Journal of Law and the Biosciences最新文献

Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents ('user agreements') and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research risks, categorizing the key information in these agreements under relevant ethical and regulatory categories, and proposing strategies to mitigate them. MHealth user agreements typically describe the nature of the data collected by mHealth technologies, why or for what purposes user data are collected and shared, who will have access to the different types of data collected, and may include exculpatory language. The risks raised by data collection and sharing typically increase with the sensitivity and identifiability of the data and vary by whether data are shared with researchers, the technology developer, and/or third-party entities. The most important risk mitigation strategy is disclosure of the key information found in user agreements to participants during the research consent process. In addition, researchers should prioritize mHealth technologies with favorable risk-benefit balances.

A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic research has been limited, and therefore these activities have attracted little regulatory attention. New technologies such as CRISPR/Cas9, however, give nonconventional experimenters more extensive gene editing abilities at an unprecedented level of accessibility. The affordability and accessibility of these powerful technologies are raising questions about whether the current largely laissez-faire governance approach is adequate. This article recommends steps to enhance self-governance, including establishing umbrella organizations to represent community interests, creating a community IRB modelled on the DIYBio Ask a Safety Expert Service, and adopting an ethical obligation to report rogue experiments.

Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The Dobbs decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions of the Federal Food Drug and Cosmetic Act (FDCA), that mifepristone may be taken by patients outside the presence of any healthcare provider (often through telemedicine prescription and shipment across state lines). Now that Dobbs has been decided, state officials have indicated that they will seek to enforce state statutes which conflict with FDA's regimen for the proper use of mifepristone, by banning its use entirely, prohibiting telemedicine prescription, or imposing other requirements which FDA has specifically considered and now rejected as contrary to the congressional mandate that FDA-approved drugs be as accessible as safety considerations allow. Litigation has already been filed to invalidate such statutes on the grounds that they are preempted by the doctrine that state law which conflicts with, or undermines the purposes of, FDA actions with respect to approved drugs are preempted under the Supremacy Clause of the Constitution. This article examines the Supreme Court caselaw and FDA actions which will dictate the outcome of that litigation. Part I details the statutory basis for FDA preemption of conflicting state law and the four decisions by the Supreme Court over the last 13 years (Levine, Mensing, Bartlett and Albrecht) which enunciate the governing legal standards for FDA preemption. We pay particular attention to the opinions of Justice Alito and the other conservative justices, which hold that such FDA preemption should be robust to ensure that there is one consistent, national policy for the distribution and regulation of drugs, under the science-based decisions of the FDA, rather than the 'parochialism' of differing state standards. Part II details FDA's comprehensive program for the balanced, though appropriately restricted, use of mifepristone, and the 22 years of FDA actions that brought that about. It then catalogs the state statutes limiting the use of the drug which, in material ways, conflict with those FDA determinations. Part III outlines the arguments made in one early lawsuit seeking preemption of the statutes of one state (Mississippi)-a law suit which previews the wider litigation to come. It then sets forth the strong arguments for FDA preemption of each type of state restriction and responses to the 'defenses' of those statutes that have been offered in an effort to avoid FDA preemption under the Supremacy Clause. That review shows that a straight-forward application of the FDCA and the Supreme Court caselaw should result in the preemption of the state restrictions that square

Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada's regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance.

The United Nations Convention on the Rights of Persons with Disabilities requires states parties to 'recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life.' This mandate has sparked debate about the interpretation of legal capacity, including within the criminal context as applied to the retrogressively named 'insanity defense.' Yet, under-examined are two questions: First, what defenses should defendants with psychosocial disabilities be able to invoke during criminal prosecutions? Second, what kind of evidence is consistent with, on the one hand, determining a defendant's decision-making capacity to establish culpability and, on the other hand, the right to equal recognition before the law? Developments in neuroscience offer a unique prism to grapple with these issues. We argue that neuroscientific evidence of impaired decision-making, insofar as it presents valid and interpretable diagnostic information, can be a useful tool for influencing judicial decision-making and outcomes in criminal court. In doing so, we oppose the argument espoused by significant members of the global disability rights community that bioscientific evidence of psychosocial disability should be inadmissible to negate criminal responsibility. Such a position risks more defendants being punished harshly, sentenced to death, and placed in solitary confinement.

Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored-but foundational-question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly 'no'. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved-including foreign collaborators-to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.

Research using three-dimensional neural tissues derived from human pluripotent stem cells-known as 'human brain organoids'-has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only been sparsely examined compared with the related ethical issues. In this paper, we explore a fundamental issue concerning the legal status of human brain organoids: whether they can be considered legal persons. We clearly distinguish between two types of legal personhood: 'natural person' as a human legal person and 'juridical person' as a nonhuman legal person. By examining natural and juridical personhood separately, we point out the bias and confusion in the remarks on the legal personhood of human brain organoids and provide a more comprehensive picture of the problem.

In recent years, we have witnessed considerable progress in neurotechnologies that visualize or alter a person's brain and mental features. In the near future, some of these technologies could possibly be used to change neural parameters of high-risk behavior in criminal offenders, often referred to as neurointerventions. The idea of delivering neurointerventions to criminal justice populations has raised fundamental normative concerns, but some authors have argued that offering neurointerventions to convicted offenders could be permissible. However, such offers raise normative concerns too. One prominent worry that is often emphasized in the literature, relates to the vulnerability of convicted offenders in prison and forensic patients in mental health facilities. In this paper, we aim to show that as far as vulnerability is considered relevant within the context of offering medical interventions to offenders, it could contribute to arguments against as well as in favor of these offers.

Philosophical discussions concerning ectogestation are trending. And given that the Supreme Court of the United States overturned Roe v. Wade (1973) and Casey v. Planned Parenthood (1992), questions regarding the moral and legal status of abortion in light of the advent of ectogestation will likely continue to be of central importance in the coming years. If ectogestation can intersect with or even determine abortion policy in the future, then a new philosophical analysis of the legal status of abortion is both warranted and urgently needed. I argue that, even if there is no 'moral' right to fetal destruction once ectogestation becomes a reality, societies ought not to implement legal prohibitions on a pregnant person's ability to safely obtain an abortion that results in fetal death because such laws are systemically misogynistic.

This article explores whether the human right to science can support the public interest as a legal basis to use and disclose confidential information. The contextual focus is scientific research; the jurisdictional focus is England. The human right to science, as reflected in the Universal Declaration of Human Rights (Article 27) and the International Covenant on Economic, Social and Cultural Rights (Article 15), hitherto has not been invoked in support of a public interest basis for lawful disclosure, but the argument is made herein that there may be scope to develop this jurisprudentially. On grounds of both law and policy, and in line with the underlying rationale of recent UK Government deployment of 'COPI Notices' for lawful use of confidential patient information in the course of the COVID-19 pandemic, I contend that the human right to science may well serve as a valuable juridical buttress to an overriding public interest justification to lawfully share confidential information. However, this could occur only in restricted circumstances where the public interest is clearly manifest, namely studies researching serious, imminent health threats to the general population that rely on confidential information accessed outside of existing statutory gateways, and not more routine scientific endeavors.