In the AER16 session B20: Research with Children: Regulations and Beyond with presenters Francis J. DiMario, MD, MA, CIP, Jaime O. Hernandez, JD, M.Be., and Robert M. Nelson, MD, PhD, I came to understand—for possibly the first time in my career—the federal regulations as accommodating. Don’t get me wrong, Subpart B, C, and D of 45 CFR 46 scrupulously outline the additional protections IRBs must consider when conducting research with vulnerable populations. However, I now realize that the regulations were written with intentional flexibility.

For example, the regulations have built-in protections for instances in which a parent might not have the child’s best interest at heart. We’d all like to believe that parents have the inherent desire to look after their child’s health and wellbeing, and the capacity to do so. Parental permission and child assent as an informed consent process underpin this assumption: first the parents agree that their daughter’s participation in a study will benefit, or at the very least not harm, her. Then the child agrees to participate in the study after coming to the same conclusion. As researchers and human beings, we are aware that this process works well in the best case scenario. Fortunately the regulations also account for other scenarios, which is why the waiver of both parents’ permission exists. Parental permission to allow a child to participate in research is a requirement based on the idea that the parents’ permission will increase the protection against risk for the child. In cases such as familial child neglect or abuse, parent permission obviously does not increase the child’s protection from harm, so the requirement can be waived.

I had not previously considered how well developed and thought-out these regulations really are. I realized, of course, that the regulations and the IRBs that follow them serve to protect vulnerable populations, but I had not considered from whom the vulnerable populations needed protection. Sometimes the protection is actually from the parent, caretaker, doctor or investigator—but not usually from the research itself. I further realized the regulations are more inclusive of vulnerable populations than exclusive, and that is why they have been put in place: not to facilitate overbearing protections or investigator headaches, but to responsibly include, despite their vulnerability, the very people who might benefit from research the most.

Protecting human subjects can take the form of collecting data to form conclusions about the safety of over-the-counter drugs for children. Protection can look like including individuals who are HIV positive in clinical trials to develop better systems of care. Protection can be talking with teens in prison to develop better reintegration programs to decrease the likelihood of recidivism. If we don’t conduct research with vulnerable populations, then we don’t know the best ways to protect and help them.  And the regulations do not exist to slow us down, minimize liabilities, or overprotect study subjects, but to let us conduct the most useful, beneficial research we possibly can. This session taught me that we should not simply worry about protecting children from research, but also focus more on how vulnerable populations can be protected through research.

Sydney Boone, IRB research operations assistant at Westat, is a member of the PRIM&R Blog Squad for the 2016 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are blogging here, on Ampersand, to give our readers an inside peek of what happened at the conference in Anaheim, CA.