Impact of the Health Insurance Portability and Accountability Act on participant recruitment and retention.

Recruiting and retaining an adequate sample is critical to the success of any research project involving humans. Recent reports indicate that the Health Insurance Portability and Accountability Act (HIPAA) privacy rule has adversely affected research. Few resources are available to help researchers navigate the challenges to recruitment and retention after HIPAA privacy rule implementation. This article addresses obstacles to recruitment in prospective clinical research studies related to the HIPAA privacy rule, as well as HIPAA-compliant strategies to enhance recruitment and retention. Recruitment challenges discussed include evolving interpretations of the HIPAA regulations, inability to directly contact potential participants, complexity of HIPAA-required documents, increased costs of recruitment, and an expanding administrative burden. Among the strategies addressed are preparatory research reviews, using clinical collaborators and staff liaisons, prescreening potential participants, minimizing participant burden during the consent process, enhancing participant follow-up, facilitating recruitment for future studies, and streamlining compliance training for staff.