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Patient data and patient rights: Swiss healthcare stakeholders' ethical awareness regarding large patient data sets - a qualitative study.

ABSTRACT: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, regulators and policy makers.We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory.All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other.The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data.

SUBMITTER: Mouton Dorey C

PROVIDER: S-EPMC5842517 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Patient data and patient rights: Swiss healthcare stakeholders' ethical awareness regarding large patient data sets - a qualitative study.

Mouton Dorey Corine C Baumann Holger H Biller-Andorno Nikola N

BMC medical ethics 20180307 1

<h4>Background</h4>There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using pat ...[more]

PMID: 29514635

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Project description:Background:The global development community has increasingly come to frame preventable maternal mortality and morbidity principally as a violation of women's basic human rights, necessitating a human rights-based approach to be appropriately addressed. In this article, we explore how human rights are understood and perceived in relation to maternal health at the local level in rural Bangladesh. This is essential given the momentum at the global level to promote rights and apply rights-based approaches to maternal health. Methods:A community-based, cross-sectional household survey was conducted in three upazilas (sub-districts) of Brahmanbaria district, Bangladesh in 2018. A total of 1367 women with a birth outcome in the past 12 months were interviewed. Descriptive statistics were used to report the awareness and perceptions of human rights related to maternal health. Multiple logistic regression was used to identify the associations between awareness and perceptions of human rights and background characteristics and, finally, with the use of skilled maternal health services. Results:Over two-thirds of women reported that they were aware that women have human rights related to maternal health. However, less than 10% were able to mention at least three specific human rights related to maternal health. Half of the women mentioned husbands as duty-bearers, while only 20% mentioned the government as a duty-bearer. One-third of women reported that they are able to realize their rights related to maternal health satisfactorily. Awareness and perceptions of human rights related to maternal health were significantly associated with higher educational attainment and wealth status. They were also associated with increased use of antenatal care. Conclusions:These findings suggest that interventions promoting the awareness of human rights related to maternal health would be appropriate within the communities of rural Bangladesh as part of a broader human rights-based approach to improving maternal health.

Project description:Introduction: Health research is gradually embracing a more collectivist approach, fueled by a new movement of open science, data sharing and collaborative partnerships. However, the existence of systemic contradictions hinders the sharing of health data and such collectivist endeavor. Therefore, this qualitative study explores these systemic barriers to a fair sharing of health data from the perspectives of Swiss stakeholders. Methods: Purposive and snowball sampling were used to recruit 48 experts active in the Swiss healthcare domain, from the research/policy-making field and those having a high position in a health data enterprise (e.g., health register, hospital IT data infrastructure or a national health data initiative). Semi-structured interviews were then conducted, audio-recorded, verbatim transcribed with identifying information removed to guarantee the anonymity of participants. A theoretical thematic analysis was then carried out to identify themes and subthemes related to the topic of systemic fairness for sharing health data. Results: Two themes related to the topic of systemic fairness for sharing health data were identified, namely (i) the hypercompetitive environment and (ii) the legal uncertainty blocking data sharing. The theme, hypercompetitive environment was further divided into two subthemes, (i) systemic contradictions to fair data sharing and the (ii) need of fair systemic attribution mechanisms. Discussion: From the perspectives of Swiss stakeholders, hypercompetition in the Swiss academic system is hindering the sharing of health data for secondary research purposes, with the downside effect of influencing researchers to embrace individualism for career opportunities, thereby opposing the data sharing movement. In addition, there was a perceived sense of legal uncertainty from legislations governing the sharing of health data, which adds unreasonable burdens on individual researchers, who are often unequipped to deal with such facets of their data sharing activities.

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Project description:BackgroundThe meaningful sharing of health data between different stakeholders is central to the advancement of science and to improve care offered to individual patients. However, it is important that the interests of individual stakeholders involved in this data sharing ecosystem are taken into account to ensure fair data sharing practices. In this regard, this qualitative study investigates such practices from the perspectives of a subset of relevant Swiss expert stakeholders, using a distributive justice lens.MethodsUsing purposive and snowball sampling methodologies, 48 expert stakeholders from the Swiss healthcare and research domains were recruited for semi-structured interviews. After the experts had consented, the interviews were audio-recorded and transcribed verbatim, but omitting identifying information to ensure confidentiality and anonymity. A thematic analysis using a deductive approach was conducted to identify fair data sharing practices for secondary research purposes. Themes and subthemes were then identified and developed during the analysis.ResultsThree distributive justice themes were identified in the data sharing negotiation processes, and these are: (i) effort, which was subcategorized into two subthemes (i.e. a claim to data reciprocity and other reciprocal advantages, and a claim to transparency on data re-use), (ii) compensation, which was subcategorized into two subthemes (i.e. a claim to an academic compensation and a claim to a financial compensation), and lastly, (iii) contribution, i.e. the significance of data contributions should be matched with a corresponding reward.ConclusionsThis qualitative study provides insights, which could inform policy-making on claims and incentives that encourage Swiss expert stakeholders to share their datasets. Importantly, several claims have been identified and justified under the basis of distributive justice principles, whilst some are more debatable and likely insufficient in justifying data sharing activities. Nonetheless, these claims should be taken seriously and discussed more broadly. Indeed, promoting health research while ensuring that healthcare systems guarantee better services, it is paramount to ensure that solutions developed are sustainable, provide fair criteria for academic careers and promote the sharing of high quality data to advance science.

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Dataset Information

Patient data and patient rights: Swiss healthcare stakeholders' ethical awareness regarding large patient data sets - a qualitative study.

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Patient data and patient rights: Swiss healthcare stakeholders' ethical awareness regarding large patient data sets - a qualitative study.

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