Regulating “higher risk, no direct benefit” studies with children: Challenging the us federal regulations

Review boards must assess whether the risks and burdens are acceptable in relation to the potential benefits to the study subjects and/or the future patients for each proposed medical research study. If the study involves children and cannot directly benefit those children, the risks and burdens involved cannot be more than The two relevant ethics documents recognized in Europe forbid review boards to make any exceptions to the requirement of minimal risk and burden. Review boards in Europe, therefore, occasionally have to reject studies that could significantly improve medical care for sick children in the future. The US Federal Regulations offer two possibilities for approving such higher risk, no direct benefit studies. This paper argues that rather than following the US Federal Regulations completely, Europe should adopt a modified policy.

• View at Publisher
• View at Scopus