Research Compliance Update

1
Research Compliance Update

• UC Berkeley RAC Forum
• May 8, 2007

2
Standing Topics Reports from Workgroups

• Humans Subjects
• Animal Welfare Regulation
• Data Management
• Conflict of Interest Issues
• Export Controls
• Research Integrity and Misconduct

3
Human Subjects Outsourcing IRB Review

• NCI and multi-site clinical trials
• UCSD and UCLA reviewing Western IRB capabilities
• VP November 2005 letter to campuses
• Possible benefits
• Quicker turnarounds (10-14 days after receiving
  complete package)
• Systematic monitoring quarterly surveys and
  annual visits

4
Human Subjects Outsourcing IRB Review

• Potential issues
• Speed review of complete packages
• Unclear on how much savings would result if
  campus IRB still receiving reports and assisting
  with packages
• Liability and indemnity issues
• Reviews limited to less complex studies and
  trials?
• Review by Regents?

5
Human Subjects Issues

• OHRP guidance on engagement
• Operation of intercampus MOU
• Expedited research only
• Implementation challenges online database
• UM pilot program SBR
• Alternative to Common rule
• 3-yr term, staff review, faculty make exemption
  determination

6
Human SubjectsFWA To Check or Not to Check

• FWA
• Certify that institution follows Common Rule
• Optional follow regardless of source of funding
• AAUP report nationwide trend to uncheck the box
• Current UC policy must apply CR regardless of
  source of funding or whether funded

7
Human SubjectsFWA To Check or Not to Check

• Consequences of not checking
• Does not give OHRP jurisdiction over
  non-federally-funded studies
• Easier to perform SBR with pregnant women?
• Application of CA law
• Additional financial disclosure requirements
• Minor consent issues
• Change in UC policy to uncheck

8
Data Management Guidelines

• Regulation 4 (1958)
• Report of essential data and final research
  results must be filed with UC
• Lab notebooks and other original research records
  are the property of the University
• Disputes over data
• When researchers leave UC
• Between faculty and grad students

9
Data Management Guidelines

• Not a policy only guidelines
• Research data belongs to University PI is the
  steward of the data
• Research data recorded information related to
  a research study and documentation require to
  reproduce results

10
Data Management Guidelines

• Research data does not include materials or
  biological samples
• PIs maintain data in accordance with federal
  rules, maintain for at least 6 years, longer for
  IP or misconduct reasons
• Students may not independently publish results
  without permission of PI
• If PI leaves, University reserves right to access
  data produced at University

11
Animal Welfare Regulation

• White paper on model animal welfare program
• Uses organizational model beginning with
  chancellor
• Role of IO
• Staffing
• Relationship to IACUC
• Relationship to School of Medicine

12
Animal WelfareOrganizational Model
13
Animal Welfare Issues

• Consulting Veterinarian activities
• New vets or new programs (UCI, UCSB, UCR, UCM)
• Animal Directors meetings
• IACUC Workgroup
• Just established
• Planning for first meeting

14
Animal Welfare Issues

• NIH Policy on Allowable Costs for Animal
  Activities
• Public Records Act requests
• Coordinated responses to systemwide requests
• Protecting researchers names and locations
• Coding sensitive information
• Information available on the Web

15
Conflict of Interest Issues

• Financial interest disclosure in human subject
  consent forms
• Detail on financial interest
• Litigation-driven
• IRB may need to get involved in reviews of HS
  studies
• OGC drafting systemwide model
• Institutional COI
• Triggers, who reviews, how, how managed
• Findings from NIH site visits
• Redefine investigator not just key personnel

16
COI Briefing for Researchers

• Ethics, COI for Designated Officials, COI for
  Researchers
• Defined population
• Content
• Federal rules
• State rules
• Journal policies
• Conflict of commitment

17
Financial Controls

• Online effort reporting system
• SAS no. 112
• Applies to UCs external auditors
• Significant deficiency and strong indicator of
  material weakness
• For complex entity in highly regulated industry,
  an ineffective regulatory compliance function.
• Could factor control weakness could have
  resulted in error that was material to financial
  statement even if known error was not.

18
Stem Cell Update

• Training grants and research grants awarded
• Litigation expect appeal of lower decision,
  possible resolution by summer
• Internal discussions on overhead
• CIRM funds some items as direct charges
• Replacement of state funds

19
Research Misconduct

• University Committee on Academic Freedom request
• Investigation statistics
• 2005/06 10 complaints at UCD 0 at UCR
• Ongoing investigation for gt2 years
• Cost of defense?
• Not defense of litigation
• University investigatory committee
• ORI Model Policy

20
Controlled Substance Program

• Off-site clinical use
• DEA taking different approach with UCSF and UCSD
• Greater role for EHS
• Revision of BUS-50

21
Export Control Issues

• DEAC Activities
• Meeting in Santa Clara
• Membership
• Scope of work
• UC comments
• Deemed export rule is cumbersome but can work if
  FRE is not limited
• Technology covered under deemed export rule
  should be limited or have sunset provisions

22
Export Control Issues Software Terms and
Conditions

• Promise to follow U.S. export laws ok
• Promise not to share with foreign nationals
• Promise not use ECI information in program to
  engage in nuclear proliferation or otherwise
  create WMD

23
Export Controls Meeting with BIS Representative

• Outreach to colleges
• Learn about UC strategy
• Use the Fundamental Research Exclusion
• Dont accept publication restrictions
• Dont accept citizenship restrictions
• Collaborative international research

24
Future Directions in Compliance

• OP Chief Compliance and Audit Officer
• SAS No. 112
• Training
• Increased federal inspections