FDA-AstraZeneca Hearing
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Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations
The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”
Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.
We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.