New approach surveys subjects to measure informed consent
Surveying subjects after they've participated can help determine effectiveness of training
Every research institution wants to know that its participants have made a fully informed, unpressured decision to enroll in research. But, often, that basic question is hard to determine.
Researchers at The Rockefeller University in New York City are testing a novel approach to surveying research subjects after they've left the hospital, in order to provide a better measure of the effectiveness of informed consent and other aspects of human subject protections.
Rhonda Kost, MD, clinical research officer and research subject advocate at Rockefeller's General Clinical Research Center, says her institution originally wanted to test research staff to measure how a specific education program affected their administration of informed consent, but realized that testing subjects would provide a better picture of how well the process worked.
"Evaluating whether investigators say certain things in an interview after they have been 'educated' is really a surrogate," she says. "What you really want to know about your whole human subjects protection education program is, in the end, did the research subjects have the information that they needed and the supportive environment that they wanted in order to make the decisions they had to make?"
Testing subjects instead of staff
Funded by a National Institutes of Health/National Center for Research Resources Human Subjects Research Enhancement Award, Kost says she began working on a plan to develop education modules for research staff at Rockefeller and other local hospitals. The plan originally was to test the effectiveness of the education by videotaping staff in standardized informed consent sessions with actors.
But in the meantime, she says, Rockefeller's physician-in-chief, Barry Coller, MD, learned about a joint project of the NIH Clinical Center and NRC+Picker, which produces a widely used survey of patient satisfaction for hospitals and other health care providers. Hospitals commonly use surveys such as Picker's to meet standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).
The NIH-Picker project would extend the standard hospital survey, which asks about such issues as meal quality, nurse attentiveness and physician wait times, to ask questions specifically geared toward clinical research participants. Did patients feel they had enough information about a study? Did they understand the conditions under which they could quit the study?
A team from Rockefeller worked with the NIH Clinical Center's Laura Lee, RN, and David Henderson, MD, to evaluate whether questions were specific enough to meet Rockefeller's needs, while still general enough to provide benchmarking with other institutions. Rockefeller's IRB reviewed the proposal, looking specifically at issues of privacy and confidentiality. The survey is mailed to subjects after they leave the hospital, Kost says, to allow them to reflect on their experience.
"Some people think, and I agree, that there's the risk of undue influence when you hand someone a survey and the research nurse is standing beside them waiting for discharge," she says.
Subjects must agree beforehand to allow the survey to be sent to their home.
"Some people might not want a research survey to come to their house, as it may reveal that they have participated in research the rest of their household does not know about," Kost says. "Particularly because our research includes HIV and drug addiction, we are especially sensitive to confidentiality issues."
Survey rolls out to more centers
After two years of applying the survey at Rockefeller, it is being refined in collaboration with NIH, Picker and selected collaborating centers, and will be shared with a number of General Clinical Research Centers (GCRCs) across the country for use in their institutions. Kost, a past president of the Society of Research Subjects Advocates (SRSA), says she and the NIH collaborators presented the idea at an SRSA national meeting last year, and found enthusiasm for the survey approach to human subjects protection outcome measures.
"We're redeveloping and validating these questions to now pilot the survey across a self-selected group of GCRCs, to learn whether it's more broadly applicable to those centers," Kost says.
"It worked well in our small center, it worked well at NIH, but in a larger academic medical center, we'd like to identify and address the obstacles to administration," Kost says. "We think it will be ultimately successful, because it's not that different from administering a non-clinical research hospital survey. We need to work out the kinds of issues that come up in the implementation before we offer this in a broader way."
Kost says Picker produces highly sophisticated survey tools, based on focus groups and thousands of patient interviews, and the research team is excited about the possibility of bringing the same degree of survey rigor to the clinical research questions.
"They use focus groups made up of patients, of caregivers, of ethicists, to go back and really scientifically validate these clinical research questions," she says. "So they're quite powerful at extracting the information we hope to have."
On the education side, Kost has developed 12 modules and made them available to Rockefeller staff through the University of Miami's Collaborative IRB Training Initiative (CITI) program.
Rockefeller's staff already used the CITI program for basic human subjects protection education, so Kost added advanced modules in areas such as informed consent. CITI adapted the Rockefeller modules so that they matched CITI's format.
Because the education project was funded in part with an NIH Human Subject Research Enhancement Award, whose conditions include sharing content outside the institution, Rockefeller has donated the modules to CITI, Kost says.
"If they find our modules valuable, they can offer them to other institutions, use them to enhance other modules or use them as ideas for developing new content," she says. "We've donated them to CITI as an educational resource."
Kost says the difficulty of education initiatives in the area of human subject protection education is that there's so little data about what works.
"There's adult learning theory, there's education in other fields, but there's very little information that I'm aware of about how to best educate researchers and participants in all these areas," she says. "We're driving on our best instincts."
That's why she's hopeful that the outcome measurement part of her project will provide more information to Rockefeller, and other centers that use it to make data-driven decisions in program development.
A key advantage to having this survey administered at centers around the country is the ability to benchmark, Kost says.
"What if you discover at your center that x percent of research volunteers still don't know, despite all of your best efforts, that they can quit participating in a research study at any time?" she says. "And you know you've told them many times: You told them in the informed consent interview, in the informed consent form, in a post-consent interview and you sent them a letter reminding them they could quit and yet, they still answer that they don't know when they can quit. What do you do?
"If you can look at aggregate data from other centers and you can see that pretty much across the country, everybody's got the same number, or you're doing better, or you're doing a little worse and you do need a different model," Kost says. "It's tremendously powerful."
She says the rollout to other centers will include confidentiality features that will protect an individual hospital's data. A hospital participating in the pilot will be the only one to see its individual scores — other institutions will only see aggregated data.
Kost says she believes this survey could become an important performance improvement tool for research institutions.
"Not only could it demonstrate in which ways their human subject education program best works, but it might provide data with which leadership could direct their performance improvement efforts based on where their problem scores are, just like they do for JCAHO for hospital performance," she says. "It could be very valuable."
Every research institution wants to know that its participants have made a fully informed, unpressured decision to enroll in research. But, often, that basic question is hard to determine.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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