Jean A. Bachman, RN, DSN, and Lloyd I. Richardson, PhD 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.
Objectives To examine the effectiveness of a new, computerbased 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. (American Journal of Critical Care. 2015;24:148-155)
©2015 American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ajcc2015983
148 AJCC AMERICAN JOURNAL OF CRITICAL CARE, March 2015, Volume 24, No. 2 www.ajcconline.org
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atients in the intensive care unit (ICU) often are unable to give informed consent
because of cognitive or physical impairments due to illness, trauma, or sedation.1,2 In such circumstances, a patient’s family member or proxy is asked to serve as a surrogate and provide informed consent on behalf of the patient.3,4 With increasing frequency, surrogates of ICU patients are being asked to provide consent for
crucial genomics research.5,6 This type of research has an immediate aspect7,8; any delay in consent for enrollment in the study may result in a missed opportunity to collect transient and perhaps vital clinical data.9,10 Furthermore, genomics research is complex and has inherent ethical, legal, and social implications.11,12 Without a basic understanding of the process of informed consent related to genomics research, surrogates may be poorly prepared to consent for their loved ones to participate in the studies.13
The ICU environment is challenging for a patient’s surrogates because of the immediate need to react to changes in the patient’s condition.14,15 Because of these multiple stressors,16-18 surrogates giving consent in the ICU may benefit from a focused computer-based educational intervention as an addition to conventional consent forms. However, no studies have specifically examined the effectiveness of such interventions on surrogates’ understanding of informed consent for genomics research in the ICU. We found 9 high-quality studies19-27 in which investigators examined a computer-based educational intervention and the outcome (understanding informed consent), but the researchers focused on procedures, a medical treatment, or non-ICU research and rarely used a surrogate. Computer-based educational interventions have been effective in enhancing understanding of the process of informed consent in procedural studies (cardiac catheterization, colonoscopy, endoscopy with parent as surrogate, and gastric banding surgery) and in a study on medical treatments (chemotherapy).19-23 Additionally, 4 studies24-27 focused on non-ICU research: 1 involved a cancer clinical trial, 1 had a sample composed of
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