Survey: Stroke patients favor emergency research
Author questions community consultation rules
A survey of patients who had suffered strokes found that most would be willing to participate in emergency research for stroke treatments, and if incapacitated, would accept surrogate decisions about enrollment by family members or even their doctors.1
The study’s author, Carol Blixen, PhD, RN, a researcher with the Cleveland Clinic Foundation in Cleveland, says she plans to use this study and planned follow-ups to better define the attitudes of stroke patients toward emergency research.
She also hopes that the information will help refine a definition of the community consultation that is required by the FDA for waivers of informed consent in emergency research. Blixen says that people who have suffered strokes or are at risk for a first stroke make up a community whose opinions about research are more relevant than a definition of community that would be limited to geographic location.
"I think that this issue of community needs to be really tightened up," Blixen says. "We hope to come out with a model that, though not predictive, can be a way to systematically attempt to identify the relevant community for stroke. And that will provide a model for assisting researchers and IRBs to meet the rather cumbersome requirements of community consultation."
Poster child for emergency research
Blixen says she could foresee similar work being done with other conditions that have a strong emergency research component — acute cardiovascular conditions or brain trauma, for example — to identify relevant communities and determine their attitudes about emergency research. In many of these cases, patients are first encountered in an emergency room, and interventions must be administered quickly in order to save lives and preserve brain and other functions.
But Blixen considers stroke to be the poster child for this type of approach, because of its increasing prevalence.
"The burden of stroke will only increase in our country because of the aging population," she says. "In fact, it’s been felt that the incidence of stroke will dramatically rise and lead to a stroke epidemic because of our aging population."
FDA regulations (21 CFR 50.24) address research done in emergency settings on patients who may lack the ability to give informed consent. The FDA allows for waivers of informed consent in these cases, but under strict requirements, including:
— Participation in such studies must hold out the prospect of direct benefit to the individual subject;
— Risks associated with the study must be reasonable in relation to what’s known about the medical condition and standard therapy; and
— The study should exclude emergency patients who emergency care personnel could reasonably infer would not agree to participate in a research study.
In addition, there must be an opportunity for "community consultation and public disclosure," to ensure that the community from which the study participants will be drawn has a chance to be involved in the IRB’s decision-making process.
The FDA defines community as "the geographic area, e.g., city or region, where the hospital or clinical investigator study site is located." The agency’s guidelines also state that the community can be characterized by analyzing the demographics of previous hospital patients with the condition being studied. Blixen says confusion about this requirement can impede the progress of emergency research. Her study was an attempt to begin identifying what she calls the "relevant community" — specifically, patients who shared the condition being studied, and who were thus most directly affected by the research.
Blixen recruited subjects who had suffered a stroke in the previous year and who helped reflect the racial, gender, and age distribution of stroke nationally. Participants were screened to ensure they had no problems with comprehension or speaking. In the end, a group of 12 patients was chosen. Researchers conducted face-to-face interviews with the subjects, gauging their understanding of research terms, their attitudes toward research and particularly emergency research, and their confidence in the ability of family members or doctors to give surrogate consent in emergency research situations. Overall, nearly all of the patients expressed approval for the idea of stroke research in general.
Eleven of the patients thought it was acceptable to treat patients who had had a stroke with a new and untested intervention, as long as the patient gave informed consent. But half had some concerns about giving such treatments without informed consent. One patient response showed the ambivalence some subjects felt about the idea: "if a patient is fully informed of all the risks and then still says yes, I want to participate, then that’s fine. I wouldn’t expect the doctor to apply those new and untested methods to a patient who hasn’t given that informed consent."
Most said they would be willing to participate in emergency research if the opportunity arose.
In cases where they were unable to consent for themselves, nine of the 12 patients surveyed would want a family member to give consent before being entered in a trial. Those nine said they had a "high level of confidence" in the ability of their family members to make the decision to enroll in a study.
Family, doctors seen as surrogates
In cases where neither the patient nor a family member could provide consent, 11 of the 12 subjects said they would trust their doctor to make the decision of enrolling them in a study. "Some people even said they trusted them more than their families," Blixen says. "That was surprising."
She says the results were consistent across gender and even racial lines, despite the fact that other studies have found African-Americans to be more distrustful of research and research institutions.
Blixen says she already has applied for grants to expand this study, interviewing a larger group and including Hispanics. She also is seeking out not just stroke patients, but people with risk factors for stroke, since the attitudes of stoke patients may be influenced by their having survived a stroke already.
With more results in hand, Blixen hopes to convince the FDA to refine its requirements regarding community consultation in emergency research, to include the idea of seeking out those who have the condition or illness being studied.
"We’re very excited about the possibility of what the results of the larger study might offer, both on a policy level and on a clinical level for researchers," she says.
In the meantime, Blixen suggests that IRBs should take the initiative to ask investigators to provide more of these types of community consultations themselves.
"They may find that this kind of inquiry into the defining the relevant community would be helpful in them looking at what investigators are doing," Blixen says. "Someone saying they’re going to put posters up in City Hall or in supermarkets, that’s not good enough for community consultation. Researchers may have to go a step further in getting a consensus from the relevant community about what they’re going to be proposing."
Reference
- Blixen CE, Agich GJ. Stroke patients’ preferences and values about emergency research. J Med Ethics 2005;31:608-611.
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