Reading Level and Length of Written Research Consent Forms

Area of Science:

• Medical Ethics
• Clinical Research Administration
• Patient Communication

Background:

• Informed consent forms (CFs) are critical for ethical clinical research.
• Regulatory bodies mandate specific essential elements for CFs.
• Readability and length of CFs can impact patient comprehension.

Purpose of the Study:

• To evaluate the length, readability, and inclusion of essential elements in Institutional Review Board (IRB)-approved CFs.
• To identify variations in CF characteristics across different medical specialties.

Main Methods:

• Analysis of 100 IRB-approved consent forms.
• Assessment of page count, Flesch-Kincaid reading levels, and presence of essential elements.
• Statistical comparison of CF characteristics by medical specialty.

Main Results:

• CFs averaged 10.3 pages with readability at an 11.6-grade level.
• Forms generally included 90.8% of essential elements, but varied significantly in length and complexity.
• Surgical specialties exhibited higher readability (13.1 grade) than pediatrics (10.5 grade).

Conclusions:

• While IRB-approved CFs contain essential elements, they are often excessively long and difficult to understand.
• Even forms for vulnerable populations (e.g., pediatrics) are written at a high reading level.
• There is a need for practical guidance to balance regulatory compliance with clear, simple communication in CFs.