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APHA Scientific Session and Event Listing

Ayse Z. Tezcan, BA¹, David Grembowski, PhD², Rita A. Altamore, MD, MPH³, and Haluk Tezcan, MD¹. (1) North Idaho Cancer Center, 700 Ironwood Dr., Coeur d'Alene, ID 83814, 208-818-6179, atezcan@tezcan.ws, (2) Health Services, University of Washington, 1959 NE Pacific St. Box 357660, Seattle, WA 98195-7660, (3) Washington Department of Health, 1610 NE 150th St., Shoreline, WA 98155

Clinical trials assure adequate protection of subjects through informed consent documents (ICD). A signed ICD by the study participant is mandatory prior to enrollment and must include these elements: capacity, disclosure, understanding, voluntariness and permission. Inadequate consenting may jeopardize the validity of trials and compromise participants' safety and rights. Additionally, improper understanding of ICD may result in litigation, which in turn may lead to the public's mistrust in integrity of clinical trials and reluctance to enroll in trials. Using a cross-sectional survey developed by Joffe et al, we measured our cancer clinical trials participants' knowledge of ICD (n=42)in 2002. Even though our clinical trial participants assessed themselves as knowledgeable in every areas of ICD, their objective knowledge scores indicated they lacked understanding of alternative treatments, study's experimental nature, benefit to subject, risks and discomforts and compensation issues. To improve understanding, we revised our ICDs by converting them into Q&A format, replacing complex legal and medical terminology with layman's language, using bold, italic text and bulleted lists to emphasize important information, changing ICD into first person and adding a generic front page that clearly explained the ICD, informed consent process, and participant's rights. After these changes, we repeated the survey (n=66)in 2005 and compared the results of two studies. We could not detect any statistically significant improvement of knowledge scores in any of the investigated areas of ICD. These results may suggest other barriers to understanding ICD by our participants than its mechanics. Further investigations are planned to improve understanding.

Learning Objectives:

• Evaluate the understanding of infromed consent document by cancer research participants and identify the areas of document that are not properly understood.
• Describe the efforts made by a cancer research program to improve the understanding of informed consent document
• Analyze whether the intervention to improve the understanding was effective.

Keywords: Research Ethics,

Presenting author's disclosure statement:

Not Answered