Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a...

Area of Science:

• Clinical Research Ethics
• Informed Consent Process
• Pharmacokinetic Studies

Background:

• The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) proposed principles and an informed consent form (ICF) template.
• Evaluating the applicability of SIDCER principles in a clinical pharmacokinetic study is essential.

Purpose of the Study:

• To assess the effectiveness of an enhanced ICF, based on SIDCER methodology, in improving volunteer understanding.
• To compare volunteer comprehension between an enhanced ICF and a conventional ICF.

Main Methods:

• 550 volunteers were randomized to receive either an enhanced or a conventional ICF in a mock informed consent process.
• Participants completed a post-test questionnaire to assess understanding.
• Primary endpoint: proportion of participants scoring ≥ 80% on the post-test.

Main Results:

• A significantly higher proportion of participants in the enhanced ICF group achieved the primary endpoint (82.2% vs. 60.4%, p < 0.001).
• The enhanced ICF group scored higher overall (19/21 vs. 18/21, p < 0.001) and spent less time on the process (20 min vs. 25 min, p < 0.001).

Conclusions:

• The enhanced ICF demonstrably improved participant understanding.
• The SIDCER ICF principles are applicable for developing improved ICFs, enhancing subject comprehension in clinical research.