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Enhancing Institutional Accountability in Research

Understanding the importance of local accountability in research institutions, focusing on ethics, privacy, security breaches, and the impact of adherence to regulations. Explore key functions and responsibilities for maintaining trust and compliance.

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Enhancing Institutional Accountability in 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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