Community research requires compromise

Michigan BioTrust provides model

IRBs increasingly will have to adjust to collaborative approaches in research, including working with community partners and other stakeholders, experts say.

Biotechnology and its many privacy and confidentiality challenges have made community-based participatory research (CBPR) an important option for facilitating research strategies that stakeholders can trust.

For instance, the state of Michigan established the Michigan BioTrust for Health as a repository for the dried blood samples collected at newborn screenings. These samples are de-identified, labeled with a code and stored at the Michigan Neonatal Biobank for research. Before the samples could be used for research, it was necessary to establish guidelines and protocols.

The Michigan Department of Community Health (MDCH) IRB that was involved with the project felt strongly that obtaining informed consent from the newborns’ families was the right thing to do, says Harry McGee, MPH, IRB chair at Michigan State University in East Lansing.

“It boiled down to in my own mind that you couldn’t assume a parent would be OK with the government using their DNA for research,” McGee explains. “IRB members felt the community, which is the entire state of Michigan, should have a voice in what was being done and could be done.”

The MDCH already had five nonaffiliated members on its IRB, but the board decided additional community representation was needed. So they helped to form a 15-member community advisory board representing religious, community, and special interest groups.

“We felt risks to groups or communities should also be a consideration, so we sought the advice of that community board on issues that would not necessarily be a risk to an individual subject, but would be a more general risk to the community,” McGee says.

“Blood was collected for screening, not for research, and the whole issue was whether or not there should be a consent process if you’re using that for research,” McGee says. “The IRB felt strongly that even if consent was not required by the regulations that it was the right thing to do.”

As the BioTrust was created, the IRB and community advisory board were intimately involved in making decisions about informed consent and other issues, he recalls.

“One of the important considerations involving the community advisory board is whether the research is in the interest of the population of Michigan,” McGee says. “If it’s going to be used for research it has to meet some potential benefit for the citizens of the state or groups within the state.”

The Michigan BioTrust’s consent policies are clearly outlined on its website at (See story on Michigan BioTrust’s consent policy, below.)

While collaborations between IRBs and community boards can result in fair decisions that consider the public health risks and benefits of research, they can also make the IRB process more complex.

“Collaborations are messy,” says James Edwards, PhD, MSW, executive director of the Johnson Center, Grand Valley State University in Grand Rapids.

Community-based research requires IRBs to deal with multiple stakeholders, including funders and directors of agencies. Plus these community partners expect immediate responses to their questions and prompt study reviews, which can be challenging, Edwards notes.

IRBs also have to deal with flexibility, which is inherent in CBPR.

“We might have an initial design of capturing this information, and then we find out early on that what we anticipated is not going to happen the way we thought,” Edwards says.

For example, investigators involved in a community-based research project were collecting data from the state about child welfare recipients and their children. State officials repeatedly assured them that they would receive the necessary information. Suddenly, the state changed its mind and said the data could not be released, Edwards recalls.

Researchers had to change the study design and meet with child welfare recipients and their families to obtain additional information and informed consent, he adds.

When funders are involved in community-based research, it can pose ethical challenges for researchers and IRBs, Edwards notes.

“IRBs are good about asking who is funding the research and where the support is coming from, but does the funder have a role in the research?” he says. “More and more we’re seeing when we’re doing this type of [community-based] research that community foundations and private funders want to be at the table to help in the design of the study and stay involved in the research process.”

Informing the community

The funders might be at the table as both a funder and as a stakeholder, and the IRB’s and research institution’s job is to balance those roles and try to protect the principal investigator from any potential bias and conflict of interest based on that involvement, Edwards says.

One strategy is for research institutions to have staff serve as a buffer between the investigators and community boards or funders by attending the meetings in place of the investigator, he notes.

“We highlight in our application those relationships and how they’re handled,” Edwards says.

Another issue that often comes up with CBPR involves informing the community about informed consent.

“This is the piece we all struggle with,” Edwards says. “We typically end up with an education process in the community.”

For example, a community-based organization might approach researchers, asking them to study the organization’s ongoing program to evaluate its work for potential results that are generalizable. The organization has its own consent form, and although the people receiving the organization’s program benefits will not see anything change, they still will need to sign a separate research consent form, he explains.

“We say to the organization that their consent form might be fine for their program, but it’s not fine for the research we’re conducting,” Edwards says. “So we have to reconsent people and offer them the option of not signing the consent and still participating in the program.”

Michigan BioTrust consent options

Its policies provide best practice model

The Michigan BioTrust for Health, which is part of the Michigan Department of Community Health, has for decades collected and stored dried blood spots following newborn screening.

When the agency decided to make these de-identified samples available for research, the department sought community input on how best to make this happen. The result was a requirement that all samples used for research would need prior informed consent.

“In Michigan we have specifically created a bio repository for those newborn screening bloods to include research,” says Harry McGee, MPH, IRB chair at Michigan State University in East Lansing.

Here’s how the BioTrust’s informed consent process works:

• Blood samples taken from births after May 1, 2010, were subject to the new parental consent process at hospitals. Hospitals and midwives give new parents an option of signing a consent form after delivery if they want their child’s remaining blood spot samples made available for future medical research. Parents can change their mind later.

“The informed consent process takes place at the time of birth when the mother is approached with information about the BioTrust,” McGee explains. “She is offered a consent form that says she has the choice of allowing or not allowing the blood that is already going to be stored for newborn screening purposes to also be used for research that would take place without the identity of the child or mother being revealed to the researcher.”

• People born between July 1984 and April 30, 2010, who do not want their stored blood spots used for future research can fill out a form to request that the sample be saved but not used for research or they can request the sample be destroyed.

• Samples prior to July 1984 were destroyed, but all samples collected since then will be saved indefinitely.

“It’s stored for immediate newborn screening purposes and stored in the long term for the personal use of the child or family,” McGee says.

For example, the stored samples could be used for forensic purposes, he adds.