BACKGROUND: Implementation of the HIPAA privacy rule in 2003 has had a measurable impact on researchers’ ability to invite patients to participate in research. This impact has not been well characterized in studies using cancer registry data in the US for drug safety studies. An ongoing 10-year surveillance program enables assessment of patient access pathways and their impact on the research process.
OBJECTIVES: To characterize the impact of various patient access pathways across 14 registries (10 state, 1 SEER regional, 3 comprehensive cancer centers) participating in a surveillance study.
METHODS: A variety of patient access pathways for release of information are required by the registries before patients with osteosarcoma can be interviewed regarding prior medication exposure. Registries were grouped into categories of similar patient access pathways. We performed a descriptive analysis of the impact of the pathways on telephone interview completion rates.
RESULTS: Between June 2004 and December 2008, 14 registries joined the surveillance program; 5 distinct pathways for accessing patients were identified. Of these pathways, the one that yielded the highest interview rate among identified cases (46%) was the one in which the patient’s MD is notified and allowed to decline before RTI contacts the patient by telephone. The lowest interview rate (19%) was for the pathway requiring doctors and patients to complete a release form prior to telephone contact.
CONCLUSIONS: More restrictive patient access pathways correlated with lower interview rates and impeded progress in monitoring drug safety in this study. No breaches of patient confidentiality have occurred in any of the 5 consenting pathways used in this study, therefore an increased privacy benefit from the more restrictive pathways is not obvious. Actual study experience could be useful as institutions consider revising privacy policies following an initial overreaction to HIPAA.
