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.