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Translation Research Barriers: Adverse Events Reporting

Mittman D, Ritchie MJ, Simon B, Chaney E, Bonner L, Simons C, Oken C. Translation Research Barriers: Adverse Events Reporting. Paper presented at: VA QUERI National Meeting; 2003 Dec 10; Washington, DC.

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Abstract:

Objectives: Investigators are required to report adverse events (AE's) to alert IRBs to actual harms and potential safety risks to study patients. Yet for QUERI low risk studies, where naturally occurring events unrelated to any research action may nevertheless require an AE report, the greater harm may be to patient privacy and confidentiality. Additionally, these reports may distort IRB assessments of risk level, perpetuating barriers to translation research. As part of the evaluation of TIDES, a QUERI translation project, a 4 step process was implemented for complying with AE reporting requirements.Methods/Approach: We carried out a survey with 750 veterans in primary care in 9 regionally diverse VAs, to detect and assess depression. The survey has the potential to detect suicidal thoughts, in as much as 3% of the sample. Each such detection is considered a potential AE. Our process consisted of 1) creating an abstraction tool to assess variations in site adverse event definitions and reporting requirements. (2) developing through an expert review process a study-related AE definition 3) developing criteria and protocols for contacting the site-PI (4) allowing each site PI to determine whether the AE fit their site's definition and to report the event as appropriate.Results/Findings: Out of 170 respondents reporting suicidal thoughts, only two required an AE report. Others were assessed by study clinicians as being of low risk for carrying out these thoughts. Many were already in treatment.Implications: Translation research implementation may be impeded by IRB regulations related to adverse event reporting. IRB's must be guided to develop consistent definition and reporting requirements for translation studies that reduce these impediments, as well as risks of confidentiality and privacy breaches. A multidisciplinary expert panel including ethicists and HR researchers and supported by national leadership would advance this process.





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