Therapeutic misconception in early phase gene transfer trials.
Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy'. We use three variables to construct a composite measure of therapeutic misconception TM, tapping misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM.
School of Medicine, University of NC at Chapel Hill, CB# 7240, Chapel Hill, NC 27599-7240, USA. ghenders@med.unc.edu
Gail E
GE
Henderson
Michele M
MM
Easter
Catherine
C
Zimmer
Nancy M P
NM
King
Arlene M
AM
Davis
Barbra Bluestone
BB
Rothschild
Larry R
LR
Churchill
Benjamin S
BS
Wilfond
Daniel K
DK
Nelson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics*; D017322:Clinical Trials, Phase II as Topic / Q000941:ethics*; D032882:Comprehension; D032962:Consent Forms; D032984:Ethics, Research; D005260:Female; D018014:Gene Transfer Techniques / Q000941:ethics; D015316:Genetic Therapy / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009042:Motivation; D033281:Nontherapeutic Human Experimentation / Q000941:ethics; D035842:Research Subjects / Q000523:psychology*; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation / Q000941:ethics; D014481:United States