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

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.

Study Overview

• Status: Completed
• Conditions: Infant; Infant, Premature; Infant, Preterm; Infant, Late
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

NICU staff and parents of infants

Description

Inclusion Criteria:

• Parents of infants in the NICU
• Parents of infants on well-baby nursery
• NICU Staff (nurses and physicians)

Exclusion Criteria:

• Non-English Speaking
• Less than 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Staff; Staff nurses and physicians in the NICU	Other: Survey; This was a survey
Parents; Parents of infants in the NICU and a smaller group of parents of infants in the well baby nursery.	Other: Survey; This was a survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determination of willingness to participate in research	This is a survey to determine attitudes / willingness to participate in a specific category of research.	15 minutes

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Principal Investigator: Robert G. Locke, DO, MPH, Christiana Care Health Services, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: vulnerable population; research; 45 CFR 46.406
• Other Study ID Numbers: CCC#34099