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
{"title":"部分放弃同意克服转化科学障碍在新生儿临床研究。","authors":"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","doi":"10.1017/cts.2025.10122","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e202"},"PeriodicalIF":2.0000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454670/pdf/","citationCount":"0","resultStr":"{\"title\":\"Partial waiver of consent to overcome translational science barriers in neonatal clinical research.\",\"authors\":\"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\",\"doi\":\"10.1017/cts.2025.10122\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":15529,\"journal\":{\"name\":\"Journal of Clinical and Translational Science\",\"volume\":\"9 1\",\"pages\":\"e202\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454670/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical and Translational Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1017/cts.2025.10122\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical and Translational Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1017/cts.2025.10122","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.