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Considering a new model for community research
A new board with more clout, stronger ties to IRB
The current system of regulating community-based participatory research (CBPR) doesn't truly engage or protect communities as it should and fails to follow up on promises made by researchers to IRBs and to those whom they study, says one community researcher.
Beverly Xaviera Watkins, PhD, an environmental health researcher with New York University School of Medicine in New York City is proposing a new model for CBPR, one that would give communities more moral and ethical authority to sign off on research projects and to follow them through implementation to deal with any questions or concerns that arise.1
Watkins says she interviewed a number of community advocates, researchers and IRB members to learn where the current CBPR model falls short and to help determine how to "close the circle" among the various stakeholders so that they all are communicating with and listening to each other.
Her model would introduce a new group, a community ethical review board (CERB), in addition to the existing community advisory boards (CABs) that are currently tapped for community input to research projects.
Watkins says the CABs usually are picked by researchers themselves and have little control over what happens in the course of a study. CABs rarely speak to field staff, who generally are the ones encountering issues on the ground with participants, and they don't communicate regularly with IRBs about problems they do learn about.
"The community advisory board has no real authority because they don't have any formal way to talk to an IRB," she says. "Really, when you look at the way we do it, it doesn't make much sense from a flow-of-information perspective. The right hand doesn't know what the left hand is doing."
Once a protocol has been approved, Watkins says, there's limited oversight to ensure that the community really is being engaged as researchers said it would be at the outset.
Sensitivity and perspective
The result, she says, is research that often lacks cultural sensitivity or the community's perspective on the potential harms of research, not just to individual participants, but to the community as a whole.
For example, she says, she knows of a study on obesity that asked mothers in a Hispanic neighborhood to undress their children for weigh-ins, even though they were not provided with a doctor's office in which to do it privately. Protests by field staff fell on deaf ears.
Or data will be presented in ways that communities find objectionable.
"If you come out with some data that says the children who live in northern Manhattan are developmentally delayed, that's not really well received," Watkins says. "There's a tendency for researchers to be insensitive to how data is presented, and no one is saying, 'Could we have said that better in a milder or different way?' Had there been community input that might be different."
Her proposal is to introduce the CERB, which would be designated within a community to deal with researchers who enter that community to do studies. They would represent existing organizations with stature and credibility in the community.
In practice, they generally would be dealing with the same institutions repeatedly, which Watkins says would help build a mutually respectful relationship.
In her model, researchers would approach the CERB at the outset of a plan to do research, and the CERB would be involved in the design of the study. It also would review the protocol after IRB approval has been obtained. Watkins says the CERB wouldn't have the regulatory authority to halt a study, but would have moral authority through its relationship with the community and with the IRB, to whom it would report regularly.
She says two members of the CERB would serve as community members on the partnering institution's IRB.
"Part of it is relying on the IRB to do what it is supposed to do," she says. "The CERB is supposed to partner with the institutional review board so people can, in a non-threatening way, contact the IRB through the CERB if there's a problem."
She says the CERB, which typically might be dealing with a half dozen major research projects at a time, would be in a better position to provide ongoing oversight than an IRB, which must keep track of hundreds of studies.
Watkins is piloting a project in which she trains a group of community leaders to act as a CERB for environmental health studies. She's creating the curriculum herself, and using past studies already approved and implemented for mock reviews.
"We're going to look at whether they would have understood these protocols after they had the training in environmental health sciences research," she says.
Watkins eventually wants to install this group as a working CERB, if she can secure funding for the project. She also hopes to expand the curricula to include other types of research that CERBs would commonly encounter, including social-behavioral and clinical studies. She hopes to partner with a Clinical and Translational Science Center for funding, since community engagement is one of the core competencies identified by the Clinical and Translational Science Awards (CTSA) program for training clinician-scientists.
"My biggest hope is that this is something that could be incorporated into their agenda because they already have lots of money to do this," Watkins says. "One of their charges is to figure out how to engage communities appropriately."
Watkins says she's already received feedback about her proposed community research model, and while some of it has been positive, she's also heard from some researchers who worry that her plan would add to the already burdensome process of conducting research.
"My response is, 'This is going to enhance your capacity to do research. If the community supports the research, you aren't going to have problems with retention and recruitment of participants. And you are going to get better data. You get better research when people are invested in it.'"
In the meantime, she says IRBs need to do more to ensure that proposals that are labeled as CBPR actually engage the communities they're studying.
"They should be demanding that any research that comes in as CBPR actually has community approval and that the researchers demonstrate that," Watkins says. "They should show that they held community forums about it, tell who in the community was involved in the design of the research, and even get letters of support from community-based organizations.
"You may even have to contact those people and ask, is this legitimate? So the IRB knows there's somebody who's watching the store."