When child donors grow up, is further consent needed?
When child donors grow up, is further consent needed?
Many think donors should be contacted once adults
Pediatric biobanks — which include samples taken from children treated for specific diseases or collected in large population-based studies — require consent from parents at the time of collection.
But the potential to use samples well into the future, past the point when these young donors have become adults, has led to questions about whether further consent from the donors themselves might be needed at that time.
Some long-term studies, such as the National Children's Study, have ongoing consent built into their designs, with young donors giving assent as soon as they're old enough and true consent when they reach adulthood.
But in other cases, when a sample was taken in infancy and there was no further participation by donors, obtaining fresh consent at adulthood would pose practical difficulties. By the time the donors have reached 18, they might be scattered across the country and nearly impossible to contact to give consent.
In a survey about genetic research, nearly half of adults presented with this hypothetical scenario – their childhood samples being used for research once they became adults – thought their consent should be obtained to continue to use the samples.
Aaron Goldenberg, PhD, MPH, assistant professor of bioethics and assistant director of the Center for Genetic Research Ethics and Law at Case Western University in Cleveland, OH, says the results of this survey mirror other attitudinal surveys regarding the use of biological samples for genetic research.
He says most respondents, even those who wanted to give further consent, seemed willing to actually do so if contacted about the use of their childhood samples.
"What we found is that it really is about control, about the ability to make decisions about one's own sample," Goldenberg says. "It's not that they want to stop research from happening, it's that they want to know what's going on."
He says that while it might always be possible to contact adults for permission to use their childhood samples, researchers and IRBs should be aware of this desire and at least consider efforts to find donors.
Hypothetical donors
Goldenberg's group conducted telephone interviews with 1,186 patients from five academic medical centers. All were asked about a hypothetical scenario in which their parents had allowed a blood sample to be taken from them in infancy. The sample had been stored along with an identification number and some background medical information about the children.
Respondents were asked: Should researchers have to obtain your permission to do further research now that you are an adult? Would you be willing to give that permission? If the researcher was unable to contact you, would it be acceptable to use your sample anyway?
In response, 543 participants (46%) thought they should be contacted to give continued permission to use the samples. Of that group, 522 (96%) thought they might be willing to give consent under those circumstances. When the 522 were asked whether it would be acceptable to use the samples if they could not be reached, 228 (or 44%) said yes.
More than a quarter of all the participants in the survey (310, or 26%) thought it was unacceptable to use childhood samples once the donors reached adulthood without obtaining their explicit consent.
Goldenberg says it's important to listen to that minority of respondents and at least consider the concerns they're raising, even if the studies involved are relatively low risk.
"Yes, an IRB's standards would say if it's minimal risk, if it's impracticable to recontact or if the samples are deidentified, you don't have to go back and find these people," he says. "But I think we need to consider that there's something special about the collection of samples from kids.
"Because people are worried about this, and because people want to have that participation, it may be important for IRBs to go beyond what the regulations say and to (ask researchers to) at least go back and try to recontact them."
Making the effort
But Goldenberg says the inability to contact all these donors decades after the fact shouldn't necessarily sink a study, as long as some effort has been made to find them.
If attempts to find the donors have been unsuccessful, researchers could instead attempt a sort of community consultation with the population from which the donors were recruited.
"In cases of minimal-risk research, where consent might be waived, it still might be important to go talk to community members about the use of these samples, to have dialogue with the communities that the samples might be taken from about the use of pediatric samples," Goldenberg says.
"That may give people who were enrolled in this study and forgot they were enrolled a chance to contact researchers, if they do want to have their samples removed," he says.
He says this would be particularly important in cases where the samples were collected for one purpose and are being proposed for a different type of study.
In going forward with new collections of pediatric samples for biobanks, Goldenberg says it's important for IRBs to ask about the future use of the samples, to give parents the most possible information at the time of their consent.
"Are samples only going to be used for a specific disease, or are they going to be open for other types of research? Are they only going to be used by the researchers associated with the biobank, or are they going to be available to lots of researchers?"
Reference
- Goldenberg AJ, Hull SC, Botkin JR, et al. Pediatric Biobanks: Approaching Informed Consent for Continuing Research After Children Grow Up. J Pediatr 2009 Oct;155(4):578-83.
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