title: Informed consent to research in persons with schizophrenia spectrum disorders.
abstract: This manuscript describes the responses and correlates of outpatients with schizophrenia spectrum disorders to a tool designed to measure comprehension before obtaining informed consent for research participation. We used the Evaluation to Sign Consent form to document comprehension in 100 outpatients as part of their consent to participate in an ongoing study of an exercise intervention. The findings suggest that using this form is a feasible and acceptable approach to documenting comprehension of research procedures prior to obtaining informed consent. Age 49 years and older and the receipt of intramuscular antipsychotic medication predicted the need for additional assistance to complete the Evaluation to Sign Consent form successfully (chi(2) = 8.29, P = 0.016). Nurse researchers should consider documenting comprehension with this tool owing to its availability, time efficiency and utility.
authors.affiliation: University of Tennessee, College of Nursing, 1200 Volunteer Blvd, Knoxville, TN 37992, USA. lbeebe1@utk.edu
authors.forename: Lora Humphrey
authors.initials: LH
authors.lastname: Beebe
authors.forename: Kathlene
authors.initials: K
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D032882:Comprehension; D032984:Ethics, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D016015:Logistic Models; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D011618:Psychotic Disorders; D012559:Schizophrenia; D015144:Southeastern United States