{"title":"The ethics of biotechnology.","authors":"N Lenoir","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Ethical considerations pertaining to biotechnology have progressively been introduced into European community law, especially with regard to research, the environment, patents, animal welfare and medicine. This article addresses the ethics of biotechnology at the European Union (EU) level. It provides insight into the European Group of Ethics and describes how European ethical values concerning science and technology are defined by law and intimately connected to Europe's cultural and political identity. In addition, this article highlights the critical need for an independent and permanent international body to spearhead discussion and collaboration so that views between the different cultures of the world can be exchanged, and, to assure access to experts whose legitimacy and accountability are universally recognized.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 2","pages":"6-10"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22197856","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}
{"title":"Cloning in America: constitutional rights and limits.","authors":"C Erwin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As readers of science fiction are well aware, the term \"clone\" refers to asexually produced offspring, that is, produced by a process of cell-division which does not begin with the union of two sex cells. A clone would be the genetic twin of the cell donor. Propagation of plants by this method is, of course, commonplace, but mammalian reproduction in this fashion would be indeed a revolutionary accomplishment, with profound and disturbing implications.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"3 4","pages":"21-33"},"PeriodicalIF":0.0,"publicationDate":"2000-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24082750","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}
{"title":"The use of stem cells in biomedical research. Biotechnology Industry Organization (BIO) position statement.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>On March 22, 1999, Carl B. Feldbaum, President of the Biotechnology Industry Organization (BIO), submitted comments to the National Bioethics Advisory Committee (NBAC) in response to their request for comments on stem cell research. In the statement submitted to Harold Shapiro, PhD (Chair, NBAC), Mr. Feldbaum made clear that BIO members want to ensure that the promise of new therapies and cures from research using stem cells is realized in a responsible and ethical way. In addition, all BIO members are committed to ensuring that every avenue of promising research can be responsibly explored to improve the health of individuals living with currently intractable diseases.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"3 1","pages":"40-4"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145776845","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}
{"title":"United States regulatory requirements for research involving human subjects.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"1 2","pages":"39-53"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378672","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}
{"title":"Clinical trials: the intersection between research and medicine.","authors":"R J R Blatt, M J Malinowski","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"1 2","pages":"3-5"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378670","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}
{"title":"Human subject protections in the United States: perspectives from the Office for Protection from Research Risks.","authors":"M Russell-Einhorn, G B Ellis","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The U.S. Department of Health and Human Services (DHHS) regulations require that all human subjects research supported by DHHS be reviewed and approved by a local institutional review board (IRB). With few exceptions, investigators may not involve human subjects in research without their informed consent, and additional safeguards are required when subjects are likely to be vulnerable to coercion or undue influence. Institutions that receive DHHS funding must enter into an \"Assurance\" of compliance with the Office for Protection from Research Risks (OPPR), which has the authority for oversight and implementation of the human subjects regulations. As discussed more fully below, Assurances are of a contract nature in that they formally commit the institutions to adherence to the regulations and the ethics standards relevant to research on human subjects. This article addresses the application of human subject protections in biomedical research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"1 2","pages":"36-8"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378671","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}
{"title":"The National Bioethics Advisory Commission: bridging the tension between scientific and public policy analysis.","authors":"R A Charo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>During the period between the early 1980s to the mid 1990s, the U.S. was distinguished from most other developed countries by its lack of a national-level public body to assist the government in its policy-making on topics of biomedical ethics. While Canada, Denmark, France, Spain, and other countries regularly sought advice from public commissions on issues ranging from reproductive technologies to euthanasia, the U.S. relied on myriad state commissions, court decisions, and academic bodies. The result was a pattern of policy-making that was slower and more unpredictable than that of its peers. With the 1996 appointment of the National Bioethics Advisory Commission (NBAC) by President Clinton, there has been a change in the process of U.S. public policy development. This article provides an overview of the NBAC and highlights recent areas of focus and related recommendations.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"1 2","pages":"84-9"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22378673","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}