部分放弃同意克服转化科学障碍在新生儿临床研究。

IF 2 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Journal of Clinical and Translational Science Pub Date : 2025-08-27 eCollection Date: 2025-01-01 DOI:10.1017/cts.2025.10122
Megha Sharma, Sarah E Diamond, Jenna Chancellor, Simon Chung, Andrew W Brown, D Micah Hester, Laura P James, Mario Schootman, Peter M Mourani, Sherry E Courtney
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引用次数: 0

摘要

新生儿研究的前瞻性同意提出了重大挑战,特别是在紧急的、时间敏感的临床研究登记窗口。在大地理区域的转诊中心尤其如此。部分放弃同意提供了一种潜在的转化科学方法,以加强对危重新生儿的研究参与。我们比较了一项研究的入组率,该研究评估了不同皮肤色素沉着的新生儿在实施部分放弃同意之前和之后的脉搏血氧仪准确性。在没有种族差异的情况下,总体入组人数显著增加,从而提高了新生儿临床研究的普遍性和效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Partial waiver of consent to overcome translational science barriers in neonatal clinical research.

Prospective consent in neonatal research poses significant challenges, particularly during urgent, time-sensitive clinical windows of study enrollment. This is especially true at referral centers for large geographic regions. A partial waiver of consent offers a potential translational science approach to enhance access to research participation in critically ill neonates. We compared enrollment rates in a study evaluating pulse oximetry accuracy across neonates with varying skin pigmentation before and after implementing a partial waiver of consent. Overall enrollment increased significantly without creating a racial disparity in enrollment, thereby improving generalizability and efficiency in neonatal clinical research.

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来源期刊
Journal of Clinical and Translational Science
Journal of Clinical and Translational Science MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
2.80
自引率
26.90%
发文量
437
审稿时长
18 weeks
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