Clinical trial awareness is important for parents

by Mindy Reeter, BS, CIP, Associate Director of the Office for Human Research Oversight at the University of Illinois College of Medicine at Peoria

As a human subjects protections professional, my children have always been exposed to medical research, and as consumers who utilize teaching hospitals and clinics for healthcare, my family has received our fair share of consent/assent forms inviting us to participate in research.

I have always realized my family’s familiarity with medical research is not the norm, but I became painfully aware of this fact when participating in a PRIM&R webinar titled Including Children in Clinical Research: Stakeholder Perspectives, Ethical Challenges, and IRB Strategies.

During the November webinar, presenter, Victoria Pemberton, RNC, MS, CCRC, of the National Heart, Lung, and Blood Institute, reported on a study that concluded that 62 percent of Americans could not name any institution or organization where pediatric research is conducted, however, 94 percent recognize that participation in clinical research is very important to advance medical science.

This lack of awareness is fueled by misunderstanding and negative perceptions of the risks associated with participation in pediatric clinical trials. The National Institutes of Health (NIH) is not taking these statistics lightly. To help increase awareness, NIH has added a powerful educational tool for individuals considering having their child participate in a clinical trial: the Children and Clinical Studies website, which features a documentary video for parents.

The website offers interviews with research professionals, parents, and child subjects, while stressing that “very little testing has been done on kids utilizing the drugs that kids take or may need take in the future.” The quality of the videos is top-notch and the information is necessarily basic. My hope is that future development might include more examples of families participating in oncology clinical trials, which represent 80 percent of patients diagnosed with a childhood cancer. I am also hopeful that the NIH will identify more ways that this tool can be utilized.

As the parent of an eighth grade student, I would recommend the addition of this video to the standard health class curriculum. Students already receive training in first aid, CPR, and emergency situation. It wouldn’t be much of a stretch to also cover the concepts—altruism, being a responsible citizen—presented in the video. As one parent states in the video, “knowledge is power.” While this phrase can be applied to studies shedding light on particular diseases, it also an apt description of the importance of understanding clinical trials.

In the second half of the webinar, presenter Yoram Unguru, MD, MS, MA, FASPHO, of Johns Hopkins University, reminds us that the federal regulations require institutional review boards (IRBs) to determine that adequate provisions are made for soliciting the assent of a child when, in the judgment of the IRB, the child is capable of providing assent. Unfortunately, the regulations place the onus on the IRB to grapple with the capacity issue and offer little guidance as to what constitutes meaningful assent.

Although my IRB routinely reviews research involving children, this webinar was enlightening. It encouraged me to think about the resources available to parents who are considering their child’s participation in research. I know that I plan to approach the health teacher at my child’s school to gauge her interest in the NIH documentary, something I am sure will make me the coolest mom ever!

Interested in checking out the webinar Mindy discussed? The webinar archive for Including Children in Clinical Research: Stakeholder Perspectives, Ethical Challenges, and IRB Strategies is available for purchase.