The 130th Annual Meeting of APHA

Abstract #41600

Thomas Emerson Wasser, PhD¹, Stephen Lammers, PhD², Christy Flener, MA¹, and Pamela Robson¹. (1) Lehigh Valley Hospital, Health Studies, 321 Avi Drive, Alburtis, PA 18011, 610-402-2497, Thomas.Wasser@LVH.com, (2) Lehigh Valley Hospital, Ethics, PO Box 7017, Allentown, PA 18104

Introduction: The informed consent process is designed to ensure that participants volunteering for research understand what is expected of them and what risks and benefits they are likely to encounter. Consent forms vary greatly in their readability depending on the type of study being done, and where the study originates. This study examines the origin of consent forms to determine if readability differences exist. Methods: Six Investigator Initiated (II) studies performed by in-house staff, nine pharmaceutical Sponsored Studies (SS), and five cancer Cooperative Group (CG) trials were used for this analysis. Flesch Reading Ease (higher scores indicate easier reading) and Flesch-Kincaid readability established grade level for the consent forms. Consent forms were scored as approved by the Institutional Review Board (IRB) and as ‘cleaned’ with medications, headings, and bullet point lists removed. Analysis of Variance with Scheffe post-hoc tests were used. Results: Significant differences existed between groups for both approved and ‘cleaned’ forms. CG studies had lower Flesch-Kincaid scores as compared to II and SS forms (p<0.001) and greater reading ease (p<0.001). These scores indicate that CG studies are at the 8th and 9th grade reading level, while II and SS studies were at the college reading level. Discussion: The high grade level of II and SS studies are problematic in ensuring that study participants’ rights are protected. High readability levels and differences between reading levels suggest that IRB’s need to make certain that consent forms contain understandable information needed by the study participant and at the appropriate grade level.

Learning Objectives:

• Participants will be able to understand readability scores and be able to assess their own work.
• Participants will understand the importance of readability of consent forms for human subject research.
• Participants will examine which methods should be used to evaluate consent forms and understand which types of consent forms need to be most closely examined.

Keywords: Ethics Training, Risk Communication

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Cooperative group researchers, Pharma company representatives.
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.