Kyle Brothers, M.D., third from left, talks with Georgina Mancilla and Eucebio Ramirez about the BioVU DNA databank, which has been expanded to include pediatric patients like their son, Daniel Ramirez, right. (photo by Mary Donaldson)
DNA databank expands to include pediatric patients
Now that the BioVU “DNA databank” has been in place for almost three years for Vanderbilt's adult patients, program leaders say the time is right to broaden the sample collection group to include children.
Louis Muglia, M.D., Ph.D., vice chair for Research Affairs at the Monroe Carell Jr. Children's Hospital at Vanderbilt, said adding pediatric patients to the BioVU system is critically important.
“The database will accelerate research for adults, and I think children should have that same benefit of scientific discovery that the adult population has. You don't want research for children to lag behind,” said Muglia.
The BioVU DNA databank takes the small amount of leftover blood from regular laboratory test samples, pulls out the DNA and stores it in a genetic library.
A patient's medical records are de-identified, or “scrubbed” clean of identifying information, but the description of medical events is retained and linked with the DNA by an anonymous code.
Parents of pediatric patients, like adult patients, will be given the opportunity to decline their child's participation, or opt out.
Preparation for including pediatric samples is under way, including a series of public service advertisements slated to begin next week.
A sizable grant request has been filed with the National Institutes of Health for equipment to handle small pediatric samples, which can be less than a third the size of the samples provided by adults.
Jill Pulley, M.B.A., director of Research Support Services, said a form that mirrors the adult patient form is ready to be used with the families of pediatric patients.
On a general treatment consent form, there is a section in large lettering that allows parents to opt their children out of the database.
When BioVU launched in 2007 there were still concerns about including young patients, who often could not speak for themselves, and so patients under age 18 were excluded.
“We needed to see how it worked in adults first, to make sure we did it right. This has never been done before in children so we needed to talk to people about it,” said Daniel Masys, M.D., professor of Medicine and chair of Biomedical Informatics who, along with Dan M. Roden, M.D., assistant vice-chancellor for Personalized Medicine and professor of Medicine and Pharmacology, helped lead the design of the BioVU program.
To that end, Ellen Wright Clayton, M.D., J.D., director of the Vanderbilt Center for Biomedical Ethics and Society, along with others, began to carefully assess public opinion about adding children to the BioVU database.
“At first we surveyed 4,000 faculty and staff at Vanderbilt and got widespread approval. So in light of the general response to BioVU for the adult population, it was time to look at the next step,” Clayton said.
Kyle Brothers, M.D., instructor in both Pediatrics and at the Center for Biomedical Ethics and Society, has interviewed 60 parents so far, in clinics at Children's Hospital to find out what they think about allowing their children to be part of BioVU.
“The BioVU concept was posed as a project that wouldn't help their child, but wouldn't hurt their child either. Nearly 90 percent said they did not have concerns, while 10 percent said they were not interested in their child's participation,” Brothers said, adding that parents liked the fact that their child would not have to suffer another needle stick.
Clayton said despite the positive review from this group of parents, Vanderbilt will maintain a healthy concern about how its patients' DNA and medical information is used.
“Our concern is one of stewardship. We are doing this as a trust for the benefit of the patients of the future and we want to make sure it's guarded well and that we use it well,” Clayton said.
About 15,000 pediatric samples will be added to the databank each year. There are some 70,000 adult samples now.
The goal is to have approximately 300,000 samples to understand the links between illness and disease and an individual's genetic code.