The study, which appears in the January-February 2004 issue of Comprehensive Psychiatry, examined prisoners with mental illness because they are the "most vulnerable of the vulnerable," the UI team reported. The study raises the question whether prisoners, while needing to be protected from being treated unethically as a population of convenience, have theoretically been overprotected from participating in research that eventually could help them.
The study is believed to be the first to have gone into a prison setting, and in a scientific and quantifiable way, studied the degree to which prisoners are able to give informed consent and the degree to which they may be susceptible to coercion or other factors that affect their ability truly to be a "volunteer," said David Moser, Ph.D., assistant professor of psychiatry in the UI Roy J. and Lucille A. Carver College of Medicine and the study's lead investigator.
Informed consent is an important step in any research study that involves humans. It helps ensure that potential participants are capable of making a free and informed decision whether to enroll, after being told of all the procedures, risks and benefits.
In order to participate in the UI study, prisoners and non-prisoners first had to consider the actual informed consent materials. The 30 prisoners with mental illness (26 men and four women) and 30 healthy non-incarcerated people (26 men and four women) who then chose to participate agreed to pretend they were potential candidates for a study of a made-up cognition-enhancing drug.
The individuals then read and considered informed consent materials that described the hypothetical trial. All participants' decision-making capacity, feelings and thinking related to any coercion, and neuropsychological (cognitive) and psychiatric states were assessed. The two groups were compared on ability to provide consent to the drug trial and susceptibility to coercion.
"Our study reveals we didn't find overt coercion among prisoners, and that nearly every prisoner, with one exception, was competent to make a decision about participating in research," Moser said. "However, although the prisoners were competent, their scores showed they generally were not as competent as the control subjects were. This underscores the need to spend extra time and effort during the consent process to ensure that these individuals understand what they are getting into.
"The study doesn't settle the issue but suggests it is ethically reasonable to do prison research, given some caveats about how that setting influences behavior and thinking," he added.
Moser said the coercion assessment (20 true-false questions) revealed that far more prisoners, compared to controls, wanted to participate for one or more reasons: to avoid being bored, meet someone new, help others or, notably, to appear cooperative.
Being in prison affects or influences voluntariness, but it may not lead to coercion, which is being forced to think or act in a way one otherwise might not, Moser said.
"We found that prisoners may decide to be in a study to look cooperative, so it's a decision-making factor that is not in play for most non-incarcerated subjects, but it doesn't constitute coercion. It is somewhere in the middle ground between totally free choice and totally coerced choice, and precisely where it lies on that continuum is a matter of debate," he explained.
An interesting finding was that 47 percent of the prisoners initially approached to be in the actual study (27 of 57) said "no," indicating that they felt free to refuse to participate altogether. Most who declined said it was because participating would interfere with recreational time or opportunities to earn wages in prison-based employment.
Moser said the findings overall have implications for improving mental health treatment for prisoners. Nearly 16 percent of all prisoners have a serious mental health condition.
"Knowing how best to treat prisoners with mental illness can be difficult. It is a dubious assumption that you can take regular mental health research done in the community setting and just apply those findings to ill prisoners," Moser said. "If research can be done in an ethical manner in prison settings, prisoners as a population might benefit.
"Now we need to find how to achieve the optimal balance between extending adequate protection to those prisoners who want to be research subjects and not placing unnecessary and restrictive guidelines on prison research so that prisoners cannot benefit from studies," Moser added.
Stephan Arndt, Ph.D., UI professor of psychiatry, and Michael Flaum, M.D., UI associate professor of psychiatry, were among the UI researchers on this study. The team also received assistance from John Monahan, Ph.D., University of Virginia and the MacArthur Foundation Research Network, and staff members at the Iowa Medical and Classification Center.
The study was supported in part by a Clinical Research Award from the UI Carver College of Medicine.
Previous research by Moser and UI colleagues indicated that people with schizophrenia are able to provide consent, although one in five persons with the condition has decreased ability to do so. A news release on that study can be found at http://www.uiowa.edu/~ournews/2002/july/0701schizophrenia.html.
University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.
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