Dispatching CARs to inform the public
Community liaisons get the word out about emergency research
When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting.
It can be difficult for researchers and IRBs to know that the consultation has been truly effective, reaching the population most likely to be affected by the study and giving the public an opportunity to ask questions and make suggestions.
At Virginia Commonwealth University in Richmond, the community engagement staff at the university's Center for Clinical and Translational Science Research has launched a program to build capacity for engaging the community in these EFIC consultations.
The approach relies on community liaisons who are already involved in local social services and community advocacy in the Richmond area. They were tapped for their knowledge of how to reach different populations and inform them about studies.
Cornelia Ramsey, PhD, MSPH, a community research liaison with the center, says the involvement of the liaisons, called community advocates for research (CARs), has extended her institution's reach in the community. She says VCU's Clinical and Translational Science Award helps maintain the network of CARs and makes them available as a resource to other investigators going forward.
Ramsey says the idea was developed while developing a community consultation plan for VCU's participation in the national Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART). RAMPART studied whether it was more effective to give seizure patients anti-seizure medication in the field via an IV or an intramuscular injection.
Because it would be impracticable to gain informed consent from seizure patients being treated by paramedics, the investigators sought an EFIC, which includes a requirement for community consultation and public disclosure.
At first, Ramsey says, the local group conducted this consultation process through traditional means, including advertising in newspapers, television and radio.
"We connected with those particular community groups that might be in the target population for the study — epilepsy groups, head trauma groups, people who were likely to have a seizure," she says. "The principal investigator went to those groups, presented the study and opened it up for questions."
Extending the conversation
In listening to those exchanges, Ramsey says she was impressed by the conversation that took place between the investigator and the public.
"It's really the bi-directional communication that is the intent of community consultation/public disclosure," she says. "Having that experience made me see that unless we figured out other ways to support that conversation, we would never hear all of their questions."
Drawing on several models of community engagement in public health, her group developed the concept of the CARs, people active in the communities affected by the study. Some were with epilepsy groups, others worked with community organizations serving populations such as homeless people and some were associated with churches in the area.
After training the group in research integrity and human subjects protection principles, the CARs were sent out to survey people about their knowledge of research at VCU and more specifically the RAMPART study. In an effort to measure exactly where the message was spreading, the CARs asked those they surveyed for the nearest intersection to their home. Ramsey's group mapped the results, showing which areas were reached by the education efforts.
After gathering this information, the CARs helped develop a plan to take the disclosure further. They called their own community meetings, and brought in the study coordinator to explain the study and answer questions. They handed out fliers and posted information on their bulletin boards and in their newsletters.
Ramsey says that because of the CARs' knowledge of their communities, the meetings they held were better attended than the university-initiated ones had been.
"It was the community advocates who opened the door a little bit more into the communities, particularly the harder-to-reach communities such as the homeless population," she says.
That increased access could be measured in survey responses.
The initial surveys about the RAMPART study, conducted in fall 2009 before the CARs began their own outreach, showed that 8.4 percent of the respondents had heard about the study, Ramsey says.
A separate but similar EFIC study was launched the following year. This time, the CARs were involved from the outset, and helped the investigator create his community consultation/public disclosure plan, using the same strategies they had piloted in the RAMPART study.
A survey conducted in fall 2010 showed that 21.5 percent of respondents now had heard of RAMPART, and 24 percent had heard about the second EFIC trial.
Because of the CTSA funding, Ramsey says VCU can maintain this network of CARs, activating it when needed to help with a study. A second generation of CARs is being recruited and trained, using materials the earlier CARs helped develop.
And the CARs themselves have gained from the experience. After spending so much time brainstorming together about community engagement strategies, Ramsey says the liaisons have begun to work on projects together outside the university.
"That's truly building that community's capacity for research," she says.
Ramsey, who also serves on VCU's social-behavioral IRB, says IRBs have an important role to play as they review community consultation and public disclosure plans, to help ensure that the plans include strategies that are likely to reach the intended people in the community.
"It's asking the important questions," she says. "Who is at high risk for being in this study? How are they represented in our community? Has every effort been made to reach into those communities and have that bi-directional communication? How is that represented in the plan? And how are we taking the information back to the community, once we have study findings?"
While not every institution has access to a CTSA grant, she says IRBs can direct investigators to institutional resources that can help them craft a more effective plan.
"Most universities have a service learning component or community outreach; if it's connected with a health system they have a health system outreach education person," Ramsey says. "There's usually somebody within the university structure who is connecting with the community and could help figure out how to start this."