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Institutional Accountability for Research

Institutional Accountability for Research. Joseph Francis, MD, MPH Deputy Chief R&D Officer (acting) Department of Veterans Affairs. Politics + Money = Accountability. Etymology Roman Senate: “Stand up and be counted” 17 th Century: “Answer for” money held in trust Ethical Principle

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Institutional Accountability for Research

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  1. Institutional Accountability for Research Joseph Francis, MD, MPH Deputy Chief R&D Officer (acting) Department of Veterans Affairs

  2. Politics + Money = Accountability • Etymology • Roman Senate: “Stand up and be counted” • 17th Century: “Answer for” money held in trust • Ethical Principle • Bible: parable of talents • Austin, 1956, “A Plea for Excuses” • Political science: Key principle of good governance • We receive $33B to care for 7.6M enrolled veterans!

  3. Why ‘Local Accountability’ in Research? • Trust - depends on local actions • Timeliness – scrutiny is on the rise • Big $ in science and health care • Changing sensibilities & perceptions • Privacy & confidentiality • Animal rights • Limits of central actions

  4. Take Home Messages • Every facility has to answer for its actions • The VAMC Director is the Institutional Official (“Go to Jail Guy”), but functions are done by • Research Office (day-to-day management) • R&D Committee & subcommittees (oversight and review) • Key functions: • Set the tone • Educate • Support • Verify

  5. Local Responsibilities • Local Knowledge: context, capability, culture, community attitudes • Local Investigator Oversight • Training, support, resources • Credentialing • Monitoring • Adverse Event Reporting

  6. Recent VA Security Incident • May 3: Break-in and theft of laptop & hard drive belonging to a VA policy analyst • Personal information of 26.5 million veterans and 2.2 million military personnel • May 16: Secretary notified by senior officials • May 22: Congress & public notified • June 6: Class Action lawsuit filed • June 21: Free Credit Monitoring offered • June 29: Laptop & hard drive recovered

  7. Concerns regarding VA Research & Cyber-security • Large data sets with PHI & individual identifiers • VA leads the nation in the electronic health record • VA also receives Medicare Data about veterans • Genomic medicine initiative raises new concerns • VA investigators have university appointments and collaborators • Abundance of portable devices and storage media • VA data may reside outside of VA firewall • Perception that researchers are indifferent to rules

  8. OIG Observations on Security Breach • No policies on use of files/datasets derived from central VA data sources • “Fascination project” pursued without explicit authorization • Old data files & multiple back-up copies • Indifference to magnitude of potential harm & lack of a sense of urgency

  9. High Stakes • Assuring compliance protects subjects and facilitates research • May also protect the researcher • Negative publicity impacts the local research program, VA research in general, and VHA health care • Our very existence may be threatened

  10. Lessons from High Reliability Organizations • Don’t be tricked by success • Listen to people on the front line • Avoid panic – it keeps you from seeing the solutions • Life is complex and unpredictable – don’t oversimplify • Accidents happen: anticipate what you can but build capacity to learn & respond Weick and Sutcliffe, Managing the Unexpected, 2001

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