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A descriptive assessment of the informed consent document used by congenital cardiac surgery centres
Kristal M Hock1,2, Katja Gist3, Pariya L Fazeli1
1School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.
Insights
Informed consent for pediatric congenital heart defect (CHD) surgery often lacks required details. Most US centers use generic documents, missing key information for families. Further research on patient understanding is needed.
Area of Science:
- Pediatric Surgery
- Informed Consent
- Congenital Heart Disease
Background:
- Informed consent for pediatric surgery, especially for congenital heart defect (CHD) procedures, is complex.
- Regulatory bodies provide guidelines for essential informed consent content.
- Understanding current practices in CHD surgical informed consent is crucial.
Purpose of the Study:
- To assess and describe the informed consent contents used in pediatric CHD surgery centers in the USA.
- To evaluate adherence to established informed consent standards.
Main Methods:
- A survey was distributed to 125 pediatric cardiac clinicians across 70 CHD surgical centers in the USA.
- The survey assessed adherence to The Joint Commission informed consent standards.
- Data collection occurred between March 14 and April 18, 2023.
Main Results:
- Thirty-seven surveys were completed, revealing varied documentation formats (paper, electronic, or both).
- Informed consent documents often lacked essential elements like procedure-specific risks, benefits, alternatives, and outcomes.
- While most centers offered Spanish versions, English-only documents were also present.
Conclusions:
- Pediatric CHD surgical centers predominantly use generic informed consent documents.
- These documents frequently fail to meet The Joint Commission standards and may not reflect family discussions.
- Further investigation into parental comprehension during the informed consent process is warranted.
Background:
Informed consent for surgery is a complex process particularly in paediatrics. Complexity increases with procedures such as CHD surgery. Regulatory agencies outline informed consent contents for surgery. We assessed and described CHD surgical informed consent contents through survey dissemination to paediatric CHD centres across United States of America.
Methods:
Publicly available email addresses for 125 paediatric cardiac clinicians at 70 CHD surgical centres were obtained. Nine-item de-identified survey assessing adherence to The Joint Commission informed consent standards was created and distributed via RedCap® 14 March, 2023. A follow-up email was sent 29 March, 2023. Survey link was closed 18 April, 2023.
Results:
Thirty-seven surveys were completed. Results showed informed consent documents were available in both paper (25, 68%) and electronic (3, 8%) format. When both (9, 24%) formats were available, decision on which format to use was based on centre protocols (1, 11%), clinician personal preference (3, 33%), procedure being performed (1, 11%), or other (4, 45%). Five (13%) centres' informed consent documents were available only in English, with 32 (87%) centres also having a Spanish version. Review of informed consent documents demonstrated missing The Joint Commission elements including procedure specific risks, benefits, treatment alternatives, and expected outcomes.
Conclusions:
Informed consent for CHD surgery is a complex process with multiple factors involved. Majority of paediatric CHD surgical centres in the United States of America used a generic informed consent document which did not uniformly contain The Joint Commission specified information nor reflect time spent in discussion with families. Further research is needed on parental comprehension during the informed consent process.
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