WHO IS WATCHING WHAT ARE THEY WATCHING WHY SHOULD I CARE

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WHO IS WATCHING?WHAT ARE THEY
WATCHING?WHY SHOULD I CARE?

• WHAT SHOULD I DO?

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RASG Meeting January 19, 2005

• Adrian A. Shelton
• Research Compliance Officer
• adrian_shelton_at_unc.edu
• 962-0338

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WHO IS WATCHING Research?

• FEDERAL REGULATORS
• DOJ grant funding, false claims, etc effort
  reporting, salary reporting, cost allocation,
  research billing, HE stem cell research regs
• HHS human subjects research review, informed
  consent, scientific misconduct
• Various Export controls, data and materials
  security

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WHO IS WATCHING Research?

• STATE REGULATORS
• Accounting practices
• Much more information on this topic will come
  from Stan Koziol

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WHO IS WATCHING Research?

• UNIVERSITY ADMINISTRATORS
• Campus research review processes
• OSR and OCT
• IRB
• IACUC
• COI
• EHS
• OTD

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WHO IS WATCHING Research?

• THE PUBLIC
• Conflict of Interest
• Informed Consent

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WHAT ARE THEY WATCHING?

• IRB review and approval for all human subjects
  research
• Informed consent
• Resource accounting
• Cost allocations, salary reporting
• Time and effort certifications
• Clinical research billing
• Research information availability (COI,
  publication restrictions, etc.)
• Research information security issues (HIPAA,
  export controls, classified research)
• Research materials controls (HE stem cells,
  select agents, etc)

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WHY SHOULD I CARE?

• The Department is responsible for
  administering the research contract or grant
• Department judges PI is competent to perform this
  research
• Department gives approval for PI to perform this
  research as described
• Department is responsible for ensuring that
  resources are accurately budgeted and approved
  for this research
• Department is responsible for ensuring that
  regulatory requirements are met by PI.

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WHY SHOULD I CARE?

• CRIMINAL PENALTIES
• FINANCIAL PENALTIES
• LOSS OF RESOURCES
• BAD PUBLICITY AND LOSS OF GOODWILL/SUPPORT
  (internal and external)
• OPERATIONAL RESTRICTIONS
• ADDITIONAL COSTS

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WHAT SHOULD I DO?At the beginning of the
research project

• Review the IPF carefully for accuracy and
  completeness because it includes significant
  department obligations for the life of the
  project. This is the most cost effective time to
  head off potential problems.
• Are all resources (personnel, funds,
  facilities, equipment, materials) accurately
  budgeted and approved? Are all the relevant
  costs included? Are the costs accurately
  calculated? Is cost matching identified?
  Approved? Is the percentage effort reasonable
  relative to existing obligations?

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Review the IPF carefully for accuracy because it
includes department obligations

• Are security issues adequately understood and
  addressed?
• Classified research, export controls (includes
  regs re foreign nationals participating in the
  research, travel, data sharing, etc), proprietary
  or other confidential information, very sensitive
  materials (select agents, human embryonic stem
  cells, etc.)

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Review the IPF carefully for accuracy because it
includes department obligations

• Have all required institutional reviews occurred?
  
• Institutional Review Board
• IACUC
• Conflict of Interest
• Institutional Biosafety Committee
• Radiation safety
• Lab Safety

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WHAT SHOULD I DO?At beginning of research project

• Support the initial contract and grant review
  process
• What would happen if we just hurried up and
  signed the agreement without review and
  negotiation? Isnt it mostly just petty
  wordsmithing?
• What about PI signing agreements that do not
  include payment obligations?

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Provisions that can come back to create
significant trouble words have real meaning

• Additional performance requirements that create
  costs not included in the budget (additional
  reports, deadlines, security obligations, etc.)
• Financial restrictions (cant spend money as PI
  thought)
• Publication restrictions (cant publish as PI
  plans)
• Personnel restrictions (cant include the grad
  student planned)
• Certifications that are fraudulent (e.g. COI not
  adequately disclosed and reviewed)
• Intellectual property transfers (PIs output
  owned by second party)
• Restrictions on PIs other research

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WHAT SHOULD I DO?During the research project

• Check to ensure required annual reviews are
  occurring - IRB, IACUC, COI etc
• Ensure that effort certification is timely and
  accurate
• Document all cost sharing
• Avoid late cost transfers and make sure to have
  appropriate justification for any that occur
• Maintain supporting documentation for all costs
• Any budget or personnel changes comply with
  requirements for reporting and approval
• Program income must be reported
• On time delivery of required PI reports or other
  deliverables

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WHAT SHOULD I DO?At the end of the research
project

• At end of research project
• Timely final reports and deliverables of PI
• Timely final accounting of revenues and
  expenditures including adjustments and cost
  transfers and any residuals

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WHAT SHOULD I DO?PI is leaving UNC-Chapel Hill

• Exit checklist Prior to PI departure
• Unexpired contracts or grants for PIs research?
  Notify OSR and OCT
• Human subjects research? Notify IRB
• Animal research? Notify IACUC
• Research animals? Notify DLAM
• What is disposition of PIs UNC-CH lab
  facilities, equipment, materials? Notify EHS
• Unsponsored research projects? Clarify
  arrangements for students or other trainees, co
  investigators, etc.
• Intellectual Property (licensing agreements,
  etc)? Notify OTD

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How can we help each other?

• Call OSR or other research review unit or
  Research Compliance Officer for help if questions
  or concerns arise.
• Collaborate on checklists and other tools
• Other ideas?