Ethical Benefits and Drawbacks of Digitally Informed Consent

As organizations steadily adopt remote and virtual capabilities, informed consent processes are increasingly managed by digital technologies. These digital methods are generating novel opportunities to collect individuals' permissions for use of private information but are blurring traditional boundaries of consent communication and documentation. Therefore, the rapid growth of digital technologies used for informed consent as well as the sheer volume of data resulting from electronic data capture are generating complex questions about individual engagement and data practices. This chapter presents emerging risks, benefits, and ethical principles about digital informed consent methods and technologies. For the areas where digital informed consent creates ethical uncertainties, ethical guidelines and user-design recommendations are provided.

PERANCANGAN SISTEM INFORMASI BERBASIS E-BANKING

Elektronik banking (e-banking) adalah layanan yang memungkinkan nasabah bank untuk memperoleh informasi, melakukan komunikasi, dan melakukan transaksi perbankan melalui alternative delivery channel media elektronik seperti Automatic Teller Machine (ATM), phone banking, electronic fundtransfer (EFT), electronic data capture (EDC)/point of sales (POS), internet banking, dan mobile banking.Bagi bank, e-banking pendapatan berbasis komisi (fee based income) dan mengurangi biaya operasional apabila dibandingkan dengan pelayanan tranksaksi melalui kantor cabang yang relatif besar untuk membayar karyawan, sewa gedung, pengamana, listrik dan lainnya.Bagi otoritas, perkembangan teknologi e-banking mendorong mewujudkan masyarakat less cash society. Less cash society adalah gaya hidup denganmenggunakan media transaksi atau uang elektronik dalam bertransaksi sehingga tidak perlu membawa uang fisik. Less cash society selain dapat meningkatkan sistem pembayaran yang cepat, aman, dan efesien, untuk mempercepat perputaran aktivitas ekonomi dan stabilitas sistem keuangan, juga dapat mencegah tindak pidana criminal maupun tindak pidana pencucian uang. Sehingga menimbulkan feedback baik kepada bank dan otoritas dari penggunaan e-banking yang di nikmati oleh masyarakat dalam kebutuhan bertransaksi.

Das Treatment Exit Options for Uveitis (TOFU) Register: Einbindung von Patienten in die Evidenzgenerierung

ZusammenfassungUveitis ist eine seltenere entzündliche Augenerkrankung, die zu schwerer Sehbehinderung und Blindheit führen kann und besonders Menschen im berufstätigen Alter betrifft. Besonders schwere Verläufe, die meist einer immunmodulierenden Therapie (IMT) bedürfen, treten bei einer Uveitis auf, die die hinteren Teile des Auges oder das ganze Auge betreffen und nicht infektiöser Ursache sind. Für diese Formen der Erkrankung gibt es nur wenig gute Evidenz zum langfristigen Management der Erkrankung und insbesondere zur Beendigung oder Reduktion einer IMT. Das Treatment exit Options For non-infectious Uveitis (TOFU) Register der Sektion Uveitis der Deutschen Ophthalmologischen Gesellschaft (DOG) hat das Ziel, Krankheitsverläufe von Patienten mit nicht-infektiöser nicht-anteriorer Uveitis zu dokumentieren und Empfehlungen zur Beendigung einer IMT zu erarbeiten. Ein wesentlicher Aspekt des TOFU-Registers ist die aktive Einbeziehung von Patienten in die Erfassung Patienten-berichteter Endpunkte über ein Patientenmodul (Patient Reported Outcomes, PROs). Neben seh- und gesundheitsbezogener Lebensqualität werden auch Fragebögen zur Therapieadhärenz, Produktivität und Auswirkungen der Therapien eingesetzt. Die eingesetzten Fragebögen wurden in dieser Kombination in einer Pilotstudie mit Patienten getestet und es hat sich gezeigt, dass die wesentlichen Patienten-relevanten Aspekte der Erkrankung und deren Auswirkungen auf den Alltag erfasst werden. Das Patientenmodul, wie das Register selbst, nutzt zur Dokumentation die electronic data capture (EDC)-Software REDCap (Version 9, Vanderbilt University, USA). Durch die Einbindung von Patienten in sowohl die Konzeption des Registers als auch die fortlaufende Datensammlung wird sichergestellt, dass Patienten-relevante Evidenz für z. B. die Erstellung von Leitlinien und Behandlungsempfehlungen generiert wird.

Research Development Using REDCap Software

Objectives: High-quality clinical research is dependent on adequate design, methodology, and data collection. The utilization of electronic data capture (EDC) systems is recommended to optimize research data through proper management. This paper’s objective is to present the procedures of REDCap (Research Electronic Data Capture), which supports research development, and to promote the utilization of this software among the scientific community.Methods: REDCap’s web application version 10.4.1 released on 2021 (Vanderbilt University) is an EDC system suitable for clinical research development. This paper describes how to join the REDCap consortium and presents how to develop survey instruments and use them to collect and analyze data.Results: Since REDCap is a web application that stimulates knowledge-sharing among the scientific community, its development is not finished and it is constantly receiving updates to improve the system. REDCap’s tools provide access control, audit trails, and data security to the research team.Conclusions: REDCap is a web application that can facilitate clinical research development, mainly in health fields, and reduce the costs of conducting research. Its tools allow researchers to make the best use of EDC components, such as data storage.

Electronic data capture system (REDCap) for healthcare research and training in a resource-constrained environment: Adoption and growth at a South African institution (Preprint)

BACKGROUND Electronic data capture (EDC) in academic healthcare organizations provides an opportunity for the management, aggregation and secondary use of research and clinical data. It is especially important in resource constrained environments such as the South African public healthcare sector, where paper records are still the main form of clinical record-keeping. OBJECTIVE We describe the strategies followed by the Faculty of Health Sciences, University of the Witwatersrand (Wits FHS), during the period of 2013-2021 to overcome resistance and encourage adoption of the Research Electronic Data Capture (REDCap) system by academic and clinical staff. REDCap has found wide use in varying domains including clinical studies, research projects and administrative, financial and human resource applications. Given REDCap’s global footprint in more than 5 000 institutions worldwide and potential for future growth, the strategies followed by the Wits FHS to support users and encourage adoption may be of interest to others utilizing the system, particularly in resource-constrained setting. METHODS The strategies to support users and encourage adoption included: 1) Top-down organizational support; 2) Secure and reliable hosting infrastructure and systems administration 3) An enabling and accessible REDCap support team 4) Regular hands-on training workshops covering data collection instrument design and use of REDCap; 5) Annual local symposia to promote networking and awareness of all the latest software features and best practices for using them 6) Participation in REDCap Consortium activities; and 7) Regular and ongoing mentorship from members of Vanderbilt University Medical Center. RESULTS During the period 2013-2021, utilization of the REDCap EDC system by individuals in the Wits FHS increased from 129 active user accounts in 2013 to 3 447 active user accounts respectively in 2021. The number of REDCap projects numbered 149 in 2013 and increased to 12 865 in 2021. REDCap at Wits also supported various publications and research outputs including journal articles and postgraduate monographs. As of 2020, a total of 233 journal articles and 87 postgraduate monographs acknowledged the use of the Wits REDCap system. CONCLUSIONS By providing reliable infrastructure and accessible support resources, we were able to successfully implement and grow the REDCap electronic data capture system at the Wits FHS and its associated academic medical centers. We believe that the increase in use of REDCap was driven by offering a dependable, secure service with a strong end-user training and support model. This model may be applied by other academic and healthcare organizations in resource-constrained environments planning to implement EDC technology.

Application of the research electronic data capture (REDCap) system in a low- and middle income country– experiences, lessons, and challenges

The challenges of reliably collecting, storing, organizing, and analyzing research data are critical in low- and middle-income countries (LMICs), particularly in Sub-Saharan Africa where several healthcare and biomedical research organizations have limited data infrastructure. The Research Electronic Data Capture (REDCap) System has been widely used by many institutions and hospitals in the USA for data collection, entry, and management and could help solve this problem. This study reports on the experiences, challenges, and lessons learned from establishing and applying REDCap for a large US-Nigeria research partnership that includes two sites in Nigeria, (the College of Medicine of the University of Lagos (CMUL) and Jos University Teaching Hospital (JUTH)) and Northwestern University (NU) in Chicago, Illinois in the United States. The largest challenges to this implementation were significant technical obstacles: the lack of REDCap-trained personnel, transient electrical power supply, and slow/ intermittent internet connectivity. However, asynchronous communication and on-site hands-on collaboration between the Nigerian sites and NU led to the successful installation and configuration of REDCap to meet the needs of the Nigerian sites. An example of one lesson learned is the use of Virtual Private Network (VPN) as a solution to poor internet connectivity at one of the sites, and its adoption is underway at the other. Virtual Private Servers (VPS) or shared online hosting were also evaluated and offer alternative solutions. Installing and using REDCap in LMIC institutions for research data management is feasible; however, planning for trained personnel and addressing electrical and internet infrastructural requirements are essential to optimize its use. Building this fundamental research capacity within LMICs across Africa could substantially enhance the potential for more cross-institutional and cross-country collaboration in future research endeavors.

Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example

Background Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.g., allocation sequence concealment) and flawed masking could bias an RCT’s findings. Moreover, investigators need to address other logistics common to all study designs, such as study invitations, eligibility screening, consenting procedure, and data confidentiality protocols. Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for survey data collection. REDCap offers unique features that can be used to conduct rigorous RCTs. Methods In September and November 2020, we conducted a parallel group RCT among Indiana University Bloomington (IUB) undergraduate students to understand if receiving the results of a SARS-CoV-2 antibody test changed the students’ self-reported protective behavior against coronavirus disease 2019 (COVID-19). In the current report, we discuss how we used REDCap to conduct the different components of this RCT. We further share our REDCap project XML file and instructional videos that investigators can use when designing and conducting their RCTs. Results We reported on the different features that REDCap offers to complete various parts of a large RCT, including sending study invitations and recruitment, eligibility screening, consenting procedures, lab visit appointment and reminders, data collection and confidentiality, randomization, blinding of treatment arm assignment, returning test results, and follow-up surveys. Conclusions REDCap offers powerful tools for longitudinal data collection and conduct of rigorous and successful RCTs. Investigators can make use of this electronic data capturing system to successfully complete their RCTs. Trial registration The RCT was prospectively (before completing data collection) registered at ClinicalTrials.gov; registration number: NCT04620798, date of registration: November 9, 2020.