Children’s health has improved and child mortality rates have decreased in recent decades, thanks in part to medical advances that improve prevention and treatment of illnesses and conditions in young populations. Vaccines for measles and mumps, for example, have dramatically improved the health of children since the 1950s.¹

Even with these advances and improvements, medical research is primarily focused on adult populations, and many solutions that could be effective in children have not been studied in infants, children, or adolescents. While data from adult studies is often extrapolated to children to reduce risk, advancing some safe and effective treatments for children may require investigation in the intended population.¹

In recent years, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have prioritized growing research in children’s health. Clinical trials that involve children have special requirements and considerations. Below is an overview of a few of the top concerns, as well as some resources that provide supporting information.

Informed Consent

Many children do not have the legal right to consent to participate in research. As a vulnerable population, special consideration must be taken. While in some cases children age 7 and older are given the ability to consent to research, each trial determines its age requirements based on the nature of the study. Extensive information regarding the trial must be provided to the consenting parent or guardian, and they must be given the opportunity to ask questions. As the trial develops, parents and children should be asked at appropriate intervals whether they wish to continue participation in the study.²

Determining Risk

Clinical research in children must be considered scientifically necessary. There are certain risk criteria a trial must satisfy. A minimal-risk procedure would be considered a one-time blood draw or physical examination, for example.² Trials involving greater than minimal risk have special IRB requirements to ensure the framework for participation remains ethical.

Conducting Well-Designed Studies

Clinical investigations that include children must be designed to maximize the information collected while minimizing the number of participants. For drug investigations, all available scientific data should be reviewed to determine safe, effective dosing for children. Similarly, in device studies, all available clinical data should be used to determine effective and efficient use.³

There are many resources available which provide detailed and specific guidance for the many considerations related to children’s involvement in clinical research:

• FDA Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs (PDF)
• FDA Draft Guidance Snapshot (PDF)
• Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Sources:

1. https://www.ncbi.nlm.nih.gov/books/NBK25542/
2. https://www.insideprecisionmedicine.com/topics/patient-care/ethical-considerations-for-including-children-in-clinical-research
3. Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs