The impact of HIPAA authorization on willingness to participate in clinical research.

PURPOSE

This study systematically examined the impact of inclusion of Health Insurance Portability and Accountability Act (HIPAA) authorization on the willingness of African Americans of diverse sociodemographic characteristics to participate in a clinical research study and explored reasons for nonparticipation.

METHODS

For a purposive sample of 384 African American outpatients at four metropolitan primary care clinics from August 2005 through May 2006, willingness to participate in a hypothetic clinical research study of an antihypertensive medication under one of two experimental conditions was compared. Interviewees were randomly assigned to undergo informed consent alone (control group) or informed consent with HIPAA authorization (HIPAA group). They were asked whether they would participate and reasons for their decisions.

RESULTS

A smaller proportion of interviewees in the HIPAA group were willing to enroll in the study (27% vs. 39%; p = 0.02), with an adjusted odds ratio of 0.56 (95% confidence interval = 0.36-0.91). Those in the HIPAA group were more likely to give reasons related to privacy (p < 0.001), poor understanding of the form (p = 0.01), and mistrust or fear of research (p = 0.04) for nonparticipation.

CONCLUSIONS

The inclusion of HIPAA authorization within the informed consent process may adversely affect the willingness of African Americans to participate in clinical research and may raise concerns about privacy, understanding the forms, and mistrust or fear of research.