Module232025

12/05/2025

Risk Vs benefit & Ethics Committees

Risk category

Procedure

Minimal (probability of harm or discomfort not greater than that ordinarily encountered in daily life) (1:100,000 death)

History, examination, BP, uss, single venepuncture

Minor

Multiple venepuncture, PVC, NG Sedation anaesthesia, surgery

Great tan minor increase over minimal risk

• Paediatric studies are governed by the same ethical guidelines as studies in adults while taking into account the unique legal status and vulnerability of children and recognises additional ethical issues unique to them • Need to ensure ethics committees properly constituted for studies in paediatric populations • Need to ensure ethics committees adequately trained on paediatric issues

The Organisation for Professionals in Regulatory Affairs

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Consent and Assent

• Parent or legal guardian gives consent • Child (where appropriate) gives assent • Assent: voluntary permission given by one with no legal status following age appropriate explanation • Written assent forms in age appropriate language

• Obtaining assent... with or without parents • Mere failure to object is not considered assent

• A participating child’s wish to withdraw from the study must be respected • Must obtain informed consent when a child reaches adult age of consent, including for retention of samples/data

The Organisation for Professionals in Regulatory Affairs

18