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The Oxford Handbook of Comparative Health Law最新文献

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Research with Human Participants in the United States 在美国进行的人类研究
The Oxford Handbook of Comparative Health Law Pub Date : 2021-02-10 DOI: 10.1093/oxfordhb/9780190846756.013.20
C. Coleman
{"title":"Research with Human Participants in the United States","authors":"C. Coleman","doi":"10.1093/oxfordhb/9780190846756.013.20","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.20","url":null,"abstract":"This chapter discusses research with human participants in the United States, most of which has been subject to federal regulations requiring prospective ethical oversight by entities known as institutional review boards (IRBs) since the 1970s. Research that is subject to the federal regulations may not begin until IRB approval has been obtained. The chapter begins by examining key aspects of the federal regulations governing IRB review of research with human participants, including the type of activities that fall under the IRB’s jurisdiction, how IRBs are organized, and some of the key substantive standards that IRBs apply. It then looks at additional regulatory standards that apply to studies involving particular populations, including pregnant women and fetuses, prisoners, and children. Finally, the chapter examines several other bodies of law related to research with human participants, including policies governing the inclusion of women and racial minorities in clinical trials; legal principles governing compensation for injuries to research participants; and requirements for registering clinical trials, reporting trial results, and disclosing research-related conflicts of interest.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"185 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120859432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medical Liability 医疗责任
The Oxford Handbook of Comparative Health Law Pub Date : 2021-02-10 DOI: 10.1093/oxfordhb/9780190846756.013.16
K. Søvig, B. Furrow
{"title":"Medical Liability","authors":"K. Søvig, B. Furrow","doi":"10.1093/oxfordhb/9780190846756.013.16","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.16","url":null,"abstract":"This chapter presents a comparison of liability/compensation systems across countries, which can be challenging because of substantial differences in tort doctrine, judicial systems, and administrative compensation mechanisms. It approaches the problem of patient injury in a healthcare system from the dual (and dueling) perspectives of system responsibility and provider culpability. The basic question that the chapter asks is this: Who should bear the economic costs of medical adverse events? The US system remains solidly anchored in the tort liability system, with its emphasis on negligence-based culpability in medical malpractice cases—but with timid moves toward enterprise liability and statutory communication and resolution programs. By contrast, the Scandinavian systems have publicly funded patient compensation funds.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129047559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetics and the Law 遗传学与法律
The Oxford Handbook of Comparative Health Law Pub Date : 2021-01-13 DOI: 10.1093/oxfordhb/9780190846756.013.30
M. Mehlman, S. Suter
{"title":"Genetics and the Law","authors":"M. Mehlman, S. Suter","doi":"10.1093/oxfordhb/9780190846756.013.30","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.30","url":null,"abstract":"This chapter examines state and federal laws in the United States that govern legal and ethical issues concerning genetic and genomic analysis for diagnostic purposes; regulation of genetic testing, genetic discrimination, and privacy; and clinical applications of genomics. At the state level, legislatures have enacted laws in various areas, including newborn screening and nondiscrimination and privacy protections. In addition, state courts have addressed some issues concerning genetics, such as the duty to warn. At the federal level, the US Congress has enacted a specific statute, the Genetic Information and Nondiscrimination Act, which protects genetic information. Other federal statutes, which do not address genetics or genomics in particular, also have relevance in the genetics context, including laws that protect against certain forms of discrimination or that regulate laboratories. Federal agencies also play a role, for example, in protecting genetic privacy or regulating genetic tests. Finally, the US Constitution is relevant to genomics, especially concerning reproductive rights, which are pertinent to reproductive genetic testing.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125113973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Communicable Disease 传染病
The Oxford Handbook of Comparative Health Law Pub Date : 2020-09-02 DOI: 10.1093/oxfordhb/9780190846756.013.43
W. Parmet
{"title":"Communicable Disease","authors":"W. Parmet","doi":"10.1093/oxfordhb/9780190846756.013.43","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.43","url":null,"abstract":"This chapter explores the key features of American infectious disease law. The history of health law in the United States begins with the colonial laws that responded to the epidemics of smallpox, yellow fever, and other infectious diseases that regularly devastated the North American colonies. In the twentieth century, as the fear of infection declined, courts began to provide greater protections for individuals and vulnerable populations subjected to infectious disease laws. Moreover, the federal government began to play a more prominent and complex role in the control of infectious diseases. The chapter then looks at the allocation of authority between the states and federal government with respect to infectious disease control. It also discusses the role that restraint on individual rights plays in infectious disease control and the limits that the US Constitution and civil rights laws place on such restraints. The chapter also considers some of the specific tools that jurisdictions employ in response to infectious disease. It concludes with a brief discussion of the United States' role in global public health.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129289954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biobanks 起生物
The Oxford Handbook of Comparative Health Law Pub Date : 2020-07-09 DOI: 10.1093/oxfordhb/9780190846756.013.50
G. Laurie, C. Coleman
{"title":"Biobanks","authors":"G. Laurie, C. Coleman","doi":"10.1093/oxfordhb/9780190846756.013.50","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.50","url":null,"abstract":"This chapter examines biobanks as a case study of multiple legal and governance challenges that cut across conventional jurisdictional lines. The advent of large-scale biobanks—collections of biomedical samples linked to personal data and other resources such as health records—has come to represent a watershed in health research regulation in many countries. As such, this chapter stresses two features of biobanks that raise questions about the role of law and regulation. First, this chapter examines the extent to which existing legal frameworks must be adapted to accommodate particular features of biobanking (and how far this is successful). Second, it highlights examples of ways in which some biobanks have developed their own governance mechanisms—in addition to legal compliance in the local country—that are aimed at promoting engaged and ethically robust biobanking practices","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"135 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127387889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetics and the Law 遗传学与法律
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/OXFORDHB/9780190846756.013.29
Harry F. J. Schroeder
{"title":"Genetics and the Law","authors":"Harry F. J. Schroeder","doi":"10.1093/OXFORDHB/9780190846756.013.29","DOIUrl":"https://doi.org/10.1093/OXFORDHB/9780190846756.013.29","url":null,"abstract":"This chapter explores the similarities and differences in the legal approaches in the United States and Europe to genetic issues. Both the United States and Europe value informed consent and autonomy in this context. As a result, individuals must give informed consent to genetic testing and can decide to opt out of being informed by their health professionals about genetic sequencing results, including results that are clinically relevant. All states in the United States conduct newborn screening using DNA samples, and most do so without parental consent. In Europe, most countries have a newborn screening program, and most of these require parental consent. The chapter also looks at the legal approaches to genetic discrimination, as well as human gene therapy and gene therapy research. As genetic technologies continue to evolve, the United States and Europe will likely continue to face similar ethical and legal issues regarding the regulation of that genetic technology. However, their approaches will likely overlap in some ways and diverge in others, reflecting differences in the legal structures and cultures of each jurisdiction.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128511763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The American Pathology of Inequitable Access to Medical Care 美国人获得医疗服务不公平的病理
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.55
Allison K. Hoffman, M. Hall
{"title":"The American Pathology of Inequitable Access to Medical Care","authors":"Allison K. Hoffman, M. Hall","doi":"10.1093/oxfordhb/9780190846756.013.55","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.55","url":null,"abstract":"This chapter maps out the complex picture of access to medical care in the United States. It reflects on how variable access illustrates an American ambivalence about health solidarity. The chapter first considers healthcare financing as one critical element that defines access to medical care and describes the multifaceted US healthcare financing structure, predominated by public insurance programs for select populations and regulated private insurance for others. Next, this chapter describes how access is equally shaped by legal requirements that create treatment obligations for doctors or hospitals regardless of how someone pays for care. There is no constitutional right to health in the United States, but various layers of statutory and common law have created some guarantees. That said, despite efforts to increase access over the past decades, the United States is still extraordinary, as compared to peer nations, on the unevenness of access to medical care among its population.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"88 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123323161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Property in Human Body Parts 人体部位的属性
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.33
J. Pila
{"title":"Property in Human Body Parts","authors":"J. Pila","doi":"10.1093/oxfordhb/9780190846756.013.33","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.33","url":null,"abstract":"This chapter surveys the current legal position concerning property in bodies and bodily materials. Of especial relevance in the current age of advanced genetic and other bio technologies, it looks beyond property in bodies and their materials ‘as such’ to consider also (a) the availability of rights of personal and intellectual property in objects incorporating or derived from them, and (b) the reliance on quasi-property rights of possession and consent to regulate the storage and use of corpses and detached bodily materials, including so-called ‘bio-specimens’. Reasoning from first principles, it highlights the practical and conceptual, as well as the political and philosophical, difficulties in this area, along with certain differences in the regulatory approach of European and US authorities. By way of conclusion, it proposes the law of authors’ and inventors’ rights as simultaneously offering a cautionary tale to those who would extend the reach of property even further than it extends currently and ideas for exploiting the malleability of the ‘property’ concept to manage the risks of extending it.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126102896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health Care Services and EU Competition Law 卫生保健服务和欧盟竞争法
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/oxfordhb/9780190846756.013.5
Okeoghene Odudu
{"title":"Health Care Services and EU Competition Law","authors":"Okeoghene Odudu","doi":"10.1093/oxfordhb/9780190846756.013.5","DOIUrl":"https://doi.org/10.1093/oxfordhb/9780190846756.013.5","url":null,"abstract":"This chapter investigates how, within a number of European Union (EU) Member States, competition law has been used to address problems of market power in the healthcare services sector. It summarizes the relevant EU and national competition laws and considers the experience of applying those laws to providers of healthcare services. The chapter is chiefly concerned with healthcare services in England, although examples are drawn for other EU Member States. Examination of the English experience provides a view of the use of competition law to address market power problems in most elements of the health system matrix. The chapter then considers three challenges that emerge from that experience of using competition law to address problems of market power in healthcare service markets. The first challenges the applicability of competition law to healthcare service providers operating in each or every element of the healthcare system matrix. The second, accepting applicability, questions the appropriateness of the substantive rules to healthcare services. The third, a battle of authority and autonomy, considers whether decisions made by healthcare service providers should be subject to external review and the type of review that competition law offers.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121194267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Decisions at the End of Life 生命终结时的决定
The Oxford Handbook of Comparative Health Law Pub Date : 2020-06-08 DOI: 10.1093/OXFORDHB/9780190846756.013.39
D. Orentlicher, J. Sandor
{"title":"Decisions at the End of Life","authors":"D. Orentlicher, J. Sandor","doi":"10.1093/OXFORDHB/9780190846756.013.39","DOIUrl":"https://doi.org/10.1093/OXFORDHB/9780190846756.013.39","url":null,"abstract":"This chapter examines the similarities and differences between US and European legal thinking and jurisprudence regarding end-of-life medical care. In recent decades, courts and legislatures have increasingly respected the right to self-determination of patients or their families in deciding about the way people want to die. In most jurisdictions, patients may have unwanted medical treatment withheld or withdrawn, even when the treatment would be or is life-sustaining. Hospice and other palliative care are important alternatives, although in many cases, suffering may still persist. In a small but growing number of jurisdictions, patients may receive a lethal dose of medication to bring about death. Less recognized, but very important too, are cases in which patients request life-sustaining care that their health care providers consider “futile.” As with other rights, the right to make medical decisions is subject to limits. In deciding the extent of rights to make end-of-life decisions, the law has recognized that while seriously ill patients have the greatest stake in their medical care, family members, healthcare providers, and the state also have important interests. Accordingly, health law has had to balance a number of competing interests in determining when it is permissible to discontinue medical care or take other actions that will shorten life, and the scope of the right to decide has been much debated.","PeriodicalId":173189,"journal":{"name":"The Oxford Handbook of Comparative Health Law","volume":"96 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132484110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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