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Listening to the community pays off for biobank project
Wisconsin effort a model for IRBs, investigators
When the Marshfield (WI) Clinic launched an ambitious biobanking project, organizers knew they'd need significant community buy-in.
The community consultation process they crafted, complete with multiple focus groups, an ongoing community advisory group and a regular newsletter to participants, stands as one of the few models available to investigators and IRBs who are looking to attempt this type of research project.1
Catherine McCarty, PhD, MPH, interim director of the Center for Human Genetics at the Marshfield Clinic Research Foundation in Marshfield, WI, is co-principal investigator for the Personalized Medicine Research Project (PMRP), which aims to use genetic information from volunteers in the Marshfield community to investigate the genetic basis of diseases.
She says her group knew they wanted to mount an in-depth education program prior to recruiting people for the biobank.
"We wanted to do right by the community," McCarty says. "We knew we wanted active consent, but more than that, we wanted to increase the general knowledge level in the community about genetics."
Jonathan Reeser, MD, PhD, chairman of the Marshfield IRB, says the community consultation process, particularly the creation of the community advisory group, has been integral to the success of the biobank, which McCarty says now has nearly 20,000 participants.
"I think the IRB views the community advisory group as a really important component of the PMRP, gauging public perception and making sure that lay viewpoint is considered in the deliberations and planning of what PMRP hopes to do. Certainly from the IRB's perspective, it's a wonderful thing to have."
Both the IRB and a separate external ethics security and advisory board monitor the project and both boards send members to community advisory group meetings.
Confidentiality a concern
McCarty says participants in the biobank donate a blood sample, answer questionnaires about diet and physical activity, and allow broad-based access to their medical records through the Marshfield Clinic. They also can give permission to be re-approached to provide more information for future studies.
That proposal naturally raises issues of confidentiality and requires explanation of how the genetic research will be conducted and the data kept secure.
So for a year prior to the initial recruitment, the group carried out a series of focus group meetings, first with people from the community at large, then with a group of Marshfield Clinic employees (the clinic and hospital employ half of Marshfield's adult population, McCarty says). Later in the process a final focus group was held with people who had declined to participate in the project.
The focus groups uncovered issues that McCarty says drove the education efforts of the PMRP. Despite the trust community residents had in the clinic, they expressed concerns about the confidentiality of data and the potential for insurance discrimination. They also worried about the possibility of human cloning being conducted with their samples.
Answers to those concerns were incorporated into the communications plan for the project, which included a recruitment video and brochures.
The project also assembled a community advisory group to continue gathering community input as the project progressed. McCarty says she sought help from all areas of the clinic – research, government relations and corporate relations – to find potential members who would represent a cross section of the Marshfield community.
"We've got a couple of dairy farmers, a number of retired individuals, a baker," she says. "We wanted the media represented, so we have local radio and newspapers represented."
That group, which began with 15 members and was intended to run for 18 months, has been meeting twice yearly since 2001.
"We initially only had funding for the first couple of years," McCarty says. "I've found and continue to find this advisory group to be very useful for us, and so with some discretionary funds we continued to have this group meet until a grant came through a little over a year ago that now covers it." She says she's now considering bringing on new members and establishing term limits to carry the group forward.
Members are paid $100 per meeting, with meetings often running for several hours. McCarty says they typically hear reports on recruitment efforts, on the various research projects being conducted with the biobank data and any results that are available. Community advisory group members also give suggestions on stories for the project newsletter, which goes out every six months to participants who have elected to receive it.
Group advises on database
Some of the issues tackled by the community advisory group have included:
Involvement in a larger database – McCarty recently received a grant through the National Institutes of Health for genome-wide association studies. The grant requires that Marshfield share data with the database of Genotype and Phenotype (dbGaP), which would make it available to outside investigators. Because that was not a part of the initial informed consent that participants signed, McCarty wanted to get the community advisory group's input.
"Although the consent form is pretty broad and allows for data and sample sharing, something to the level of dbGaP we didn't envision, because it didn't exist when we wrote our consent form six years ago," she says. "So our community advisory group suggested that we have a piece in our newsletter, and see what we got back in response. If we got a big negative response we could go back and think about re-consenting."
In the end, McCarty says, only one participant contacted them with concerns.
Unanticipated findings – Over the past few years, Reeser says the Marshfield IRB has been working on a new policy addressing unanticipated findings. While it was not directly related to the PMRP, Reeser says he knew the community advisory group would be interested in hearing about it.
Currently, the PMRP's consent forms state that individual results are not returned to participants.
McCarty says the group opinion mirrored those of other lay groups that have discussed this issue. "They say they don't necessarily want the information, but they want the choice to decide."
Reeser says he expects a final policy in the next several months that will encompass return of research results in general as well as unanticipated findings. McCarty says the issue of whether and how to return individual findings from the PMRP likely will be the next big issue the community advisory group will tackle over the next 12 to 18 months.
While the IRB has monitored the community consultation and education process, it doesn't do so as closely as it once did, McCarty says. The IRB approved a recruitment video and initially wanted to see newsletters before they were distributed, but no longer requires that. Reeser and the external ethics board chairman, Norm Fost of the University of Wisconsin, attend community advisory group meetings when they can.
Reeser says he's been impressed with the depth of the discussions he's seen on the community group. "They're a well-reasoned and well-read group," he says. "I think Cathy's got a really nice collection of individuals that bring a lot to the table, and that's a good thing."
He notes that while the IRB has nonscientific members, this larger group provides an even greater opportunity for public input to the research process.
"If you go down the list of occupations and life experiences from those members, I think you'll find a fairly substantial diversity exists," Reeser says. "It gives everybody the reassurance that all angles have been considered and all opinions have been given an opportunity to be heard and voiced."