Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties that (...) might conflict with a potential duty of physicians to support SeConts. (shrink)

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this paper (...) aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

Research question The secondary use of clinical data for research and learning activities has the potential to significantly improve medical knowledge and clinical care. To realize this potential, an ethical and legal basis for data use is needed, preferably in the form of patient consent. This raises the question: Do patients have a moral duty to provide their clinical data for research and learning activities? Methods On the basis of an ethical approach that we call “caring liberalism,” we evaluate plausibility (...) and moral weight of the following arguments in favor of a duty on patients to provide their clinical data for research and learning activities: the general duty to help; solidarity; the duty to act in the public interest; the free-rider argument; transgenerational justice; the principle of giving back; the do-not-harm principle; freedom of research and the value of science. Results The general duty to help and the duty to act in the public interest are strong reasons for a moral duty of patients to provide their clinical data for research and learning activities. Transgenerational justice and the principle of giving back are ethically weak reasons for such a duty but might be motivational factors. The other reasons are not appropriate to justify a duty. The results are relevant in several respects: for patients who are asked to consent to the secondary use of their clinical data; for the ethical discussion of the question whether and to what extent deviations from the classical specific consent are ethically justifiable under certain conditions; for the legal discussion of the conditions for a proportionate secondary use of clinical data for research and learning activities. (shrink)

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim (...) is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures. (shrink)

Research question The secondary research use of treatment data has the potential to expand medical knowledge and improve patient care. Hospitals play an important role in systematic secondary research use: they generate large amounts of treatment data and are supposed to establish the necessary structures for their use in research. This raises the ethical question: do hospitals have a moral duty to support secondary research use of treatment data by establishing and operating the necessary resources and infrastructure? Procedure Our aim (...) is to outline a conceptual framework to discuss the question and to propose a first normative position. Building on insights from business and organizational ethics, we develop a conceptual framework in which we view hospitals as moral actors. Our normative-ethical analysis is based on a reconstructive stakeholder approach, in which we identify the following general duties of hospitals: orientation towards patient wellbeing; cost efficiency; enabling employees to act in accordance with professional ethical standards; supporting public health and research. We examine whether these general duties provide reasons for a specific duty of hospitals to support secondary research use of treatment data. We discuss potential objections to such a duty arising from other, potentially conflicting general duties of hospitals (e.g., data protection), from practice (e.g., costs/resources), or related discourses (data ownership). Conclusion Certain general duties (orientation towards patient wellbeing, cost efficiency, support of public health) justify a duty of hospitals to support secondary research use of treatment data. The duty to enable employees to act in accordance with professional ethical standards is only an indirect reason; the duty to support research applies solely to university hospitals. Potential objections apply to a certain extent but can be mitigated through targeted measures. (shrink)

Die sekundäre Forschungsnutzung von Behandlungsdaten hat großes Potenzial, biomedizinisches Wissen zu erweitern und die Patientenversorgung zu verbessern. Gleichzeitig sind für eine bessere Ausschöpfung dieses Potenzials diverse Herausforderungen zu bewältigen. Dies gilt insbesondere in Deutschland, wo im Vergleich zu anderen Ländern, wie z.B. Dänemark oder Finnland, die sekundäre Forschungsnutzung von Behandlungsdaten unterentwickelt ist. Die Intensivierung der Nutzung der Daten aus Diagnose und Therapie von Patienten und die Entwicklung der dafür notwendigen Strukturen in Deutschland ist ethisch und politisch geboten: für die Verbesserung (...) der Gesundheitsversorgung durch neue Erkenntnisse, Therapien und Qualitätssicherung. Aus diesem Grund fordern die Autor:innen alle Akteure des Gesundheitssystems, von der Bundes- und den Landesregierungen über die Krankenkassen, Kliniken, Ärzt:innen und Patient:innen dazu auf, einen Beitrag dazu leisten, eine Kultur der sekundären Forschungsnutzung von Behandlungsdaten zu etablieren. Basierend auf den Ergebnissen eines dreijährigen Verbundprojekts beantworten die Autor:innen aus den Bereichen Medizin, Rechtswissenschaften, Ethik und Sozialwissenschaften die Frage was notwendig ist, damit in Deutschland die Daten von Patient:innen systematisch für medizinische Forschung und die Analyse der klinischen Versorgungsqualität verwendet werden können und wirklich auch verwendet werden. Sie nennen zehn zentrale Forderungen und legen eine Liste von 23 Empfehlungen mit konkreten Maßnahmen vor, welche von den genannten Akteuren umgesetzt werden sollten. (shrink)