Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US

Abstract

ObjectiveTo explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US.Study designA series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process.ResultsA total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child’s medical information. A total of 157 parents were asked “Is it okay to tell you about this kind of research using this handout?” – 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose “no consent needed”. There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific).ConclusionFew parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.

Sharing longitudinal, non-biological birth cohort data: a cross-sectional analysis of parent consent preferences

“…These findings support previous research that identified parent preference of opt-out consent in biobanking [ 42 ]. This survey moves beyond another to note that parents preferred opt-out (or no consent) over other processes, rather than simply not voicing an objection, [ 48 ]. This coincides with a recent systematic review that suggested that no consensus exists on the most appropriate consent for biobanks [ 16 ].…”

“…Because parents were not asked to compare or even consider other consent processes, this perceived acceptability of opt-out consent for biobanking is incomplete. In another study, 166 parents of children in pediatric wards were surveyed about consent preferences for hypothetical observational research [ 48 ]. Fifty-two percent chose an opt-in consent approach, 33% selected opt-out, and about 15% felt that consent was unnecessary [ 48 ].…”

“…In another study, 166 parents of children in pediatric wards were surveyed about consent preferences for hypothetical observational research [ 48 ]. Fifty-two percent chose an opt-in consent approach, 33% selected opt-out, and about 15% felt that consent was unnecessary [ 48 ]. The generalizability of consent preferences for observational research compared to consent for secondary data use is unclear as the latter is characterized by greater diversity and uncertainty.…”

Opt-out Consent in Children’s Emergency Medicine Research

“…[33] In the USA, researchers avoided this situation by checking with attending clinicians about parental distress and the stability of the child's condition. [34] With this safeguard, only two of 166 parents objected to opt-out consent. It was concluded that opt-out consent was acceptable and family-friendly if parents' questions could be answered.…”