Empirical legal research seeks to understand and explain how law works in the real world. Empirical research on law has become a recognized part of the social science research environment and the results of empirical research are central to an academic analysis of law. This article begins by offering some reflections on the relationship between research and government. It considers examples of empirical research on law influencing policy-making and reflects briefly on what these (...) case studies suggest about the relationship between empirical research on law and the policy-making process. Following this, it seeks to identify the factors that need to be addressed to ensure that the research and policy-making process is as strong and integrated as possible. In the end, the article argues that researchers and policy-makers should consciously work toward the development of a strategic program of empirical research on law, justified for its wider potential impact on society. (shrink)

The role of the REC is to aim for a fair and effective trial protocol and to provide to potential trial subjects sufficient information to allow them to make a rational decision on whether to participate in it or not. The members are medical specialists and members of the public together fitted to these tasks. In his paper ‘Illegality in the research protocol: the duty of research ethics committees under the 2001 Clinical Trials Directive’ Roy-Toole has made a (...) number of suggestions on how to improve the function of the RECs, but he has not given persuasive evidence to show that the RECs themselves are the most effective bodies to implement possible legal requirements to improve medical research. (shrink)

This article deals with the objective nuances of empirical research, within the ambit of the quantitative kind. It begins with an overview of conducting empirical legal research, discussing its research design, implementation, and challenges faced. Theorizing in empirical legal scholarship comes in different forms: in some projects theories seek to provide insight into a wide range of phenomena, others are tailored to fit particular situations. In the clarification process the researcher translates abstract notions into concrete (...) ones. To convert the data into an analyzable form, empirical legal researchers make use of a variety of data-generation mechanisms. Researchers can implement random sampling in various ways depending on the nature of the problem. Data analysis enables researchers to compare their overlap. The goal of empirical legal research is to find facts about the unknown. The last step of empirical legal research is to present its results, for which, documentation is a requisite. (shrink)

Empirical legal research is defined in many ways. These differences in definition are important when considering the place of empirical legal studies in the law school curriculum. In this regard, this article reflects on school curricula in law schools in the United States and the United Kingdom. Empirical legal studies are largely absent from law school curricula. One indispensable pre-condition for any law school curriculum is that it must reflect what those teaching it believe to be (...) true. Empirical legal studies can be properly incorporated into the law school curriculum if students not only use and understand such studies but also understand the methods used and the theories upon which they are based. Law schools throughout the world are in a state of flux. Empirical legal research has to compete for the attention of academics in law schools with a number of other areas of research that are becoming more popular. (shrink)

Until quite recently questions about methodology in legal research have been largely confined to understanding the role of doctrinal research as a scholarly discipline. In turn this has involved asking questions not only about coverage but, fundamentally, questions about the identity of the discipline. Is it (mainly) descriptive, hermeneutical, or normative? Should it also be explanatory? Legal scholarship has been torn between, on the one hand, grasping the expanding reality of law and its context, and, on (...) the other, reducing this complex whole to manageable proportions. The purely internal analysis of a legal system, isolated from any societal context, remains an option, and is still seen in the approach of the French academy, but as law aims at ordering society and influencing human behaviour, this approach is felt by many scholars to be insufficient. Consequently many attempts have been made to conceive legal research differently. Social scientific and comparative approaches have proven fruitful. However, does the introduction of other approaches leave merely a residue of 'legal doctrine', to which pockets of social sciences can be added, or should legal doctrine be merged with the social sciences? What would such a broad interdisciplinary field look like and what would its methods be? This book is an attempt to answer some of these questions. (shrink)

This article deals with the qualitative approach to empirical studies. This approach is presumed to be closer to the social sciences. Data collection in the qualitative approach follows a combination of these three methods—direct observations, in-depth interviews, and document analysis. It typically starts with the identification of methodology, data collection, analysis, ethical concerns, and adapt to the dynamics if working in a team. Well-compiled qualitative research enhances comprehensibility of social phenomenon. The technique used in the selection of data collection (...) depends on the research question, leading to the research strategy that best fits the research objective, availability/access to particular data sources, and available resources. While various beliefs are held in common between the quantitative and the qualitative, a researcher must first assert the purpose and nature of the project, in order to come to a deterministic conclusion as to which approach is best suited for the research to be conducted. (shrink)

The art, craft, and science of policing -- Crime and criminals -- Criminal process and prosecution -- The crime-preventive impact of penal sanctions -- Contracts and corporations -- Financial markets -- Consumer protection -- Bankruptcy and insolvency -- Regulating the professions -- Personal injury litigation -- Claiming behavior as legal mobilization -- Families -- Labor and employment laws -- Housing and property -- Human rights instruments -- Constitutions -- Social security and social welfare -- Occupational safety and health -- (...) Environmental regulation -- Administrative justice -- Access to civil justice -- Judicial recruitment, training, and careers -- Trial courts and adjudication -- Appellate courts -- Dispute resolution -- Lay decision-makers in the legal process -- Evidence law -- Civil procedure and courts -- Collective actions -- Law and courts on development and democratization -- How does international law work? -- Lawyers and other legal service providers -- Legal pluralism -- Public images and understandings of courts -- Legal education and the legal academy -- The (nearly) forgotten early empirical legal research -- Quantitative approaches to empirical legal research -- Qualitative approaches to empirical legal research -- The need for multi-method approaches in empirical legal research -- Legal theory and empirical research -- Empirical legal research and policy-making -- The place of empirical legal research in the law school curriculum -- Empirical legal training in the US academy. (shrink)

Multi-method research is any research that uses more than one research technique or strategy to study one or several closely related phenomena. This method is described by triangulation. This article examines the multi-method tradition in empirical legal research, defines basic concepts, discusses when and why multi-method research is useful, and how the different actions of research can provide unique approaches to the same questions. It explores examples of projects to demonstrate how research (...) that employs multiple tactics for observing and understanding is more reliable than a single study if the studies are of comparable quality. At the same time, multi-method research comes with great costs and risks that must be considered at the outset of such a project as well as during the project itself. However, it is speculated that multi-method research is perhaps the most effective way to understand the relationship between law and society. (shrink)

This article attempts at a close appraisal of legal research, dating back to the pre-war times. It begins by discussing the burst of research in the United States in the 1920s and 1930s as well as the dash of such research prior to 1920. Following this, it considers the funding dilemmas that confronted the undertaking of this research, why the research was found almost exclusively in the United States, and the methodologies employed for this (...) research. It discusses a variety of themes found in the early empirical legal research with a particular focus on projects and findings that presage debates and concerns in contemporary empirical legal research. Finally, it concludes with a discussion of why empirical work seemed to fade out in the late 1930s and what lead to its revival in the 1950s. (shrink)

Purpose. The study is aimed at highlighting in the historical-comparative context the influence of anthropological teachings on the development and formation of such a legal phenomenon as "legal certainty", proving that the category of legal certainty appeared as a consequence of anthropocentric philosophical approach in law. Theoretical basis. In the article, using the system approach, the content of the term "legal certainty" was analyzed. The axiological approach allowed generalizing various manifestations of legal certainty within the (...) limits of one va-lue concept and generalizing it by formulating and emphasizing the importance of the anthropophilosophical approach in the study of legal phenomena. The method of comparison, analysis, synthesis, generalization of philosophical concepts was used, in which the principle of legal certainty was expressed in different periods of historical development. Originality. This article supports a wide approach to understanding the principle of legal certainty, and the latter one relates to general theoretical legal principles. It is alleged that legal certainty consists of a number of requirements for lawmaking and law enforcement. In conducting a historical analysis for these requirements of legal certainty, it was established that they were historically originated and developed as a part of anthropological philosophical doctrine and subsequently embodied in law. The connection with anthropological teaching in jurisprudence is transformed into a relationship between the realization of the principle of legal certainty and human rights. Conclusions. Anthropological approaches in the study of legal phenomena allow providing value humanistic orientation to law. Human rights and freedoms as the most important social value require observance of them even when the legislation is imperfect, uncoordinated, contains gaps and uncertainties. The principle of legal certainty enables to overcome these difficulties, due to it the requirements of lawfulness and observance of human rights and freedoms are agreed upon. This principle is generally legal, and its content is revealed through a set of components – requirements. (shrink)

Recent national calls for ethical, legal, and social implications (ELSI) research to “assess and address how ethical, historical, social, economic, legal, regulatory, socio-cultural, and contextual...

This article addresses three questions concerning the legal regulation of the use of race as a category in biomedical research: how does the law currently encourage the use of race in biomedical research?; how might the existing legal framework constrain its use?; and what should be the law's approach to race-based biomedical research? It proposes a social justice approach that aims to promote racial equality by discouraging the use of “race” as a biological category while (...) encouraging its use as a socio-political category to understand and investigate ways to eliminate disparities in health status, access to health care, and medical treatment. (shrink)

Critical theory encapsulates the many connections between theory and praxis. This Research Handbook addresses the broad range of these connections in relation to legal thought. Featuring contributions from leading scholars of law and critical theory, the Handbook confronts the logic of the institutional with its specific challenges right across the broad field of legal thought. The Research Handbook initially addresses the question of definition, tracking the origins and development of critical legal theory along its European (...) and North American trajectories. Thematic connections are made between the development of legal theory and other currents of critical thought including feminism, Marxism, critical race theory, varieties of postmodernism, as well as the various 'turns' (ethical, aesthetic, political) of critical legal theory. Finally, particular legal disciplines are examined, including labour, criminal and intellectual property law, exploring what critical approaches reveal about them with the clear focus on opportunities for social transformation. This comprehensive and forward-looking Research Handbook will be of great interest to adherents of critical legal theory and scholars of jurisprudence more widely, as it provides a valuable analysis of the latest research and thinking in this dynamic field. (shrink)

Purpose: This review identifies the prominent topics in the literature pertaining to the ethical, legal, and social issues raised by research investigating personalized genomic medicine. Methods: The abstracts of 953 articles extracted from scholarly databases and published during a 5-year period were reviewed. A total of 299 articles met our research criteria and were organized thematically to assess the representation of ELSI issues for stakeholders, health specialties, journals, and empirical studies. Results: ELSI analyses were published in both (...) scientific and ethics journals. Investigational research comprised 45% of the literature reviewed and the remaining 55% comprised normative analyses. Traditional ELSI concerns dominated the discourse including discussions about disclosure of research results. In fact, there was a dramatic increase in the number of articles focused on the disclosure of research results and incidental findings to research participants. Few papers focused on particular disorders, the use of racial categories in research, international communities, or special populations. Conclusion: Considering that strategies in personalized medicine increasingly target individuals’ unique health conditions, environments, and ancestries, further analysis is needed on how ELSI scholarship can better serve the increasingly global, interdisciplinary, and diverse PGM research community. (shrink)

This article presents research on the scale of the phenomenon of sexual violence against students at selected 33 universities across Poland, the mechanisms used to combat the problem and the awareness of students on the subject. The study focuses on the practical dimension of combating sexual violence against students in the Polish academic environment. It looks at the existence and functioning of both specialised bodies and the procedures used to help the victims and punish the perpetrators. Additionally, the paper (...) describes how the diversity of available legal measures to address the problem by both helping the victims and holding perpetrators accountable creates the issue of the coexistence of two systems—criminal and intra-university. Presenting preliminary results of gathered opinions of universities’ officials regarding functioning of the bodies specialised in combating sexual violence shows not only the most dominant observations and conclusions the professionals have regarding the functions they hold at their home universities, but also main challenges that have to be considered in both creating sufficient policies in order to deal with sexual violence and conducting comprehensive research on said phenomenon. (shrink)

The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However, this rationale is less (...) defensible if there is a comprehensive compensation for injury programme available in which subjects are asked to waive some legal rights in order to participate in the programme. In this situation, subjects should be allowed to waive some legal rights to obtain the benefits of the programme. (shrink)

This engaging book examines the origins and first effects of the concept ‘legal semiotics’, focusing on the inventor of the term, Roberta Kevelson. It highlights the importance of her ideas and works which have contributed to legal theory, legal interpretation and philosophy of language. Kevelson’s work is particularly relevant today, in our world of global electronic communication networks which rely so much on language, signs, signals and shortcuts. Kevelson could not have foreseen the 21st century, yet the (...) story of her work and influence deserves more attention as it is key to our understanding of modern legal discourse and why law fascinates and is accepted in modern society. The authors draw on Kevelson’s hitherto unknown Office Papers and Notes, and a biographical examination points to key influences in her work such as the early feminist movements of the US East Coast, the philosophy of Charles Sanders Peirce and the semiotics of Thomas Sebeok. This forms the basis for a more encompassing research of Kevelson’s position, work and philosophical background, which the authors call for. A quick and enlightening read, this book interests a wide range of readers with an interest in legal history and the fields which Kevelson both drew on and influenced, including lawyers, students and scholars. (shrink)

In this article, we discuss current legal restrictions governing the use of race in medical research. In particular, we focus on whether the use of race in various types of research is presently permitted under federal law and the federal constitution. We also discuss whether federal restrictions on the use of race in research ought to be expanded, and whether federal policies that encourage the use of race ought to be abandoned.

Despite recurring efforts, a gap exists across a variety of contexts between the protection of patients' safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients' safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It highlights (...) how the role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; 'non-therapeutic' clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare. Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance. (shrink)

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has (...) previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the (...) case at the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the (...) case at the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist (...) aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU. (shrink)

The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been (...) and what guidance future cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned. (shrink)

In a survey on research misconduct, roughly 20% of the respondents admitted that they have submitted federal grant proposals that include scholars as research participants even though those scholars were not expected to contribute to the research effort. This manuscript argues that adding such false investigators is illegal, violating multiple federal statutes including the False Statements Act, the False Claims Act, and False, Fictitious, or Fraudulent Claims. Moreover, it is not only the offending academics and the false (...) investigators that face civil and criminal penalties because administrators may also be liable if they sign off on proposals and are in a position to know that false investigators might be included. Policy recommendations that should reduce the use of false investigators include changing institutional cultures, better training and oversight of the responsible conduct of research, and, most importantly, making all grant reviews double blind. (shrink)

Human reproductive cloning has become the most palpable example of the globalization of science. Throughout the world, events and conjectures in the media, such as the birth and death in the United Kingdom of the cloned sheep Dolly and projects to clone human beings by Korean scientists, by members of the Canadian-based Raelian cult, and by the Italian physician Antinori in an undisclosed country, have galvanized the political will of individual countries to ban human reproductive cloning.Yet, international attempts to harmonize (...) policies in the area of biomedical ethics and human research, such as the 1997 Council of Europe’s Convention on Human Rights and Biomedicine, and most recently, the United Nations’ efforts to adopt an international convention against human reproductive cloning, have been insufficient to trigger a substantial global policy design process on issues relating to these new technologies. (shrink)

This insightful Research Handbook provides a definitive overview of the New Legal Realism (NLR) movement, reaching beyond historical and national boundaries to form new conversations. Drawing on deep roots within the law-and-society tradition, it demonstrates the powerful virtues of new legal realist research and its attention to the challenges of translation between social science and law. It explores an impressive range of contemporary issues including immigration, policing, globalization, legal education, and access to justice, concluding with (...) and examination of how different social science disciplines intersect with NLR. (shrink)

This article aims at linking empirical research to legal theories, in a way that could enhance the benefits of this synergy. Jurisprudence, until recently the usual term for theoretical approaches to law, is now often replaced by the term legal theory. Difference between legal theory and empirical research is reflected in their consideration of subject matters, aims, and methods of research. However, there also exist commonalities between the two, i.e. both aim at comprehending law (...) and legal systems. While legal theory uses philosophical tools, its subject matter still remains a social phenomenon, for social ends. And since empirical research is a means to gather information about law, it could act as a prime source of information for legal theory. While empirical research has its own end to follow, what is missing is, attention to some legal theory, not just general legal theory, but which can also critique philosophical discourses to legality. (shrink)

This comprehensive Research Handbook explores the wide variety of work conducted in legal semiotics, providing a thorough understanding of how the law works through signs and symbols. Demonstrating that the law is a strategical system of fluctuating signs, contributors critically analyse the ever-evolving conceptualisations of law and legal discourse. Bringing together leading international experts, this Research Handbook focuses on the material, everyday forms of law comprised by non-verbal legal semiotics. Contributors conduct culturally nuanced semiotic analyses (...) of the modern world, covering topics from COVID-19, religion, and human rights, to comic books and music. Chapters consider the foundations of semiotics, as well as the philosophy of law, identifying the cross-cultural similarities in how legal semiotics and visual legal semiotics intersect. Ultimately, the Research Handbook demonstrates that the law is in a state of perpetual flux, with many unique dimensions only made visible by semiotic analysis. The Research Handbook on Legal Semiotics will be an invaluable resource for students and scholars of law, jurisprudence, legal culture, linguistics, and semiotics. It will also be an important guide for legal practitioners seeking to better understand the nuances of the legal system. (shrink)

The scientific validity of racial categories has been the subject of debate among population geneticists, evolutionary biologists, and physical anthropologists for several decades. After World War II, the rejection of eugenics, which had supported sterilization laws and other destructive programs in the United States, generated a compelling critique of the biological basis of race. The classification of human beings into distinct biological “races” is a relatively recent invention propped up by deeply flawed evidence and historically providing the foundation of racist (...) ideology and inequities of power. Social scientists’ conclusion that race is socially constructed was confirmed by genomic studies of human variation, including the Human Genome Project, showing high levels of genetic similarity within the human species. Some scholars came to believe that the science of human genetic diversity would replace race as the preeminent means of grouping people for scientific purposes. (shrink)

The new generation of psychopharmacological products have proved their efficacy. Some neuro-degenerative diseases, such as Parkinson's and Alzheimer's diseases, could be treated by means of the gene therapy. Although the aetiology of such diseases is still not completely known, it has been proven that the patients lack some substances that could be produced by means of the transfer of in vivo or ex vivo genes that codify them in the proper places of the brain. Furthermore, it is announced that the (...) implantation in laboratory grown stem cells of diverse origins is very hopeful. Cerebral (micro)electronic implants could be effective to fight some motor diseases as well as sensory functions. All of these kinds of new treatments need to be tested through clinical research. Most national legislation includes provisions on the clinical trials of drugs and a series of guarantees, procedures and conditions which are designed to ensure protection for individuals used in experiments and to assure that the trial is indeed of scientific relevance. However, few lay down similar regulations or provide for specific controls for the research of other treatments. Finally, enhancement of psychic capacities pose new problems for society as well as do the need for new legal decisions. (shrink)

This article is a response to the letter from the Department of Health that was published in the previous edition of the Research Ethics Review upon the matter of the legal duty of the research ethics committees. It also deals briefly with the article published in the current edition of Research Ethics Review by Colin Parker on what appears to be the same topic.

The new scientific acquisitions are numerous and even more are their future promises. The debate on bio-technologies involves the fundamental rights of the individual and the advancements in research must merge with the supremacy of the human being on the interests both of the ‘science’ and of society at large. In the attempt to combine ‘democracy’ with techno-scientific issues, Law has turned from pure technical rules (meant to reflect, without any critique, some knowledge) into a tool meant to fill (...) cognitive gaps and its role is showing to be not only crucial, but also innovative for legal professionals themselves. (shrink)

This timely Research Handbook offers significant insights into an understudied subject, bringing together a broad range of socio-legal studies of medicine to help answer complex and interdisciplinary questions about global health - a major challenge of our time. Interdisciplinary chapters explore both how the terrain of medicine can generate new questions about law, regulation and the state, and how the law intersects with health and medicine at every level. Bringing together leading international scholars, the Research Handbook assembles (...) concrete case studies to suggest avenues for further research on socio-legal inquiries, such as the construction of disorders by law, the reparation of injuries, and how race and gender impact justice. The Research Handbook for Socio-Legal Studies of Medicine and Health will be an inspiring read for researchers, academics and graduate students in the fields of health law, socio-legal studies, and gender and sexuality. (shrink)

Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the (...) 2016 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use—including development of resistance—we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions. (shrink)

We have previously addressed the use of race in health care generally. Subsequent developments have made the issue even more pointed. Given the recent Food and Drug Administration approval of BiDil as a result of a clinical trial limited to participants identifying themselves as African-American, this Symposium could not be more timely as an effort to further advance the dialogue on the issue of race in medical research. While this dialogue has informed our own analysis, we believe our distinctive (...) contribution concerns the extent to which the law does and should constrain such use of race. Even in legal academic circles – somewhat notorious for considering problems of little practical significance – the issue has been given little thought. This piece, therefore, attempts to analyze extant legal regimes against the backdrop of medical and scientific developments. (shrink)