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Examining informed consent in persons with schizophrenia.

Lora Humphrey Beebe¹, Kathlene Smith

¹College of Nursing, University of Tennessee, Knoxville, Tennessee 37996-4180, USA. lbeebe1@utk.edu

Issues in Mental Health Nursing

|April 3, 2008

Summary

This study found that schizophrenia outpatients in supervised housing or on multiple antipsychotics needed more help understanding research consent. The Evaluation to Sign Consent (ESC) tool is useful for assessing comprehension in these patients.

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Area of Science:

Psychiatry
Clinical Psychology
Medical Ethics

Background:

Informed consent is crucial for ethical research participation.
Assessing comprehension in vulnerable populations, such as individuals with schizophrenia, presents unique challenges.
Standardized tools can aid in documenting comprehension before research participation.

Purpose of the Study:

To evaluate the utility of the Evaluation to Sign Consent (ESC) form in assessing comprehension among outpatients with schizophrenia.
To identify factors associated with difficulties in understanding informed consent for research.

Main Methods:

A descriptive study involving 29 outpatients with schizophrenia.
Utilized the Evaluation to Sign Consent (ESC) form to document participants' comprehension.
Analyzed data based on living situation (supervised housing vs. alone) and number of antipsychotic medications.

Main Results:

Participants residing in supervised housing were more likely to require prompts to understand consent compared to those living alone (p = 0.024).
Patients on two antipsychotic medications required more prompts than those on one (p = 0.023).
The ESC form proved to be a practical tool for documenting comprehension.

Conclusions:

Living situation and polypharmacy are associated with comprehension challenges in schizophrenia outpatients.
The ESC form is a valuable, time-efficient tool for nurse researchers to document informed consent comprehension.
Consideration of these factors can improve the informed consent process in schizophrenia research.