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Toward a construct definition of informed consent comprehension.

Laura D Buccini¹, Peter Caputi, Don Iverson

¹Department of Public Health, School of Health and Behavorial Sciences, University of Wollongong, Wollongong, NSW 2519, Australia. lb346@uow.edu.au

Journal of Empirical Research on Human Research Ethics : JERHRE

|April 23, 2009

Summary

Standardizing the definition of informed consent comprehension is crucial for developing reliable tests. This study used expert consensus to establish a framework for informed consent comprehension instruments.

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Area of Science:

Medical Ethics
Health Literacy Research
Psychometrics

Background:

Informed consent comprehension tests vary widely due to a lack of standardized construct definition.
A standardized definition is needed for consistent instrument development, implementation, interpretation, and application.

Purpose of the Study:

To establish a standardized construct definition for informed consent comprehension.
To provide a framework for developing and evaluating informed consent comprehension instruments.

Main Methods:

Utilized the Delphi consensus approach.
Convened an international expert panel (N = 19).
Conducted three revision cycles to achieve expert consensus.

Main Results:

Achieved expert consensus on a construct definition for informed consent comprehension after three revision cycles.
The consensus provides a foundational step toward standardization.

Conclusions:

The Delphi consensus approach successfully yielded a construct definition for informed consent comprehension.
This definition serves as a critical step towards standardizing instruments used to assess patient understanding in healthcare settings.