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Parental Perspectives on a Trial Using Waived Informed Consent at Birth
Anup Katheria1, Georg Schmolzer2, Brenda Law2
1Sharp Mary Birch Hospital for Women & Newborns.
Research Square
|November 14, 2023
Summary
Most parents found waived consent acceptable for neonatal trials and would allow future participation. This approach supports ethical research while respecting parental views on their child's health.
Area of Science:
- Neonatal research ethics
- Pediatric clinical trials
- Informed consent procedures
Background:
- Waiver of consent is sometimes used in neonatal research for non-vigorous infants.
- Parental perspectives are crucial for evaluating ethical research practices.
- Understanding parental acceptance of consent methods is vital for trial recruitment and retention.
Approach:
- Anonymous surveys were administered to biological parents of infants randomized in a delivery room intervention study using a waiver of consent.
- Data collection occurred after infant discharge to allow for reflection.
- 121 survey responses were analyzed to gauge parental opinions.
Key Points:
- 92% of parents found the waived consent process acceptable.
- 96% of parents would consent to future participation for another child.
- Over 90% reported clear understanding of post-randomization information.
- Only 4% expressed negative opinions regarding the study's impact on their child's health.
Conclusions:
- The majority of parents accepted the study design involving a waiver of consent in the neonatal period.
- Most parents perceived the study positively regarding its effect on their child's health.
- Further research is recommended to explore diverse parental involvement and pediatric consent methodologies.
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