Individuals with mental illness deserve a voice in the research enterprise. Given the vulnerable nature of the setting (i.e., locked unit, acute psychopathology), precautions are needed to ensure adequate understanding of a study’s purpose, risks, and benefits. The current findings demonstrate that, overall, hospitalized psychiatric patients with SMI recruited from a large urban public hospital are able to understand several key elements of clinical research as assessed by a brief consent screening instrument. The findings are consistent with prior research with outpatients with SMI (Moser et al., 2006
; Palmer et al., 2005
) and extend the findings to a racial-ethnically, socioeconomically, and psychiatrically diverse, urban sample of hospitalized adults with SMI.
Demographics and clinical variables were not correlated with performance on the 3Q, consistent with Palmer and colleagues’ finding of no significant associations between age and education with scores on the Understanding or Reasoning subscales of the MacCAT-CR (Palmer et al., 2005
). In concordance with our findings, Palmer and colleagues did not find an association of age and education with 3Q scores among outpatient veterans with schizophrenia. Our sample tended to be younger, restricting the ability to detect agerelated differences in performance. Moreover, previous literature that found an association between performance on capacity measures and education used more comprehensive capacity assessment tools and included primarily patients with schizophrenia (see Dunn, Candilis, & Roberts 
for a review of this literature). Given that, in the present study, the consent form was read aloud to potential participants, and that the items were meant to be easily understood by individuals of any educational background, this finding highlights the broad utility of this brief measure for use with samples from diverse backgrounds.
The sample’s mean 3Q score of 4.2 is slightly higher than the mean 3Q score of 3.9 found among an outpatient sample of veterans with schizophrenia (Palmer et al., 2005
), a diagnosis that is often associated with specific types of cognitive impairment. In our study, eight patients received a diagnosis of schizophrenia, and this subgroup scored a mean (SD) 3Q score of 3.9 (1.8), identical to Palmer’s.
Another concern expressed about potentially vulnerable populations has been their ability to exercise voluntary choice when consenting to research (Appelbaum, Lidz, & Klitzman, 2009a
). In particular, some worry that financial incentives for research will influence patients with low socioeconomic status to accept risks that they otherwise would not (Grady, 2009
). For the parent smoking cessation trial described here, participants were reimbursed for study-related time and travel during follow-up assessments. These financial incentives were designed to be noncoercive (i.e., $10 for the initial assessment, with a maximum of $110 total, distributed in $20 increments at five follow-up visits, over 12 months). Although the University’s IRB guidance specifies that payment be listed in a separate section of the consent form from “benefits,” a substantial subgroup (28 participants; 23%) nevertheless identified it as such. This finding is consistent with Dunn and Gordon’s (2005)
argument that payment is often viewed as a benefit among research participants, regardless of how or where payment is described in consent forms. Study participants who identified the financial incentive as a study benefit also identified other benefits; thus, regardless of how we scored responses listing payment as a benefit (), mean 3Q total score was essentially unchanged. Furthermore, it is unknown how individuals weighed the different perceived benefits when deciding whether to participate. Notably, studies examining voluntariness in vulnerable populations have not found strong evidence that financial incentives serve as an undue influence for research participation (Appelbaum et al., 2009b
; Dunn et al., 2009
). However, further research is necessary to examine whether incentives such as larger payments or other, nonmonetary incentives (e.g., treatment access) may influence research participation in unexpected ways.
Few participants reported the study’s purpose as informing smoking cessation services for smokers with mental health problems, despite the interviewer explicitly reading this statement. Instead, many participants (59%) reported that the study was designed to help them stop smoking. The responses suggest at least some degree of therapeutic misconception (Lidz et al., 2004
)—i.e., believing that the purpose of the study was more personally tailored (i.e., to help the individual patient to stop smoking) than it actually was.
A limitation of the current study was recruitment of participants from a single hospital. The sample may not be representative of inpatients in other geographic regions or hospital settings. On the other hand, the setting was an urban public hospital serving a highly marginalized patient population with high rates of substance abuse and low socioeconomic status. Therefore, this sample represents an understudied population in the research ethics literature. Yet, this seriously psychiatrically ill population, with numerous comorbid conditions, represents the kinds of potentially vulnerable patients that elicit greater concerns about understanding of content in a consent form. Structured clinical diagnostic interviews were not administered and data on cognitive functioning were not available; therefore, we could not ascertain the extent to which cognitive abilities such as working memory related to 3Q scores. Prior research has shown that cognitive abilities assessed using neuropsychological tests correlate with scores from decisional capacity instruments in the expected direction (Carpenter et al., 2000
; Cohen et al., 2004
; Moser et al., 2002
). We did not have access to data regarding medication use specific to the timing of the assessment, which may have affected attention.
Another clear limitation of this study was the lack of a full capacity assessment, as the 3Q was not developed as a comprehensive decisional capacity instrument. Thus, we cannot say with confidence that all participants would be considered capable if they had been administered the full MacCAT-CR. However, there is no consensus on what score, on which subscales or combination of subscales of the MacCAT-CR, should be construed as adequate decisional capacity (Dunn, Nowrangi et al., 2006
). This important normative issue of setting cutpoints continues to elicit discussion and debate in the literature. Although we would not argue that a score of 3 out of 6 represents adequate understanding for every type of study, it does provide reassurance that these individuals understood at least two of three key elements of the study being considered. Moreover, the findings were consistent with other studies that used brief screening tools in patients with schizophrenia, in which the majority were able to perform adequately (Moser et al., 2002
; Palmer et al., 2005
). Nevertheless, a strength of the present study is the examination of research understanding in the context of an actual, rather than hypothetical, clinical trial. While the 3Q does not provide a comprehensive measure of decisional capacity, nonetheless, it has the advantage of being brief, provides clear information about which study components need clarification, and is feasible to administer in an inpatient psychiatric setting.