Module232025

07/05/2025

“To be approved, a new drug must make people live longer or feel better, ideally both – and it could be approved if it makes people live shorter but feel a LOT better” Can this apply to children? Dr Ray Lipicky, FDA Director of Cardiovascular and Renal Products, 1984-2002 “In a clinical trial, we come to a “deal” with triallists: we will give you a strange chemical or new gadget and record data in such a way that we can make a reliable decision about whether that chemical or gadget could become a medicine or a treatment” Can children enter into such a “deal”? Dr Joe Brierley, Consultant Paediatric Intensivist, GOSH “The ethical conduct of research involving human subjects requires a balancing of society's interests in protecting the rights of the subjects and in developing knowledge that can benefit the subjects or society as a whole”. 1 Is this applicable to children? Is scientific research a moral duty for those willing to enjoy the benefits of research? 2 Can children shoulder such a moral duty? Other ways of looking at clinical trial ethics - 1

The Organisation for Professionals in Regulatory Affairs

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Other ways of looking at clinical trial ethics - 2

Hans Jonas (1903-1993) rejected teleological justifications, and held that clinical research can be made “right” only by such authentic identification with the cause that it is the subject’s as well as the researcher’s cause 3 Immanuel Kant (1724-1804) held that because humans are rational beings, each human deserves respect, being able to set his own goals and being treated as an end in and of himself, not merely a means toward fulfilling others’ goals . 4 Can children “identify” with the researcher’s cause? Do children have autonomous will to embrace the researcher’s end? Do children really have a “choice”? Their dissent must be respected in EU and Australia , but is their choice really yes/no, rather than fully understanding all the implications of the trial? Is that really different for adults?

The Organisation for Professionals in Regulatory Affairs

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