Am J Psychiatry 1985; 142:624-627
Copyright © 1985 by American Psychiatric Association
Informed consent as a form of volunteer bias
MJ Edlund, TJ Craig and MA Richardson
Two nontreatment studies of tardive dyskinesia were examined to see if
giving or refusing informed consent might bias results. Three prominent
psychiatric journals were also reviewed to determine whether the outcome of
informed consent procedures was sufficiently well described to permit
evaluation of potential bias. The nontreatment studies suggested that the
bias created by requiring informed consent may cause both false-positive
and false-negative findings. The literature review showed that treatment
studies have generally ignored the potential impact of these biases on
results. Accurate interpretation of research reports, particularly clinical
trials, demands that more attention be given to the process of obtaining
and reporting informed consent.
