1. What is “Informed Consent”What is “Informed Consent”
• Context of health care
• “Understand what is going on with your health”
• “Good things” (benefits) / “Bad things” (risks)
• “Consent”: agree, say “yes” to …
• Understand risks and benefits and agree …

2. When is Informed Consent needed?When is Informed Consent needed?
• Before examining, treating or caring for a child, you
must seek informed consent
• Implied consent: attendance, no potentially injurious
intervention is planned
• Expressed consent
• Material risk: those risks which a responsible doctor
or expert would disclose in similar circumstances

3. Can Children Consent for Themselves?Can Children Consent for Themselves?
• 16 – 17 years old: competent to give consent
• Younger children who understand fully can also give
consent (ideally, parents involved)
• If a competent child consents to treatment, a parent
cannot over-ride that consent
• Legally, a parent can consent if a competent child refuses

4. Who can get Consent?Who can get Consent?
• The person actually treating the patient
• You can seek consent “on behalf of colleagues” if:
– you are capable of performing the procedure
– you have been specially trained to seek consent for that
procedure

5. Does it matter how a patient gives Consent?Does it matter how a patient gives Consent?
• Consent can be written, oral or non-verbal
• A signature on a consent form does not prove that the consent
is valid
• The discussion of information and assessment of patient
understanding is vital
• Written consent should be accompanied by the information
form
• Consent must be voluntary

6. The Consent FormThe Consent Form
1. Patient details
2. Name of the test or treatment
3. The aim of the procedure
4. The benefits
5. The risks
6. Additional procedures
7. Alternatives to the procedure
8. Appropriate signatures

7. Informed Consent: The EvidenceInformed Consent: The Evidence
• Informed Consent, parental awareness and reasons
for participating in a randomised controlled study
• van Stuijenberg M et al, Arch Dis Child 1998, 79
120-5

8. Aim and MethodsAim and Methods
• To assess the quality of the informed consent process in a
paediatric setting
• 230 children enrolled in a RCT of ibuprofen
• 2 weeks after febrile seizure
• Explanation: rationale, design, procedures, drugs, risks, side
effects, freedom to withdraw
• Personal copy of signed consent form
• Time to consider consent
• Questionnaire developed, returned by 181 parents (79%)

9. Awareness of major trial characteristicsAwareness of major trial characteristics
• Aim %
– Correct interpretation 53
– Incorrect interpretation 46
– Don’t remember 2
• Reason for signing consent
– Informed consent 75
– Protection (investigator/family) 8/7
– Do not remember why signed 9 (1)
• Possible SFX 40
• 50% placebo 88
• Random allocation 50
• Possibility of withdrawing 91%

10. Reasons for giving consentReasons for giving consent
Felt obliged to participate
No (136) Yes (45)
• Contribution to medical science 49% 56%
• Benefit to own child 34 27
• Benefit for future children 3 2
• Give in return for care 7 7
• Doctor asked 3 4

11. Informed Consent: ResourcesInformed Consent: Resources
• Report of working group on Informed Consent
• www.doh.gov.uk/consent
• Trust Research Ethics Group
• Caldicott Group
• Child and Family Centre Care Group
• Black and Ethnic Minority Group
• Clinical Records, Donor Action, SPOCC, Medical
Illustration, Risk Management, Clinical Governance