Parents OK baby sample research, with permission
Consent plummets if not consulted
More than 75% of parents surveyed in a nationwide study would be willing to allow their children's newborn screening samples to be used for future research — if researchers first asked their permission.
But if they're not asked for permission, parental support plummets — only 28% of parents in the survey would be willing to allow research with their newborns' blood spots in that case. More than 50% declared themselves "very unwilling" to allow the research without permission.
The Internet-based survey was administered in April 2008 to more than 1,500 respondents who had at least one child younger than 18.
Beth Tarini, MD, MS, a researcher at the University of Michigan's C.S. Mott Children's Hospital in Ann Arbor, says she was interested in learning about parents' attitudes toward research with newborn blood spots after listening to opinions expressed in the research community that it was possible to go ahead with research without parents' consent.
"Some would say, 'These samples are the property of department of health, therefore they're ours and we don't have to ask for permission,'" Tarini says. "But these samples were taken for a different intention, and I thought, 'I'm not sure the public feels the same way.'"
She says that as states go forward with plans for using newborn blood spots, and as IRBs review studies, they should recognize and respect parents' desire to be informed about it and to give some sort of permission.
"There has to be some bit of respect," Tarini says. "There needs to be some good-faith, good-will attempt to say we're being transparent and open about the process."
Past vs. future samples
Tarini says IRB members dealing with a particular proposed use of blood spots should differentiate between those collected in the past and a proposal to use blood spots gathered in the future.
Since it may be impractical to contact millions of parents whose children were born in the past few decades to seek consent, Tarini says it might be ethical to use the old samples for research under certain circumstances, perhaps by educating the community and providing a way for parents to withdraw samples.
"It doesn't mean you can willy-nilly use the stored spots," she says. "But I don't necessarily think they should be treated the same as future blood spots."
The new Michigan Biotrust for Health makes this distinction, requiring informed consent for research with new blood spots, but allowing for public education and an "opt-out" policy for the use of existing stored spots.
In addition, Tarini says exceptions should be made for quality assurance tests being conducted to improve and maintain the newborn screening program. For example, she says, a test that looks at the effectiveness of a particular screening tool would be permissible without consent, even for use of new blood spots. "Because that's for the newborn screening program and these samples were collected under the program."
However, a test to look at the prevalence of a disorder that's not currently being screened for, on the premise that one day the state might screen for it, would not be quality assurance, Tarini says. "That doesn't allow you to fall under the heading of newborn screening quality assurance — it is research."
Jeffrey R. Botkin, MD, MPH, associate vice president for research integrity at the University of Utah in Salt Lake City, says nearly all newborn blood spot research carried out to date has been with deidentified samples.
Botkin says the use of deidentified samples could raise issues for IRBs — for example, if there are links to the original donor information and research brings to light important health concerns about a particular child.
"In that case, what's our ethical obligation to contact this family and let them know about this health condition?" Botkin says. He says IRBs might want to forestall that problem by ensuring all linkages to original donor information are removed.
Tarini notes that the research community needs to be extremely careful in explaining to parents what "deidentified" means, adding that it may not meet their expectations of "anonymity."
"People seem to use the words deidentified and anonymous interchangeably, without clarification, both among experts and to the public," she says. "Are you telling people that the data is anonymous, in which case there is no possible way to ever link that data, or should they be using the word 'deidentified'?
"I've seen the potential public policy complications of saying, 'Oh we said it was anonymous but it's pretty much anonymous because of encryption,'" Tarini says. "While the outcome may be the same in terms of risk, the perception of the public may be different."
Unspecified research
One challenge of informing parents about the secondary use of blood spots is that it's impossible now to tell them every potential use of the samples. It's similar to challenges faced by developers of other types of biobanks and tissue repositories, says 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 .
"It's a challenge for informed consent and for human subjects protections when you're collecting biological samples for unspecified future research," Goldenberg says. "One of the questions that people have raised is can you get fully informed consent from someone if you're not exactly sure what the samples will be used for?"
He says some biobanks deal with this problem by creating a dynamic consent process, to keep donors updated over time. However, that may be less possible with newborn blood spots, when there are millions of donors and researchers have no way of contacting all of them.
"You're talking about a very different kind of need for better communication with parents about this."
Above all, Tarini says, it's clear that parents want information and options about how their children's samples are stored and later used.
She says the research community ignores that desire at its peril. Even if legal and IRB authorities determine that researchers can use samples without permission, the public could still have the last word.
"If they believe what you're doing is not publicly palatable, it doesn't matter if it's legal or ethical, they may choose not to participate," she says. "They could easily change the law. In my opinion, getting them on board is nothing but a win."
Reference
- Tarini BA, Goldenberg A, Singer D, et al. Not without my Permission: Parents' Willingness to Permit Use of Newborn Screening Samples for Research. Public Health Genomics 2009 July 11 (Epub)
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