Improving the informed consent process for research subjects with low literacy: a systematic review

Area of Science:

• Clinical Research
• Health Literacy
• Informed Consent

Background:

• Low health literacy can hinder participants' understanding of the informed consent (IC) process.
• Effective interventions to improve IC comprehension in low literacy populations require evaluation.

Purpose of the Study:

• To evaluate evidence supporting interventions aimed at improving the informed consent process comprehension for individuals with low health literacy.

Main Methods:

• A comprehensive literature search of MEDLINE and bibliographies was conducted (1966-2011).
• Studies modifying the IC process to enhance comprehension in low literacy populations were selected.
• Data on study design, population, interventions, and outcomes (comprehension via written or verbal tests) were extracted.

Main Results:

• Only six studies met eligibility criteria, involving 1620 participants, predominantly older ethnic minorities with below 8th-grade literacy.
• The teach-back or teach-to-goal methods showed the highest comprehension, while altering readability resulted in the lowest.
• Only one study employed a randomized design, and interventions varied significantly across studies.

Conclusions:

• The evidence base for interventions improving IC comprehension in low literacy populations is very limited.
• One-on-one discussions with study team members appear most effective, but this is based on a single study.
• Further research is crucial to identify and validate effective strategies for enhancing informed consent understanding in diverse populations.