Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

Mascalzoni, Deborah; Melotti, Roberto; Pattaro, Cristian; Pramstaller, Peter P.; Gögele, Martin; Grandi, Alessandro De; Biasiotto, Roberta

doi:10.1038/s41431-022-01160-4

Cited by 24 publications

(22 citation statements)

References 30 publications

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“…For example, the GA Registry [218] is patient-led and permits large-scale data sharing while letting users decide which data sets to share and with whom. Exemplary projects and patient portals include the tailored, ongoing communication of the CHRIS longitudinal study [202], NIH-funded All of Us Research Program [219], Connect Care (Canada) [220] that allows bidirectional interaction with the patient, Sundhed (Denmark) [221], and Health data hub (France) [222].…”

Section: Findings In Relation To Broader Contextmentioning

confidence: 99%

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

Cumyn¹,

Ménard²,

Barton³

et al. 2023

J Med Internet Res

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Background Secondary use of health data has reached unequaled potential to improve health systems governance, knowledge, and clinical care. Transparency regarding this secondary use is frequently cited as necessary to address deficits in trust and conditional support and to increase patient awareness. Objective We aimed to review the current published literature to identify different stakeholders’ perspectives and recommendations on what information patients and members of the public want to learn about the secondary use of health data for research purposes and how and in which situations. Methods Using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a scoping review using Medline, CINAHL, PsycINFO, Scopus, Cochrane Library, and PubMed databases to locate a broad range of studies published in English or French until November 2022. We included articles reporting a stakeholder’s perspective or recommendations of what information patients and members of the public want to learn about the secondary use of health data for research purposes and how or in which situations. Data were collected and analyzed with an iterative thematic approach using NVivo. Results Overall, 178 articles were included in this scoping review. The type of information can be divided into generic and specific content. Generic content includes information on governance and regulatory frameworks, technical aspects, and scientific aims. Specific content includes updates on the use of one’s data, return of results from individual tests, information on global results, information on data sharing, and how to access one’s data. Recommendations on how to communicate the information focused on frequency, use of various supports, formats, and wording. Methods for communication generally favored broad approaches such as nationwide publicity campaigns, mainstream and social media for generic content, and mixed approaches for specific content including websites, patient portals, and face-to-face encounters. Content should be tailored to the individual as much as possible with regard to length, avoidance of technical terms, cultural competence, and level of detail. Finally, the review outlined 4 major situations where communication was deemed necessary: before a new use of data, when new test results became available, when global research results were released, and in the advent of a breach in confidentiality. Conclusions This review highlights how different types of information and approaches to communication efforts may serve as the basis for achieving greater transparency. Governing bodies could use the results: to elaborate or evaluate strategies to educate on the potential benefits; to provide some knowledge and control over data use as a form of reciprocity; and as a condition to engage citizens and build and maintain trust. Future work is needed to assess which strategies achieve the greatest outreach while striking a balance between meeting information needs and use of resources.

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Section: Findings In Relation To Broader Contextmentioning

confidence: 99%

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

Cumyn¹,

Ménard²,

Barton³

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

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“…The study, which started in 2011, collects data and biological samples from a closed cohort of 13,389 adult participants enrolled between 2011 and 2018. The mother tongue of most residents in Val Venosta/Vinschgau is German [11]. Participant recruitment and the broader empirical RbG study have been described elsewhere [7,8] and summarized in Table 1.…”

Section: Study Settingmentioning

confidence: 99%

“…The present work was motivated by process of policy design for RbG studies within the CHRIS study [7]. A participant-centered approach, which considers participant views, is key in the CHRIS study, which uses dynamic consent as an informed consent model [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Participant perspective on the recall-by-genotype research approach: a mixed-method embedded study with participants of the CHRIS study

et al. 2023

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Recall-by-genotype (RbG) research recruits participants previously involved in genetic research based on their genotype. RbG enables the further study of a particular variant of interest, but in recalling participants, it risks disclosing potentially unwanted or distressing genetic information. Any RbG strategy must therefore be done in a manner that addresses the potential ethical and social issues. As part of an RbG pilot on the penetrance of Parkinson’s disease variants, we conducted an empirical mixed-method study with 51 participants of the Cooperative Health Research in South Tyrol (CHRIS) study to understand participant views on RbG research approach. Participants were disclosed the disease under investigation but not the individual variant carrier status. Results showed that participants filtered the information received through personal experience and enacted mechanisms to address the concerns raised by invitation by resorting to personal resources and the support provided by experts. While the non-disclosure of the Parkin variant carrier status was deemed acceptable, disclosing the disease under study was important for participants. Participant preferences for disclosure of the disease under investigation and the carrier status varied according to how the knowledge of individual carrier status was perceived to impact the participant’s life. This study provided insights into participant response to the RbG research approach, which are relevant for RbG policy development. A suitable communication strategy and granular options addressing preferences for invitation in the original informed consent are critical for an ethically informed RbG policy.

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“…The Australian Genomics Health Alliance has piloted a platform to trial a dynamic consent approach, in which patients are given authority to make decisions about their participation and use of their data in research studies [27]. Similar efforts have been trialled in European countries, for example, Cooperative Health Research in South Tyrol [28] and Dwarna in Malta [29]. However, centralised platforms can pose security risks arising from the handling of large volumes of data, and they are less able to facilitate active patient participation [30,31].…”

Section: Introductionmentioning

confidence: 99%

Balancing the safeguarding of privacy and data sharing: perceptions of genomic professionals on patient genomic data ownership in Australia

et al. 2023

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There are inherent complexities and tensions in achieving a responsible balance between safeguarding patients’ privacy and sharing genomic data for advancing health and medical science. A growing body of literature suggests establishing patient genomic data ownership, enabled by blockchain technology, as one approach for managing these priorities. We conducted an online survey, applying a mixed methods approach to collect quantitative (using scale questions) and qualitative data (using open-ended questions). We explored the views of 117 genomic professionals (clinical geneticists, genetic counsellors, bioinformaticians, and researchers) towards patient data ownership in Australia. Data analysis revealed most professionals agreed that patients have rights to data ownership. However, there is a need for a clearer understanding of the nature and implications of data ownership in this context as genomic data often is subject to collective ownership (e.g., with family members and laboratories). This research finds that while the majority of genomic professionals acknowledge the desire for patient data ownership, bioinformaticians and researchers expressed more favourable views than clinical geneticists and genetic counsellors, suggesting that their views on this issue may be shaped by how closely they interact with patients as part of their professional duties. This research also confirms that stronger health system infrastructure is a prerequisite for enabling patient data ownership, which needs to be underpinned by appropriate digital infrastructure (e.g., central vs. decentralised data storage), patient identity ownership (e.g., limited vs. self-sovereign identity), and policy at both federal and state levels.

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Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

Cited by 24 publications

References 30 publications

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

Participant perspective on the recall-by-genotype research approach: a mixed-method embedded study with participants of the CHRIS study

Balancing the safeguarding of privacy and data sharing: perceptions of genomic professionals on patient genomic data ownership in Australia

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