SIDCER informed consent form: principles and a developmental guideline.

Area of Science:

• Clinical Research Ethics
• Informed Consent Process
• Participant Comprehension

Background:

• Informed consent forms (ICFs) in clinical research are often lengthy and complex, hindering participant understanding.
• This complexity can negatively impact a research participant's ability to make informed decisions.
• Improving the clarity and conciseness of ICFs is essential for ethical research conduct.

Purpose of the Study:

• To develop and evaluate a simplified Informed Consent Form (ICF) template based on key ethical principles.
• To enhance the quality of ICFs for clinical research participants.
• To improve the clarity and relevance of information presented to potential research subjects.

Main Methods:

• Developed the SIDCER ICF template guided by three core principles: regulatory compliance, decision-making relevance, and simple presentation.
• Structured the template with instructions to aid investigators in creating enhanced ICFs.
• Tested the SIDCER ICF's applicability using a Phase I study protocol.
• Gathered expert feedback from ethics and clinical research specialists on a three-page ICF draft.

Main Results:

• The SIDCER ICF template was developed based on principles of regulatory completeness, participant relevance, and simplified language.
• Expert evaluation of a three-page SIDCER ICF for a Phase I study informed its refinement.
• The template was refined and finalized based on expert feedback and testing.

Conclusions:

• The SIDCER ICF offers a valuable tool for improving the quality of informed consent forms in clinical research.
• Simplified and relevant ICFs can enhance participant understanding and support ethical decision-making.
• The developed template provides a practical approach to creating more effective ICFs for diverse research settings.