When is waiver of consent appropriate in a neonatal clinical trial?
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 25287456.
- Also identified by DOI 10.1542/peds.2014-0207 and PMC identifier 4533281.
- No licence information is recorded for this record.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
Medical subject headings
- Emergency Medical Services
- Infant, Newborn
- Parental Consent
- Randomized Controlled Trials as Topic