Ethics Committees in India: Past, present and future.
Ethics Committees in India: Past, present and future.
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DOI：
10.4103/2229-3485.198549
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发表时间：
2017-01-01
影响因子：
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通讯作者：
Marathe, Padmaja A
中科院分区：
文献类型：
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作者：
Thatte, Urmila M;Marathe, Padmaja A
在对附表Y进行了分水岭修正之后，印度的星星在临床研究（特别是临床试验）领域迅速崛起。同样戏剧性的是这个帝国的衰落。这些事件的核心是参与者，间接地是主要为保护这个人而设立的道德委员会。本文追溯了EC的概念在印度的演变，研究这些委员会在该国的现状，并提出了前进的方向。过去：要求EC监督临床研究首先是在ICMR政策声明伦理出版于1980年，然后再次在附表Y（1988年）。后来，修订后的附表Y（2005年）将监管责任分配给了EC，ICMR指南（2006年）描述了EC的功能。查明了若干挑战，包括正规培训不足、非技术成员的贡献、行政支助以及没有标准操作程序和工作量繁重。在缺乏对伦理委员会的监管监督的情况下，印度临床试验注册中心（CTRI）的引入以及通过自愿认证计划进行的自我监管带来了一定程度的问责制和透明度。一系列监管改革导致超过1000个EC在CDSCO注册，尽管这些新法规对参与者的保护和安全的实际影响仍有待观察。WAY前进：一种方法来监督所有的EC，改善EC的功能，包括现场监测，中央EC的多中心研究，指标的发展，以评估EC的能力，以保护参与者的其他ideas for the future.CONCLUSIONS：虽然EC在印度已经从仅仅是橡皮图章批准的协议，有效运作的认证EC，但还有很多工作要做，并由伦理委员会。
Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward.THE PAST: The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency.THE PRESENT: A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen.WAY FORWARD: A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future.CONCLUSIONS: Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees.