Abstract
While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss.
Highlights
Informed consent has been established as a necessary prerequisite for research involving identifiable human samples or personal health related data
European General Data Protection Regulation on issues of consent and the ethical debate on models of consent. (Sect. 2), We present some of the suggested models of consent (Sect. 3), identify ethical concerns incorporated in these models (Sect. 4), and set out to give a structured overview of pros and cons, based on the ethical concerns identified, of each of the models
It is subject to scholarly controversy whether broad consent, as traditionally understood and practiced in biobank research, is acceptable under the General Data Protection Regulation (GDPR) regimen, or whether GDPR consent must rather be understood along the lines of narrower consent models such as dynamic consent (Hallinan 2020, Gefenas et al 2021)
Summary
Informed consent has been established as a necessary prerequisite for research involving identifiable human samples or personal health related data. It is understood as study specific consent that is given by research. 4), and set out to give a structured overview of pros and cons, based on the ethical concerns identified, of each of the models This overview leads us to conclude that no single model of consent can address all of the ethical concerns at stake adequately. As a balancing of ethical perspectives becomes inevitable (Sect. 6) contextual factors need to be taken into account (Sect. 7)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have