Accession Number:

ADA444052

Title:

Exploring the Readability of Consent Forms in Human Research in the United States Army

Descriptive Note:

Final rept. Jul 2004-Jul 2005

Corporate Author:

BROOKE ARMY MEDICAL CENTER FORT SAM HOUSTON TX

Personal Author(s):

• Mon, Heidi P.

Report Date:

2005-03-01

Pagination or Media Count:

57.0

Abstract:

Informed consent documents used in human subject research within the United States Army appear increasingly complex and lengthy and are rife with medical and legal terminology. It becomes difficult to discern whether the intent of consent forms is to inform the patient or protect the researcher and organization from litigation. A literature review highlighted two observations 1 consistently, every article published about consent forms concluded that these documents were too complex for the lay person and 2 there is a gap in the literature concerning the readability of consent forms in military protocols. Using a 1997 study conducted by Mader and Playe n 94 as a foundation, this study evaluated the readability of consent forms n 60 in human research performed within the U.S. Army. Studying the effects of 10 dependent variables based on 2 levels of risk minimal risk and greater than minimal risk, the author found significance across 5 of the 10 variables with Army consent forms p .01. The results demonstrate that the readability of consent forms within the U.S. Army is too complex for the average reader. A readability standard of the sixth-grade level would better serve the interests of participants in human subject research.

Descriptors:

• *ARMY RESEARCH
• *RESEARCH MANAGEMENT
• *FORMS(PAPER)
• *MEDICAL RESEARCH
• *READING
• RISK
• ARMY PERSONNEL
• LITERATURE SURVEYS
• HUMANS
• REGULATIONS
• DOCUMENTS
• HISTORY
• ETHICS
• STATISTICAL ANALYSIS
• VOCABULARY

Subject Categories:

• Administration and Management
• Information Science
• Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE