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Health Services Research & Development

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Using Data and Information Systems in Partnered Research

Am I Doing What’s Right? (Navigating Ethical and Regulatory Issues with VA Patient and Operational Data)


by Linda Kok, MA ; Tom Puglisi, PhD ; Nina Smith, MPH ; Sam White,
Seminar date: 11/17/2015

Description: As VA researchers engaged in partnered efforts to improve health care for our Veterans, we all want to do the right thing when it comes to accessing VA patient and operational data. However, we are sometimes uncertain about how to navigate VA’s regulatory environment and do not know where to turn to obtain guidance on what we should do. During this session, panelists will introduce a framework and resources for ethical and regulatory decision-making. They will also answer frequently asked questions, i.e.,
1. As a PhD researcher, can I access the patient medical record?
2. Why do I have to get consent from the patient if I house VA data at the university?
3. When is it necessary to have a data use agreement? What is the difference between a data use agreement and a memorandum of understanding? What is the trigger for needing one?
4. What is VA sensitive data?
5. If my sponsor approves of my accessing VA patient or organizational data, isn’t that enough?
6. I am thoroughly confused now – can I get a consultation with somebody? Who? If you have additional questions, please send them to: https://www.surveymonkey.com/r/CMDHLMX so that speakers can prepare appropriate resources and responses. Objectives: After this session, the audience will: • Become familiar with a framework and resources for ethical and regulatory decision-making for accessing and analyzing VA patient and operational data • Know answers to frequently asked questions/be aware of common issues & conditions in this area Opening Remarks by Joe Francis, MD, MPH, Director of Clinical Analytics and Reporting, Office of Informatics and Analytics

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