Security and Privacy Requirements for Electronic Consent

Verreydt, Stef; Yskout, Koen; Joosen, Wouter

doi:10.1145/3433995

Cited by 6 publications

(5 citation statements)

References 44 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Overall, data completeness, legibility and accuracy were consistently improved by electronic processes as compared with paper-based ones. This is an important and hoped-for benefit, with implications for healthcare quality and safety as well as organisational efficacy 14–17. These critical findings should assure provider institutions that there is immediate and concrete value to automating clinical consent processes.…”

Section: Discussionmentioning

confidence: 92%

Electronic consent in clinical care: an international scoping review

Chimonas

Lipitz‐Snyderman

Matsoukas

et al. 2023

BMJ Health Care Inform

View full text Add to dashboard Cite

ObjectiveDigital technologies create opportunities for improvement of consenting processes in clinical care. Yet little is known about the prevalence, characteristics or outcomes of shifting from paper to electronic consenting, or e-consent, in clinical settings. Thus questions remain around e-consent’s impact on efficiency, data integrity, user experience, care access, equity and quality. Our objective was to scope all known findings on this critical topic.Materials and methodsThrough an international, systematic scoping review, we identified and assessed all published findings on clinical e-consent in the scholarly and grey literatures, including consents for telehealth encounters, procedures and health information exchanges. From each relevant publication, we abstracted data on study design, measures, findings and other study features.Main outcome measuresMetrics describing or evaluating clinical e-consent, including preferences for paper versus e-consenting; efficiency (eg, time, workload) and effectiveness (eg, data integrity, care quality). User characteristics were captured where available.ResultsA total of 25 articles published since 2005, most from North America or Europe, report on the deployment of e-consent in surgery, oncology and other clinical settings. Experimental designs and other study characteristics vary, but nearly all focus on procedural e-consents. Synthesis reveals relatively consistent findings around improved efficiency and data integrity with, and user preferences for, e-consent. Care access and quality issues are less frequently explored, with disparate findings.Discussion and conclusionThe literature is nascent and largely focused on issues that are immediate and straightforward to measure. As virtual care pathways expand, more research is urgently needed to ensure that care quality and access are advanced, not compromised, by e-consent.

show abstract

Section: Discussionmentioning

confidence: 92%

Electronic consent in clinical care: an international scoping review

Chimonas

Lipitz‐Snyderman

Matsoukas

et al. 2023

BMJ Health Care Inform

View full text Add to dashboard Cite

show abstract

“…Using an eIC solution in a clinical study requires training of research staff and the development of standard operating procedures, and thus may be considered burdensome [ 37 ]. Another implementation challenge of eIC is related to achieving interoperability with other healthcare applications [ 38 ]. To this end, a guidance framework could emphasize the importance of standards, such as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR), to design eIC solutions that can connect to other systems in order to ease the burden for the site.…”

Section: Discussionmentioning

confidence: 99%

Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study

Sutter

Borry

Huys

et al. 2023

BMC Health Serv Res

View full text Add to dashboard Cite

Background Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research. Methods Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis. Results Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard. Conclusion The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.

show abstract

“…We first searched for recent survey papers to compare different survey methodologies [136,65,131,2] to find the most suitable survey methodology for this paper. We follow the methodology of Kitchenham B.…”

Section: Survey Methodologymentioning

confidence: 99%