Commonly performed procedures in clinical research: A benchmark for payment

Commonly performed procedures in clinical research: A benchmark for payment
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DOI:
10.1016/j.cct.2012.05.001
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发表时间:
2012-09-01
影响因子:
2.2
通讯作者:
Grady, Christine
Grady, Christine
中科院分区:
医学4区
文献类型:
--
作者:
Dominguez, Dinora;Jawara, Mandy;Grady, Christine

文献摘要

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临床研究的登记缓慢或不足,以及对研究参与者的高需求,引发了对参与激励的必要性和使用的问题,包括支付。关于研究参与者支付报酬的现有文献大多集中在伦理问题上,很少涉及指导方针、基准或公式,以帮助调查人员为参与临床研究试验和程序的个人分配或评估适当的报酬。本研究使用四年收集的关于内部调查人员分配给选定临床研究程序的不便单元的数据,提供了常用程序的支付基准。结果来自2004年8月至2008年8月收集的36,273起向研究参与者支付程序的数据。对分配给特定程序的不便单位值的分析表明,尽管分布广泛且经常出现异常值,但实际上大多数程序确实存在围绕分布中心的趋同。作为首批发表的报告数据的研究之一,这些数据反映了特定临床研究程序的支付金额,这些数据可以指导研究人员和机构审查委员会建立和审查向研究参与者提供适当金额的支付。我们的数据可能有助于促进程序的支付标准,从而补充建议根据时间和程序进行支付计算的建议或指导方针。由爱思唯尔公司出版。
Slow or insufficient enrollment in clinical research and a high demand for research participants raises questions about the need for and use of incentives to participate, including payment. Much of the available literature on payment to research participants focuses on ethical concerns, and rarely addresses guidelines, benchmarks, or formulas to assist investigators to assign or evaluate appropriate payment for individuals who take part in clinical research trials and procedures.Using four years of data collected about the inconvenience units assigned by intramural investigators to selected clinical research procedures conducted at the National Institutes of Health (NIH) Clinical Center, this study provides payment benchmarks for commonly performed procedures.Results were obtained from data collected on 36,273 incidents of payment made for procedures to research participants from August 2004 to August 2008. Analysis of the inconvenience units value assigned to specific procedures suggests that despite a wide distribution and frequent outliers, a convergence in practice around the center of distribution for most procedures does exist. As one of the first published studies reporting data reflecting payment amount for specific clinical research procedures, these data can guide investigators and institutional review boards as they establish and review an appropriate amount of payment to offer research participants. Our data may be useful in promoting payment standards for procedures, thereby complementing proposals or guidelines that advise payment calculations according to time and procedures. Published by Elsevier Inc.