Module232025

07/05/2025

Are children’s legal rights really not affected?

• In some countries, a minor aged >14 may seek contraceptive services, and undergo a pregnancy termination, without parental permission if the medical practitioner is convinced she is “competent”. If a minor aged 14 16 in a clinical trial becomes pregnant and is withdrawn, because the parents/guardians gave permission for her inclusion, are they entitled to know the reason for her withdrawal? • A similar question arises for sexually-transmitted diseases. • Discrepancies between the consent ages for trial participation and data processing, and the supremacy of GDPR Recital 161, means that 13-16 year olds may withhold consent data processing in normal life, but not in a clinical trial. • The UK Duty of Candour Regulations may be inapplicable to clinical trials, so if something goes “wrong”, patients may not receive the same explanation and apology which they would in normal clinical practice.

The Organisation for Professionals in Regulatory Affairs

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1749: Lind’s study of scurvy in sailors aboard HMS Salisbury 1790s: Jenner’s protective cowpox vaccination/variolation 1890s: Sanarelli’s identification of the tsetse fly as yellow fever transmitter 1930-70: Tuskegee (syphilis, black population) 1937-45: Japanese “medical experiments” (Unit 731) (prisoners) 1940-45: Nazi “medical experiments” (prisoners) 1944-47: Manhattan plutonium experiments (cancer patients) 1946-48: Guatemala (syphilis, native population) 1951-74: Holmesburg Prison (dermatology, prisoners) 1959: Willowbrook State School (hepatitis, mentally-impaired) 1961-73: Ireland (vaccine trials on children in mother and baby homes) 1963: Jewish Chronic Disease Hospital (cancer, elderly terminally ill) 1999: Jesse Gelsinger (gene Rx) The “Medical Experiments” (paediatrics) Crime List

The Organisation for Professionals in Regulatory Affairs

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