医学研究中的非财务利益冲突:监管是正确答案吗?

Journal of law and health Pub Date : 2024-01-01
Nehad Mikhael
{"title":"医学研究中的非财务利益冲突:监管是正确答案吗?","authors":"Nehad Mikhael","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nonfinancial Conflict of Interest in Medical Research: Is Regulation the Right Answer.\",\"authors\":\"Nehad Mikhael\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.</p>\",\"PeriodicalId\":73804,\"journal\":{\"name\":\"Journal of law and health\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of law and health\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of law and health","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

医学研究在推动人类知识进步、开发新的疗法和程序以及减少人类痛苦方面发挥着至关重要的作用。在纳粹时期,德国医生以医学研究的名义犯下了暴行,随后举行了纽伦堡审判,并制定了道德准则,以确定医学研究的运作范围。因此,法律制度在这一伦理基础上制定了确保医学研究完整性和人类受试者安全的法律。这些法律旨在通过最大限度地减少研究过程中可能出现的利益冲突来保护人类受试者。此外,利益冲突可能是经济性的,如金钱收益,也可能是非经济性的,如晋升和职业发展。然而,由于开发一种新药的成本中位数为 11 亿美元,这些法律的重点是针对经济利益冲突。但是,我们是否应该将这些法律扩大到包括非经济利益冲突?本文强调了支持和反对规范医学研究中的非财务利益冲突的主要论点。文章进一步得出结论,适当的制度政策--而不是额外的法规--能够在防止非财务利益冲突的有害影响和避免过度监管的弊端之间取得适当的平衡。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Nonfinancial Conflict of Interest in Medical Research: Is Regulation the Right Answer.

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
The Ninth Amendment: An Underutilized Protection for Reproductive Choice. Distorted Burden Shifting and Barred Mitigation: Being a Stubborn 234 Years Old Ironically Hasn't Helped the Supreme Court Mature. How Bodily Autonomy Can Fail Against Vaccination Mandates: The Few vs. the Many. When Governors Prioritize Individual Freedom over Public Health: Tort Liability for Government Failures. Without Due Process of Law: The Dobbs Decision and Its Cataclysmic Impact on the Substantive Due Process and Privacy Rights of Ohio Women.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1