修订需求：《2019年新药与临床试验规则》中的伦理审查委员会（EC）程序、成员培训及薪酬公式
Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.
作者信息
Ghooi Ravindra Bhaskar
机构信息
Scientia Clinical Services, Pune, Maharashtra, India.
出版信息
Perspect Clin Res. 2022 Jul-Sep;13(3):129-131. doi: 10.4103/picr.picr_251_21. Epub 2022 Jun 30.
The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.
《新药与临床试验规则》（NDCTR）于2019年生效，这些规则带来了一些变化，但某些早期部分，如第122条药物审批委员会（DAB）规则，未作修改地被纳入其中。NDCTR的一些条款存在问题，需要修订以确保印度临床试验的顺利进行。伦理委员会（EC）成员和其他利益相关者的培训是临床研究的一个非常重要的推动因素，但尚未明确界定。此外，EC审查的一些流程需要重新审视。赔偿公式于2013年确定；现在，经济形势的变化已经侵蚀了货币价值。因此，为保护研究参与者，建议紧急审查赔偿公式。
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