A computer-based education intervention to enhance surrogates' informed consent for genomics research.
BACKGROUND
Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research.


OBJECTIVE
To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research.


METHODS
A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent.


RESULTS
Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004).


CONCLUSIONS
Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care.
Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri. ashelto@siue.edu.
Ann K
AK
Shelton
Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri.
Bradley D
BD
Freeman
Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri.
Anne F
AF
Fish
Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri.
Jean A
JA
Bachman
Ann K. Shelton is an assistant professor, Department of Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curator's Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri.
Lloyd I
LI
Richardson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research; D003194:Computer-Assisted Instruction; D016638:Critical Illness; D003657:Decision Making; D005260:Female; D023281:Genomics; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019727:Proxy; D020458:Third-Party Consent; D055815:Young Adult