Assisted reproductive technologies: advances in medical practice or human subject research?

IF 0.3 4区医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2013-01-01

Stefanie L Rokosz

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引用次数: 0

Abstract

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.

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辅助生殖技术:医学实践的进步还是人体实验研究的进步?

虽然人体研究是由联邦机构监管的，但研究和创新临床实践之间的区别往往是模糊的。研究和创新实践有着相似的目标，即获得更多的知识和改善医疗。然而，研究被更具体地定义为“一种系统的调查，包括研究开发、测试和评估，旨在发展或促进可推广的知识。”符合此定义的程序受不同的联邦法规和其他道德程序保障的约束。当不受监管的创新实践(不完全符合研究的定义)首次实施时，保障措施不一定存在，因为这些程序的使用主要由医生个人判断指导。我们认识到，应用抗逆转录病毒技术的创新进展可能会使许多潜在的不孕症患者受益，并且最初可能看起来是安全有效的，但这些新的和新颖的程序可能伴随着未知的长期风险和安全问题，除非进行更正式的科学研究来支持其有效性和安全性。

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来源期刊

Food and drug law journal 医学-食品科技

CiteScore

0.20

自引率

50.00%

发文量

审稿时长

>36 weeks

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.