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Author List:
Striplin DT (Ann Arbor HSR&D)
Hayward RA (Ann Arbor HSR&D)
Damschroder LJ (Ann Arbor HSR&D)
Pritts JL (Georgetown University)
Neblo MA (Ohio State University)
Objectives:
The HIPAA Privacy Rule went into effect in April 2003, giving IRBs general guidelines about when researchers can access protected health information (PHI) without permission from patients. Patients’ opinions on this issue are essential but difficult to obtain because the topic is complex and value-laden. We used a mixed-methods approach based upon deliberative democracy theory and methods seeking veterans’ recommendations on how to interpret the privacy rules.
Methods:
Veterans from four diverse study sites were randomly selected and invited to an all-day deliberation session. Short surveys were administered at baseline, during the deliberative session, and at follow-up. 217 veteran patients attended the all-day deliberative sessions across the four sites. They were divided into 8-10 deliberation subgroups at each site (n = 36 subgroups total). After being presented with balanced written materials and brief presentations (followed by Q&A sessions), each subgroup deliberated about considerations important when deciding whether to allow researchers access to PHI without individual authorization.
Results:
Veterans think it is important for the VA to conduct minimal risk research, with 89% of the groups rating it either critically or very important. However, veterans also thought that getting permission to use their record for studies was also critically or very important, but the percent endorsing this view declined after deliberation (78% pre-deliberation vs. 48% post-deliberation; p<0.001). This change remained stable at follow-up 4-6 weeks later. The majority (78%) of groups felt that a procedure for VA patients to give permission to use their records for research should be put in place, with many endorsing a one-time opt-in approach.
Implications:
Veterans believe it is important to conduct minimal risk research in the VA but they also feel their PHI should rarely be used for research without them never having been asked. A one-time opt-in approach was a popular compromise solution that arose spontaneously in many deliberation groups (e.g., “I think it is very important to ask at least once.”) The deliberative process appeared to change several veterans’ opinions and these opinions remained stable at follow-up.
Impacts:
These results deserve careful consideration by VHA and local IRBs in implementing the HIPAA privacy rule.
