Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit

Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit
Research
Jessica Hodson, Christiana Garros, Jodie Jensen, Jonathan P. Duff, Gonzalo Garcia Guerra, Ari R. Joffe
Journal of Intensive Care, 16 December 2019; 7(60)
Open Access
Abstract
Background
The aim of the study was to determine opinions and knowledge regarding the process of obtaining informed consent to participate in observational research in pediatric intensive care.
Methods
Survey 1 asked decision makers what model(s) of consent was acceptable for each type of observational research both before and after background information. Survey 2 asked decision makers about the experience of being asked for consent to observational research, and knowledge regarding the consent process both before and after background information.
Results
Cooperation rate was 100/117 (85%). The proportion in favor of any of the offered alternatives to signed informed consent for observational research, after receiving all the background information, was 74-80%, lowest for observational prospective research with a minimal risk intervention 37/50 (74%; 95% CI 60–84%). The proportion who agreed they felt overwhelmed by being approached for consent to observational research was 26 (52%; 95% CI 39-65%). Most respondents (from 60 to 74%) felt they understood the concepts regarding observational research; however, after reading background information, most (from 60 to 74%) felt their understanding had improved “a great deal”.
Conclusion
Understanding of risk, practical difficulties, consent bias, and Research Ethics Board safeguards was poor. Future study is needed to confirm our finding that most agreed with alternative methods of consent for observational research.

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