Audio-assisted informed consent forms significantly improved the willingness of a sample of primarily African American patients to participate in a mock clinical trial.1 “Clinical trial informed consent language has become increasingly complex and difficult to understand for prospective subjects, regardless of race and ethnicity,” says Brenda Jamerson, PharmD, the study’s principal investigator and an adjunct assistant professor in the Department of Psychiatry and Behavioral Sciences at Duke University. A lack of understanding of medical and research information drives unwillingness to participate in clinical research studies. At the same time, African American and Hispanic communities only account for approximately 10% and 6% of clinical trial participation, respectively.2
Jamerson and colleagues wanted to determine if fostering understanding of informed consent language via audio assistance and teach-back could overcome this disparity. The researchers compared a standard, read-only informed consent form to an audio-assisted approach (both with and without teach-back). The audio assistance software read the informed consent form summary and participants controlled the pace of the text. Audio-assisted presentation of informed consent language improved willingness to participate in clinical trials, but the teach-back component did not. “This might be due to our sample size. Or it could be that audio methods of presenting complex information are effective in themselves,” suggests Jamerson.
Clinical trial researchers have an ethical duty to determine whether a prospective subject understands the information presented in informed consent language, underscores Jamerson. “Fostering appreciation and understanding of informed consent language helps assure subject autonomy. It could also improve recruitment of participants from underrepresented communities who might be prone to distrusting medical research,” says Jamerson.
REFERENCES
- Jamerson B, Shuster B. Evaluation of informed consent with teach-back and audio assistance to improve willingness to participate in a clinical trial among underrepresented minorities: A randomized pilot trial. J Empir Res Hum Res Ethics 2023;18:372-379.
- Turner BE, Steinberg JR, Weeks BT, et al. Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Reg Health Am 2022;11:100252.
Audio-assisted informed consent forms significantly improved the willingness of a sample of primarily African American patients to participate in a mock clinical trial.
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