About this item:

279 Views | 569 Downloads

Author Notes:

Dr. Raymond L Ownby, Department of Psychiatry and Behavioral Medicine, Nova Southeastern University, Room 1477, 3200 South University Drive, Fort Lauderdale, FL, USA 33314, Tel: +1-954-262-1481; Email: ro71@nova.edu

The authors also acknowledge other members of the investigative team which included Drs. Sara J. Czaja and David Loewenstein (Center on Aging at the University of Miami Miller School of Medicine in Miami, Florida, USA); Rosemary Davenport, RN, MSN, ARNP, Study Coordinator; Dr. Ana-Maria Homs, assessor; Ms. Lilly Valiente who provided data management assistance; and Maria Lago, MSW, who provided assistance with participant recruitment.

Research Funding:

This study was supported by a grant to Dr. Ownby from the US National Heart, Lung, and Blood Institute (R01HL096578).

This study was supported by a grant to Dr. Ownby from the US National Heart, Lung, and Blood Institute.

The funding source provided review of the grant application and financial support for the conduct of the study but was not otherwise involved in the design, data collection, execution, analysis, and interpretation of study or the decision to submit this article for publication.

Health literacy predicts participant understanding of orally-presented informed consent information.


Journal Title:

Clinical research and trials


Volume 1, Number 1


, Pages 15-19

Type of Work:

Article | Post-print: After Peer Review


Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

Copyright information:

©2015 Ownby RL.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/).

Creative Commons License

Export to EndNote