NCT02482012

Minor Increase Over Minimal Risk Research in NICU

Minor Increase Over Minimal Risk Without Direct Patient Benefit Research in the NICU: Parental and Staff Perspectives

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 96 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations. This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.

Conditions

• Infant, Premature
• Infant, Late
• Infant, Preterm
• Infant

Interventions

Type	Name	Description
OTHER	Survey	This was a survey

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-10-01
• Completion: 2015-05-01
• First posted: 2015-06-25
• Last updated: 2016-02-25

Locations

1 site across 1 country: United States