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State biobank collects bloodspots from newborn screening
Program seeks consent from new parents for research use of leftover samples
The state of Michigan has moved forward with its plan to store blood samples left over from screening newborns for medical conditions in a biorepository that will make the deidentified samples available for research.
Hospitals began last fall distributing information brochures and consent cards for the newly created Michigan BioTrust for Health to give to new parents.
In creating the program, Michigan officials are attempting to skirt controversies that have plagued other states, where parents rebelled against so-called "opt-out" procedures that allowed newborn bloodspots to be used for research unless parents contact the state to withdraw their child's samples.
By contrast, the Michigan Department of Community Health (MDCH) requires explicit permission from all parents of newborns to use the infants' bloodspots in the BioTrust. To do so, they launched an ambitious education program to train nurses in hospitals across the state to explain the BioTrust to new parents.
Carrie Langbo, MS, CGC, BioTrust outreach coordinator for the MDCH in Lansing, says the state sought public input about the BioTrust plan using phone and online surveys, contacting health advocacy groups and holding focus groups across the state.
Most Michigan residents surveyed anywhere from 79 percent to 99 percent strongly favored using leftover bloodspots for research. But Langbo says a "significant minority" also believed parents should be asked to give permission for their children's bloodspots to be used.
MDCH's then-IRB Chairman Harry McGee, PhD agreed.
"It's a basic respect for persons that you ask somebody for their permission if you want to use those stored bloodspots for research, even if you're not providing any identifying information," says McGee, who is currently chairman of the social/behavioral IRB at Michigan State University in East Lansing. "My feeling was, regardless of the regulations, it was the right thing to do."
Previously, he says, bloodspots had been stored for specific purposes quality assurance of the screening procedures and to allow parents and adults to access their own bloodspots if needed later.
McGee says that when his IRB consulted the federal Office for Human Research Protections, OHRP agreed that the purpose of storing the bloodspots had changed and that using them for research would require either consent from parents of a waiver of consent.
"And we didn't feel like we could meet the criteria for waiving consent," McGee says.
With its IRB mandating an "opt-in" approach, the MDCH created a training program for nurses in Michigan's 80-plus birthing hospitals so that they could describe the BioTrust to parents and seek permission to include their children's leftover bloodspots.
Throughout the process, Langbo says, it was important to ensure that parents understood the difference between the newborn screening, which is state-mandated, and the BioTrust, which is not.
"We needed staff to explain to parents that what you're consenting for is the use of the leftover dried bloodspots through the BioTrust and not the newborn screening itself," Langbo says.
Although the screening is technically mandatory, she says parents can decline it. Langbo and McGee say Michigan officials didn't want confusion over the BioTrust to cause parents to refuse the screenings, which can identify rare but serious disorders that require early medical treatment.
"I thought that if that was going to jeopardize newborn screening, that we shouldn't allow it at all," McGee says. "The challenge was to have an educational process that allowed the newborn screening program to continue to function as it had, but then to give people the choice to say whether this blood that was already going to be stored for newborn screening could be used for research."
The department piloted the education and consent process at 11 hospitals across the state in spring 2010. Training sessions were held for nursing staff and brochures and consent forms, located on the back of newborn screening cards, were distributed.
"But we were really very relieved that we saw great reception from all the staff," Langbo says. "They felt that it bolstered awareness about newborn screening with their patients and within the staff themselves."
One problem did turn up during the pilot program. Initially, the consent on the newborn screening card only had space for a parent to agree to research use of the bloodspots. Parents who declined were instructed not to sign the card, and it would be returned to the MDCH.
This made some parents uncomfortable, Langbo says. Worried that someone would fill in the card afterward, they would write the word "declined" on the signature line. But Langbo says this approach created problems for staff reading the cards who sometimes couldn't determine whether the parent was signing or declining.
For the later rollout of the program to the entire state, the MDCH changed the card to provide a box at the top that the nurse could check if the information was presented to the parents but the parents declined to allow the use of the bloodspots in the BioTrust.
In expanding the program to all of Michigan's birthing hospitals in fall 2010, the state began offering several means of training nurses. In addition to live inservices, the department conducted a webcast that hospitals could access, and then posted the presentation on its website in a PowerPoint format for hospitals to see later. All the training programs allow nurses to earn continuing education credits.
"It was great to see that hospitals are actually combining it as part of their new orientation for staff," Langbo says.
Community board partners with IRB
At every step along the way, both the MDCH IRB and a community values advisory board have approved the materials and educational components.
The community board was convened in 2009, with members drawn from various community organizations and from different populations in the state.
"They were charged with meeting quarterly, but actually have met monthly, up until a few months ago," Langbo says. "They went through all of the informed consent material, line by line, word by word, making sure that it would meet the needs of all the communities in the state, including all educational levels."
She says the interaction between the MDCH IRB and the community board has been key to the success of the project. One community values advisory board member now serves as a full member of the IRB.
In addition, McGee says he made it clear to the community board that the IRB may come to them for advice if situations arise that fall outside the IRB's regulatory authority, particularly as it reviews future research proposals that would seek to use the bloodspots.
"For example, the IRB regulations are intended to protect human subjects rather than groups, and any research that may involve potential risk to a group rather than an individual would be something that we'd come to the community values advisory board for advice on," he says.
Langbo believes that seeking community input, as well as making the process transparent, has helped Michigan avoid problems seen in other states, where parents have refused to allow their children to be screened or even sued the state to prevent research from being done with newborn bloodspots.
"In discussions with states where they don't have a consent process in place, we're hearing that they're getting a significant number of parents declining newborn screening because they're upset about not being involved in the process," she says.
"We're hoping this will work and will have an opposite effect," Langbo says. " . . . That parents will feel more in control of what happens to those specimens by having those conversations."