Risks and benefits of research on children: developing an ethical framework to meet children’s needs

Clin Risk 2008;14:215-217
doi:10.1258/cr.2008.080080
© 2008 Royal Society of Medicine Press

 

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Risks and benefits of research on children: developing an ethical framework to meet children’s needs

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Patient safety


James Appleyard, MD FRCP

Email: Jimappleyard2510{at}aol.com

Children are put at unnecessary risk in everyday clinical practiceby being given medicines whose safety and efficacy have notbeen adequately researched.

The lack of appropriate dosage forms for many ‘essentialmedicines’ for the main five treatable conditions causingthe deaths of 10 million children worldwide under the age of5 years are a major reason why countries are not achieving theirmillennium developmental goals.

There has been understandable reluctance to undertake the necessaryresearch on children. The reasons for this are reviewed. Theexisting levels of protection for child subjects worldwide areinsufficient. Key principles are suggested both to encourageclinical research and to ensure adequate protection for childrenaround the world.

Risks and benefits of research on children: developing an ethical framework to meet children’s needs
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