BackgroundThe 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 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.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 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 followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe 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. (shrink)

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. (shrink)

Background Healthcare professionals face a myriad of ethical challenges during the coronavirus disease 2019 pandemic. However, there is limited literature examining the ethical challenges faced by HCPs in low- and medium-income countries. The research was designed to explore the ethical challenges experienced by HCPs in a Malaysian hospital setting during the pandemic. Methods Semistructured interviews were conducted via video calls with 10 Malaysian HCPs across different clinical disciplines involved in managing patients diagnosed with COVID-19 infections. The calls were audio-recorded, transcribed (...) verbatim and checked. Thematic analysis with constant comparison across transcripts was carried out to identify categories and themes. Results Three main themes emerged. Firstly, there was deprioritisation of care for non-COVID-19 patients resulting from resource limitations. HCPs raised concerns that there was curtailed access to various healthcare services by non-COVID-19 patients. There was also a trade-off between protecting individual patient safety and public health interests. Secondly, patients were disempowered from decision-making; the decision to segregate suspected COVID-19 patients to high-risk areas without seeking patients’ approval may result in an increased risk of infection. Lastly, HCPs expressed internal conflicts when balancing the professional duty of care against concerns about contracting COVID-19 and spreading it to their family members. Conclusion The study highlighted ethical issues faced by HCPs in Malaysia during the pandemic. It underscores the need for clinical ethics consultation services in hospitals to navigate the various ethical dilemmas. (shrink)

Health research ethics training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal (...) education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: define the purposes, intended uses and scope of the framework; describe the context in which practice occurs; gather data using a variety of methods to inform the competency framework; translate the data into competencies that can be used in educational programmes; report on the competency development process and results and evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement. (shrink)