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When it comes to training community partners on human research protection ethics, IRBs would do well to create educational content that best suits the needs of those partners, an IRB chair suggests.
Research ethics training that is presented in an interactive and engaging format will benefit the IRB as well as the people receiving the training, says Ryan Spellecy, PhD, an associate professor of bioethics and medical humanities and psychiatry and behavioral medicine at the Medical College of Wisconsin in Milwaukee.
Human research protection training is not one-size-fits-all, notes Stephanie Solomon, PhD, an assistant professor at Saint Louis University.
Solomon and Patricia Piechowski, MPA, MSW, MA, were instrumental in creating a flexible model for training community partners in research ethics and protection. The training program was developed by a team at the Michigan Institute for Clinical and Health Research, and the University of Michigan unit supported by a clinical translational science award (CTSA). It was implemented as a pilot test at nine sites for the study.1
"We did this at our own institution to fill a need," Solomon says.
Their goals for the training program were to increase awareness and competency in community partners’ conduct of ethical human subjects research.1
"I work a lot at the national level with community engagement and ethics," she adds. "Different institutions are coming out with training in this area."
Spellecy and Solomon offer these tips on how to educate community partners and address the research issues and concerns most relevant to them:
• Address the blurry line between a community organization’s services and a research study. "Things that start out being a practice or intervention can turn into a research study at some point," Solomon says. "The blurry line between service and interventions and research is very hard and actually very gray."
Education facilitators can help community partners understand the differences by offering stories that illustrate both an organization’s service and its involvement in research.
A story example might involve a community-based organization like a women’s community health clinic that provides sexual education, Solomon says.
In one scenario, the story’s protagonist is a social worker who encourages clients of the health clinic to take a free course on how to prevent the spread of sexually transmitted diseases (STDs), she explains.
The second scenario has a social worker who questions whether the clinic’s free sex education course is increasing people’s knowledge of STDs. The social worker wants to ask people about their experience in a group setting to see whether the education actually is working, she adds.
In a group setting, a facilitator could ask community partners to describe the difference between the two scenarios and how the second one could be research or quality improvement, Solomon says.
• Use the group setting to collaborate and enrich discussions. Education geared toward community partners in a group setting has the advantage of encouraging discussions and networking, Spellecy says.
"We found that getting different community groups together in the same room was beneficial for networking," he explains. "Some collaborate and talk about common issues."
For instance, one community partner might bring up a problem his organization had with the IRB during a research project, and another person will say, "Yes, we had that too, but this is how we addressed it," Spellecy says.
When the facilitator is with the IRB, this also is helpful.
"Having me there as an IRB chair was beneficial because it put a face on the IRB and we could talk about things they cared about," Spellecy says.
For some community partners, the IRB is an impersonal regulatory entity that makes research more challenging. Seeing an actual IRB chair or member at these educational sessions helps to demystify the IRB process, he adds.
• Design process to include flexibility. For the pilot test, each participating location chose a facilitator who had knowledge of good research practices and a health ethics education. Facilitators were offered online training materials as well as face-to-face sessions and training sessions via webinar. The training sessions were designed to be responsive to local community needs. Investigators took existing research protection education and adapted for community partners after consulting with local IRBs and community partners.1
As the educational sessions were launched, facilitators quickly found that there needed to be flexibility throughout the process, Spellecy notes.
"You have all these different groups at the table and need to have a rich discussion and have interaction," he says. "But we also need to be more flexible in the shape of training as it went on."
For example, one module might generate a great deal of discussion. So the facilitator could choose to spend more than the allotted time on that module and cut a different module a little short to make up the time, he says.
"That’s what happens in face-to-face discussion," he says.