{"title":"Public views about COVID-19 'Immunity Passports'.","authors":"Mark A Hall, David M Studdert","doi":"10.1093/jlb/lsab016","DOIUrl":"https://doi.org/10.1093/jlb/lsab016","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To determine public views regarding government and private conferral of immunity privileges.</p><p><strong>Design and setting: </strong>National on-line survey fielded in June 2020. Participants were randomly asked about either government 'passports' or private 'certificates' for COVID-19 immunity.</p><p><strong>Participants: </strong>Adults from a standing panel maintained for academic research, selected to approximate national demographics.</p><p><strong>Main outcomes/measures: </strong>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.</p><p><strong>Results: </strong>Of 1315 respondents, 45.2% supported immunity privileges, with slightly more favoring private certificates than government passports (48.1% vs 42.6%, <i>p</i> = 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%).</p><p><strong>Conclusions and relevance: </strong>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab016"},"PeriodicalIF":3.4,"publicationDate":"2021-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2a/2a/lsab016.PMC8271136.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39181408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Law, biomedical technoscience, and imaginaries","authors":"Mark L. Flear, R. Ashcroft","doi":"10.1093/jlb/lsaa088","DOIUrl":"https://doi.org/10.1093/jlb/lsaa088","url":null,"abstract":"This special issue advances understanding of the way in which imaginaries underpin law’s engagement with biomedical technologies and science. It is the first collection of law-led interdisciplinary accounts of imaginaries. The articles draw upon examples from biomedical technoscience to illuminate the hitherto unseen or underappreciated roles of imaginaries in the relationships between law and biomedical technoscience. We have conceptualized ‘law’, ‘biomedical technoscience’, and ‘imaginaries’ in broad, inclusive, and dynamic ways. ‘Law’ and ‘biomedical technoscience’ (biomedical technology and science) require no further clarification. ‘Imaginaries’, though, is a relatively novel concept within legal, socio-legal, and regulatory studies scholarship, 1 and as such it requires an introduction. In the following, we introduce imaginaries before explaining how this special issue aims to address the dearth of law, ensuring and mediating the boundaries of responsibility and accountability, and the legitimation of law and regulation, seem to be even more pressing. We believe it is essential that imaginaries figure more centrally in addressing these questions, and that law, encompassing legal and regulatory arrangements and discourse, takes a more central place in discussion on imaginaries. Imaginaries are central to investigating and resolving the ‘state of delicate tension’ between law, technology, and society. 12 It is with this in mind that we hope this special issue spurs further discussion.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41358524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Corporations, high-stakes biomedical research, and research misconduct: yes they can (and sometimes do).","authors":"E H Morreim","doi":"10.1093/jlb/lsab014","DOIUrl":"https://doi.org/10.1093/jlb/lsab014","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab014"},"PeriodicalIF":3.4,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f2/b1/lsab014.PMC8247552.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39081489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"China's evolving biosafety/biosecurity legislations.","authors":"Cong Cao","doi":"10.1093/jlb/lsab020","DOIUrl":"https://doi.org/10.1093/jlb/lsab020","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab020"},"PeriodicalIF":3.4,"publicationDate":"2021-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/47/0d/lsab020.PMC8245076.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39081491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Universal forensic DNA databases: acceptable or illegal under the European Court of Human Rights regime?","authors":"Oliver M Tuazon","doi":"10.1093/jlb/lsab022","DOIUrl":"https://doi.org/10.1093/jlb/lsab022","url":null,"abstract":"<p><p>Universal forensic DNA databases are controversial <i>privacy-wise</i> given their omnibus scope of incorporating DNA profile data of the entire population into the system. Following the landmark decision of the European Court of Human Rights on the retention of DNA profiles in <i>S. and Marper v. the United Kingdom</i>, two differing opinions emerged on its application to universal databases: their acceptability and illegality. This paper makes use of the elements of the right to respect for private life (Article 8 ECHR), distilled from the Court's jurisprudence involving collection and retention of DNA profile data, in the form of tests-preliminary interference, legality, legitimate purpose, and proportionality-in assessing the feasibility of establishing population-wide DNA databases in Europe.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab022"},"PeriodicalIF":3.4,"publicationDate":"2021-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/b9/lsab022.PMC8231703.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39053188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing the developing brain: tensions between parent, child, and state in the United States.","authors":"Anita S Jwa","doi":"10.1093/jlb/lsab017","DOIUrl":"https://doi.org/10.1093/jlb/lsab017","url":null,"abstract":"<p><p>Recent technological advances in neuroscience offer a novel way for parents to nurture their children: altering brain activation to improve cognitive functions. Parental use and state regulation of cognitive enhancement will inevitably cause tensions between parent, child, and state. These tensions stem from three different but fundamentally related causes, namely minors' incompetency in making decisions about their own welfare, parental autonomy to make decisions about the upbringing of their minor children, and the state's interests in protecting minors' well-being. However, these tensions are not without precedents. The courts have frequently struggled to set the boundary of parental autonomy and to balance parents' rights, children's interests, and state's interests, and have accumulated extensive precedents in various contexts. This article reviews previous US court decisions in select contexts analogous to cognitive enhancement-medical intervention, education, and mandatory vaccination-and analyzes their implications for the use of cognitive enhancement on minors. This article will provide a useful guide for policy makers and researchers to identify and analyze issues regarding cognitive enhancement and to develop sound policies to ensure responsible use of this novel technology.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab017"},"PeriodicalIF":3.4,"publicationDate":"2021-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2a/cb/lsab017.PMC8223904.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39053187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Standard contractual clauses for cross-border transfers of health data after <i>Schrems II</i>.","authors":"Laura Bradford, Mateo Aboy, Kathleen Liddell","doi":"10.1093/jlb/lsab007","DOIUrl":"https://doi.org/10.1093/jlb/lsab007","url":null,"abstract":"<p><p>Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in <i>Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems</i> (<i>Schrems II</i>) placed heavy conditions on their use. The <i>Schrems II</i> Court found that SCCs were valid as 'appropriate safeguards' for data transfers from EU entities to others outside the EU/EEA as long as unspecified 'supplementary measures' were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding <i>Schrems II</i> SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in <i>Schrems II</i> misunderstood the purpose of SCCs and other Article 46 GDPR 'appropriate safeguards'. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission's new draft SCCs support this analysis.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab007"},"PeriodicalIF":3.4,"publicationDate":"2021-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/11/4d/lsab007.PMC8216070.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39021075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bioethics in <i>China's Biosecurity Law</i>: forms, effects, and unsettled issues.","authors":"Leifan Wang, Fangzhong Wang, Weiwen Zhang","doi":"10.1093/jlb/lsab019","DOIUrl":"https://doi.org/10.1093/jlb/lsab019","url":null,"abstract":"<p><p>The Biosecurity Law has laid down a regulatory framework on bioethics in China, from raising awareness through education, requiring researchers to conform to ethical principles and conduct ethical reviews on biomedical research, to giving special attention to human genetic resources. The law constructively leaves a wide range of discretion to medical institutions and professionals in ethical decision-making, adaptive to the biotechnology-ethics-regulation dynamics. This regulatory strategy poses crucial institutional challenges in its implementation, particularly on how to safeguard institutional review boards (IRB), a core mechanism in the governance, to effectively protect human subjects but not unnecessarily hinder the progress of biomedical research. Further measures need to clarify important issues on the IRB-based governance, including legal status of the IRB review decision, potential liabilities, and protections of the IRB members.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab019"},"PeriodicalIF":3.4,"publicationDate":"2021-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7d/32/lsab019.PMC8208103.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39250003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Legal provisions for enforcing social distancing to guard against COVID-19: the case of Hong Kong.","authors":"Janice Y C Lau, Shui-Shan Lee","doi":"10.1093/jlb/lsab006","DOIUrl":"https://doi.org/10.1093/jlb/lsab006","url":null,"abstract":"<p><p>The implementation of social distancing measures through legal regulations to contain an epidemiologic outbreak has received little research attention. We reviewed and synthesized data on epidemiology, mobility trends and enforcement activities in the first 5 months of the COVID-19 epidemic in Hong Kong to examine the effectiveness of the newly enacted social distancing regulations. Data collected showed reduced patronage of retail and recreational activities during the epidemic. The regulations' enforcement could be inferred from the increase in the number of inspections, verbal warnings given to operators of scheduled premises and to people in public gatherings, but which rarely led to prosecutions. In parallel, the number of reported COVID-19 cases became stabilized. Our analyses suggested that public compliance with social distancing regulations could be maintained through promotional efforts without enforcement by prosecution. The adverse impacts of prolonged social distancing on the economy and citizens' social and psychological well-being were, however, of concern.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab006"},"PeriodicalIF":3.4,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1093/jlb/lsab006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39060457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abortion & 'artificial wombs': would 'artificial womb' technology legally empower non-gestating genetic progenitors to participate in decisions about <i>how</i> to terminate pregnancy in England and Wales?","authors":"Elizabeth Chloe Romanis","doi":"10.1093/jlb/lsab011","DOIUrl":"https://doi.org/10.1093/jlb/lsab011","url":null,"abstract":"<p><p>'Artificial womb' technology is highly anticipated for the benefits it might have as an alternative to neonatal intensive care and for pregnant people. In the bioethical literature, it has been suggested that such technology will force us to rethink the ethics of abortion. Some scholars have suggested that a pregnant person may be entitled to end a pregnancy but, with the advent of ectogestation, they may not be unilaterally entitled to opt for an abortion where the other genetic progenitor does not agree. Following two high-profile cases in England and Wales in the late 70s and 80s, English law is clear that genetic progenitors who do not gestate have no say in abortion decisions. It might be argued, however, that ectogestation casts doubt on the exclusion of all claims by genetic progenitors. In this article, I assess what a legal challenge to a decision to opt for abortion might look like with the advent of this technology, by examining whether genetic progenitors have the locus standi or grounds to seek an injunction to prevent abortion. I argue that such a challenge is unlikely to be successful.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"8 1","pages":"lsab011"},"PeriodicalIF":3.4,"publicationDate":"2021-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1093/jlb/lsab011","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39049425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}