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.
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.
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.
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.