University facilitates more CEnR involvement

Program guides investigators, community members through IRB approval process

As Washington University in St. Louis, MO, expanded its interest in community-engaged research (CEnR), officials realized that both the researchers and their community partners needed to better understand human subjects protection requirements.

In response, they've developed a program that not only ensures community groups are trained to help conduct research ethically, but guides researchers through the sometimes overwhelming process of IRB review. The university's Human Research Protection Office (HRPO) also has posted materials on its website for both partners and researchers, including checklists, necessary documents and training opportunities.

Washington University's CEnR efforts recently garnered a 2010 Award for Excellence in Human Research Protection — Best Practice from the Health Improvement Institute in Bethesda, MD.

The key to the program's success has been gathering input from all the stakeholders — researchers, community partners and institutional partners, say Sarah Fowler-Dixon, PhD, an education specialist and Martha F. Jones, MA, CIP, executive director, both of the Human Research Protection Office at Washington University.

"To make a program like this work, more than anything else, you have to involve a lot of different entities and be willing to listen to a lot of viewpoints," Jones says. "You really have to sit down and think about what parts of your institution need to be involved as well as the outside community part."

Pushing for community projects

Fowler-Dixon says the HRPO first began looking at improving resources for CEnR in 2008, convening a task force to develop a community partner manual. In speaking with task force members, she says they found that navigating the IRB was a struggle not just for community partners unfamiliar with human subjects research, but for investigators, some of whom were new to the idea of community-engaged research.

Around the same time, Washington University, in partnership with St. Louis University and BJC Healthcare in St. Louis, had created the St. Louis Community/University Health Research Partnership, which provides awards for research locally. Projects must have principal investigators from both an academic institution and from a community organization in order to qualify for the grants.

"With this push here at the university, the IRB was approached to provide more resources for community-engaged researchers and their partners," Fowler-Dixon says.

She says another task force was assembled, representing IRB officials, local community organizations and researchers from a range of disciplines engaged in community-based research, including public health and practice-based research networks.

Among the issues they tackled were determining when a community agency or community members are actually engaged in research and then training those individuals in human subjects protection.

Although researchers at Washington University typically go through the CITI training course, the HRPO has developed alternatives for community members.

"It's a common complaint from researchers who work with community partners that they don't want that community partner to have to go through all the regulatory material that, say, a biomedical researcher doing a clinical trial would have to review," Jones says.

Fowler-Dixon says research teams can use the information in the CITI modules to create training courses that can be taught to community partners.

"People can devise their own programs using that information as a basis," she says. "I have to approve it and I have to approve who the trainers are going to be — you have to have certain qualifications to be a trainer."

Fowler-Dixon also is the point person for researchers and community partners who are working to get protocols approved by the Washington University IRB. Jones describes one instance in which Fowler-Dixon was working with a researcher who also was dealing with a local school district.

"In that situation, the researcher was really caught in the middle because they were trying to get an approval through both systems," Jones says.

"Because Sarah had an understanding of both sides, she was able to guide the researcher through even minor things like timing — when do you submit to us, versus when you submit to the school district? What documents can be used in both places and when do you have to do a document uniquely for one? It's a way to really operationalize the rules to that very specific project."

Seeing another perspective

Fowler-Dixon says her background — she worked for a community agency before coming to the university — has helped her see their perspective on research projects. And the task force meetings have reinforced those perspectives, focusing on the issues that are important to the community being studied.

"From an academic standpoint, we spend a lot of time with regulatory issues — what's allowable, what's not," she says. "In the community, ethics is what drives the conversation — what should be done, and what shouldn't. You can only get that if you have individuals who have a lot of contact with the community or you actually have community representatives on your task force."

Institutions interested in developing similar programs can find resources on the HRPO website (http://hrpohome.wustl.edu/community_research/cbr.aspx). But Jones says ideas must be adapted to the particular situation at an institution.

For example, she says the Washington University group used ideas from the University of Iowa, where she was director of the Human Subjects Office before her current job.

Jones says the Iowa program has much more emphasis on monitoring research sites, because those sites are fairly far-flung in rural areas across the state.

"Here's that's not as big of an issue because the sites that are community-engaged are local sites — these are people and entities that we know and might be interacting with anyway," she says.

"So as other places develop their own support systems, they need to really contour it to their environment."