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.
Authors
- Peter M. Mourani (ORCID: https://orcid.org/0000-0002-1829-3775)
- Andrew William Brown (ORCID: https://orcid.org/0000-0002-1758-8205)
- Mario Schootman (ORCID: https://orcid.org/0000-0003-1162-8824)
- D. Micah Hester (ORCID: https://orcid.org/0000-0001-7022-7436)
- Sherry E. Courtney (ORCID: https://orcid.org/0000-0003-1180-6598)
- Laura P. James (ORCID: https://orcid.org/0000-0002-4266-3924)
- Megha Sharma (ORCID: https://orcid.org/0000-0002-9807-1856)
- Simon Chung
- Sarah E Diamond
- Jenna Chancellor
Institutions
- Arkansas Children's Hospital (US)
- Institute for Community Health (US)
- University of Arkansas for Medical Sciences (US)
Publication Details
- Journal
- Journal of Clinical and Translational Science
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1017/cts.2025.10122
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Children’s Hospital of Wisconsin Research Institute
- National Institutes of Health
- National Institute of General Medical Sciences
- National Center for Advancing Translational Sciences