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Informed consent

Medical Consent Guidelines

□ Informed Consent Guidelines for Medical Procedures

Category Component Details & Requirements
□ CONSENT FORM AVAILABILITY Online Access Most commonly performed procedures available digitally
Physical Copies Available in reading room
Inpatient Timing
Obtain consent day before procedure when parents are available
□ SPECIAL CONSENT SITUATIONS Phone Consent
  • Required when parents/caregivers not present
  • IR staff member must witness the process
  • Witness confirms caregiver understanding and signs form
Interpreter Services
  • Interpreter must sign consent form
  • Use professional interpreters, not family members
ℹ️ PRE-PROCEDURE INFORMATION Procedure Details
  • Name and purpose of procedure
  • Technique to be used
  • Medical indication for treatment
Alternative Options
  • Non-invasive treatments
  • Surgical alternatives
  • Observation/monitoring only
Expected Outcomes
  • Success rates for procedure
  • Symptom relief goals
  • Realistic expectations
⚠️ RISK DISCLOSURE Common Risks Bleeding • Infection • Pain • Access site complications
Procedure-Specific Risks Organ perforation • Vessel injury • Device migration
Serious Complications
Organ damage • Emergency surgery requirements
Radiation Considerations
  • Cumulative dose exposure
  • Repeat procedure impact
  • Pediatric radiation sensitivity: Children have increased lifetime cancer risk
Contrast Agent Risks Allergic reactions • Kidney effects
□ TECHNICAL DETAILS Access Approach Arterial/venous route selection • Access site location
Anesthesia Options Local anesthesia • Conscious sedation • General anesthesia
Time Requirements Procedure duration • Recovery time expectations
Medical Devices Permanent implants • Stents • Coils or other devices • Expected duration of drain
□ POST-PROCEDURE CARE Recovery Requirements Bed rest duration • Activity restrictions • Return to normal function timeline
Monitoring Needs
  • Vital signs checks
  • Access site monitoring
  • Extended observation often required in children
Follow-up Care Imaging studies schedule • Clinic visits timing • Surveillance requirements
Warning Signs
When to seek immediate medical attention • Emergency contact information
Pediatric Considerations
School absence planning • Sports participation restrictions
□ SPECIAL MEDICAL CONSIDERATIONS Medication Management Anticoagulation adjustments • Pre-medication protocols
Pre-Procedure Screening Pregnancy status verification • Kidney function assessment • Previous reaction history
✍️ CONSENT AUTHORITY Adult Patients Direct consent from patient with decision-making capacity
Pediatric Consent Process
  • Parental permission required (all minors under 18)
  • Child assent: Agreement from children ≥7 years when appropriate
  • Adolescent involvement: Respect developing autonomy
Age-Appropriate Communication
  • Simple, concrete terms - Avoid medical jargon
  • Visual aids: Child-friendly materials, models, drawings
  • Honest disclosure: Acknowledge discomfort, emphasize pain management
  • Family presence: Allow parents/caregivers during discussions
□ DOCUMENTATION REQUIREMENTS Capacity Assessment
  • Patient understanding confirmation
  • Developmental assessment for children
Required Signatures Patient/parent • Physician • Witness (when applicable) • Dates on all signatures
Process Requirements
  • Adequate discussion time before procedure
  • Professional interpreters for non-English speaking families (not family members)

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  • Home
  • Procedures
  • Protocols
  • Online Library
    • Pediatric IR Papers
    • Presentations and Webinars
    • IR Equipment and IFU
  • BCH IR Fellows Homepage
  • About Us