FDA Draft Guidance Aims to Protect Children in Clinical Trials

By Leah Lawrence - Last Updated: October 11, 2022

The U.S. Food and Drug Administration (FDA) has issued a draft guidance designed to protect children who are participating in clinical trials. The guidance is designed to assist industry, sponsors, and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products, and medical devices.

The guidance describes the ethical framework for protecting children involved in clinical research, including risk and benefit considerations. The draft includes information on fundamental concepts for the ethnical framework that IRBs, sponsors, and industry should consider when reviewing or conducting clinical trials involving children.

These include considerations such as the scientific necessity of the trial, how to evaluate if an intervention offers a prospect of direct benefit to the child, and more.

The guidance also includes details on parental or guardian permission and child assent for participation. For example, children 7 years of age and older are often considered capable of assent; however, the age, maturity, and psychological state (mental capacity and developmental stage) of the child involved in the research must be considered, according to the draft guidance.

“Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who can’t provide consent for themselves and are afforded additional safeguards when participating in a clinical investigation,” said Dionna Green, MD, director of the FDA’s Office of Pediatric Therapeutics. “The best way to provide children with safe and effective treatment options is by including them in clinical research and providing these additional safeguards to protect them during clinical trials.”

The public can provide comments on the draft guidance, titled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” Any comments should be submitted within 90 days to ensure that the agency considers them when finalizing the draft guidance.



New FDA Draft Guidance Aims to Protect Children Who Participate in Clinical Trials