Compliance 101

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Compliance101
The pieces really can fit together truly!

• Lynette M. Schenkel
• Director, Responsible Conduct of Research
• University of Oregon

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You hoped compliance was supposed to make life
like this.
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But it really feels like this
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Todays Puzzle Strategy

• Lets find the edge pieces first
• Do you have any identifiable pieces?
• Grouping pieces into similar colors
• Those must have pieces
• It takes a whole team to make
• The perfect fit

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Finding the Edge Pieces

• Federal Agency Rules Regulations
• NIH, NSF, DoE, DoD, OHRP, OLAW, etc.
• State Laws
• Your Institutions Policies
• But Lets take a closer look at HHS-OIG recently
  published DRAFT guidelines (included in your
  materials as Attachment 1)

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OIG Compliance Guidance

• For recipients of PHS Research Awards
• To assist in preventing fraud and abuse
• Focused specifically on grant compliance and
  administration issues
• Contains 8 elements widely recognized as
  fundamental to an effective compliance program

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Federal Sentencing Guidelines
(Or, rules will set you free.)

• Implementing written policies procedures
• Designating a compliance officer compliance
  committee
• Conducting effective training and education
• Developing effective lines of communication
• Conducting internal monitoring and auditing
• Enforcing standards through well-publicized
  disciplinary guidelines
• Responding promptly to detected problems
• Defining roles responsibilities and assigning
  oversight

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COGR Response to Guidelines
Attachment 2

• We disagree with proposed guidelines
• HHS NIH have provided and continue to provide
  extensive guidance in the broad area of pre- and
  post-award management and the ethical conduct of
  research
• Because guidance issued by OIG, grant recipients
  will likely view and auditors will treat it as
  mandatory, not as guidance.
• Promotes proliferation of similar guidance by
  other federal agencies

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List of Existing Policy-Guidance

• NIH Grants Policy Statement
• Compendium of Findings Observations
• Resulting from the Proactive Compliance Site
  Visits conducted by NIH Office of Extramural
  Research
• ORI - Model policies for managing research
  misconduct
• OHRP IRB Guidelines
• OLAW Guide for the Use of Laboratory Animals
• NIH Objectivity in Research Policy
• HHS-NIH Regulations, policies, guidance
  regarding stem cells, recombinant DNA, select
  agents
• COGR Managing Externally Funded Programs at
  Colleges and Universities
• AAMC Manuals on the Management of Academic
  Medical School Research Programs
• NCURA Regulation Compliance (compendium)

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OIG Thoughtful Considerations

• Rely on the 8 basic elements, but develop your
  program suited to your needs
• MAY require a significant commitment of time and
  resources.
• Institutions may also want to note that several
  of the elements of this compliance guidance are
  considered mitigating factors that must be
  considered as part of a formal debarment action
  by the OIG Department.
• (45 CFR 76.870(l), (n), (p), and (q))
• http//a257.g.akamaitech.net/7/257/2422/12feb20041
  500/edocket.access.gpo.gov/cfr_2004/octqtr/pdf/45c
  fr76.860.pdf (Included in your handouts as
  Attachment 3)

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Written Policies Procedures

• Should be provided to all faculty members and
  other employees who are affected by them, to
  students who may be conducting research and to
  any agents or contractors who may furnish
  services in connection with research awards.
• Are yours web available?
• Have you determined how your policies are
  practically implemented?

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The Compliance Officer

• Designate a CP who will have day-to-day
  responsibility for overseeing and coordinating
  the compliance program.
• Designating a CP with the appropriate level of
  authority is critical to the success of the
  program.
• Should have direct access to the governing body,
  senior administration legal counsel.
• Should have sufficient funding, resources staff

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Compliance Committee

• Should have representation from operations,
  finance, audit, human resources, and legal as
  well as faculty members.
• Should have the requisite seniority and
  comprehensive experience to recommend and
  implement any necessary changes to policies and
  procedures.

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Effective Training

• Should include administrators, both at the
  institution and dept. levels, faculty (including
  PIs), other staff, and contractors.
• Areas of training may be identified through
  internal audits, monitoring, review of past
  problems.
• General and specific training should be provided
  both upon initial employment as well as on some
  periodic schedule.

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Effective Communication

• Develop confidentiality non-retaliation
  policies
• You must be prepared to balance this
• Use hotlines, email, newsletters, suggestion
  boxes, etc.
• Employees should be permitted to report matters
  on an anonymous basis

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Auditing Monitoring

• Reviews should be focused on particular areas of
  activity
• Post-award grant monitoring follow the money!
• Post-approval protocol (animal human subjects)
• Environmental health safety
• The reviews should evaluate whether
• The institution has polices covering the areas of
  risk
• The policies were communicated implemented
• The policies were followed

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Enforcing Standards

• Clear and specific disciplinary policies should
  set out the consequences of violating Federal,
  State requirements, the Institutions code of
  conduct or its policies procedures.
• Each situation must be considered on a
  case-by-case basis, taking into account all
  relevant factors.
• Intentional and material non-compliance should
  not be tolerated.

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Responding Promptly

• CP must immediately investigate allegations to
  determine whether a material violation has
  occurred.
• The institution should promptly report the
  existence of misconduct to the appropriate
  authorities (within 60 days)
• Provide information regarding which law was
  violated, potential financial and scientific
  impact

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Roles Responsibilities

• Ignorance is not bliss know your part
• Compliance is not solely the CPs responsibility
• More on this later!
• The Institution may be the responsible legal
  entity but the PI accepts responsibility for
  the scientific conduct of the project
• Departmental Administrators must not only be
  accountable, but equally importantly, be
  supported and protected.

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• Individual ethical behavior is likelier to
  flourish within a just society. So in order to
  lead an ethical life one should work for a just
  society. That is, if most of us will behave
  about as well as our neighbors, it is incumbent
  on us to create a decent neighborhood.
• Randy Cohen
• The Good, the Bad and the Difference

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Do you have any identifiable pieces?
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Begin With What You Have

• Take stock of your resources
• Make note of and communicate your gaps to the
  people with the purse strings.
• Tell horror stories if necessary
  (hopefully they wont come from your
  institution.)
• Catalyzing Events

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Reasons to Invest in Compliance

• 1998 University of Minnesota settles with
  Government for 32M for profiting from sales of
  an unlicensed drug
• Expanded Authorities removed for 3 years, 55
  required Corrective Actions T. Schumacher,
  Dir., Office of Institutional Compliance, Univ.
  Minnesota NCURA conference, Nov. 2003
• University estimates that by 2004 it had spent an
  additional 48M to recover reorganize NCURA
  Conference, July 2004
• Chair of Surgery asked to resign (1994) and
  indicted on 18 felony counts (later exonerated on
  all counts) Time Magazine 05/11/95
• Consulting group brought in to help reorganize
  concluded tenure was a major obstacle to
  re-engineering, sparked 1996 Tenure War
  American Association of University Professors,
  ACADEME, Vol 85, 6 (1999)
• Marked decrease in NIH awarded funds American
  Association of University Professors, ACADEME,
  Vol 85, 6 (1999)

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Build on Your Existing Resources

• Sponsored Programs Office
• Pull together your policies
• Can you build from IRB IACUC resources?
• What help can central business office provide?
• Communicate, educate, implement

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Grouping Pieces into Similar Colors

• Create a compliance website that holds all
  available information from all areas.
• Appoint one individual (if you dont have a CP)
  to be responsible for overseeing and advising
• Keep your various groups talking (nascent
  compliance committee)

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Those Must Have Pieces
HHS Designated Risk Areas

• Time Effort Reporting
• Institutions must have effective timekeeping
  systems
• Must have accurate consistent treatment of
  institutional base salary (IBS)
• Proper Allocation of Charges to Projects
• It is fraudulent to bank or trade awards between
  personnel, or charges amongst awards.
• Cost Sharing
• The reporting of other financial support is a
  required elementfailure to provide this
  information could subject an institution
  tocriminal investigation.

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Those Must Have Pieces
2006 OIG Work Plan Attachment 4

• Conflicts of Interest (COI)
• Must have written policy, must report to NIH
  PIs COI how it has been managed, reduced or
  eliminated
• Time Effort Reporting
• Sub-contract Costs Monitoring
• We are responsible to know whether or not our
  sub-recipients have met their audit requirements
  (site visits, review of perf., financial
  reporting, risk assessments)
• University Administrative Clerical Salaries
• Are support staff, clerical grant
  administrators being incorrectly charged as
  direct expense?
• Cost Transfers
• Are they allowable, are they properly documented?
  NIH total cost transfer are approaching 20
  Billion annually

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Those Must Have Pieces
NSF 2006 Audit Plan Attachment 5

• Proper Allocation of Charges to Projects
• Subcontract Costs Monitoring
• Close Out Award Financial Management
• Disposition of Federally owned property
• Overstating IDC recovery
• Hurricanes Katrina Rita
• The NSF has gt60 awardees in the states effected
  by the hurricanes.
• Transfer awards for faculty students
  temporarily at other institutions supplemental
  funding requests fund grants studying the quick
  response on natural disasters.

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On Site Review Modules Used during the Site Visit
to Conduct the Review of Targeted Areas

• Time effort reporting for personnel
• Fringe benefits
• Travel
• Consultants
• Cost Sharing
• Participant Support
• Indirect Costs
• Procurement
• Subrecipient Monitoring
• Property

Director, Division of Institution and Award
Support
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Take note of the overlap

• Time Effort Reporting
• HHS-OIG
• Allocation of Charges-Cost Transfers
• HHS-OIG-NSF
• Subcontracts Monitoring
• HHS-NSF

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It Takes a Whole Team
Roles Resp Matrix Attachment 6

• First Base The PI
• Second Base Dept Grants Admin.
• Third Base IRB, IACUC
• Pitcher Sponsored Programs Office
• Home Base Institutional Official
• Short Stop Compliance Officer
• Outer Field Ancillary Support Services
• Umpire Agency Auditors Administrators

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Event versus Operational Compliance

• Compliance Officers
• Write policy
• Help PIs, departments, schools create processes
  and procedures
• Provide education or are an educatory resource
• Investigate issues of Non-compliance

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Event versus Operational Compliance

• PIs, Dept Personnel, SPOs
• Incorporate principles of policy into their daily
  work
• Have a general knowledge of applicable
  regulations and work accordingly
• Handle day-to-day issues on their own
• Call upon the CP as needed

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Striving for the Perfect Fit

• "For a scientist research administrator,
  integrity embodies above all the individual's
  commitment to intellectual honesty and personal
  responsibility For an institution, integrity
  is a commitment to creating an environment that
  promotes responsible conduct by embracing
  standards of excellence, trustworthiness, and
  lawfulness"
• - Integrity in Scientific Research, The National
  Academy of Sciences

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Striving for the Perfect Fit

• the effectiveness of an ethics and
  compliance program is not only measured in terms
  of the channels and messages it uses for
  communicating with employees it is also
  effective in terms of the ways and extent to
  which it institutionalizes itselfOne way to
  institutionalize itself is the command-and-control
  structure that sets up the program, designs its
  policies and procedures, and communicates them to
  the organization.

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Striving for the Perfect Fit

• The otherand far more effectiveis the
  participatory structure that seeks the
  participation of employees, managers, officers,
  and directors (and other stakeholders, as
  appropriate) in the design, implementation, and
  evaluation of the programThus, if an ethics and
  compliance program is going to be truly
  effective, it will need to become simply the way
  the organization goes about its business.
• - Justification for Suggested Changes to Proposed
  Amendments to FSGO Stuart Gilman, Robert Olson,
  Michael Hoffman.

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Questions?
schenkel_at_uoregon.edu