Module232025

07/05/2025

ETHICS CHALLENGES IN PAEDIATRIC CLINICAL TRIALS My personal top 10 (based on ~600 protocols reviewed 2017-2023)

6 Pregnancy (child privacy, post-trial follow-up, pregnant partner) 7. Post-Trial Access to IMP (protocol ambiguous or silent, toxicology) 8. Communication of Trial Results (onus on participants, child to adult) 9. “Aging Out” (no process, incorrect process) 10. Paediatric Assent and Information Sheets (length, complexity)

The Organisation for Professionals in Regulatory Affairs

25

Pregnancy and personal privacy – some misperceptions

Is “ Gillick ” competence in UK applicable in CTIMP? Adolescent subjects need to be informed “If your pregnancy test is positive your parents will be informed immediately” Should they – if the child is over 13/14? Parental data privacy permissions continue after subject attains age of consent – must be actively revoked. Information sheets rarely mention this. “Your pregnant partner will be required to…..” No – she CANNOT be required to do ANYTHING Pregnancy trials require the baby’s father’s consent Only under 45 CFR part 46, subpart A and Shari’ah law

26

13