Hospital’s e-learning tool teaches informed consent
Video demonstrates eliciting consent
The Medical College of Wisconsin is enlisting technology in the task of teaching investigators — and research participants — about the importance of obtaining truly informed consent in clinical research.
The effort, which was funded by grants from the NIH, goes beyond improving consent documents, says William R. Hendee, PhD, senior associate dean and vice president of the college in Milwaukee.
"We said having an adequately prepared informed consent is only half the issue," Hendee says. "The other issue is the process with which you elicit informed consent. Not only what the patient signs, but also how do you go about the process? And we realized that was also flawed in our institution and probably in all institutions, because there’s not adequate guidance."
The college has put together web-based instructional materials, with videos embedded in them, showing good and bad ways of eliciting consent from prospective research subjects. The web material is scheduled to be available on-line — both to researchers at the college and to those outside the institution — after May 1.
Hendee says the college decided to focus on informed consent, believing it to be one of the most problematic areas in the whole clinical research process.
"We could see this when applications were coming into the IRB that would include the informed consent documents," he says. "Those were oftentimes the reasons the applications were returned by the IRB to the investigator, because the informed consent documents were not prepared adequately."
NIH grants funded project
Hendee says concerns about the documents prompted his group to use an NIH Human Subjects Research Enhancement Award to prepare guidance on how to prepare informed consent documents. That guidance was put up on the college’s web site for researchers to consult.
But Hendee says it also was clear from audits — in which researchers were observed recruiting patients for clinical research — that the process of obtaining informed consent was flawed as well.
"It really wasn’t that people were trying not to obtain informed consent or they were being derelict in their responsibilities," he says. "It’s just that there are good ways and bad ways to communicate with people. There are ways to recognize when somebody’s understanding what you’re saying and when they’re not. And there are places to obtain informed consent and places that are not appropriate. People just didn’t think."
So the college sought, and received, a second NIH award to improve that process as well, through educational materials. Again, text would be made available on-line explaining the process of obtaining informed consent. But this time, embedded in the text, would be links to short video clips, or vignettes, showing a staffer either properly speaking with a patient or doing so improperly.
For example, one vignette shows a physician speaking with a potential research participant in a crowded hallway, with people walking past. The physician repeatedly stops the conversation to speak with other people in the hall. The patient appears distracted. A second clip shows a meeting in a more private and less distracting environment.
In another set of vignettes, a physician discusses the risks of participation in a study. The first clip has her speaking rapidly and using a lot of medical jargon, with the patient looking dumbfounded. The second has her explaining the study more coherently, and even drawing a picture when the patient asks for more elaboration.
Other issues covered include recognizing low literacy in a patient, identifying patients with particular vulnerabilities and establishing realistic expectations of the study.
"We’re trying to model good ways and poor ways, and we’re using our own experience in this to identify problem areas and how they can be resolved," Hendee explains.
The vignettes were filmed using staff at the hospital, and are used not only to educate investigators, but also in the informational web materials for prospective research subjects.
The subjects also will see both good and bad examples of informed consent, to give them an idea of what they should expect, Hendee says.
"We do show them a couple cases of comparison where it’s not well done," he says. "I think it’s good for the participant to see," noting that it helps a subject recognize when he or she should ask for more information.
The second NIH award required that the project be of use not just to a specific institution, but to the research community at large. As part of meeting that requirement, the college is disseminating the web instructional materials to other institutions, through various networks of researchers and ethicists, Hendee says. Although the primary focus is on institutions in Wisconsin, other institutions can access it after May 1 via the college’s web site, www.mcw.edu/mcwhrpospecialprojects.
Hendee says the project was the work of a steering committee that included IRB members, investigators, patients and community members, including a research subjects advocate who also is a chaplain.
The committee split into groups that worked on various aspects of the project — identifying aspects of informed consent on which to focus, preparing the text, producing the video vignettes, and one committee that looked at the project as a whole.
Get buy-in going in
Hendee says institutions wishing to do something similar in their own organization should seek to get the support of groups such as investigators and participants by going to them at the beginning of a project.
"You poll the investigators and the [clinical research coordinators] to see what are some of the issues and the problems they are running into in soliciting informed consent," he says. "The project becomes something that they’ve contributed to at the beginning, so there’s more of a buy-in than if you try to do something independently and just spring it on everybody."
Hendee says each institution has to arrive at the best way to educate its own researchers.
"We’re pretty directive here, in expecting investigators to do things pretty much according to the book," he says. "Our investigators don’t object to that, but I can see in some institutions, where they’ve had a lot more freedom to operate in the way that they want to, they might be resistant to being guided in the way we’ve done here.
"So I think you’d have to tailor this to the way the clinical research programs work in individual institutions," Hendee says. "But chances are, the problems that we uncovered aren’t going to be much different from the problems at any institution."
The Medical College of Wisconsin is enlisting technology in the task of teaching investigators and research participants about the importance of obtaining truly informed consent in clinical research.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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