Research staff tasked with obtaining informed consent from study participants often are inadequately trained to do so. “Untrained research coordinators will, in essence, read the consent forms. Informed consent is a whole process that involves conversation, not just documents,” asserts Robert Sege, MD, PhD, director of the Center for Community-Engaged Medicine at Tufts Medical Center in Boston.
This raises some ethical concerns on whether study participants actually are giving true informed consent. Typically, research staff do not receive standardized training on how to engage in informed consent discussions. “The training they do have to go through is about the ethical principles of clinical research, the history of the rules of informed consent, and what the rules are, which is important and foundational,” Sege says. “But what they are not trained in is how to have the discussion.”
At Tufts Clinical and Translational Science Institute (CTSI), research staff gain this expertise with a novel approach: Community members act as simulated prospective study participants in role-playing exercises.1 Tufts CTSI’s Stakeholder Expert Panel is a group of more than 40 community members, researchers, patients and families, and healthcare providers. The group advises researchers, provides feedback, and helps develop training.
Some panel members had acted as simulated patients to train medical students and residents to take patients’ medical histories. “It has become an important way for us to observe some of the soft skills involved in medical care,” Sege says.
The panel members suggested study investigators use the same method to train research staff on informed consent. Some panelists enthusiastically volunteered to serve as simulated prospective study participants. “We are not looking for people who are skeptical about research. We are looking for people who think it is important,” Sege explains.
The community members expressed strong opinions on how informed consent is handled, based on their own experiences. Some recalled research staff rushing them through the process. Others could not explain the purpose of the study, or provided inaccurate, incomplete information on risks. “They take their own lived experience of having been a research participant and use that to help train the research coordinators in the skills that they need,” Sege explains.
The research staff appreciated the chance to practice informed consent skills. One participant stated, “My simulated patient really challenged me and made me think a lot about how I introduce myself and approach a consent conversation.”
Research staff practiced how to determine if a person with limited English language ability needs an interpreter. Many people know enough English to get along in everyday life, but not good enough to make an informed decision on participating in a clinical trial. Research staff also gained practice in using the teach-back method, asking the participant to explain in their own words what they think the study is about.
Both the learners and the simulated study participants had some fun with the process. “We asked the community members to adopt different attitudes, to see how the research staff would handle it,” Sege recalls.
Community members were asked to act skeptical about the study, act as though they were in a rush, or to decide against participation. Research staff were observed to see how they responded to these challenges.
The community members also are involved with improving the informed consent process on the IRB side. The IRB includes panel members with diverse backgrounds, including a social worker, a history professor, a pastor in a local church whose first language is not English, and a person who spent most of his life unhoused. “We don’t need to simulate people with different backgrounds, because we have people with different backgrounds,” Sege says.
One panelist is part of an IRB committee that is reviewing informed consent forms and evaluating what a reasonable person should be expected to understand about a study. The panelists’ involvement opens another level of expertise from which IRBs can draw. “These are trained community members who believe in research, but who are also really aware of the flaws in the process,” Sege observes.
Researchers are striving to enroll diverse study participants, but face challenges. “One of the main reasons trials fail is lack of enrollment, or lack of diverse enrollment,” Sege says.
If people believe staff are not truly engaging, then they are less likely to participate in clinical trials. “That’s particularly true for people with less previous experience with research, or who have faced discrimination in their lives,” Sege notes.
The community members’ involvement with informed consent processes has made research, overall, more ethical. “Research fundamentally depends on a collaboration between investigators and people going into trials,” Sege concludes.
REFERENCE
1. Markman KM, Weicker NP, Klein AK, Sege R. Community-engaged training in informed consent. J Clin Transl Sci 2023;7:e108.
At Tufts Clinical and Translational Science Institute, research staff learn how to provide informed consent by working with community members acting as simulated prospective study participants in role-playing exercises. More than 40 community members, researchers, patients and families, and healthcare providers offer feedback and help develop training.
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