Autonomy in Child Health Research

 

As many of us in the MSBS program have learned from our independent research projects, consenting adults for research is pretty simple: they either do or don’t want to participate. Research in minors, however, isn’t always as straightforward. As I have learned working in clinical research at Children’s Hospital Colorado, parents and children may have conflicting ideas about participating in a research study. When that happens, who gets the final say?

The answer is: it depends.

In the United States, the legal age of majority is 18. That means that until an individual turns 18, they cannot provide informed consent. A minor, however, can provide what is known as assent, which means that they understand what is going on and they agree to it. But unlike consent, assent is not legally binding. So why do we even bother obtaining it?  

It turns out that most institutional review boards, the groups that review and approve research studies, require assent from children over the age of about 6 or 7. In doing so, it gives minors some power over their participation; but that power has limits. If a child could directly benefit from taking part in a study, and that benefit is only available through the study, parental consent can override the child’s veto. The same holds true if the investigators determine that the child is not cognitively able to understand the study (Field & Behrman, 2004). In other words, a minor can really only say no to non-therapeutic studies. But if a minor wants to participate in a study and their parents object, there’s not a lot they can do.

You can see how this could lead to ethical dilemmas if, for instance, a minor did not want to participate in an investigational drug trial that their parents signed them up for, or if their parents refused to let them participate in a study that they were interested in. Of course, the Code of Federal Regulations is intentionally vague to allow IRBs to make exceptions to parental permission, as is the case with abused or neglected children. But even a surface level discussion raises a lot of important questions about autonomy in minors. Is a 6- or 7-year-old capable of providing meaningful assent? Does an 18-year-old really have greater decision-making capacity than a 17-year-old? It’s hard to say. But for those of you who plan on having kids, it’s important to recognize just how much power you have over your child’s care.

 

References

Field, M. J., & Behrman, R. E. (Eds.). (2004). Understanding and agreeing to children's participation in clinical research. Ethical Conduct of Clinical Research Involving Children. Retrieved November 27, 2021, from https://www.ncbi.nlm.nih.gov/books/NBK25560/.