Journal of Law and the Biosciences最新文献

This article employs the notion of 'sociotechnical imaginaries' from the discipline of science and technology studies in order to consider the role that constructions of Japan play within UK policy discourse on science, technology, and innovation. The analysis is parsed in relation to the three dominant constructions that emerged from within the discourse under study: Japan as collaborator, as comparator, and as competitor. The mentioning of Japan within policy texts seems often aimed at evoking an imaginary of an economically successful and technoscientifically inventive nation, geared up for investment and innovation. Japan was present in the texts analyzed as a country that was simultaneously the same and other to the UK: similar enough for meaningful comparisons to be made, while sufficiently different to motivate the UK to 'do better' and to galvanize symbolic and material resource to become 'more like' Japan. Thus, a sociotechnical imaginary emerged that was at once familiar to and yet also distinct from that of the UK. Sociotechnical imaginaries of other/Other nations can govern through enabling and shaping political and policy conversations, which can ultimately inflect and indeed help to determine different forms of legal and regulatory tools, processes, and discourses.

Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks actually use have not been empirically examined, apart from some small case studies. In particular, no industry-wide evidence exists on three points of biobanks' IP practice: (i) if and how biobanks implement these five types of IP clauses, (ii) whether any norms or standards have emerged, and (iii) whether the norms and standards align with commentators' recommendations for using the five IP clauses. To address these three gaps, the authors conducted a systematic, global survey of the IP clauses used by large, human biobanks. The results indicate that biobanks draft bespoke policies to meet their own needs, and probably do so without knowledge of the gamut of IP terms available. This study also revealed that, in general, biobanks are using IP terms differently from the advice of the commentators. On reviewing the differences, we encourage the use of march-in and grant-back clauses, discourage biobanks from using redundant non-obstruction clauses, and call for more research on return-of-results clauses. We also encourage the use of reach-through clauses to claim royalties (not IP), but only in limited circumstances; for example, where user access fees do not cover a biobanks' operational costs.

Suicide remains a problem of public health importance worldwide. Cognizant of the emerging links between social media use and suicide, social media platforms, such as Facebook, have developed automated algorithms to detect suicidal behavior. While seemingly a well-intentioned adjunct to public health, there are several ethical and legal concerns to this approach. For example, the role of consent to use individual data in this manner has only been given cursory attention. Social media users may not even be aware that their social media posts, movements, and Internet searches are being analyzed by non-health professionals, who have the decision-making ability to involve law enforcement upon suspicion of potential self-harm. Failure to obtain such consent presents privacy risks and can lead to exposure and wider potential harms. We argue that Facebook's practices in this area should be subject to well-established protocols. These should resemble those utilized in the field of human subjects research, which upholds standardized, agreed-upon, and well-recognized ethical practices based on generations of precedent. Prior to collecting sensitive data from social media users, an ethical review process should be carried out. The fiduciary framework seems to resonate with the emergent roles and obligations of social media platforms to accept more responsibility for the content being shared.

Importance: Discovery of effective vaccines and increased confidence that infection confers extended protection against coronavirus disease (COVID-19) have renewed discussion of using immunity certificates or 'passports' to selectively reduce ongoing public health restrictions.

Objective: To determine public views regarding government and private conferral of immunity privileges.

Design and setting: National on-line survey fielded in June 2020. Participants were randomly asked about either government 'passports' or private 'certificates' for COVID-19 immunity.

Participants: Adults from a standing panel maintained for academic research, selected to approximate national demographics.

Main outcomes/measures: Level of support/opposition to immunity privileges, and whether views vary based on: government vs. private adoption; demographics; political affiliation or views; or various COVID19-related attitudes and experiences.

Results: Of 1315 respondents, 45.2% supported immunity privileges, with slightly more favoring private certificates than government passports (48.1% vs 42.6%, p = 0.04). Support was greater for using passports or certificates to enable returns to high-risk jobs or attendance at large recreational events than for returning to work generally. Levels of support did not vary significantly according to age groups, socioeconomic or employment status, urbanicity, political affiliation or views, or whether the respondent had chronic disease(s). However, estimates from adjusted analyses showed less support among women (odds ratio, 0.64; 95% confidence interval, 0.51 to 0.80), and among Hispanics (0.56; 0.40 to 0.78) and other minorities (0.58; 0.40 to 0.85) compared with whites, but not among blacks (0.83; 0.60 to 1.15). Support was much higher among those who personally wanted a passport or certificate (75.6% vs 24.4%) and much lower among those who believed this would harm the social fabric of their community (22.9% vs 77.1%).

Conclusions and relevance: Public views are divided on both government or private uses of immunity certificates, but, prior to any efforts to politicize the issues, these views did not vary along usual political lines or by characteristics that indicate individual vulnerability to infection. Social consensus on the desirability of an immunity privileges programs may be difficult to achieve.

Science has long been vulnerable to research misconduct (RM). Biomedical sciences, with vast financial stakes, carry heightened temptations. However, RM is standardly seen as an undertaking of individual scientists, not as something that could be committed by an organization such as a corporation or university. Rather, organizations are generally regarded merely as supervisors to encourage scientific integrity and investigate suspected RM. Indeed, federal regulations expressly embrace this perspective, and the federal Office of Research Integrity has never deemed an organization guilty of committing RM. This article aims to rewrite this corner of research integrity: organizations can directly commit RM and should be held accountable as such. Although the conclusions apply to organizations such as universities and government agencies, the focus here is on corporations in the biomedical sciences. After defining 'research misconduct' in Part II, Part III describes corporate-level RM and distinguishes it from individuals' misconduct. Part IV provides five case studies exemplifying corporate RM, while Part V discusses implications, describes ways in which federal regulations could already encompass organization-level RM, and identifies some needed legal and regulatory adjustments.

This paper represents a systematic effort to describe and assess China's evolving biosafety/biosecurity legislative and regulatory regime. It catalogs and analyzes laws, regulations, and measures, including the newly passed Biosafety/Biosecurity Law. Various reasons are underlying China's recently accelerating legislative process for such a law, from international attention increasingly turning biosafety/biosecurity governance into a more regular fixture; the emergence of infectious diseases and even pandemics linked with zoonosis; advances in the global frontier of the life sciences and biotechnology and their integration with other technologies, which, while holding great promise for advancements in global health, raises biosafety/biosecurity concerns; to the strengthening of biosafety/biosecurity governance in many countries. Chinese leadership's 'holistic view of national security' encompasses broad areas of concerns of national security with biosafety/biosecurity being an integral part. However, having progressed alongside its development of the life sciences and biotechnology, China's current biosafety/biosecurity legislative and regulatory regime is far from rising to the challenges and even the newly enacted Biosafety/Biosecurity law still has room for improvement. The paper's findings have significant policy implications for further enhancing China's biosafety/biosecurity legislation and governance and making them better serve domestic interests while converging with international norms.