Laura Weiss Roberts1, Jane Paik Kim2. 1. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA 94305-5717, USA. Electronic address: RobertsL@stanford.edu. 2. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA 94305-5717, USA. Electronic address: janepkim@stanford.edu.
Abstract
OBJECTIVE: 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. METHOD: 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. RESULTS: Investigators underestimated the importance of research about physical illness, mental illness, and healthy people to participants (βPI=0.59, 95% CI [0.36, 0.83]; βMI=0.60, 95% CI [0.27, 0.92]; βH=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 (β=-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 (β=0.69, 95% CI [0.25, 1.13]). CONCLUSIONS: 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.
OBJECTIVE: 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. METHOD: 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. RESULTS: Investigators underestimated the importance of research about physical illness, mental illness, and healthy people to participants (βPI=0.59, 95% CI [0.36, 0.83]; βMI=0.60, 95% CI [0.27, 0.92]; βH=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 (β=-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 (β=0.69, 95% CI [0.25, 1.13]). CONCLUSIONS: 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.
Authors: John Kanazawa; Sara Gianella; Susanna Concha-Garcia; Jeff Taylor; Andy Kaytes; Christopher Christensen; Hursch Patel; Samuel Ndukwe; Stephen A Rawlings; Steven Hendrickx; Susan Little; Brandon Brown; Davey Smith; Karine Dubé Journal: BMC Med Ethics Date: 2022-01-11 Impact factor: 2.652
Authors: John Kanazawa; Sara Gianella; Susanna Concha-Garcia; Jeff Taylor; Andy Kaytes; Christopher Christensen; Hursch Patel; Samuel Ndukwe; Stephen Rawlings; Steven Hendrickx; Susan Little; Brandon Brown; Davey Smith; Karine Dubé Journal: PLoS One Date: 2021-07-16 Impact factor: 3.240