The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process for referring research involving children in cases where such research would not normally be approvable by an IRB. In such cases, an IRB may refer the study to FDA or the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP).
Conducting pediatric clinical trials is a sensitive matter, and researchers and regulators must be even more cautious when they are involved in clinical trials or other regulated human subjects research. Typically, if a trial puts a patient at any significant risk, an IRB must oversee the study to ensure the interests of patients are addressed…
