HSR&D Citation Abstract
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Confidentiality & Privacy Risks in Adverse Event Reporting for HSR&D Studies
Simon B, Mittman D, Bonner L, Ritchie MJ, Oken C, Simons C, Chaney E. Confidentiality & Privacy Risks in Adverse Event Reporting for HSR&D Studies. Paper presented at: VA HSR&D National Meeting; 2004 Mar 10; Washington, DC.
Objectives: In HSRandD studies, adverse events are usually natural occurrences unrelated to any research action. AE polices may not benefit patients in naturalistic studies but may adversely affect patient privacy and confidentiality. Our objective is to assess variations in AE policies as applied to a multi-site depression survey.Methods: We carried out a survey to detect and assess depression in 750 veterans in 9 regionally diverse VAs. The survey has the potential to detect severe suicidal thoughts in as much as 3% of the sample; each such detection is considered a potential AE. Study procedures require supportive intervention, but may also require reporting of confidential information to IRBs. We used an abstraction tool to assess for reporting requirements in AE policies in VA and VA-affiliated IRBs.Results: Wide AE reporting variation exists across the 9 sample AE policies. Information investigators are required to report ranged from 5 or more identifying items (name, SSN, DOB, Medical Record #, Date of Death, Date of Event (1 site) to none (2 sites)Conclusions: AE reporting requirements involving patient identifiers vary widely across sites, putting patients at varying risk for loss of privacy and confidentiality.Impact: Given variations in AE reporting, HSRandD multi-site studies must consider AE reporting as a potential source of privacy and confidentiality loss; patients are entitled to know what will reported if an adverse event occurs during the course of study participation. Further study is needed to determine how to prevent and disclose such loss in naturally occurring AE's for HSRandD studies.