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Patient views on research use of clinical data without consent: Legal, but also acceptable?

ABSTRACT: The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients. A questionnaire study was conducted among 700 outpatients of a northern German university hospital to assess their attitude towards use of clinical data for scientific research without consent. There was both strong willingness to give broad consent for secondary data use (468 of 503 responders, 93.0%) and strong approval of abolishing patient consent (n?=?381, 75.7%) among study participants. The willingness to give consent was moderately associated with approval of the respective stipulations by the EU-GDPR. In research settings where broad consent is widely accepted (e.g. university hospitals), abolishing consent for secondary research use of clinical data will likely be acceptable to a large majority of patients.

SUBMITTER: Richter G

PROVIDER: S-EPMC6777530 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Patient views on research use of clinical data without consent: Legal, but also acceptable?

Richter Gesine G Borzikowsky Christoph C Lieb Wolfgang W Schreiber Stefan S Krawczak Michael M Buyx Alena A

European journal of human genetics : EJHG 20190125 6

The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients. ...[more]

PMID: 30683927

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Project description:BackgroundThe landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.MethodsSemi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.ResultsInterviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.ConclusionsInterviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.

Project description:BackgroundLittle is known about Canadians' knowledge of and level of support for using administrative and other large, routinely collected data for health research, despite the benefits of this type of research to patients, health care systems and society. We sought to benchmark the views of Canadian adults on this topic.MethodsResearchers and patient leaders of 3 joint and skin disease organizations codeveloped a cross-sectional online survey that was conducted between January and August 2017. The patient partners were engaged as full partners. Recruitment was mainly through the organizations' websites, email and social media. The survey captured respondents' initial perceptions, then (after background information on the topic was provided) elicited their views on the benefits of health research using routinely collected data, data access/privacy concerns, ongoing perceptions and educational needs.ResultsOf the 230 people who consented, 183 (79.6%) started the survey, and 151 (65.6%) completed the survey. Of the 151, 117 (77.5%) were women, 84 (55.6%) were British Columbians, 87 (57.6%) were university graduates, and 101 (66.9%) had a chronic disease. At the beginning of the survey, 119 respondents (78.8%) felt positively about the use of routinely collected data for health research. Respondents identified the ability to study long-term treatment effects and rare events (114 [75.5%]) and large numbers of people (110 [72.8%]) as key benefits. Deidentification of personal information was the top privacy measure (135 [89.4%]), and 101 respondents (66.9%) wanted to learn more about data stewards' granting access to data. On survey completion, more respondents (141 [93.4%]) felt positively about the use of routinely collected data, but only 87 (57.6%) were confident about data security and privacy.InterpretationRespondents generally supported the use of deidentified routinely collected data for health research. Although further investigation is needed with more representative samples, our findings suggest that additional education, especially about access and privacy controls, may enhance public support for research endeavours using these data.

Project description:BackgroundIn Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts.ObjectiveThis study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers.MethodsSemistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis.ResultsStakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees.ConclusionsMore efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

Project description:ObjectivesUK National Health Service/Health and Social Care (NHS/HSC) data are variably shared between healthcare organisations for direct care, and increasingly de-identified for research. Few large-scale studies have examined public opinion on sharing, including of mental health (MH) versus physical health (PH) data. We measured data sharing preferences.Design/setting/interventions/outcomesPre-registered anonymous online survey, measuring expressed preferences, recruiting February to September 2020. Participants were randomised to one of three framing statements regarding MH versus PH data.ParticipantsOpen to all UK residents. Participants numbered 29 275; 40% had experienced an MH condition.ResultsMost (76%) supported identifiable data sharing for direct clinical care without explicit consent, but 20% opposed this. Preference for clinical/identifiable sharing decreased with geographical distance and was slightly less for MH than PH data, with small framing effects. Preference for research/de-identified data sharing without explicit consent showed the same small PH/MH and framing effects, plus greater preference for sharing structured data than de-identified free text. There was net support for research sharing to the NHS, academic institutions, and national research charities, net ambivalence about sharing to profit-making companies researching treatments, and net opposition to sharing to other companies (similar to sharing publicly). De-identified linkage to non-health data was generally supported, except to data held by private companies. We report demographic influences on preference. A majority (89%) supported a single NHS mechanism to choose uses of their data. Support for data sharing increased during COVID-19.ConclusionsSupport for healthcare data sharing for direct care without explicit consent is broad but not universal. There is net support for the sharing of de-identified data for research to the NHS, academia, and the charitable sector, but not the commercial sector. A single national NHS-hosted system for patients to control the use of their NHS data for clinical purposes and for research would have broad support.Trial registration numberISRCTN37444142.

Project description:BackgroundThe process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant's autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.MethodsResearch staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.ResultsResearch participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.ConclusionsResearch participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.Trial registrationNot applicable.

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Patient views on research use of clinical data without consent: Legal, but also acceptable?

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Patient views on research use of clinical data without consent: Legal, but also acceptable?

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