This paper argues that assessing personal responsibility in healthcare settings for the allocation of medical resources would be too privacy-invasive to be morally justifiable. In addition to being an inappropriate and moralizing intrusion into the private lives of patients, it would put patients’ sensitive data at risk, making data subjects vulnerable to a variety of privacy-related harms. Even though we allow privacy-invasive investigations to take place in legal trials, the justice and healthcare systems are not analogous. The duty (...) of doctors and healthcare professionals is to help patients as best they can—not to judge them. Patients should not be forced into giving up any more personal information than what is strictly necessary to receive an adequate treatment, and their medical data should only be used for appropriate purposes. Medical ethics codes should reflect these data rights. When a doctor asks personal questions that are irrelevant to diagnose or treat a patient, the appropriate response from the patient is: ‘none of your business’. (shrink)

Social media data hold considerable potential for predicting health-related conditions. Recent studies suggest that machine-learning models may accurately predict depression and other mental health-related conditions based on Instagram photos and Tweets. In this article, it is argued that individuals should have a sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. The article (1) develops three basic arguments for a right to protection of personal data trading (...) on the notions of social control and stigmatization, (2) argues that a number of features of AI profiling make individuals more exposed to social control and stigmatization than other types of data processing (the exceptionalism of AI profiling), (3) considers a series of other reasons for and against protecting individuals against AI profiling based on publicly available data, and finally (4) argues that the EU General Data Protection Regulation does not ensure that individuals have a right not to be AI profiled based on publicly available data. (shrink)

Data-driven technologies have come to pervade almost every aspect of business life, extending to employee monitoring and algorithmic management. How can employee privacy be protected in the age of datafication? This article surveys the potential and shortcomings of a number of legal and technical solutions to show the advantages of human rights-based approaches in addressing corporate responsibility to respect privacy and strengthen human agency. Based on this notion, we develop a process-oriented model of Privacy Due Diligence to complement (...) existing frameworks for safeguarding employee privacy in an era of Big Data surveillance. (shrink)

Governments around the world collect huge amounts of personal data from their citizens for counterterrorist purposes. While mining this data has arguably increased the security of populations, the practices through which these data are currently collected in many countries have been criticised for violating individuals’ rights to privacy. Yet it is not clear what a permissible data collection regime would look like and thus also how we could reform existing regimes to make them morally acceptable. (...) This article explores a number of ways in which we might justify a data collection regime to those affected in spite of the setbacks to their privacy. In contrast to existing justifications, I argue that individuals can be asked to surrender their personal data as a requirement of reciprocity in a cooperative system in which they gain security from others doing likewise. Relying on this justification, though, has significant implications for how we should reform existing data collection regimes. In particular, more stringent limits will need to be placed on the forms which these regimes can legitimately take. (shrink)

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 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. (shrink)

Approximately twenty years after it was necessary to fight for human rights, the time came when it was necessary to do it again. Or to begin at the very least to protect them very strongly and thoroughly in a preventive manner. Other methods and means will revert to time when human rights were formally anchored but their material establishment is not yet realized, or not at least to the extent expected corresponding to their real substance. The beginning of (...) the 90’s in Central and Eastern Europe was a success in that human rights began to be looked on as natural, forming the basis of democratic State respecting the rule of law. Today we are increasingly more often encountering the reality that human rights, on the contrary, to the same extent that they have been able to be established, they are losing in value. The biggest danger consists in the fact that limiting of human rights often is attended by silence, without wider public discussion or deliberations. The lack of qualified discussion during the limiting of human rights by way of laws and implementing regulations is however a systemic problem. Correction of its results can be often very complex and doing away with the causes a long term effort. It is dependent on the quality of representative democracy and of the civil society as well. This article is devoted to problem of implementation of evidence of data accompanying telecommunications traffic, the so-called data retention, and in its development from lack of legal regulation to roughly unconstitutional legal regulation and finally to hope for a reasonably constitutional solution. (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood (...) data collection technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. (shrink)

This article introduces an important concept: Transparency by way of Humanistic Intelligence as a human right, and in particular, Big/little Data and Sur/sous Veillance, where “Little Data” is to sousveillance as “Big Data” is to surveillance. Veillance is a core concept not just in human–human interaction but also in terms of Human–Computer Interaction. In this sense, veillance is the core of Human-in-the-loop Intelligence, leading us to the concept of “Sousveillant Systems” which are forms of Human–Computer Interaction in (...) which internal computational states are made visible to end users, allowing users to “jump” into the computational feedback loop whenever or wherever they want. An important special case of Sousveillant Systems is that of scientific exploration: not only is data considered, but also due consideration must be given to how data is captured, understood, explored, and discovered, and in particular, to the use of scientific instruments to collect data and to make important new discoveries, and learn about the world. Science is a domain where bottom-up transparency is of the utmost importance, and scientists have the right and responsibility to be able to understand the instruments that they use to make their discoveries. Such instruments must be sousveillant systems! (shrink)

Property rights of personal data have been advocated for some time. From the perspective of economics of law some argued that they could lower transaction costs for contracts involving personal data. This may be the case, but new transaction costs are introduced by propertization and the issue has not been settled. In this paper, I focus on a different and potentially more important aspect. In the actual situation, data collectors externalize costs and internalize benefits. An ownership (...) regime that enables every citizen to hold a personal data account, like a bank account, and that gives people ownership rights over secondary use of personal data could correct these misallocations. I hope to shed new light on the normative implications of the issue by offering normative justifications for property rights of personal data (Sections 2–4). Secondly, I present fundamental goals and building blocks of a property regime of personal data (Section 5) and, thirdly, I illustrate how income from personal data ownership could for instance contribute to financing pensions under proper regulation (Section 6). (shrink)

Data subject rights provide data controllers with obligations that can help with transparency, giving data subjects some control over their personal data. To date, a growing number of researchers have used these data subject rights as a methodology for data collection in research studies. No one, however, has gathered and analysed different academic research studies that use data subject rights as a methodology for data collection. To this end, we (...) conducted a systematic literature review that searched, compiled, and analysed 32 academic studies that use data subject rights as a data collection method. We find that the right of access is the most commonly-used data subject right by researchers, most studies are interested in measuring data subject rights compliance, and that a variety of difficulties exist in conducting research studies with data subject rights. We conclude that researchers should explore other data subject rights for alternative purposes, ease the process of exercising data subject rights, and improve the scalability of these studies. (shrink)

Digital transformation and “artificial intelligence (AI)”—which can more adequately be called “data-based systems (DS)”—comprise ethical opportunities and risks. Therefore, it is necessary to identify precisely ethical opportunities and risks in order to be able to benefit sustainably from the opportunities and to master the risks. The UN General Assembly has recently adopted a resolution aiming for ‘safe, secure and trustworthy artificial intelligence systems’. It is now urgent to implement and build on the UN General Assembly Resolution. Allowing humans and (...) the planet to flourish sustainably in peace and guaranteeing globally that human dignity is respected not only offline but also online, in the digital sphere, and in the domain of DS, requires two policy measures: (1) human rights-based data-based systems (HRBDS): HRBDS means that human rights serve as the basis of digital transformation and DS. (2) International Data-Based Systems Agency (IDA): IDA should be established at the UN as a platform for cooperation in the field of digital transformation and DS, fostering human rights, security, and peaceful uses of DS, as well as a global supervisory institution and regulatory authority in digital transformation and DS. The establishment of IDA is realistic because humanity has already shown in its past that we are able to not always “blindly” pursue the technically possible but also to limit ourselves to what is technically feasible when humanity and the planet are at stake. For instance, humans researched the field of nuclear technology, developed the atomic bomb, and detonated it several times. Nonetheless, the same humans limited research and development in the field of nuclear technology to prevent even worse consequences by establishing the International Atomic Energy Agency (IAEA) at the UN. (shrink)

Since approval of the EU General Data Protection Regulation (GDPR) in 2016, it has been widely and repeatedly claimed that the GDPR will legally mandate a ‘right to explanation’ of all decisions made by automated or artificially intelligent algorithmic systems. This right to explanation is viewed as an ideal mechanism to enhance the accountability and transparency of automated decision-making. However, there are several reasons to doubt both the legal existence and the feasibility of such a right. In contrast to (...) the right to explanation of specific automated decisions claimed elsewhere, the GDPR only mandates that data subjects receive meaningful, but properly limited, information (Articles 13-15) about the logic involved, as well as the significance and the envisaged consequences of automated decision-making systems, what we term a ‘right to be informed’. Further, the ambiguity and limited scope of the ‘right not to be subject to automated decision-making’ contained in Article 22 (from which the alleged ‘right to explanation’ stems) raises questions over the protection actually afforded to data subjects. These problems show that the GDPR lacks precise language as well as explicit and well-defined rights and safeguards against automated decision-making, and therefore runs the risk of being toothless. We propose a number of legislative and policy steps that, if taken, may improve the transparency and accountability of automated decision-making when the GDPR comes into force in 2018. (shrink)

The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for ‘treatment refractory’ psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown‐status trials related (...) to psychiatric DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area. (shrink)

Several studies have documented that when presented with data from social media platforms machine learning (ML) models can make accurate predictions about users, e.g., about whether they are likely to suffer health-related conditions such as depression, mental disorders, and risk of suicide. In a recent article, Ploug (Philos Technol 36:14, 2023) defends a right not to be subjected to AI profiling based on publicly available data. In this comment, I raise some questions in relation to Ploug’s argument that (...) I think deserves further discussion. (shrink)

Hepatitis C is a global public health threat, affecting 56 million people worldwide. The World Health Organization has committed to eliminating hepatitis C by 2030. Although new treatments have revolutionised the treatment and care of people with hepatitis C, treatment uptake has slowed in recent years, drawing attention to the need for innovative approaches to reach elimination targets. One approach involves using existing notifiable disease data to contact people previously diagnosed with hepatitis C. Within these disease surveillance systems, however, (...) competing tensions exist, including protecting individual rights to privacy and autonomy, and broader public health goals. We explore these issues using hepatitis C and Australia’s legislative and regulatory frameworks as a case study. We examine emerging uses of notification data to contact people not yet treated, and describe some of the ethical dilemmas associated with the use and non-use of this data and the protections that exist to preserve individual rights and public health. We reveal weaknesses in rights protections and processes under Australian public health and human rights legislation and argue for consultation with and involvement of affected communities in policy and intervention design before notification data is used to increase hepatitis C treatment coverage. (shrink)

The properties of DNA -- DNA as universal property -- DNA as intellectual property -- DNA as national property -- DNA as personal property -- DNA as academic property -- DNA as taxable propety.

This paper investigates the conceptual possibility for, and the institutions relating to a positive right of private property to data. To do so, it distinguishes between structured data, as a designator, and datapoints, which are data embedded in the timeline. The reasoning being explored here is: the agents generating datapoints – he source of the data – have a right to private property to the datapoints they generate. The agents, then, can choose to retain the datapoints (...) or to sell them to data-users, aggregators, etc. Once these data-users render property of data themselves, they can further market it. There are, however, challenges to this view. One is the relative high cost of managing private property to data versus the relative low cost of misappropriating data and datapoints. The other is network effects: more precisely, data created or enriched in networks. (shrink)

The increasing availability of digital data reflecting economic and human development, and in particular the availability of data emitted as a by-product of people’s use of technological devices and services, has both political and practical implications for the way people are seen and treated by the state and by the private sector. Yet the data revolution is so far primarily a technical one: the power of data to sort, categorise and intervene has not yet been explicitly (...) connected to a social justice agenda by the agencies and authorities involved. Meanwhile, although data-driven discrimination is advancing at a similar pace to data processing technologies, awareness and mechanisms for combating it are not. This paper posits that just as an idea of justice is needed in order to establish the rule of law, an idea of data justice – fairness in the way people are made visible, represented and treated as a result of their production of digital data – is necessary to determine ethical paths through a datafying world. Bringing together the emerging scholarly perspectives on this topic, I propose three pillars as the basis of a notion of international data justice: visibility, engagement with technology and antidiscrimination. These pillars integrate positive with negative rights and freedoms, and by doing so challenge both the basis of current data protection regulations and the growing assumption that being visible through the data we emit is part of the contemporary social contract. (shrink)

The article analyzes ethnic data collection pertaining to criminal justice in Hungary. With such a sensitive and delicate issue at hand, Hungary has decided on an evasive approach, resisting ethnic data collection by law enforcement authorities. The author argues that this approach has become one of the obstacles in fighting discrimination and ethnic profiling. Moreover, Hungary’s restrictive approach to ethno-national data classification also causes severe constitutional problems in other, noncriminal legal circumstances, where ethnic data is used (...) in the context of additional rights and affirmative protection provided for ethno-national minorities. The first part of the article describes general problems relating to ethnic data collection and analyses of the Hungarian minority protection framework, in particular, the minority self-government structure (a unique constitutional institution). The second part focuses on the criminal justice system; the author’s aim is to show that prohibiting the official recognition and collection of data on ethnicity by criminal justice authorities has potentially ethnically discriminatory consequences. (shrink)

Studies suggest that machine learning models may accurately predict depression and other mental health-related conditions based on social media data. I have recently argued that individuals should have sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. In a comment, Holm claims that there are scenarios in which individuals have a reason to prefer attempts of social control exercised on the basis of accurate AI predictions and that (...) the suggested right burdens individuals unfairly by allowing for those individuals to consent to AI profiling. In this reply, I address both of these alleged problems and their underlying assumptions and show why they fail to provide any reasons not to introduce the suggested right. (shrink)

This paper presents the results of an empirical study that reflects monitoring and evaluation of the implementation of some legal acts on the labour of the Republic of Lithuania. The analysis of legal documents at the national and international level is provided. A review of cognate studies conducted by foreign and Lithuanian researchers is presented and the professional situation of a Lithuanian teacher from the employee rights perspective is highlighted. The professional activities contexts and sectors, wherein systematic violations of (...) teachers’ rights to a healthy and safe working environment are possible, are distinguished. A lack of generalized scientific data of employee (especially teacher) working conditions, the actual security of relevant rights and its monitoring and evaluation is still felt both in the country and abroad. A contradiction between: a) insufficient research of the issue and b) its importance to science and practice, exactly presupposes the scientific problems of the empirical study presented in the given paper. The subject of the study: teachers’ rights to a healthy and safe working environment and a fair remuneration for their work. The objective of the study: to conduct monitoring and evaluation of the effective implementation of relevant legal norms and legal acts applying a written sociological survey. The study is based on the results of a mass country-wide written survey of teachers. (shrink)

The paper has three parts. First, a survey and analysis is given ofthe structure of individual rights in the recent EU Directive ondata protection. It is argued that at the core of this structure isan unexplicated notion of what the data subject can `reasonablyexpect' concerning the further processing of information about himor herself. In the second part of the paper it is argued thattheories of privacy popular among philosophers are not able to shed much light on the issues (...) treated in the Directive, whichare, arguably, among the central problems pertaining to theprotection of individual rights in the information society. Inthe third part of the paper, some suggestions are made for a richerphilosophical theory of data protection and privacy. It is arguedthat this account is better suited to the task of characterizingthe central issues raised by the Directive. (shrink)

This article focuses on the issue of data mining as it relates to the consumer and to the issue of whether the consumer's private information has any proprietary status. A brief review of data mining is provided as a background for a better understanding of the purposes and uses of data mining. Also examined are several issues of the ethics of data mining, including a review of stakeholders, who they are and which may be most seriously (...) affected by unethical data mining practices. Several suggestions for the improvement of data mining as it relates to the consumer are further presented: suggestions that would allow for data mining that would be beneficial to both the business community and the consumer. (shrink)

Artificial Intelligence systems—and in particular various types of machine learning models—have significant potential for improving the performance and effectiveness of diagnostics and treatme...

Participant rights and voices are protected through institutional ethical considerations in the social sciences and applied linguistics. Yet, several ethical concerns remain. In addition to adhering to institutional macroethics, researchers should develop microethics to address contextual issues within their research. The need for the development of microethics is particularly important in the qualitative research process where researchers engage in studies with participants rather than treating them merely as data sources. Drawing on key concepts in philosophical hermeneutics, the current (...) study discusses an ethical framework for data collection and analysis that embraces participants’ rights and voices through reflexive questioning, reciprocal dialogues, unbiased listening, and rightful analysis of participants’ data with and from two multilingual families in Norway. Participatory diagramming was employed in a collaborative participatory approach to present the collected data and initial data analysis to the participants, allowing them to review and validate the data analysis conducted by the researchers. Using thematic analysis to analyze participants’ experiences and reflections, our findings indicate that the ethical framework of interview and analysis enhanced researchers’ understanding, empowered participants in the research process, facilitated member-checking, created beneficial collaboration opportunities for the participants, and facilitated reaffirmation of informed consent. (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by (...) the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

In 2009, with the enactment of the Lisbon Treaty, the Charter of Fundamental Rights of the European Union entered into force. Under Article 8 of the Charter, for the first time, a stand-alone fundamental right to data protection was declared. The creation of this right, standing as a distinct right to the right to privacy, is undoubtedly significant, and it is unique to the European legal order, being absent from other international human rights instruments. This commentary examines (...) the parameters of this new right to data protection, asking what are the principles underpinning the right. It argues that the right reflects some key values inherent in the European legal order, namely: privacy, transparency, autonomy and nondiscrimination. It also analyses some of the challenges in implementing this right in an era of ubiquitous veillance practices and Big Data. (shrink)

In this paper, we argue that there is at least a pro tanto reason to favor the control account of the right to privacy over the access account of the right to privacy. This conclusion is of interest due to its relevance for contemporary discussions related to surveillance policies. We discuss several ways in which the two accounts of the right to privacy can be improved significantly by making minor adjustments to their respective definitions. We then test the improved versions (...) of the two accounts on a test case, to see which account best explains the violation that occurs in the case. The test turns out in favor of the control account. (shrink)

Moving away from the strong body of critique of pervasive ‘bad data’ practices by both governments and private actors in the globalized digital economy, this book aims to paint an alternative, more optimistic but still pragmatic picture of the datafied future. The authors examine and propose ‘good data’ practices, values and principles from an interdisciplinary, international perspective. From ideas of data sovereignty and justice, to manifestos for change and calls for activism, this collection opens a multifaceted conversation (...) on the kinds of futures we want to see, and presents concrete steps on how we can start realizing good data in practice. (shrink)

Susser and Cabrera (2024) assess the role of bespoke neuro-privacy regulations including the creation of a novel right to mental privacy. They argue that focusing on what distinguishes mental priva...

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent (...) and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Background. The SA DTA was updated to better serve the South African research community by providing clarity on exactly when – at what stage during research – institutions hold rights to the data they generate in collaborative research contexts where raw data are received and integrated with other data. SA DTA 1.1 introduces significant enhancements in data governance, focusing on the explicit definition and management of ‘inferential data’. Objectives. To introduce SA DTA 1.1 and (...) demonstrate its practical application in real-world research contexts. Methods. Using a descriptive design, the study presents two practical case studies: one involving two universities and another a university and a pharmaceutical company. The first case focuses on identifying genetic markers for neurodegenerative diseases, while the second addresses genetic markers for chronic diseases. Results. In the first case study, the entity conducting the analysis generated inferential data independently, thereby gaining sole rights in such data. In the second case study, both collaborating entities contributed to the data analysis, leading to joint rights in the inferential data. These findings demonstrate the flexibility and clarity provided by SA DTA 1.1 in managing data ownership and intellectual property rights. Conclusion. SA DTA 1.1 significantly advances data governance by providing clear and adaptable guidelines for data rights in collaborative research. It supports ethical and efficient data sharing, protecting researchers’ interests and fostering global scientific innovation. (shrink)

This article extends property-owning democracy to the digital realm and introduces “data-owning democracy,” a new political economic regime characterized by the wide distribution of data as capital among citizens. Drawing on republican theory and acknowledging data's unique role in the digital economy, it proposes a two-tier model that combines different modes of data ownership and corresponding rights. The first layer of “data-owning democracy” is characterized by a digital public infrastructure that enables citizens to collectively (...) generate data and have a say in how their citizen data are used. In the second layer, individuals automatically receive machine-readable copies of their data whenever they are generated—a slightly more advanced form of the European Union's existing right to data portability (Art. 20). With its focus on empowerment, data-owning democracy is designed to be complementary to existing data protection regulations. It also illustrates how political theory more broadly, and republican theory specifically, can be instructive for specifying the normative components of a new political economy dealing with questions of empowerment and digital rights. (shrink)

The United Nations deemed internet access to be of critical importance for human rights in 2016. In 2020, schools around the world closed during the COVID-19 pandemic. As schools were closed, inequities in internet access gained widespread public attention as many educational opportunities shifted online. Amidst this shift, this paper analyzes an Ontario provincial announcement to provide 21,000 iPads and free data for young people, during the pandemic. The closure of schools in Ontario, Canada, meant that young people (...) and families who faced technological challenges, such as a lack of devices, stable and affordable internet connections, or sufficient data allowances, could experience barriers to their right to an education. This paper revisits a community informatics model of internet access, the Access Rainbow, to analyze attempts to operationalize the right to an education through technology in Ontario. In parallel to rights, however, the field of CI faces the ongoing presence of profit-oriented corporations within universal access efforts. This paper argues that socio-technical infrastructural elements of access to the internet became visible through the breakdown of the pandemic. Furthermore, it considers the multi-stakeholder efforts required to implement useful and effective access, where school boards responded in varied ways locally. The paper contributes the concept of refraction to offer continued theorization of a distributive paradigm and a rights-informed approach in community informatics against the backdrop of the pandemic, which could also act as an opening for privatization and disaster capitalism. (shrink)

The technological solutions adopted during the current pandemic will have a lasting impact on our societies. Currently, COVID-19 health status certificates are being deployed around the world, including in Europe, the United States and China. When combined with identity verification, these digital and paper-based certificates allow individuals to prove their health status by showing recent COVID-19 tests results, full vaccination records or evidence of recovery from COVID-19. Most countries in the Global South, where vaccination rates are low, have not yet (...) fully implemented such certificates, although several initiatives are currently underway. That is, for instance, the case in the African Union. Yet, it is not sufficient to develop technical solutions for the verification of COVID-19 health status. Because technologies do not evolve in a legal vacuum, the existing laws and regulations must be respected. The risks of implementing such technologies must be anticipated and mitigated as much as possible before any large-scale deployment. Risk mitigation should also underpin strategies throughout the deployment of these certificates. This article evaluates the key legal implications of COVID-19 health status certificates for data privacy and human rights. In doing so, it contributes to the current debates, thus informing policymakers in this area of vital national and international interest. (shrink)

ObjectivesTo determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.MethodsCohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and (...) if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.ResultsThe industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).ConclusionsPublication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct. (shrink)

In today’s digital societies, it has become very difficult for people to exercise meaningful control over what and how data is collected and used. McCoy and colleagues (2023) seek to address this p...

Life on earth is bound together by a common heritage, centered around a molecule that is present in almost every living cell of every living creature. Deoxyribonucleic acid (DNA), composed of four base pairs, the nucleic acids thymine, adenine, cytosine, and guanine, encodes the data that directs, in conjunction with the environment, the development and metabolism of all nondependent living creatures. Except for some viruses that rely only on ribonucleic acid (RNA), all living things are built by the interaction (...) of DNA and RNA within cells and their environments. There is no worldwide consensus yet as to whether portions of the human genome should be granted intellectual property protection, as indeed they are in the United States and a number of other nations. DNA posed numerous challenges to the legal framework for patent protection and may suggest developing an entirely new social and legal category recognizing its uniqueness. (shrink)

Data and ideas are the capital of research productivity. Is it ethical to preempt the publication of another researcher’s unpublished data or preliminary analysis, perhaps without citation? The long-established answer is ‘certainly not’—but recent ‘open data’ use suggests otherwise. A research competition was held using data from The Systolic Blood Pressure Intervention Trial. This SPRINT Data Analysis Challenge created a novel environment for using open data as data became open early. This allowed third-party (...) researchers the opportunity to assess some of the trial’s outcomes before trialists. Could this infringe on trialists’ right to analyse their data? Simultaneously, trialists had access to analyses from submissions to the competition that were not formally ‘published’ with a typical author credit or citation. Therefore, trialists had the opportunity to view the competition submissions and published on those ideas first without a typical way to cite the source of that idea. Could this infringe on researchers’ right to be credited for their ideas? This is not intended as a criticism of open data, the SPRINT Data Analysis Challenge, or similar systems/ventures, but is an effort to objectively note what may be remediable flaws in the worthwhile, growing and dynamic uses of open data. We offer preliminary analytics to shed more light and provide fodder for additional discussion. (shrink)

Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the (...) normative legitimacy of the industry’s demand to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; (...) in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

This paper has four aims. First it distinguishes two kinds of philosophical accounts of the ‘formal’ features of rights: models and theories. Models outline the ‘conceptually basic’ types of rights (if indeed a given model deems there to be more than one), their differences, and their relationships with duties, liabilities, etc. Theories of rights posit a supposed ultimate purpose for all rights and provide criteria for determining what counts as ‘a right’ in the first place. Second, (...) the paper argues that Monistic rights models (ones positing only a single basic type of right) are under-inclusive. They wrongly exclude and cannot explain relevant data, i.e., ordinary and legal linguistic practices. The third aim is to show that certain Pluralistic models are over-inclusive in terms of what they count as ‘rights’. Fourth, the paper begins to touch upon, but does not provide, criteria for determining what counts as ‘a right’. Two candidate factors will be addressed. (shrink)

Businesses increasingly rely on algorithms that are data-trained sets of decision rules (i.e., the output of the processes often called “machine learning”) and implement decisions with little or no human intermediation. In this article, we provide a philosophical foundation for the claim that algorithmic decision-making gives rise to a “right to explanation.” It is often said that, in the digital era, informed consent is dead. This negative view originates from a rigid understanding that presumes informed consent is a static (...) and complete transaction. Such a view is insufficient, especially when data are used in a secondary, noncontextual, and unpredictable manner—which is the inescapable nature of advanced artificial intelligence systems. We submit that an alternative view of informed consent—as an assurance of trust for incomplete transactions—allows for an understanding of why the rationale of informed consent already entails a right to ex post explanation. (shrink)