The UAMS Institutional Review Board has updated its policy 17.1, Children in Research. We have added language to increase flexibility on parental permission requirements for research not subject to federal regulations. Specifically, this policy revision codifies the Institutional Review Board’s flexibility to consider requiring only one parent’s permission for a child to participate in research that has been found to pose greater than minimal risk and no prospect of direct benefit to individual participants (pediatric category III research). Normally two parent signatures are required for this research category. However, because the UAMS Human Research Protection Program has chosen to apply “equivalent protections,” rather than federal requirements, to studies that don’t fall under Office for Human Research Protections or Food and Drug Administration oversight, we wanted to give ourselves the flexibility to consider options that protect subjects’ rights, safety, and welfare while facilitating the research process.
Note that this flexibility can only be exercised to studies not subject to federal regulations or any other standard, such as contract language, that requires the signature of both parents.