{"title":"辅助生殖技术:医学实践的进步还是人体实验研究的进步?","authors":"Stefanie L Rokosz","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Although human subject research is regulated by federal agencies, the differences between research and innovative clinical practice are often blurred. Research and innovative practices share the similar goals of obtaining additional knowledge and improving medical treatment. Research, however, is more specifically defined as \"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.\" Aprocedure consistent with this definition is subject to distinct federal regulations and other ethical procedural safeguards. When unregulated innovative practices, not neatly fitting within this definition of research, are first implemented, safeguards do not necessarily exist because use of these procedures is primarily guided by individual physician judgment. Recognizing that the application of innovative advancements in ART may very well benefit numerous prospective infertile patients and may initially appear to be safe and effective, these new and novel procedures may be associated with yet unknown long-term risks and safety concerns unless more formal scientific study is conducted to support efficacy and safety.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assisted reproductive technologies: advances in medical practice or human subject research?\",\"authors\":\"Stefanie L Rokosz\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Although human subject research is regulated by federal agencies, the differences between research and innovative clinical practice are often blurred. Research and innovative practices share the similar goals of obtaining additional knowledge and improving medical treatment. Research, however, is more specifically defined as \\\"a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.\\\" Aprocedure consistent with this definition is subject to distinct federal regulations and other ethical procedural safeguards. When unregulated innovative practices, not neatly fitting within this definition of research, are first implemented, safeguards do not necessarily exist because use of these procedures is primarily guided by individual physician judgment. Recognizing that the application of innovative advancements in ART may very well benefit numerous prospective infertile patients and may initially appear to be safe and effective, these new and novel procedures may be associated with yet unknown long-term risks and safety concerns unless more formal scientific study is conducted to support efficacy and safety.</p>\",\"PeriodicalId\":12282,\"journal\":{\"name\":\"Food and drug law journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2013-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Food and drug law journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Assisted reproductive technologies: advances in medical practice or human subject research?
Although human subject research is regulated by federal agencies, the differences between research and innovative clinical practice are often blurred. Research and innovative practices share the similar goals of obtaining additional knowledge and improving medical treatment. Research, however, is more specifically defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Aprocedure consistent with this definition is subject to distinct federal regulations and other ethical procedural safeguards. When unregulated innovative practices, not neatly fitting within this definition of research, are first implemented, safeguards do not necessarily exist because use of these procedures is primarily guided by individual physician judgment. Recognizing that the application of innovative advancements in ART may very well benefit numerous prospective infertile patients and may initially appear to be safe and effective, these new and novel procedures may be associated with yet unknown long-term risks and safety concerns unless more formal scientific study is conducted to support efficacy and safety.
期刊介绍：
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.
Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law.
All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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