Institutional improvements in readability of written informed consent forms sustained post-revised Common Rule

Area of Science:

• Clinical Research Ethics
• Health Literacy Studies
• Regulatory Compliance in Research

Background:

• Informed consent is essential for ethical human subjects research.
• Informed consent forms (ICFs) contain complex information, often challenging for research subjects.
• Regulatory changes, like the revised Common Rule, necessitate additions to ICF language, potentially increasing complexity.

Purpose of the Study:

• To assess the readability of informed consent forms (ICFs) at an academic medical center.
• To evaluate changes in ICF readability following the implementation of a plain language template.
• To address challenges posed by limited health literacy among research participants.

Main Methods:

• Longitudinal assessment of ICFs over time.
• Analysis of ICF readability metrics before and after template introduction.
• Focus on plain language principles in ICF development.

Main Results:

• Introduction of a plain language ICF template led to measurable changes in readability.
• The updated template aimed to improve comprehension for individuals with varying health literacy levels.
• Ongoing evaluation is crucial for maintaining accessible research documentation.

Conclusions:

• Optimizing ICF readability is vital for ethical research and participant understanding.
• Plain language initiatives can effectively improve the accessibility of complex research information.
• Academic medical centers should prioritize health literacy in informed consent processes.