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1.
JMIR Nurs ; 7: e53592, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38723253

ABSTRACT

BACKGROUND: Health monitoring technologies help patients and older adults live better and stay longer in their own homes. However, there are many factors influencing their adoption of these technologies. Privacy is one of them. OBJECTIVE: The aim of this study was to provide an overview of the privacy barriers in health monitoring from current research, analyze the factors that influence patients to adopt assisted living technologies, provide a social psychological explanation, and propose suggestions for mitigating these barriers in future research. METHODS: A scoping review was conducted, and web-based literature databases were searched for published studies to explore the available research on privacy barriers in a health monitoring environment. RESULTS: In total, 65 articles met the inclusion criteria and were selected and analyzed. Contradictory findings and results were found in some of the included articles. We analyzed the contradictory findings and provided possible explanations for current barriers, such as demographic differences, information asymmetry, researchers' conceptual confusion, inducible experiment design and its psychological impacts on participants, researchers' confirmation bias, and a lack of distinction among different user roles. We found that few exploratory studies have been conducted so far to collect privacy-related legal norms in a health monitoring environment. Four research questions related to privacy barriers were raised, and an attempt was made to provide answers. CONCLUSIONS: This review highlights the problems of some research, summarizes patients' privacy concerns and legal concerns from the studies conducted, and lists the factors that should be considered when gathering and analyzing people's privacy attitudes.


Subject(s)
Privacy , Humans , Privacy/legislation & jurisprudence , Monitoring, Physiologic/methods
2.
Front Med (Lausanne) ; 9: 995688, 2022.
Article in English | MEDLINE | ID: mdl-36237540

ABSTRACT

Background: Owing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study aimed to investigate stakeholders' experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research. Results may serve as the cornerstone to rethink the informed consent process in clinical research. Materials and methods: This study consisted of an online survey among three stakeholder groups across European Union (EU) Member States and the United Kingdom. The stakeholder groups included (i) investigators, (ii) data protection officers (DPOs) or legal experts working in the pharmaceutical industry, academia, and academic biobanks, and (iii) ethics committee (EC) members. Data collection occurred between April and December 2021. The data collected were analyzed using descriptive and inferential statistics. Results: The online survey was completed by 191 respondents, of whom 52% were investigators. Respondents were active in 24 out of the 27 EU Member States and the United Kingdom. The majority of each stakeholder group considered validated electronic methods moderately or extremely useful to re-consent previously enrolled research participants upon study amendments or to obtain consent from COVID-19 patients. Nevertheless, this exploratory survey identified that only 13% of DPOs/legal experts, 26% of investigators, and 41% of EC members had experience with eIC. In addition, results suggest that the legal acceptance of eIC across EU Member States and the United Kingdom is variable and that a definition of eIC, issued by national law or policy, is rarely available. The results also showed that the COVID-19 pandemic brought additional challenges to inform participants and to obtain their consent; for example, related to travel restrictions. Conclusion: A number of alternative consenting methods were recommended, for example by the European Medicines Agency, to ensure clinical study continuation during the COVID-19 pandemic. Although stakeholders support the use of eIC in clinical research, it seems that the experience with eIC is low. To harmonize eIC practices as much as possible, further investments in multi-stakeholder, multi-national guidance are needed.

3.
Front Med (Lausanne) ; 9: 995689, 2022.
Article in English | MEDLINE | ID: mdl-36300179

ABSTRACT

Background: The COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic. Materials and methods: The study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis. Results and conclusion: In total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

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