Tips for parents of children enrolled in a research study

On the Pulse recently posted a story on bioethics and research from Ben Wilfond, MD. In that story, Wilfond defended a research study that had been criticized by federal officials over the informed-consent requirements. We thought it would be helpful to follow up with tips for parents who are interested in or have children enrolled in research studies. This is the first in what we hope will be a series on the topic, with both parents and researchers weighing in, to increase awareness about research at Seattle Children’s.

Katelyn and Jennifer MhyreAs biomedical researchers, my husband and I are both very invested in the research process. Our daughter, Katelyn, has a disease that is incurable, but we are optimistic that her participation in various research studies could have a positive impact on not only her life, but also on the lives of other children in the future. Nevertheless, we take each opportunity to participate in a study under thoughtful consideration before signing our consent.

Assess the risk of participating in research

The first factor that we think about is risk. If the study can be done with a low amount of risk to Katelyn’s health and well being, then we almost always agree to participate. For example, if the study involves a saliva sample or collection of a dirty diaper, we would consider that a very minor inconvenience to us and would enroll Katelyn.

Look for help, other families’ experiences online

When we were given the opportunity to have Katelyn participate in the EPI-743 clinical trial, we were definitely nervous because we felt that the risk involved was high. This was an experimental drug tested in only a small number of children, and we were worried that it might hurt instead of help our daughter.

I went online and found other parents whose children had been enrolled in the same study at other universities. I read their blogs, talked to some over the phone or in-person and collected as much information as possible before heading to Katelyn’s neurometabolic specialist to discuss our concerns. I walked out of that visit feeling that all of my questions had been answered, and I was confident that enrolling Katelyn was the best decision for her and the entire family. I think that confidence is key, and also trust. I trusted the entire team that was involved in Katelyn’s trial.

Will the study cause pain, or add to medical procedures for my child?

The second factor that we think about is pain or procedures. We have a chronically ill child who is subject to frequent lab tests or medical procedures, so if the study involves an extra trip to the hospital, we think about that very carefully. In that case we would hope that the benefit of the study would outweigh the risk of exposing her to germs in the hospital, or subjecting her to yet another blood draw.

Make an informed decision

The third factor that we think about is what state of mind we are in when asked to make the decision to participate. Are you in the hospital with a sick child, not sleeping well, having trouble concentrating? It might be a good idea to have a family member or friend who can serve as an advocate- make sure that you are asking questions and making an informed decision.

Jennifer Mhyre is a medical researcher with a PhD in neuropharmacology. Daughter Katelyn was diagnosed with mitochondrial disease almost five years ago, Mhyre and husband Andrew (who also has a PhD in neuropharmacology) have two other children.

Interested in learning more? Visit Seattle Children’s Program for Mitochondrial Medicine and Metabolism.