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Ethical, social and public awareness issues in gene therapy EuropaBio. 基因治疗中的伦理、社会和公众意识问题。
The journal of biolaw & business Pub Date : 2002-01-01
{"title":"Ethical, social and public awareness issues in gene therapy EuropaBio.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>EuropaBio, the European Association for Bio-industries, represents 40 corporate members operating world wide and 14 national associations (totaling up to 700 small- and medium-sized enterprises) involved in research, development, testing, manufacturing, sales, and distribution of biotechnology-derived products and services in the field of health cae, agriculture, food, and the environment. AGE is a group of researchers and university professors involved in high-level professional activities related to bioethics, and particularly interested in ethical issues related to the development and use of modern technology. It is essential that industry actively participates in, and contributes to, the social debate on emerging technologies. Therefore, EuropaBio presents herein its view on gene therapy and its responsible development and use.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 2","pages":"59-62"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378024","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
Informed consent: a necessity for human research. 知情同意:人类研究的必要条件。
The journal of biolaw & business Pub Date : 2002-01-01
Joseph W H Lough
{"title":"Informed consent: a necessity for human research.","authors":"Joseph W H Lough","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As flaws in the informed consent process have come to light, rising research costs and heightened competition have exposed informed consent to increasing scrutiny as a possible source for industry savings. However, we believe that the informed consent process needs to be refined and strengthened, not weakened or abandoned. This article describes why protecting human research participants through informed consent is necessary for institutions that conduct human research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"48-9"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22445543","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
Towards harmonization: the European biotechnology patent directive. 迈向协调:欧洲生物技术专利指令。
The journal of biolaw & business Pub Date : 2002-01-01
Duncan Curley
{"title":"Towards harmonization: the European biotechnology patent directive.","authors":"Duncan Curley","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Having first been proposed over a decade ago to harmonize European patent law for the benefit of Europe's fledgling biotechnology industry, the Biotechnology Patent Directive underwent a somewhat tortured introduction to adolescence when its adoption was challenged by a legal annulment action from the Governments of the Netherlands, Italy and Norway. This article explores the nature of the legal challenge to the Directive, which to an extent typify European concerns about biotechnological inventions, particularly the \"patenting of life.\"</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"64-8"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22444925","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
Core ethical values: EuropaBio. 核心道德价值观:EuropaBio。
The journal of biolaw & business Pub Date : 2002-01-01
{"title":"Core ethical values: EuropaBio.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>EuropaBio, the European Association for BioIndustries, represents 40 companies operating world wide and 14 national association (totaling around 600 small and medium-sized enterprises) involved in the research, development, testing, manufacturing, marketing, sales and distribution of biotechnology products and services in the fields of healthcare, agriculture, food and the environment.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 2","pages":"63"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22453583","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
No privacy for all? Serious failings in the HHS medical records regulations. 所有人都没有隐私?卫生与公众服务部的医疗记录条例存在严重缺陷。
The journal of biolaw & business Pub Date : 2002-01-01
Richard Sobel
{"title":"No privacy for all? Serious failings in the HHS medical records regulations.","authors":"Richard Sobel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Bush administration surprised many by the approval without major revisions of the Clinton administration's HHS medical records regulations, despite heavy lobbying from the health industry. Though these \"privacy rules\" are supposed to protect patient confidentiality, what has gone unmentioned are the regulations' major lapses that breach informed consent and confidentiality. Recently issued \"clarifications\" of the regulations reveal that they do not prevent unconsented access to sensitive medical information by marketers, health plans, health care clearinghouses, and law enforcement. These problems with the regulations constitute a serious breach of patient privacy, endangering the doctor-patient relationship and potentially driving up health care costs, and need to be addressed.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 2","pages":"45-8"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378021","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
Protecting clinical research and human participants: considerations for domestic and foreign clinical trials. 保护临床研究和人体受试者:国内外临床试验的考虑。
The journal of biolaw & business Pub Date : 2002-01-01
Judith E Beach
{"title":"Protecting clinical research and human participants: considerations for domestic and foreign clinical trials.","authors":"Judith E Beach","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In recent years there has been a shift in focus from national and international \"Ethics Influentials\" related to the approval of life-saving therapies to a national and international reassessment of the conduct of clinical trials and human subject protection. Due to intense and ongoing pressure from several groups (including the media, patients and families, tort lawyers, patient advocacy groups, ethicists, and government advisory bodies), there are several initiatives underway to revise ethical standards for the conduct of clinical trials. This article discusses the need for an integrated approach to improving the ethical conduct of clinical trials as well as the need to promote the equally important ethical consideration of efficient approval of safe and effective life-saving medical therapies.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"41-5"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22445541","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
EuropaBio's ethics committee and Advisory Group on Ethics(AGE): an overview. 欧罗巴伦理委员会和伦理咨询小组(AGE):概述。
The journal of biolaw & business Pub Date : 2002-01-01
Erik Tambuyzer, Nathalie Moll, Paul Muys
{"title":"EuropaBio's ethics committee and Advisory Group on Ethics(AGE): an overview.","authors":"Erik Tambuyzer,&nbsp;Nathalie Moll,&nbsp;Paul Muys","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 2","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":"22378023","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 impact of privacy regulations on clinical research. 隐私法规对临床研究的影响。
The journal of biolaw & business Pub Date : 2002-01-01
Kendra Dimond
{"title":"The impact of privacy regulations on clinical research.","authors":"Kendra Dimond","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The enactment of the Health Insurance Portability and Accountability Act (HIPAA) has garnered significant attention in the health care sector. This legislation represents a major effort to address patient confidentiality and privacy. In general, HIPAA has three goals: first, to create a framework in which protected health information may flow; second, to make it difficult for this information to escape outside the system, and finally, to give patients more control over their medical records and to inform them about how their medical information is used. The effects of HIPAA will impact virtually every aspect of health care. Pharmaceutical manufacturers and biotechnology companies conducting clinical trials or research involving treatment in a covered entity need to be aware of the additional duties that HIPAA imposes on collaborators. This article offers a brief overview of HIPAA privacy rules and the ways in which HIPAA regulations may create obstacles for clinical research efforts, along with initial observations on how research organizations may limit these obstacles.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 3","pages":"50-3"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22444923","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 regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts? 遗传疾病家庭诊断测试的监管:FDA能否基于设备的社会影响拒绝上市前应用?
The journal of biolaw & business Pub Date : 2002-01-01
James D Kerouac
{"title":"The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?","authors":"James D Kerouac","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article discusses the Food and Drug Administration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"5 1","pages":"34-43"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22389421","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
Products, Partners & Public Health: Transfer of Biomedical Technologies from the U.S. Government. 产品、合作伙伴与公共卫生：来自美国政府的生物医学技术转让。
The journal of biolaw & business Pub Date : 2002-01-01
Steven M Ferguson
{"title":"Products, Partners & Public Health: Transfer of Biomedical Technologies from the U.S. Government.","authors":"Steven M Ferguson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The United States (U.S.) leads the world in government support for non-military research and development (R&D), especially support for work that directly relates to health and human development. A focal point for such investments to date in biomedical research has been the National Institutes of Health (NIH), receiving $23.3 billion in fiscal year 2002. Whether internal or externally based, the biomedical research performed has led to a large variety of novel basic, and clinical research discoveries - all of which generally require commercial partners in order to develop them into products for hospital, physician or patient use. This article describes the role of the NIH, including ways in which it works with corporate partners or licensees to commercialize its funded research into products in order to help fulfill it mission as a healthcare agency within the U.S. Department of Health and Human Services (DHHS).</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":" ","pages":"35-39"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2840653/pdf/nihms139127.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28842453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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