Preconsent education about research processes improved African Americans' willingness to participate in clinical research

Abstract

Objective: To determine whether preconsent education about research processes and protections affects the willingness of African Americans to participate.

Study design and setting: This study examined the willingness of 192 African American outpatients (stratified by age, gender, and education) to participate in a hypothetical clinical study under varying consent conditions: phase I participants underwent a typical informed consent process and were asked to indicate whether they would be willing to participate in the hypothetical clinical study and the reasons for their decision; their responses were used to develop a preconsent educational digital video disk (DVD). Phase II participants viewed the DVD before the consent process. We compared the proportion of those who stated they were willing to participate in the clinical study using Fisher's exact tests and used qualitative methods to analyze open-ended responses.

Results: When the consent process included education about research processes and protections, significantly more patients reported willingness to participate in the hypothetical clinical study (43% vs. 27%; P=0.002). Patients receiving preconsent education were significantly less likely to cite mistrust, fear of side effects, lack of perceived benefits, and privacy as reasons for not participating.

Conclusion: Preconsent education may improve the willingness of African Americans to participate in clinical research and may address important concerns about research participation.