Institutional Accountability for Research

1
Institutional Accountability for Research

• Joseph Francis, MD, MPH
• Deputy Chief RD 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)
• RD 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

• Dont 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 dont
  oversimplify
• Accidents happen anticipate what you can but
  build capacity to learn respond

Weick and Sutcliffe, Managing the Unexpected, 2001