Shawn Harmon

Open science versus commercialization: a modern research conflict?

BackgroundEfforts to improve research outcomes have resulted in genomic researchers being confronted with complex and seemingly contradictory instructions about how to perform their tasks. Over the past decade, there has been increasing pressure on university researchers to commercialize their work. Concurrently, they are encouraged to collaborate, share data and disseminate new knowledge quickly (that is, to adopt an open science model) in order to foster scientific progress, meet humanitarian goals, and to maximize the impact of their research.DiscussionWe present selected guidelines from three countries (Canada, United States, and United Kingdom) situated at the forefront of genomics to illustrate this potential policy conflict. Examining the innovation ecosystem and the messages conveyed by the different policies surveyed, we further investigate the inconsistencies between open science and commercialization policies.SummaryCommercialization and open science are not necessarily irreconcilable and could instead be envisioned as complementary elements of a more holistic innovation framework. Given the exploratory nature of our study, we wish to point out the need to gather additional evidence on the coexistence of open science and commercialization policies and on its impact, both positive and negative, on genomics academic research.

The Stem Cell Research Environment: A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

Solidarity: A (New) Ethic for Global Health Policy

This article explores solidarity as an ethical concept underpinning rules in the global health context. First, it considers the theoretical conceptualisation of the value and some specific duties it supports (ie: its expression in the broadest sense and its derivative action-guiding duties). Second, it considers the manifestation of solidarity in two international regulatory instruments. It concludes that, although solidarity is represented in these instruments, it is often incidental. This fact, their emphasis on other values and their internal weaknesses diminishes the action-guiding impact of the solidarity rules. The global health and human subject research scene needs a completely new instrument specifically directed at means by which solidarity can be achieved, and a reformed infrastructure dedicated to realising that value.

Not “human” enough to be human but not “animal” enough to be animal – the case of the HFEA, cybrids and xenotransplantation in the UK

Innovations in scientific and medical technologies, such as xenotransplantation and admixed embryos, invariably become the target of regulatory agencies and often demand new regulatory frameworks. In making decisions associated with these innovations, it is sometimes necessary for regulators to adopt certain positions about the status and significance of the human–animal embryo or body. In the UK, the regulatory and advisory bodies involved in the sphere of human/non-human transfer and exchange of material are: (1) the Human Fertilisation and Embryology Authority (HFEA); (2) the (defunct) UK Xenotransplantation Interm Regulatory Authority; and (3) the Home Offices Animal Procedures Committee (APC). In this article, we critically examine the reasons for the HFEAs involvement in regulating and advising in research which uses admixed embryos, given that the HFEAs remit is the governments fertility watchdog regulating in the area of human embryos. This expansion, we argue, was partly due to pressure from pro-cybrid supporters and the need to fill an institutional void left by the decommissioning of UKXIRA. Ironically, specific institutions such as UKXIRA may have been better placed to deal with animal–human fusions.

Yearworth v. North Bristol NHS trust : a property case of uncertain significance?

It has long been the position in law that, subject to some minor but important exceptions, property cannot be held in the human body, whether living or dead. In the recent case of Yearworth and Others v North Bristol NHS Trust, however, the Court of Appeal for England and Wales revisited the property debate and threw into doubt a number of doctrines with respect to property and the body. This brief article analyses Yearworth, (1) reviewing the facts and the Court’s decision with respect to the originators’ proprietary and contractual interests in their body and bodily products, (2) considering the significance of relying on property and its use a legal metaphor, (3) questioning the scope of the property right created, and (4) querying whether an alternate conceptual approach to extending rights and a remedy was warranted. It concludes that, while Yearworth engages with, and impacts on, important theoretical and practical issues—from legal, healthcare and research perspectives—it does not offer a great deal of guidance and, for that reason, its precedential significance is in doubt.

Of plants and people. Why do we care about dignity

References to human dignity are littered throughout modern human rights and bioethics instruments, from the Universal Declaration of Human Rights (1948) and the European Convention on Human Rights (1950), to UNESCOs Universal Declaration on Bioethics and Human Rights (2005) and the latest version of the Declaration of Helsinki (2008). Dignity is both the background value of these texts, and the primary principle upon which they are constructed. > Ultimately, the value of dignity is in the eye of the beholder; it depends on their interpretation and sociopolitical objective Despite this ubiquitous reliance on dignity, it remains a notoriously slippery concept; it can be either a positive and empowering value, or a negative and constraining one (Harmon, 2008). Here, I define ‘values’ as deeply held ideas or moral concepts about what is good and right—which are constitutive of the self—and what supports human flourishing and contributes both to personal and to social identity—which are the tenets of justice. In both cases, values are complex, overlapping and opaque, and therefore often hidden. I define ‘principles’ in much the same way, but with one subtle difference: values are more social, idealistic and of a higher order than principles, which are more legally grounded and instrumental. Ultimately, the value of dignity is in the eye of the beholder; it depends on their interpretation and sociopolitical objective. In short, although dignity is intuitively comprehensible and universally appealing—no one wants to be said to act against dignity—it is also confounding and contentious, and, as such, its utility as an action‐guiding tool has been questioned (Macklin, 2003; Harmon, 2005). Despite the fact that dignity is a rather opaque concept, it persists as a pillar in the legal realm. The first article of the German Constitution, for example, states that, “Human dignity shall be inviolable. To respect …

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.

Foresighting Futures: Law, New Technologies, and the Challenges of Regulating for Uncertainty

It is perhaps trite but worth repeating that existing social and legal systems aimed at promoting human wellbeing and prosperity face significant and multi-faceted challenges. Some come from the natural world and some from humankind itself. Of the latter, some come from the way we behave and treat each other, some from the way we interact with and wish to shape our environment, and, most challenging of all, some come from the way we envision and seek to shape our future. Many of these implicate the law. Indeed, never have we demanded so much from our legal and regulatory frameworks and those who operate them, and never have they faced so many pressures and variables. The following captures the character of the times:

Ethical rhetoric: genomics and the moral content of UNESCO’s “universal” declarations

Genomic research is an expanding and subversive field, leaking into various others, from environmental protection to food production to healthcare delivery, and in doing so, it is reshaping our relationship with them. The international community has issued various declaratory instruments aimed at the human genome and genomic research. These soft law instruments stress the special nature of genomics and our genetic heritage, and attempt to set limits on our activities with respect to same, as informed by the human rights paradigm. This paper examines the primary thrust and, more importantly, the joint value position of the Universal Declaration on the Human Genome and Human Rights and the Universal Declaration on Bioethics and Human Rights, concluding that, though important legal instruments from the human rights paradigm, these instruments, or rather the values contained therein, must find a more influential hard law voice and a broader policy environment.

MEDICAL RESEARCH DATA-SHARING: THE ‘PUBLIC GOOD’ AND VULNERABLE GROUPS

One of the moral tests of governments is how they treat those in the twilight of life (the elderly). As such, it is important not only to take care of the needs of the elderly, but also to place their reality in the forefront of deliberations and actions. Now that we are in the so-called century of biology, we must ensure that the newly transformed and increasingly relied on biosciences not only respond to the needs of the elderly but also reflect the reality of the elderly. While many arguments can be made in support of increased data-sharing in biomedical research (and indeed within and across healthcare systems more generally), there are some persuasive age-based arguments that might serve to encourage science regulators, through both funding structures and the law, to fundamentally reshape the research environment so as to enhance its potential to achieve public goods such as improved health and more effective healthcare systems. In this paper, after noting the new research model arising from population genomics, with its intense data needs, we advance three age-based arguments, in favour of increased and improved data-sharing, and we conclude with some brief observations about how increased data-sharing might be achieved.