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Parental perspectives on a trial using waived informed consent at birth
Anup C Katheria1, Georg M Schmölzer2, Brenda Law2
1Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA. anup.katheria@sharp.com.
Summary
Most parents found using a waiver of consent acceptable for neonatal research. They reported understanding information and feeling comfortable with the process, with few concerns about their child's health.
Area of Science:
- Neonatal research ethics
- Pediatric clinical trials
- Informed consent in research
Background:
- Waived consent is sometimes used in neonatal research to facilitate timely enrollment.
- Parental perspectives on waived consent are crucial for ethical research practices.
- Understanding parental acceptance is key to refining consent procedures.
Purpose of the Study:
- To evaluate parental acceptance of a waiver of consent in a neonatal research trial.
- To assess parental understanding and comfort levels with the waived consent process.
- To gather feedback on the impact of waived consent on parental views of neonatal studies.
Main Methods:
- Anonymous surveys were administered to birth parents of term infants enrolled under a waiver of consent.
- Data collection occurred post-infant discharge to ensure privacy and reduce immediate study impact.
- Quantitative analysis of survey responses assessed acceptability, comfort, understanding, and perceived health effects.
Main Results:
- A high percentage of parents (92%) found the waiver of consent acceptable for neonatal research.
- Most parents (96%) expressed comfort with future participation under similar conditions.
- The majority (91%) reported adequate understanding of study information and sufficient time for consideration.
- A small minority (4%) held negative opinions regarding the study's impact on their child's health.
Conclusions:
- The study design utilizing a waiver of consent was largely acceptable to responding parents in the neonatal period.
- Parents perceived the research process positively, with minimal concerns about their child's health.
- Further research is recommended to explore diverse parental involvement and alternative pediatric consent methods.
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