon, Lithuania, and Malaysia) stated that no edits were introduced to the original PIS/ICF; eight (Canada, Colombia, Philippines, India, Ireland, Pakistan, Portugal, and Switzerland) added some elements of information in the national PIS/ICF; and three (Italy, Peru, and Spain) reported not participating in the trial. None of the elements included in the original PIS/ICF were omitted from the edited PIS/IFC. Six elements of information were omitted and five deficiently described in the original PIS/ICF. The number of elements omitted from the edited PIS/ICFs varied (range = 2-5). Nine PIS/ICFs incompletely described or omitted the informing of study participants about the study results, while five deficiently described or omitted the anticipated expenses for trial participation. Information concerning whom to contact for more information or in case of injury was deficient in six PIS/ICFs. Unlike the original PIS/ICF, all edited PIS/ICFs informed participants about the existence of compensation or treatment for any injury related to the trial.

    CONCLUSIONS: WHO should consider adding three of the omitted elements in PIS/ICFs of future multinational similar trials.

    Matched MeSH terms: Consent Forms*
  2. Adlina, S., Ambigga, D., Narimah, A.H.H., Ridha, A.Z.
    MyJurnal
    Home phototherapy treatment has been available in the Klang Valley (comprising Petaling ]aya, Kuala Lumpur; Shah Alam and Klang) since 2003. This study was conducted to create awareness of the existence of home phototherapy and its usage in Malaysia. This was a retrospective study using 1297 informed consent forms that parents had to read and sign prior to the commencement of home phototherapy. lt was found that the majority ofthe babies was males (41.2%), at or over 36 weelds gestation (97.2%), from areas in Selangor (57.4%), fully breastfed (53 %) and referred by doctors (98%). The mean age of the babies at initiation of lwme phototherapy was 6. 7 days. The mean bilirubin level at the start of home phototherapy was 243.8 umoVL and the mean bilirubin level at the end of home phototherapy 5 was 139.3 umoVL. The mean decrease in bilirubin level was 103.12 umoVL and the mean number of days of usage was 3.5 days which is a daily decrement of about 29 umoVL (29.46 + 13.8). Home phototherapy remains a viable clinical option for full term babies with physiological jaundice.
    Matched MeSH terms: Consent Forms
  3. 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: Consent Forms
  4. Mohd Rizal Abdul Manaf
    Int J Public Health Res, 2012;2(1):129-136.
    MyJurnal
    Introduction Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology. The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. A physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self. This paper presents some information regarding medical ethics, including the values and principles of ethical conduct. Later the requirements of consent form is presented to guide the researchers before conducting a study.
    Matched MeSH terms: Consent Forms
  5. 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: Consent Forms
  6. Parasuraman S, Sam AT, Yee SWK, Chuon BLC, Ren LY
    Int J Pharm Investig, 2017 Jul-Sep;7(3):125-131.
    PMID: 29184824 DOI: 10.4103/jphi.JPHI_56_17
    Objective: This study aimed to study the mobile phone addiction behavior and awareness on electromagnetic radiation (EMR) among a sample of Malaysian population.

    Methods: This online study was conducted between December 2015 and 2016. The study instrument comprised eight segments, namely, informed consent form, demographic details, habituation, mobile phone fact and EMR details, mobile phone awareness education, psychomotor (anxious behavior) analysis, and health issues. Frequency of the data was calculated and summarized in the results.

    Results: Totally, 409 respondents participated in the study. The mean age of the study participants was 22.88 (standard error = 0.24) years. Most of the study participants developed dependency with smartphone usage and had awareness (level 6) on EMR. No significant changes were found on mobile phone addiction behavior between the participants having accommodation on home and hostel.

    Conclusion: The study participants were aware about mobile phone/radiation hazards and many of them were extremely dependent on smartphones. One-fourth of the study population were found having feeling of wrist and hand pain because of smartphone use which may lead to further physiological and physiological complication.
    Matched MeSH terms: Consent Forms
  7. Che Ngah A
    J Int Bioethique, 2005 Mar-Jun;16(1-2):143-61, 199.
    PMID: 16637139 DOI: 10.3917/jib.161.0143
    The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.
    Matched MeSH terms: Consent Forms
  8. 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: Consent Forms
  9. Karbwang J, Koonrungsesomboon N, Torres CE, Jimenez EB, Kaur G, Mathur R, et al.
    BMC Med Ethics, 2018 09 15;19(1):79.
    PMID: 30219106 DOI: 10.1186/s12910-018-0318-x
    BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.

    METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).

    RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).

    CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

    Matched MeSH terms: Consent Forms/ethics*
  10. Mathews A, Azad AK, Abbas SA, Bin Che Rose FZ, Helal Uddin ABM
    J Pharm Bioallied Sci, 2018 12 21;10(4):226-231.
    PMID: 30568380 DOI: 10.4103/JPBS.JPBS_80_18
    Background: In Malaysia, community pharmacies play an important and vital role in both urban and rural areas with approximately 30% of 12,000 registered pharmacists with annual retention certificate practicing in community pharmacies. The main objective of this study was to find the perception of respondents on the value and necessity of pharmacists.

    Materials and Methods: The questionnaire was divided into two sections: the first section assessed the visits to community pharmacies, purpose, interaction with pharmacy staffs, professional fee, and improvements to pharmacy practices; the second section evaluated the characteristics of respondents including an e-consent form. Data were analyzed using the Statistical Package for the Social Sciences software (version 11.5).

    Results: The highest number of respondents (66.1%) consulted with the pharmacists for cough and cold, 33.1% for gastric and stomach ailments, and 28.9% for diarrhea and constipation. Only 34% of cases were handled by the pharmacists, whereas 52.1% by the sales assistant. Approximately 88.5% showed satisfaction with the counseling provided. A total of 46.3% did not know whom they dealt with, whereas 51.2% wanted personal attention of the pharmacists instead of the sales assistants. However, 66.9% of respondents preferred to a private consultation room. Records of only 32.2% of respondents were secured by the pharmacies, whereas 42.1% showed interest to pay a professional fee. Moreover, 83.3% agreed the fee of RM5 only, whereas 20.8% agreed to RM10. Among the respondents, majority agreed to pay a fee willingly, but approximately 30% stayed neutral.

    Conclusion: There is a need for the community pharmacists to play vital roles firsthand at the front desk to serve the patients professionally instead of handing over the responsibilities to the sales assistant.

    Matched MeSH terms: Consent Forms
  11. Nurul Asyikin, Y., Nor Shaida, A., Nur Amirah, Z.
    MyJurnal
    Introduction: Physiological changes in the oral cavity and dental-related complications may occur during pregnancy. These intraoral changes that occur during pregnancy combined with lack of routine dental check-ups and delays in treatment for oral disease, place pregnant women at higher risk for dental infections. The objectives of this study was to assess the knowledge and awareness of pregnant women on periodontal disease and its effect on pregnancy, to investigate the relationship of their knowledge and awareness with level of education and the barriers of oral healthcare utilization among pregnant women.
    Methodology: A self-administered questionnaire with an introductory letter and consent form were given to pregnant women who came for their routine maternity check-up at the Obstetrics and Gynecology Clinic, Kuala Lumpur Hospital. Data entry and analysis was done using Statistical package for Social Sciences (SPSS) version 12.
    Result: Ninety-two pregnant women responded to the questionnaire. Only 23.9% answered correctly to the question on what is plaque. However, 45.7% knew that plaque can cause gum disease and a majority of the respondents 72.8% also knew that bleeding gum is an indication to inflamed gums. The result shows that, although 59.8% of the respondents were aware that it is necessary to brush their teeth frequently during pregnancy, only less than half of the respondents (44.6%) were aware that dental plaque and poor plaque control may cause periodontal disease among pregnant women. The majority (33.7%) feels that the long waiting time in the clinic would be their main barrier in seeking dental treatment.
    Conclusion: A majority of pregnant women have limited knowledge and poor awareness on periodontal disease and its effect on pregnancy.

    Study site: Obstetrics and Gynecology Clinic, Kuala Lumpur Hospital
    Matched MeSH terms: Consent Forms
  12. Barrett RJ, Parker DB
    Monash Bioeth Rev, 2003 Apr;22(2):9-26.
    PMID: 15069953
    The significance of informed consent in research involving humans has been a topic of active debate in the last decade. Much of this debate, we submit, is predicated on an ideology of individualism. We draw on our experiences as anthropologists working in Western and non Western (Iban) health care settings to present ethnographic data derived from diverse scenes in which consent is gained. Employing classical anthropological ritual theory, we subject these observational data to comparative analysis. Our article argues that the individualist assumptions underlying current bioethics guidelines do not have universal applicability, even in Western research settings. This is based on the recognition that the social world is constitutive of personhood in diverse forms, just one of which is individualistic. We submit that greater attention must be paid to the social relations the researcher inevitably engages in when conducting research involving other people, be this in the context of conventional medical research or anthropological field work. We propose, firstly, that the consenting process continues throughout the life of any research project, long after the signature has been secured, and secondly, that both group and individual dimensions of consent, and the sequence in which these dimensions are addressed, should be carefully considered in all cases where consent is sought.
    Matched MeSH terms: Consent Forms
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