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Educating potential subjects is crucial
Federal regulations require researchers to maintain an equitable selection of participants, and IRBs take this into consideration when reviewing study protocols. But what are the ethical implications when a study has difficulty recruiting or retaining subjects? From an IRB perspective, recruitment must not be coercive, but how can researchers ensure participants are truly willing volunteers in small studies that require a major physical commitment?
This issue can arise in studies that prove physically or emotionally challenging for specific participant populations.
For example, a new study about functional magnetic resonance imaging (MRI) recruited stroke survivors and asked for their perceptions of the study’s physical demands.1 Participants underwent procedures that required multiple visits and spending a long time in an MRI, says Niloufar Niakosari Hadidi, PhD, APRN, CNS-BC, FAHA, associate professor and coordinator, adult/gerontological clinical nurse specialist at the University of Minnesota in Minneapolis.
Ischemic stroke patients underwent two MRI sessions, each lasting 1.5 hours and including functional MRI tasks.1
"When participants go through the functional MRI, they can be in there for one and a half hours, and we give them tasks to do," Hadidi says. "We show them images, so they’re not just lying there."
It proved to be a difficult study for recruiting: "It took a year to recruit 10 participants," Hadidi says.
"We didn’t reimburse them much — only free parking and a $100 gift card at the end," Hadidi says. "It was our little way of saying, Thank you.’"
Recruitment also was challenging because of exclusion criteria that kept out of the study any stroke survivors with pacemakers or other implanted magnetic devices.
IRBs and researchers should keep in mind that unintended coercion can occur when doing research that involves lengthy or potentially uncomfortable procedures, Hadidi notes.
"The patient might feel obligated to participate in a study conducted by someone who impacts the patient’s care," she explains. "I’ve seen how that can happen."
One way to prevent this is for IRBs to review recruitment procedures and suggest that someone other than the potential participants’ physician approach patients about participating in a study, Hadidi says. "You can say, There’s someone here who would like to talk with you about a study. Would you be willing to listen to this?’"
Then the researcher would approach the people who said "yes."
Another recruitment challenge involves placebo studies in situations where every potential participant would like to receive the study intervention, Hadidi says.
"We have to adhere to the protocol," she says.
IRBs and researchers walk a fine line between seeing the study from the patient participant’s perspective and following the study’s protocol while adhering to research regulations, she adds.
None of the MRI study participants dropped out, but retention can be as challenging as recruitment, Hadidi notes.
"Often, as researchers, we are so into our protocol and what we have to do next that we forget about what participants’ experience," Hadidi says. "So I did a study that looked at what they experience and how they see the whole study."
Investigators interviewed each participant in person and, after the last MRI procedure, asked them about their experience and their advice for researchers or patients, she says.
The goal for adding the questions was to learn more about the patient’s experience, both to improve recruitment and to understand and improve the patient’s experience as a study participant, she says.
Hadidi learned that participants needed to be well educated about the study, its procedures, and goals. They especially wanted to learn more about MRIs and safety. Claustrophobia, pain, and temperature discomfort were not a problem, the participants reported.
"There were themes emerging from the study: It would be helpful to do education and give them a tour of the place before taking them into it," she adds. "They did the study because they wanted to help other stroke survivors and contribute to science."
Another strategy for improving retention involves making certain potential participants know from the beginning how challenging the study’s tasks and time commitment might be.
"I took the time to say from the beginning, Is this something you could commit to because it will take eight sessions with two functional MRIs, and we prefer that if you are unable to stay with the study that you let us know now,’" Hadidi says.
"I’d make sure they were really comfortable with the study before we’d begin."