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

Towards 'engagement 2.0': insights from a study of dynamic consent with biobank participants

Web 2.0 technologies have enabled new methods of engagement, moving from static mono-directional sources of information to interactive user-led experiences. Use of Web 2.0 technologies for engagement is gaining momentum within the health sector however this is still in its infancy in biobanking research. This paper reports on findings from focus groups with biobank participants to gauge their views on a Web 2.0 dynamic consent interface. The findings from this study suggest that participants would welcome more interactive engagement with biobanks, and the opportunity to hear more about how their data and samples are being used in research. We propose that by adopting Web 2.0 tools for dynamic consent, we can move towards an ‘Engagement 2.0’ model whereby research participants have the opportunity for more interactive engagement with medical research, setting up a two-way communication channel between participants and researchers, for the benefit of both

Creative regulatory practices to develop stem-cell technology: the way forward for Malaysia

Malaysia aspires to develop regenerative medicine through stem-cell technology. It needs a regulatory system that could facilitate development and prevent unethical practices. A comparative legal analysis on the regulation of stem-cell technology, with a focus on stem-cell research in Malaysia and selected Commonwealth countries that are experienced in regulating this complex technology, demonstrates that the selected Commonwealth countries have adopted a hybrid of different regulatory mechanisms. This paper argues that Malaysia should consider adopting a similar approach to equip relevant authorities with different regulatory mechanisms that are able to promote innovation in stem-cell research activities and cultivate a successful and profitable regenerative medicine industry in the future. Such a strategic action can produce an optimal regulatory outcome and help Malaysia to realize its aspiration

Post kala-azar dermal leishmaniasis: an unresolved mystery

Post kala-azar dermal leishmaniasis (PKDL), a cutaneous sequela of visceral leishmaniasis (VL), develops in some patients alongside but more commonly after apparent cure from VL. In view of the pivotal role of PKDL patients in the transmission of VL, here we review clinical, epidemiological, parasitological, and immunological perspectives of this disease, focusing on five hypotheses to explain the development of PKDL: (i) the role of antimonial drugs; (ii) UV-induced skin damage; (iii) reinfection; (iv) organ specific failure of memory T cell responses; and (v) genetic susceptibility of the host. This review will enable researchers and clinicians to explore the unresolved mystery of PKDL and provide a framework for future application of ‘omic’ approaches for the control and eventual elimination of VL

Data sharing in genomics - re-shaping scientific practice

Author manuscript. Final version published by Nature. Available online at http://www.nature.com/Funding bodies have recently introduced a requirement that data sharing must be a consideration of all funding applications in genomics. As with all new developments this condition has had an impact on scientific practice, particularly in the area of publishing and in the conduct of research. We discuss the challenges that must be addressed if the full benefits of data sharing, as envisaged by funders, are to be realized

Planning for translational research in genomics

Translation of research findings into clinical practice is an important aspect of medical progress. Even for the early stages of genomics, research aiming to deepen understandings of underlying mechanisms of disease, questions about the ways in which such research ultimately can be useful in medical treatment and public health are of key importance. Whilst some research data may not apparently lend themselves to immediate clinical benefit, being aware of the issues surrounding translation at an early stage can enhance the delivery of the research to the clinic if a medical application is later found. When simple steps are taken during initial project planning, the pathways towards the translation of genomic research findings can be managed to optimize long-term benefits to health. This piece discusses the key areas of collaboration agreements, distribution of revenues and recruitment and sample collection that are increasingly important to successful translational research in genomics

Equitable Participation in Biobanks: The Risks and Benefits of a “Dynamic Consent” Approach

Participation in biobanks tends to favor certain groups—white, middle-class, more highly-educated—often to the exclusion of others, such as indigenous people, the socially-disadvantaged and the culturally and linguistically diverse. Barriers to participation, which include age, location, cultural sensitivities around human tissue, and issues of literacy and language, can influence the diversity of samples found in biobanks. This has implications for the generalizability of research findings from biobanks being able to be translated into the clinic. Dynamic Consent, which is a digital decision-support tool, could improve participants' recruitment to, and engagement with, biobanks over time and help to overcome some of the barriers to participation. However, there are also risks that it may deepen the “digital divide” by favoring those with knowledge and access to digital technologies, with the potential to decrease participant engagement in research. When applying a Dynamic Consent approach in biobanking, researchers should give particular attention to adaptations that can improve participant inclusivity, and evaluate the tool empirically, with a focus on equity-relevant outcome measures. This may help biobanks to fulfill their promise of enabling translational research that is relevant to all