skip to page content
Talk to the Veterans Crisis Line now
U.S. flag
An official website of the United States government

Health Systems Research

Go to the VA ORD website
Go to the QUERI website

HSR&D Citation Abstract

Search | Search by Center | Search by Source | Keywords in Title

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.

Related HSR&D Project(s)


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.

Questions about the HSR website? Email the Web Team

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.