An observational study in Pediatric Surgery, Informed Consent and Shared Decision-making, sponsored by University of Chicago. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University of Chicago · Observational
This study will evaluate how parents or legal guardians perceive responsibility for surgical risk after the informed consent discussion for their child's operation, focusing on whether the process feels like "risk sharing" with the clinical team or "risk dumping" onto the parent. In pediatric surgery, parents often serve as surrogate decision-makers, and little is known about how consent conversations shape feelings of support, blame, trust, and decisional burden.
Using a mixed-methods, cross-sectional design, the study will recruit parents/legal guardians of children under 18 years of age undergoing pediatric surgical procedures at Comer Children's Hospital after the clinical consent discussion and before surgery. Participants will complete a post-consent survey assessing perceptions of risk sharing versus risk dumping, understanding of risks and benefits, satisfaction with the consent process, trust in the surgeon/institution, decisional conflict, anxiety, and relevant demographic and clinical factors. A subset of participants will also complete semi-structured interviews to further explore experiences of responsibility, blame, institutional support, and suggestions for improving the consent process.
The goal is to characterize parental perceptions of responsibility in pediatric surgical consent and identify communication, demographic, and clinical factors associated with greater perceived risk dumping. Findings may help inform interventions to improve informed consent and shared decision-making practices in pediatric surgery.
This hospital-based mixed-methods study examines parental attitudes after informed consent for pediatric surgery, specifically whether parents perceive the consent process as one in which risks are shared with the surgeon and the institution or shifted primarily onto the parent. The study addresses an important gap in pediatric surgical decision-making, where existing literature suggests that parents may have difficulty understanding probabilistic risk information and that trust, stress, communication quality, and shared decision-making influence their experiences.
Eligible participants are parents or legal guardians of children younger than 18 years who are scheduled for a surgical procedure requiring formal informed consent and who were present for that discussion. After completion of the clinical consent process, research staff will approach eligible parents/guardians for voluntary research participation. Participants will complete a survey before the child's surgery. Survey domains include demographics and clinical context, perceived risk sharing versus risk dumping, shared decision-making, quality of the consent process, trust in physician/institution, satisfaction, decisional conflict, anxiety, and open-ended feedback. A subset of participants will undergo semi-structured interviews exploring perceptions of responsibility, blame, support, and abandonment during the consent process.
Quantitative data will be analyzed descriptively and with bivariate and multivariable methods to identify predictors of perceived risk dumping. Qualitative interview transcripts will undergo thematic analysis. Integrated findings will be used to develop a conceptual mode of "risk sharing versus risk dumping" in pediatric surgical informed consent and to inform future improvements in communication and shared decision-making.
University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.
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Parents and legal guardians of pediatric patients younger than 18 years undergoing surgical procedures at Comer Children's Hospital for which formal surgical informed consent has been obtained. Participants are recruited after the clinical consent discussion and before the child's surgery. The study population is intended to represent parents or guardians serving as surrogate decision-makers in pediatric surgical care.
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Exclusion Criteria:
Parents or legal guardians of children younger than 18 years who are scheduled for a pediatric surgical procedure requiring formal informed consent who were present for the clinical consent discussion. Participants complete a one-time post-consent survey before the child's surgery to assess perceptions of risk sharing versus risk dumping, share decision-making, trust, satisfaction, anxiety, and decisional conflict. A subset of participants will also complete semi-structured interviews exploring experiences of responsibility, blame, support, and the informed consent process. No study intervention is administered.
Other: Research data collection only
No intervention will be performed. Post-consent survey and optional semi-structured interview will be performed. No therapeutic, preventive, diagnostic, or behavioral intervention is administered for this study.
Parental perception of risk sharing versus risk dumping after pediatric surgical informed consent
Parent/legal guardian perception of whether responsibility for surgical risk was shared with the clinician and institution or shifted primarily onto the parent following the informed consent discussion for the child's surgical procedure. This outcome will be measured using a study survey composed of Likert-scale items assessing perceived shared responsibility, blame, partnership, and legalistic versus supportive framing of risk.
Time frame: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery
Parental understanding of risks and benefits
Parent/legal guardian self-reported understanding of the risks, benefits, and alternatives discussed during the surgical informed consent process, assessed by post-consent survey items.
Time frame: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery.
No study locations are listed for this record.
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Plan to share: Undecided — Data may contain sensitive survey and interview information from parents/legal guardians about their child's surgical consent experience. Because this is a single-site minimal-risk study involving potentially identifiable qualitative narratives, the study team has not yet made a final decision regarding whether de-identified IPD can be shared in a manner consistent with participant confidentiality and institutional requirements. Any future sharing would be considered only for fully de-identified data and only with appropriate approvals and data use protections in place.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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