A Normative Framework for the Reconciliation of EU Data Protection Law and Medical Research Ethics

Abstract

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics.

Information Provision for Informed Consent Procedures in Psychological Research under the GDPR: A Practical Guide

“…It is beyond the scope of this tutorial to elaborate on these discussions. We would, however, point the interested reader to Hallinan (2021), which expands the discussion and proposes a way forward. In this paper, the author highlights the relevance of both ethical and legal rules, and suggests a three-step approach for dealing with instances in which they overlap: i) look to the law to establish hard boundaries for action; ii) look to ethical rules for guidance as to how to act in relation to uncertainties left by law; iii) look back to the law to perform a control on the normative quality of solutions produced via a consideration of ethical rules.…”

Ethical considerations for precision psychiatry: A roadmap for research and clinical practice

“…Alternatively, let's imagine that the risk assessment is not performed; what would be the results in a few years' time? To address these sorts of questions, this study will consider ethical values in a broader sense, for example, by taking into account some of the different principles present in the charter of fundamental rights of the European Union -starting from dignity, freedom, equality, solidarity, citizens' rights and justice ( Table 1 ) ( European Union, 2012 ;Hallinan, 2021 ). In particular, human dignity and human flourishing are the most crucial elements from an ethical point of view that are tightly linked to autonomy and selfdetermination (which is modulated by several factors such as physical health, psychological state, sociocultural environment, as well as values and beliefs).…”

Learning accountable governance: Challenges and perspectives for data-intensive health research networks

“…Data protection law such as the GDPR creates a fundamental distinction between data controllers who determine the aim, scope and means of data use, and data processors who have to abide by binding data transfer agreements (Kalkman et al, 2019b; Mostert et al, 2016). Yet for large-scale health data research, this distinction's legitimacy and suitability are contested, since the ensuing rules, responsibilities and requirements among both sides remain uncertain (Forgó et al, 2021; Hallinan, 2021; Marelli et al, 2021). In addition, horizontal forms of collaboration mean that only minor difference exists between principal and agent roles.…”

“…To provide more specific input on who to involve regarding which questions, governing bodies should actively build on and translate international efforts that develop guidance and consensus on responsible governance (e.g., Global Alliance for Genomics and Health (GA4GH), 2014, 2016, 2021Knoppers, 2014;Knoppers et al, 2011;Rehm et al, 2021). Drawing on contextual considerations for incorporating and applying international guidance on involvement raises the potential of triggering reflexive learning processes.…”