title: Do investigators understand ethically-important perspectives of clinical research participants?: a 'piggy-back' study of attunement and alignment in serious illness research.
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.
  
  
  METHODS
  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: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA 94305-5717, USA. Electronic address: RobertsL@stanford.edu.
authors: Laura Weiss
authors: LW
authors: Roberts
authors: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA 94305-5717, USA. Electronic address: janepkim@stanford.edu.
authors: Jane Paik
authors: JP
authors: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000208:ethnology / Q000628:therapy; D006801:Humans; D008175:Lung Neoplasms / Q000208:ethnology / Q000628:therapy; D008297:Male; D001523:Mental Disorders / Q000208:ethnology* / Q000628:therapy*; D008875:Middle Aged; D025341:Principal Component Analysis; D012108:Research Personnel / Q000523:psychology*; D055815:Young Adult
keywords: Autonomy; Burden of disease; Clinical research enrollment; Ethics in psychiatric research; Therapeutic misconception; Vulnerable populations