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Learning from experience: privacy and the secondary use of data in health research. 从经验中学习:隐私和卫生研究中数据的二次使用。
The journal of biolaw & business Pub Date : 2003-01-01
William W Lowrance
{"title":"Learning from experience: privacy and the secondary use of data in health research.","authors":"William W Lowrance","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In this fast-moving age of data banking, data are a currency, and often a commodity. Electronic health records are being developed everywhere. Increasingly, data collected for various primary purposes are being re-used for research. With personal mobility, contracting of services, and telemedicine, health care data are crossing national borders, and therefore so are genetic information, biological materials, and reimbursement data. There is much public and legal concern about the implications. This article addresses the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for health research without compromising the privacy of the data-subjects?</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 4","pages":"30-60"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24458270","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 high road to success: how investing in ethics enhances corporate objectives. 成功之路:道德投资如何提升企业目标。
The journal of biolaw & business Pub Date : 2003-01-01
Richard Dashefsky
{"title":"The high road to success: how investing in ethics enhances corporate objectives.","authors":"Richard Dashefsky","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>There is a growing gap between the tidal wave of information emerging from the Human Genome Project and other molecular biology initiatives, and the clinical research needed to transform these discoveries into new diagnostics and therapeutics. While genomics-based technologies are being rapidly integrated into pharmaceutical R&D, many steps in the experimental process are still reliant on traditional surrogate model systems whose predictive power about human disease is incomplete or inaccurate. There is a growing trend underway in the research community to introduce actual human disease understanding as early as possible into discovery, thereby improving accuracy of results throughout the R&D continuum. Such an approach (known as clinical genomics: the large scale study of genes in the context of actual human disease) requires the availability of large quantities of ethically and legally sourced, high-quality human tissues with associated clinical information.Heretofore, no source could meet all of these requirements. Ardais Corporation was the first to address this need by pioneering a systematized, standardized network for the collection, processing, dissemination and research application of human tissue and associated clinical information, all of which rest on the highest ethical standards. Based on a novel model of collaboration between industry and the academic/medical community, Ardais has created procedures, structures, technologies, and information tools that collectively compromise a new paradigm in the application of human disease to biomedical research. Ardais now serves as a clinical genomics resource to dozens of academic researchers and biopharmaceutical companies, providing products and services to accelerate and improve drug discovery and development.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 2","pages":"25-9"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24130712","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
Maintaining informed consent for doctor-patient confidentiality: more serious failings in the HHS medical regulations. 维护医患保密的知情同意:卫生与公众服务部医疗条例中更严重的缺陷。
The journal of biolaw & business Pub Date : 2003-01-01
Richard Sobel
{"title":"Maintaining informed consent for doctor-patient confidentiality: more serious failings in the HHS medical regulations.","authors":"Richard Sobel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Health and Human Services (HHS) regulations on medical records, approved by the Clinton administration in December 2000, and by the Bush administration in April 2001, improved confidentiality protection from the preliminary rule by incorporating fair information practices, consent and minimal necessary disclosures provisions. The Fall 2002 removal of the consent requirements seriously breaches these promises. The consent provisions need to be strengthened, not weakened.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 2","pages":"61-5"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24130717","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
Sponsored research agreements, university and government licensing, and clinical trial agreements: special contractual and intellectual property rights considerations. 赞助研究协议、大学和政府许可以及临床试验协议:特殊合同和知识产权考虑。
The journal of biolaw & business Pub Date : 2003-01-01
Jeffrey P Somers
{"title":"Sponsored research agreements, university and government licensing, and clinical trial agreements: special contractual and intellectual property rights considerations.","authors":"Jeffrey P Somers","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article addresses contractual and intellectual property considerations that frequently arise in the drafting and negotiation of sponsored research agreements (\"SRAs\"), license agreements with universities (and other non-profit organizations) and the federal government, and clinical trial agreements. Each of these subjects is addressed separately, but most of the article is devoted to sponsored research, which is the driver for much of the innovation in the medical and life sciences industries.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 4","pages":"5-13"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24458269","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
A physician's duty to warn family members of genetic risks: limiting the importance of Tarasoff. 医生有责任提醒家庭成员注意遗传风险:限制塔拉索夫的重要性。
The journal of biolaw & business Pub Date : 2003-01-01
Scott Russell
{"title":"A physician's duty to warn family members of genetic risks: limiting the importance of Tarasoff.","authors":"Scott Russell","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This paper addresses whether a physician should be held liable for failing to warn family members of potential risks of genetic disease. Resolution of this complex issue requires consideration of physician-patient responsibility, the psychological impact of the warning, the efficacy of genetic testing, and the need to protect the physical well being of family members. The paper concludes that application of the Tarasoff factors, which focus primarily on the foreseeable aspect of the threat and the identifiable nature of the third parties, is an insufficient means for determining whether this duty to disclose exists. Instead, in addition to the Tarasoff factors, a physician must consider a number of case-specific factors in deciding whether the benefits of disclosure outweigh the psychological effects of knowing of the disease and the public policy reasons behind physician-patient confidentiality. Likewise, a court should consider these same factors as applied to a hypothetical \"reasonable physician\" before concluding that a specific physician has a duty to warn family members potential of genetic threats.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 1","pages":"28-38"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24603744","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
Behavioral genetics: scientific and social acceptance. 行为遗传学:科学和社会认可。
The journal of biolaw & business Pub Date : 2003-01-01
David R Lorenz
{"title":"Behavioral genetics: scientific and social acceptance.","authors":"David R Lorenz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Human behavioral genetics can be broadly defined as the attempt to characterize and define the genetic or hereditary basis for human behavior. Examination of the history of these scientific enterprises reveals episodes of controversy, and an apparent distinction between scientific and social acceptance of the genetic nature of such complex behaviors. This essay will review the history and methodology of behavioral genetics research, including a more detailed look at case histories involving behavioral genetic research for aggressive behavior and alcoholism. It includes a discussion of the scientific versus social qualities of the acceptance of behavioral genetics research, as well as the development of a general model for scientific acceptance involving the researchers, the scientific literature, the scientific peer group, the mainstream media, and the public at large. From this model follows a discussion of the means and complications by which behavioral genetics research may be accepted by society, and an analysis of how future studies might be conducted.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"6 2","pages":"30-9"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24130715","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
Bioethics and the commodification of biotechnology. 生物伦理学和生物技术的商品化。
The journal of biolaw & business Pub Date : 2002-01-01
Andrew Scheinman
{"title":"Bioethics and the commodification of biotechnology.","authors":"Andrew Scheinman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Although recent advances in biotechnology have brought with them a raft of ethical issues, other ethical challenges are arising not from new technologies, but rather from the expansion of biotechnology into \"commodified\" mass consumer applications, non-medical applications with no \"purpose\" other than entertainment or the satisfaction of consumer demand. In other words, commodity products targeted at a market that biotechnology does not currently exploit--the mass consumer market. This article will discuss two such examples of commodified biotechnology, the use of DNA sequence comparisons to construct genealogies; and the use of such comparisons to derive \"ethnic\" identities, and will conclude with a discussion of the possible consequences of such applications.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"56-8"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22444924","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
Ethics: the risk management tool in clinical research. 伦理:临床研究中的风险管理工具。
The journal of biolaw & business Pub Date : 2002-01-01
Jill Wadlund, Leslie A Platt
{"title":"Ethics: the risk management tool in clinical research.","authors":"Jill Wadlund,&nbsp;Leslie A Platt","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Scientific discovery and knowledge expansion in the post genome era holds great promise for new medical technologies and cellular-based therapies with multiple applications that will save and enhance lives. While human beings long have hoped to unlock the mysteries of the molecular basis of life; our society is now on the verge of doing so. But new scientific and technological breakthroughs often come with some risks attached. Research--especially clinical trials and research involving human participants--must be conducted in accordance with the highest ethical and scientific principles. Yet, as the number and complexity of clinical trials increase, so do pressures for new revenue sources and shorter product development cycles, which could have an adverse impact on patient safety. This article explores the use of risk management tools in clinical research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"39-40"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22445540","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
Clinical trials in the face of adversity. 面对逆境的临床试验。
The journal of biolaw & business Pub Date : 2002-01-01
Karl Clodfelter
{"title":"Clinical trials in the face of adversity.","authors":"Karl Clodfelter","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Technological advances in genetic and biomedical research have led to a startling number of adverse events in clinical trials. Reporting systems for adverse and serious adverse events should be aimed at reducing the future risks through analysis of the conditions leading to the adverse events. Unfortunately, current reporting systems are not adequate for performing this function. Many medical organizations, most notably the Institute of Medicine (part of the National Academy of Sciences), have written suggestions on how to renovate the current reporting systems. It is the author's view that these suggestions and the responses from other organizations fall short of developing a fully useful system of adverse event reporting. Instead, a system that the public, the regulatory bodies, and the researchers can easily understand and utilize for developing safer, more responsible, clinical trials is proposed.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"34-8"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22445537","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
Fast track to disaster? Considerations raised by the current recruitment techniques for clinical research subjects. 通往灾难的捷径?当前临床研究对象招募技术提出的考虑。
The journal of biolaw & business Pub Date : 2002-01-01
John M Isidor, Sandra P Kaltman
{"title":"Fast track to disaster? Considerations raised by the current recruitment techniques for clinical research subjects.","authors":"John M Isidor,&nbsp;Sandra P Kaltman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Efforts to obtain Food and Drug Administration (FDA) approval of new drugs on a \"fast track\" are not without hazards for physicians and other providers involved in conducting clinical research. Increasingly, research sponsors have implemented competitive subject recruitment techniques that encourage investigators and their staffs to move studies along rapidly, but may also raise concerns about subject safety. The purpose of this article is to examine competitive recruitment practices and to examine the ethical and legal issues related to obtaining information consent for clinical research within this current framework.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"46-7"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22445542","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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