Michael Morrison

Dynamic consent: a patient interface for twenty-first century research networks

Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes.

Patenting human pluripotent cells: balancing commercial, academic and ethical interests

The article addresses the issue of the ethics of patenting in human embryonic stem (hES) cells. The current stance of the European Patent Office in citing moral objections to patents on hES cells and the monopolistic scope of the Wisconsin Research Alumni Fund/Geron patents granted by the United States Patent and Trademark Office represent twin obstacles to achieving an ethical balance in patent rights in this field. The particular issues and strategies around granting patents on hES cells can be better understood by placing them in the context of the biotechnology industry and its role in the global bioeconomy. Some possible avenues of redress are considered based on the potential to open up cell pluripotency as new terrain for intellectual property offered by new technological breakthroughs such as induced pluripotent cells. Any changes in patent law should be accompanied by increased collaboration through devices such as patent pools.

Beyond the ‘embryo question’: human embryonic stem cell ethics in the context of biomaterial donation in the UK

Discussion about the ethics of human embryonic stem cell (ESC) research in the UK tends to be dominated by the divisive and potentially intractable issue of the moral status of the embryo. This can have the effect of silencing or marginalizing other concerns, especially in the context of public engagement with science in this field. One such area of potential public concern is the donation of oocytes and embryos to stem cell research. Contemporary research on the views of donors and potential donors about a wide range of biomaterials, from solid organs to gametes and bone marrow, is reviewed and used to illustrate the range and types of ethical concerns articulated by this important group of stakeholders. Attitudes to donation are found to vary according to the type of tissue being donated or collected, the purpose for which donation is being sought and the nature of the recipient of the donation. Pertinently, attitudes towards donating oocytes are found to differ in some respects from donation of embryos or fetal tissue. The implications of these findings for ensuring ethically robust informed consent and publicly acceptable sourcing of human biomaterials for stem cell research are then considered.

StemBANCC: Governing Access to Material and Data in a Large Stem Cell Research Consortium.

This paper makes the case for implementing an internal governance framework for sharing materials and data in stem cell research consortia. A governance framework can facilitate a transparent and accountable system while building trust among partner institutions. However, avoiding excessive bureaucracy is essential. The development and implementation of a governance framework for materials and data access in the Stem cells for Biological Assays of Novel drugs and prediCtive toxiCology (StemBANCC) consortium is presented as a practical example. The StemBANCC project is a multi-partner European research consortium, which aims to build a resource of 1,500 well characterised induced pluripotent stem cell (iPSC) lines for in vitro disease modelling and toxicology studies. The project governance framework was developed in two stages. A small working group identified key components of a framework and translated the project legal agreements into a draft policy document. The second phase allowed input from all consortium partners to shape the iterative development of a final policy document that could be agreed by all parties. Careful time management strategies were needed to manage the duration of this component. This part of the process also served as an exploratory space where different options could be proposed, potential gaps in planning identified, and project co-ordination activities specified.

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.

Exploring the Role of Dedicated Online Biotechnology News Providers in the Innovation Economy

In this article, the authors examine the role of dedicated online biotechnology news providers in disseminating and shaping stories of technological promise within the bioeconomy. In this field, communication of future-orientated claims is closely linked to a firm’s ability to attract speculative investment and so dedicated biotech news services play an important role in facilitating this interaction between technology producers and investors. Using the emerging field of regenerative medicine (RM) as a case study, the authors illustrate how coverage of RM biotechnologies and firms by these online news services acts to increase the intensity of promissory communication and how interaction between news providers can create dominant framings of particular events in which some aspects are emphasized while others are marginalized. Considered cumulatively, the authors show how these accounts ultimately present a highly linear account of technological innovation which renders the actions of multiple technoscientific actors meaningful to investors but at a cost to addressing the local contingencies of scientific research.

The European general data protection regulation: Challenges and considerations for iPSC researchers and biobanks

Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.

Overdiagnosis, medicalisation and social justice: commentary on Carter et al (2016) ‘A definition and ethical evaluation of overdiagnosis’

The concept of ‘overdiagnosis’ is one of a number of related, normative concepts, such as ‘too much medicine’,1 ,2 that have emerged recently and which try and describe harms associated with the excessive or undue application of medicine. It is worth considering to what extent the concept of overdiagnosis (and other recent coinages) represents a refinement, an alternative, or a possible successor to the older concept of medicalisation.3 Medicalisation, it has been argued, has been overused, becoming in the process too broad and too nebulous to provide a useful critique of medical practice or organisation.4 In this context, overdiagnosis may be regarded as an attempt to regain this critical edge by focusing on a specific facet of medical practice—diagnosis—and attempting, as Carter et al 5 have done, to delineate a clear set of problems to be addressed. Critiques, of course, are of their; they are shaped by the perspectives of the communities from which they arise, and the wider social context of the particular problems that they seek to address. While several drivers of overdiagnosis have been identified, it is perhaps most pertinent that the concept has arisen in an …

“A good collaboration is based on unique contributions from each side”: assessing the dynamics of collaboration in stem cell science

The rise of ‘big biology’ is bringing academic and industrial scientists together in large consortia to address translational challenges in the life sciences. In order to assess the impact of this change, this paper examines the existing norms and styles of collaboration in one high profile translational domain; stem cell research. Data is drawn from qualitative interviews with academic and industry scientists working in a large European stem cell research project. Respondents discussed what they perceived as the main benefits and risks of collaborative research, what styles of collaboration they were familiar with, and what collaborative work in stem cell science normally involves. A wide range of materials, data, and expertise can be exchanged during collaborative work. Informal collaborations are governed by an ethos of reciprocity and mediated by trust while formal project agreements can provide a safe space for sharing between unfamiliar partners. These characteristics make stem cell research well suited to pre-competitive public-private ventures but translation of new products to market may be more challenging.

Infrastructural expectations: exploring the promise of international large-scale induced pluripotent stem cell banks

This paper investigates the recent emergence of several major projects to bank and distribute large numbers of human induced pluripotent stem cells (hiPSCs) for translational research. The conceptual framework of the sociology of expectations is applied to interrogate the promise underpinning these developments. An analytic distinction is made between expectations associated with the field of hiPSC research more broadly and those specifically invested in cell banks as a form of scientific infrastructure, with the focus predominantly on the latter element. Empirical data for the analysis comes from qualitative interviews with stem cell scientists involved in a major European hiPSC banking project. In order to unpack these expectations, parallels to previous infrastructures of dissemination will be highlighted, with an emphasis on the functions of circulating and securing the quality of biological research materials.