Assessing usefulness and researcher satisfaction with consent form templates

Area of Science:

• Clinical Research
• Health Literacy
• Regulatory Science

Background:

• The traditional research consenting process can be complex and difficult for patients to understand.
• Improving patient comprehension is crucial for ethical research conduct and informed decision-making.

Purpose of the Study:

• To develop and evaluate simplified consent form templates to enhance the research consenting process.
• To assess the usability and adoption of these simplified templates by clinical researchers.

Main Methods:

• Four consent form templates were created at an 8th-10th grade reading level.
• Experts in clinical research, health literacy, and regulatory affairs reviewed the templates.
• Researchers using expedited review protocols were surveyed before and after template implementation.

Main Results:

• Initial awareness and use of templates were low (20.9% awareness, 5.8% use).
• After two years, awareness significantly increased to 54.2% and usage to 87.5%.
• The study indicates a growing acceptance and utilization of simplified consent forms.

Conclusions:

• Simplified consent form templates show promise in improving patient comprehension and research process efficiency.
• Successful implementation necessitates substantial time for development and requires strong support from Institutional Review Boards (IRBs) and technical staff.
• Template adoption is feasible but depends on institutional buy-in and resources.