Adding kids to the mix

Inclusion of pediatric samples in biobank prompts ethical questions

When Vanderbilt University's BioVU biobank considered whether to add pediatric biospecimens to the adult samples already being gathered, officials faced a range of ethical questions.

Kyle Brothers, MD, a pediatrician and adjunct professor of law at Vanderbilt in Nashville, TN, says they examined those questions in the framework of BioVU's opt-out procedure, in which all patients who arrive at the hospital or its related clinics sign a form stating that they know their leftover biospecimens could be used for research. Those who do not wish such use check a box to opt out of the program.

Brothers says biobank officials wanted to know how parents felt about the idea of collecting these types of samples from their children during pediatric visits. At that point, officials weren't sure whether to extend the same opt-out procedure to the pediatric samples or to require a more stringent consent process.

"I originally became involved because I'm a pediatrician and an ethicist," he says. "I went into clinics and while parents were waiting to talk to their children's doctor, I took advantage of that time to tell them about BioVU, to show them the opt-out forms and get their opinion about the whole thing."

Parental support

Brothers says he met with more than 60 parents in a variety of settings, and found overwhelming support for the idea.

"Parents recognized that research in children was important, and they really liked that this was a way to do that research without having to give children an extra needle stick," he says.

Although Brothers intentionally avoided settings where children were extremely sick, he did visit clinics to talk to parents whose children had chronic illnesses. He says those parents were particularly supportive of the opt-out plan.

Based on these results, the decision was made to keep the opt-out process essentially the same for children, he says.

The process is set up to make opting out easy, regardless of whether the decision is made by the parent, by the child if he or she is able, or even by another caregiver who brings the child in for a doctor's visit.

"We don't require for this that you have to have legal authority to consent (in order to opt out) — it's the opposite," he says. "You're opting out and we don't want any unnecessary barriers to opting out.

"So if Grandma brings the kids to the clinic and reads that and says, 'I don't want my baby to be involved in that,' she can check that box. We won't go back to her and say, "I'm sorry you're not the parent, you can't legally do that.'"

Likewise, he says, a teenager can read the form, check the box and samples will not be taken.

Re-id risk

Brothers says one key ethical element to consider in biobanking is the risk of re-identification of participants, even those whose data has been stripped of the common HIPAA identifiers.

As an example, he points to a county near Nashville, which has high-income residents and is much more homogenous than the city itself.

"So a person of a certain ethnic group, of a certain age, of a certain gender in that county could be identifiable to one person," Brothers says.

Vanderbilt has addressed this issue through an innovative approach. For any proposal to share BioVU's information outside the hospital — for example, to the Database of Genotypes and Phenotypes (dbGaP) — the biobank uses an informatics tool that closely examines the data being shared.

In effect, Brothers says, it attempts a sort of re-identification of those records, by comparing the data to other publicly available databases. If this comparison turns up records at high risk for re-identification, those records have more data removed.

"What the software does is it gives us the opportunity to reduce the amount of information in that particular record, so that it becomes less identifiable," Brothers says. The process is not necessary for research conducted in-house, he says, because all of Vanderbilt's researchers have signed data use agreements that forbid them from attempting to re-identify participants.

Brothers serves on a committee, separate from the IRB, which reviews all proposals for use of the biorepository. That committee assesses the scientific value of the research and operational questions, as well as the risk of re-identifiability in the study's design.

"I have not talked to a lot of people who report that they are the ethics reviewer for a biorepository," Brothers says of his role. "I think that generally there's a compliance question that the IRB helps answer. But these are relatively unique questions about the re-identification risk."

Reference

Brothers, KB. Biobanking in pediatrics: The human nonsubjects approach. Per Med. 2011 Jan;8(1):79.