Contractual Mechanisms for Securing the Public Interest in Data Sharing in Public-Private Health Research Partnerships

Public private partnerships (PPPs) are increasingly common in health research, with large European investment over the last 20 years and renewed focus in the wake of the global health crisis COVID-19. PPPs have been used for health research that seeks to collect, analyse and share personal data from research participants, often on the basis of informed or broad consent. PPPs are underpinned by contracts, both to govern the use of data and samples necessary for health research, and to govern the agreement between the public and private contracting parties of a project. This raises the question of how far contracts adequately protect public interests, for example in privacy and data protection when patient data are exposed to a broader range of potential uses from the private sector. A core principle of contract law is that you cannot contract for unlawful activity. As such, contracts could be void if their design or performance entails a breach of statute or common law, for example data protection and privacy laws or the common law duty of confidentiality. This paper analyses the implications of this general principle of illegality for contracts underpinning PPPs in health research, particularly to understand the extent to which it could operate to protect the public interest as conceived by privacy and data protection law. The paper will show how this heavily policy-driven doctrine has scope to ensure that contracts and contract terms that are contrary to public policy are void or unenforceable which, in the context of PPPs using personal information for health innovation and research, is a welcome, though limited, accountability mechanism in private law that could operate to serve the public interest

Engagement and Co-Design: Routes to Lawful Research?

Background The ‘deficit’ model of engagement, which educates the public about research, has been subject to increasing criticism, as if people’s attitudes arise from ignorance which should be corrected. Nevertheless, a number of attempts to understand public views on the use of Administrative Data for research have used informative models. This can be problematic from a legal perspective, as the law is concerned with data subjects’ ‘reasonable expectations’, not their hypothetical expectations had they received more information. Recent controversies around reasonable expectations have included Google DeepMind and Royal Free, as well as Cambridge Analytica. Objectives This paper considers how public engagement can help administrative data controllers meet their legal obligations when data are processed for research, and how to avoid confusion by placing too much reliance on the views of informed participants as a means of gauging wider public opinion. Methods We refer to the findings of an exploratory study of individual attitudes towards Administrative Data Research, which indicate that views and norms around ADR are incipient and ambivalent, especially when compared to perceptions of ‘conventional’ medical research. We consider the legal obligations administrative data controllers have to shape reasonable expectations in light of this uncertainty. Findings Engagement which informs the public about research does have value. It indicates what the attitudes of the public might be, were certain facts about research more commonly known, and thus underscores the importance of public information campaigns. However, this work cannot provide an accurate representation of public opinion as a whole in the absence of wider dissemination of information across society. Conclusions There will inevitably be a number of facets to public engagement: information, representation and transparency. Each of these will correlate differently with data controllers’ legal obligations, and it is essential to understand these connections

Biomodifying the ‘Natural’: from adaptive regulation to adaptive societal governance

Biomodifying technologies—such as gene editing, induced pluripotent stem cells and bioprinting— are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas — such as ‘nature,’ ‘product’ and ‘donation’— that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this ‘Adaptive Societal Governance’ approach, in which a self-organising network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of ‘life.

Discovery of drug-omics associations in type 2 diabetes with generative deep-learning models.

The application of multiple omics technologies in biomedical cohorts has the potential to reveal patient-level disease characteristics and individualized response to treatment. However, the scale and heterogeneous nature of multi-modal data makes integration and inference a non-trivial task. We developed a deep-learning-based framework, multi-omics variational autoencoders (MOVE), to integrate such data and applied it to a cohort of 789 people with newly diagnosed type 2 diabetes with deep multi-omics phenotyping from the DIRECT consortium. Using in silico perturbations, we identified drug-omics associations across the multi-modal datasets for the 20 most prevalent drugs given to people with type 2 diabetes with substantially higher sensitivity than univariate statistical tests. From these, we among others, identified novel associations between metformin and the gut microbiota as well as opposite molecular responses for the two statins, simvastatin and atorvastatin. We used the associations to quantify drug-drug similarities, assess the degree of polypharmacy and conclude that drug effects are distributed across the multi-omics modalities. [Abstract copyright: © 2023. The Author(s).

Controversies between regulations of research ethics and protection of personal data:informed consent at a cross‑road

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper

Biomodifying the ‘natural’ : from adaptive regulation to adaptive societal governance

Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas—such as ‘nature’, ‘product’, and ‘donation’—that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this ‘Adaptive Societal Governance’ approach, in which a self-organizing network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of ‘life’