Ethical Issues for User Involvement in Technological Research Projects (original) (raw)
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Research Square (Research Square), 2023
Human participation in technological research projects has become more frequent in recent years. However, most of the technological researchers who organize such experimentation are unaware about the various ethical and legal implications involved. Further, when it is a medical device prototype that is being evaluated, the ethical and legal implications may be even more complex. A review of the laws, standards and recommendations in Europe has been drawn up regarding human participation in new technology co-design, development and evaluation, focusing on technological research for assistive and medical devices. An easy-to-use tool, called Ethool, which acts as a guideline for European technological researchers has been designed and developed. In this manuscript, the iterative usability evaluation of Ethool is explained as well as the improvements made, following participants' feedback. Ethool was rated as acceptable and usable by participants obtaining a SUS score of 93.0 in its last evaluation. The tool is currently available to be used by any interested parties with the aim of gathering additional feedback.
2015_The Ethical Health Implications of New Technologies and Citizen Participation_EGE_Opinion 29
Recent years have witnessed a wave of innovation in health technologies driven by new medical breakthroughs, novel scientific approaches and the rise of digital health technologies. Pioneering methods of drug development and disease diagnosis, the rise of ‘big health data’, and new means of providing networked care have led to predictions that European health systems are on the cusp of transformation. While much of the promise held in these technological in- novations remains to be fully realised, the rise of new health technologies are accompanied by a profound set of shifts in the way individuals — whether as patients, citizens or consumers — engage with matters of health. From the consumer who orders a genetic testing kit online to the patient receiving genetically customised medication; from the diabetic monitoring her blood sugar level with a smartphone, to rare-disease patients who mobilise online communities of sufferers to run a DIY clinical trial; individuals and collectives are participating in new and unprecedented ways in the conduct of health research, health policy, and health practice. The ‘participatory turn’ in health offers a number of new roles to citizens, whether as experimenters, stake- holders, purveyors of data, research participants, or us- ers. It covers not only the gathering and volunteering of data, and the involvement of non-experts in scientific experimentation and analysis, but also the lobbying ef- forts of interest groups, public input into research and funding, as well as in the formulation and regulation of policies. Citizen involvement manifests at different stages in the process — from upstream interventions in priority setting, and influencing funding decisions to a more direct downstream involvement of citizens and patients in the use and application of medical knowledge and information. It covers both those active, informed participants who engage from a position of agency as well as those unaware of their contribution. New ethical complexities of citizen participation in health The implications of growing citizen involvement in healthcare and health research are complex and potentially transformational. The benefits could be substantial: more informed, empowered patients, taking great- er control of their own health, in more effective health systems, driven by medical research that harnesses the power of big data. Certain European governments have already signalled the above-described innovations as a key means to make healthcare more efficient and the solution to preserving European health budgets against a backdrop of population ageing, rationing of care, and rising pressures on the price of drugs, medical devices and services. Yet the multifaceted nature of participation poses a complex set of new ethical considerations for policy- makers, practitioners and participants. Even as trends offer the realisation of greater autonomy on the part of individuals, the potential for empowerment is nuanced by a set of tensions or risks: voluntary involvement can become an obligation to participate; empowerment can be joined by demands that individuals take greater responsibility for their health; and citizen participation in health research can come to resemble instrumentalisation, even exploitation. Terms such as ‘citizen science’, which are applied to new phenomena of citizen involvement, embody these inherent ambiguities. ‘Citizen science’ is often used as a supposedly self-evident notion, with a set of implied positive connotations. But it is an ambiguous expression, with many possible meanings, which need a systematic conceptual reflection in order to move beyond the ‘rhetoric’, demythologise the expression and understand the diverse meanings with a critical awareness. As a deeper consequence of these scientific and technological developments and upsurge in citizen participation, the traditional assumptions and institutional arrangements surrounding science (including medicine) have become the object of discussion on a conceptual, social, ethical and juridical level. How does the increas- ing individualisation and consumerism in healthcare alter principles of solidarity which underpin European health systems? How is the doctor–patient relationship being transformed and where do sources of legitimate, trusted medical authority now lie? As we witness an increasingly dynamic citizen engagement in medical science and research, at which point does willing participation become a manipulation of the notion of consent? EU policy relevance Such questions are likely to become increasingly pertinent, not only for national health providers, but also for European policymakers. Precision or ‘personalised medicine’ has gained growing prominence at EU level while e-health forms a pillar of the EU’s digital agenda; EU funding for research and innovation is channelled towards mHealth start-ups and citizen science-based projects and an EU big data industrial policy is in the offing to exploit the potential presented by growing quantities of health data. Furthermore, EU and international policy approaches reflect increasing recognition of the importance of participation, in a shift from what might be termed a ‘health for all’ approach to one of ‘all for health.’ Indeed, the health dimension of the Europe 2020 strategy has been titled ‘Together for Health’ and the WHO’s European Health 2020 Strategy emphasises political, professional and civil society engagement to improve health within what it calls a ‘whole-of-society and whole-of-government approach.’ In recognition of the important shifts underway and their growing EU relevance, the EGE was requested by the President of the European Commission to produce an Opinion on the ethical issues arising from the development of new health technologies and particularly, from the dimension of citizen participation. Scope of the Opinion This Opinion explores the transformations that citizen participation in health and medicine induces across different domains together with the resulting ethical implications. Trends and implications of citizen involve- ment are examined in light of new technologies that have been developed and that are emerging in the do- main of health, as well as wider cultural, societal and political shifts, which are transforming the context in which health and healthcare are perceived, organised and delivered. It does not attempt to give an exhaustive account of health technologies, rather it scrutinises citizen participation via a selection of case studies of scientific and technological innovation, chosen because they embody a broader set of shifts in health and medicine. These shifts include, first, evolving understandings of health and illness and associated changing perceptions of the self and the body; second, changing notions of what it means to be a patient in a modern health context; and third, the increasingly diverse roles performed by citizens/individuals and patients in the production of knowledge and innovation on health. Chapter 1 of this Opinion examines the principal health technologies which are most central to the shifts out- lined above, including data-intensive medicine, omics, ‘personalised’ medicine as well as so-called ‘remote’ forms of medicine such as e-health, mHealth, telemedi- cine and online health resources. The chapter then traces the emergence of the phenomenon of citizen science and citizen participation with specific regard to healthcare and medical research. It critically analyses the diverse meanings and functions of these terms be- fore outlining recent examples of citizen participation in the domain of health. Chapter 2 of this Opinion sets out the ethical implications of the paradigm shift (or set of shifts) identified in Chapter 1. In unpacking both the promise and potential challenges associated with citizen participation in health, the chapter identifies five sets of considerations: first, the implications of new health technologies and new modes of involvement on perceptions of the ‘self’, of personhood and of the body in a medical context; second, the implications of potential transformations in the patient–physician relationship; third, the implications of citizen involvement in the research endeavour and the tensions between empowerment, engagement and exploitation; fourth, the implications of new health technologies and citizen involvement on societal understandings, principles and structures governing health; and fifth, implications for notions of solidarity and justice. Chapter 3 of this Opinion examines the adequacy of current governance arrangements, and identifies new questions and gaps presented by the nexus between new health technologies and new practices of citizen participation. It undertakes, first, an examination of the legal landscape pertaining to participation, charting the rights and protections enshrined in international human rights treaties and jurisprudence which establish the entitlements of citizens to participate in, and enjoy the results of, science and technology. It then identifies potential gaps in the regulatory framework in relation to new health technologies and the suitability of existing oversight mechanisms to cover new practices of knowledge generation and innovation engaging the individual. Chapter 4 of this Opinion puts forward a set of recom- mendations, aimed at EU and national-level policymak- ers, industry and other stakeholders, which aim to max- imise the benefits and minimise the harms associated with new health technologies and citizen participation in health policy, research and practice.
Data protection and consent to biomedical research: a step forward?
The Lancet, 2014
on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). 2 Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community.
An Ethical Framework for Evaluating Experimental Technology
How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society.
Research Participants’ Rights To Data Protection In The Era Of Open Science
Depaul Law Review, 2020
Clinical trials are increasingly using sensors embedded in wearable devices due to their capabilities to generate real-world data. These devices are able to continuously monitor, record, and store physiological metrics in response to a given therapy, which is contributing to a redesign of clinical trials around the world. Traditional clinical trials are immensely expensive and limited in testing options, as they typically entail research participants coming to designated sites for measuring responses to an investigational treatment. This process creates a costly, time-intensive pathway from discovery to market and may not produce results that future patients wish to know, particularly around improvements in activities of daily living and overall quality of life. While wearable devices present potential benefits, including a reduction in expense
2010
1. Rogers EM. Diffusion of innovations. 5th edition. New York: Free Press; 2003 2. Welsh S, Hassiotis A, O'Mahoney G, Deahl M. Big Brother is watching you–the ethical implications of electronic surveillance measures in the elderly with dementia and in adults with learning difficulties. Aging and Mental Health 2003; 7 (5): 372–375 Keywords: ethics, user trials, best practice Address: Simon Fraser University, Vancouver, BC, Canada; E: wmortens@ sfu. ca
Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee
2015
For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168–175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, ...
Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations
Journal of Law, Medicine & Ethics, 2020
Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.
Protections for Human Subjects in Research: Old Models, New Needs?
MIT Case Studies in Social and Ethical Responsibilities of Computing, 2022
Research within the United States that involves collecting and analyzing certain types of data from individual people has been subject to regulation since 1974. The rules governing research with so-called "human subjects" emerged out of specific research practices in the biomedical and social sciences within the government, as well as in response to revelations of egregious abuses of participants. Among other provisions, the federal regulations require prior review of certain proposed research projects by an institutional review board, or IRB. Many of the features of the federal regulations, including requirements for securing "informed consent" from research participants, focus on protections at the point of data collection. More recent research projects in computing and the data sciences, which rely upon large volumes of human-sourced data and information, have often collected their data via third-party platforms rather than via direct interaction with individual human subjects. As a result, such projects have rarely been subject to formal IRB review. Given the potential for harm to individuals and groups that have been identified for some computing projects, such as racial discrimination and loss of privacy, is it time to revisit or expand the existing human-subjects regulations?