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Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study
1Office of Medical Bioethics, Faculty of Medicine, University of Calgary, Calgary, AB, Canada. ellen.burgess@CalgaryHealthRegion.ca
Insights
Parents in neonatal intensive care units want to make research decisions for their newborns. They feel informed and prefer to decide over doctors, suggesting earlier information delivery for better recruitment.
Area of Science:
- Neonatal Research Ethics
- Clinical Trial Recruitment
- Parental Decision-Making
Background:
- Recruitment for neonatal intensive care unit (NICU) research presents challenges.
- Concerns exist regarding parental involvement in research enrollment decisions.
Purpose of the Study:
- To investigate parental perceptions of the recruitment and enrollment process for research conducted in the NICU.
- To understand parental views on decision-making authority for study participation.
Main Methods:
- A questionnaire-based study involving both retrospective and prospective data collection from parents of newborns in NICU trials.
- Inclusion of closed-ended, open-ended, and demographic questions to gather comprehensive feedback.
Main Results:
- High parental confidence (90%) in making informed decisions and understanding study elements.
- Overwhelming opposition (93%) to relinquishing enrollment decisions to physicians.
- Parents suggested providing research information prior to delivery for process improvement.
Conclusions:
- Parents strongly prefer retaining decision-making authority for NICU research enrollment.
- Healthcare teams should empower parents as decision-makers and improve research staff accessibility.
- Enhanced and timely provision of research information is crucial for effective recruitment.
Background:
Recruitment into research studies in the neonatal intensive care unit has been problematic. Therefore suggestions have been made to take decision making about enrollment out of the hands of the parents.
Objective:
To understand parental perceptions of the process of recruitment and enrollment for research in the neonatal intensive care unit.
Method:
A questionnaire was developed and used in both a retrospective survey and a prospective study of parents whose newborns were enrolled in trials in a neonatal intensive care unit. Closed ended and open ended questions were included, as well as demographic questions.
Results:
The retrospective survey had a 79% response rate (29 of 38). Overall, 90% of parents felt that they had made informed decisions, and 93% were against the option that a doctor decide if the newborn should be enrolled into a study, rather than the parent. Although some parents (38%) found that recruitment did add "stress to an already stressful situation", 90% felt that they had made informed decisions and understood the elements of the study. Most parents had been requested to enroll their newborn into more than one trial, and, on average, they thought that they would be comfortable with enrollment into two studies (range 0-6). When asked how the process could be improved, parents suggested that information be made available before delivery. The responses of parents in the prospective study were mostly consistent with those from the retrospective survey.
Conclusions:
Overall the parents did not support the suggestion that decision making about enrollment be taken away from parents and put into the hands of doctors. The healthcare team should support parents in their role of decision maker, enhance availability of the research staff, and provide more information about the research.
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