Using iterative learning to improve understanding during the informed consent process in a South African psychiatric...

Area of Science:

• Global Health Research
• Psychiatric Genomics
• Informed Consent Process

Background:

• Obtaining informed consent presents challenges in global health research, particularly in low- and middle-income countries.
• Empirical research on informed consent in genomics research within these regions is limited.
• There is a need for tools to assess and enhance participant understanding during recruitment.

Purpose of the Study:

• To investigate the quality of informed consent in a South African psychiatric genomics study.
• To evaluate the effectiveness of the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC) in improving participant understanding.
• To identify predictors of better understanding of research study elements.

Main Methods:

• A Xhosa language version of the UBACC was administered to 528 individuals with schizophrenia and 528 controls.
• Participants underwent screening for capacity to consent and understanding of research study elements.
• Iterative learning was employed to improve understanding, with pre- and post-intervention scores analyzed.

Main Results:

• Initially, 55% of cases and 33% of controls scored below the acceptable understanding cut-off.
• After iterative learning, only 7% of cases and 2.5% of controls remained below the cut-off.
• Psychiatric nurse recruiters, higher education, and being a control predicted better initial understanding.

Conclusions:

• The UBACC is an effective tool for improving research participant understanding of study elements during the consent process.
• Iterative learning using the UBACC is valuable for complex research, including genomics studies.
• The UBACC is particularly beneficial for individuals with severe mental illness and lower education levels, highlighting the recruiter's role in consent quality.