The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...) that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

Phishing is a fraudulent form of email that solicits personal or financial information from the recipient, such as a password, username, or social security or bank account number. The scammer may use the illicitly obtained information to steal the victim’s money or identity or sell the information to another party. The direct costs of phishing on consumers are exceptionally high and have risen substantially over the past 12 years. Phishing experiments that simulate real world conditions can provide cybersecurity experts with (...) valuable knowledge they can use to develop effective countermeasures and prevent people from being duped by phishing emails. Although these experiments contravene widely accepted informed consent requirements and involve deception, we argue that they can be conducted ethically if risks are minimized, confidentiality and privacy are protected, potential participants have an opportunity to opt out of the research before it begins, and human subjects are debriefed after their participation ends. (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)

BackgroundHealth data holds great potential for improved treatments. Big data research and machine learning models have been shown to hold great promise for improved diagnostics and treatment planning. The potential is tied, however, to the availability of personal health data. In recent years, it has been argued that data from health records should be available for health research, and that individuals have a duty to make the data available for such research. A central point of debate is whether such secondary (...) use of health data requires informed consent.Main bodyIn response to recent writings this paper argues that a requirement of informed consent for health record research must be upheld. It does so by exploring different contrasting notions of the duty of easy rescue and arguing that none of them entail aperfectduty to participate in health record research. In part because the costs of participation cannot be limited to 1) the threat of privacy breaches, but includes 2) the risk of reduced trust and 3) suboptimal treatment, 4) stigmatization and 5) medicalisation, 6) further stratification of solidarity and 7) increased inequality in access to treatment and medicine. And finally, it defends the requirement of informed consent by arguing that the mere possibility of consent bias provides a rather weak reason for making research participation mandatory, and that there are strong, independent reasons for making.ConclusionArguments from the duty of easy rescue in combination with claims about little risk of harm and potential consent bias fail to establish not only aperfectduty to participate in health record research, but also that participation in such research should be mandatory. On the contrary, an analysis of these arguments indicates that the duty to participate in research is most adequately construed as animperfectduty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent. (shrink)

The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific consent, broad consent, blanket consent (...) or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)

Die Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten hat das Potenzial, medizinisches Wissen und klinische Versorgung erheblich zu verbessern. Zur Realisierung dieses Potenzials bedarf es einer ethischen und rechtlichen Grundlage für die Datennutzung, vorzugsweise in Form der Einwilligung von Patient*innen. Damit stellt sich die grundsätzliche Frage: Haben Patient*innen eine moralische Pflicht, ihre klinischen Daten für Forschungs- und Lernaktivitäten zur Verfügung zu stellen?Auf Basis eines ethischen Ansatzes, der als „sorgender Liberalismus“ bezeichnet werden kann, werden folgende Argumente zur Begründung einer Pflicht von (...) Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten auf Plausibilität und moralisches Gewicht untersucht: die allgemeine Hilfspflicht; Solidarität; die Pflicht zu gemeinwohlförderlichem Handeln; das Trittbrettfahrerargument; transgenerationale Gerechtigkeit; das Prinzip des Zurückgebens; das Prinzip des Nicht-Schädigens; die Forschungsfreiheit und der Wert der Wissenschaft.Die allgemeine Hilfspflicht und die Pflicht zu gemeinwohlförderlichem Handeln sind gewichtige Gründe für eine moralische Pflicht von Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten. Das Argument der transgenerationalen Gerechtigkeit und das Prinzip des Zurückgebens sind ethisch schwache Gründe für eine solche Pflicht, können jedoch eine motivationale Rolle spielen. Die anderen Gründe sind nicht geeignet, eine Pflicht zu begründen. Das Ergebnis ist in mehrfacher Hinsicht relevant: für Patient*innen, die um die Einwilligung in die Sekundärnutzung ihrer klinischen Daten gebeten werden; für die ethische Diskussion der Frage, ob und inwieweit Abstriche von der klassischen spezifischen Einwilligung unter bestimmten Bedingungen ethisch akzeptabel sind; für die rechtwissenschaftliche Diskussion der Bedingungen für eine juristisch verhältnismäßige Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten. (shrink)

Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues.