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Abstract
The authors sought to compare investigators' predictions of clinical research participants' attitudes regarding ethically-important considerations in serious illness research with attitudes expressed by participants ("attunement"), to compare the personal attitudes of investigators and clinical research participants ("alignment"), and to explore the association between views expressed and covariates.The authors queried clinical research participants with either physical or mental illness (n=100) and faculty investigators conducting the clinical research protocols in which these participants were enrolled (n=77). Outcomes included attitudes regarding importance of medical research, attributes of seriously ill people in the research situation, and influences on enrollment decisions by seriously ill people. Generalized estimating equations and linear regression models were used.Investigators underestimated the importance of research about physical illness, mental illness, and healthy people to participants (ßPI=0.59, 95% CI [0.36, 0.83]; ßMI=0.60, 95% CI [0.27, 0.92]; ßH=0.93, 95% CI [0.57, 1.29]). Investigators incorrectly predicted that participants would assess seriously ill people as more vulnerable in the research situation than participants did (ß=-0.68, 95% CI [-1.11, -0.25]). Investigators and participants were aligned on the importance of illness research. Participants expressed greater agreement than investigators regarding the influences of ill individuals indicative of will and cognition in their enrollment decisions (ß=0.69, 95% CI [0.25, 1.13]).Investigators are attuned to and aligned with research participants in many, but not all, respects. Investigators may bring a protective bias in their predictions of the vulnerabilities of ill volunteers.
View details for DOI 10.1016/j.jpsychires.2014.01.012
View details for PubMedID 24507883