Small Business Subcontracting Plans by LiamMessam

VIEWS: 14 PAGES: 98

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FINANCIAL COMPLIANCE
UPDATE

TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009

 Pat Dodson
 Sponsored Projects Accounting
    FINANCIAL COMPLIANCE UPDATE
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        Guidelines for Cost Transfers
        Guidelines for Effort Reporting
        Summer Pay
        Supplemental Pay
        Termination Checklist
        Other Items of Interest
    COST TRANSFERS
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     Reminder that cost transfer policy was updated as of Sept
       5, 2008
        Can be found on ABS web site –
        http://abs.colorado.edu/ABS_WEB/policies/costtrans
          fer.pdf

     Cost transfers (aka JEs) require specific format and
       documentation
        Sponsors and auditors review these
        Need to easily and readily identify them
        JEs represent a potential problem area
        See handout for summary guidelines
    EFFORT REPORTING
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      Reminder that effort reporting (ePERs) policy was
      updated as of June 3, 2008
       Can be found on ABS web site –
       http://abs.colorado.edu/ABS_WEB/policies/epers.pd
        f

      Because salary represents ~70% of total charges to
      projects, this is key issue to Federal sponsors
       Effort needs to be expended in the time period for
        which you were paid
       Shouldn’t bill wages for 3 months of summer if on
        vacation or writing proposals
    SUMMER SALARY
5

    Salary amounts that can be earned during summer & that can be
    charged to sponsored projects are directly related to Faculty
    member’s AY Salary, referred to as Base Salary

       Definition: AY salary is the sum paid in consideration of normal
        services rendered during AY, described as 9/9th of an AY faculty
        member’s salary

       A-21 states ―In no event will charges to sponsored
        agreements…exceed the proportionate share of the base salary
        for that period.‖
         And -- Charges for work performed by faculty members on
          sponsored projects during the summer will be at the monthly rate
          of the base salary [for AY, generally 1/9th]
         In other words, one month in summer = one month of base pay
    SUMMER SALARY (cont’d)
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     Summer Salary Limitations are also supported by UCB policy
      The July 2001 ―Boulder Campus Policy on Additional Pay to
       Regular & Research Faculty‖ says AY= allows a maximum of
       additional 3/9ths to be earned in salary for activities
       conducted in summer months, not to exceed 1/9th per month
      3/9ths for summer salary includes:

        Any salary paid from sponsored projects
        Summer teaching for either summer school or continuing ed
        Maymester is summer teaching, not AY overload
        Administrative stipends (i.e., Dept Chairs and Faculty
         Directors)
    SUPPLEMENTAL PAY
7


     During AY
     o UCB 2001 Policy:

       o Prohibits AY faculty from supplementing their 9/9ths
         salary with grant funds or other university research
         salary during AY

        o   May substitute some base salary with grant dollars if
            workload is adjusted
             o Needs permission of Dean
             o course buyout reduces university-paid salary
             o monthly base salary remains unchanged
    SUPPLEMENTAL PAY (cont’d)
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     Allowable Additional Compensation not included in base salary
     UCB 2001 Policy:
     o Overload teaching during AY – those activities in excess of teaching
        activities expected as part of the defined workload formula

     o   Service that includes responsibility when it is not a regular and
         ongoing component of normal workload

     o   Monetary awards for exceptional service, teaching, research, or other
         contributions

     o   Compensation for consulting activities with entities not associated with
         the university
          o Dollar amount not restricted
          o Amount of time faculty can devote to consulting during AY is
            restricted to 1/6 of total time and effort
    SALARY LIMITATIONS
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    External Salary Caps
      Federal:
       o Some federal agencies require salary cap for employees
         working on projects they fund
       o Current NIH cap (through 12/31/09) is $196,700

       o NSF will pay only 2 months effort in calendar year


      Private Agencies:
      o Some private agencies also set salary limits, such as American
         Cancer Society

      To know if there are limits, look at the Additional Terms and
        Conditions Attachment of the Notice of Grant Award
     OTHER ITEMS OF INTEREST
10


      ARRA (American Recovery & Reinvestment Act of 2009):
       We know there are many reporting requirements tied to this
        money but don’t have details
       We have taken steps to identify these funds within UCB so
        they can be segregated and accounted for
      Checklist guide for terminating PIs:
      o See handout for this tool
      o PIs have additional responsibilities that need to be
        addressed before they leave
      Reassignment of some duties in SPA compliance area:
      • JEs now approved by Jim Sheppard
      • ePERs now responsibility of Hua Xu
      • PET approvals still handled by Hua Xu
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     SPA ePER CONTACTS
     Pat Dodson : Internal Compliance Coordinator
          Pat.Dodson@colorado.edu
     Hua Xu: PET, PO & SPO Req approver; ePERs specialist
           Hua.Xu@colorado.edu
     Jim Sheppard: JE approver
          James.Sheppard@colorado.edu
     Demetria Ross: Cost Sharing; ePERS back-up
          Demetria.Ross@colorado.edu

     See the UCB ABS website for ePERS policy and info on
       training opportunities http://abs.colorado.edu/
     General contact address: spa@colorado.edu
                                       12




AUDITS IN THE
COMPLIANCE AREA


TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009
Jean Stewart, Director
Internal Audit
13   AUDITS IN THE COMPLIANCE ARENA
     University of Colorado Internal Audit
     Jean Stewart, Director

     1800 Grant St. Ste #600
     Denver, CO 80203-1185

     (303) 837-2200
     www.cu.edu/audit
     FEDERAL REGULATIONS
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                                       Biosafety,
                                       Radiation,
                          Financial   Haz Materials
                           Status                     Contracting
                          Reports



               Cost                                              Grants
            Accounting                                        Administration




             Scientific                                        Animal Use
            Misconduct                                          & Welfare

     USDA
                                                        Human
                      Conflicts of                     Subjects
                       Interest                        Research
                                         Export
                                        Controls
     WHAT’S THE WORST THAT CAN HAPPEN?
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          Loss of funding
          Legal liability – individual/organizational
          Institutional suspension
          Compliance integrity agreements
          Harm to institutional reputation
          Harm to researcher reputation
          Loss of public trust
     WHAT’S THE WORST THAT CAN HAPPEN?
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                                       Florida International Univ
                                         Effort Certification &
                                              Direct Costs
                                             $11.5 million              Johns Hopkins Univ
      University of Minnesota
                                                                         Effort Certification
       Misuse federal funds                                                  $2.7 million
            $32 million              Univ California/San Francisco
                                       Animal Care Allegations       New York University Medical
     Univ of Southern California              $92,500 fine                       Center
         Questioned Costs                                            Inflated research grant costs
           HHS/OIG Audit                                                      $15.5 million
              $400,000

       East Carolina Univ               Results of Non-                   Mayo Foundation
       Questioned Costs                  Compliance:                  Mischarging federal grants
         HHS/OIG Audit                                                       $6.5 million
          $2.4 million
                                          Significant
                                       Audits/Settlements
                                                                             Cornell Medical
               Univ                                                     Clinical Research Issues
      Alabama/Birmingham
       Effort Certification &                                                  $4.4 million
     Clinical Research Billing
            $3.4 million                                              University of Tennessee
                                                                      Export Control Violations
                    Harvard/BIDMC          Northwestern University       Professor Criminal
                    Costing Issues          Committed Time/Effort            conviction
                     Self-Reported               $5 million
                     $3.25 million

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     AUDITORS, AUDITORS, EVERYWHERE!
18




        Federal Auditors (and investigators, too)
        Office of the State Auditor
        External Financial and Compliance (KPMG)
        Internal Audit


        Report all external audit contacts to Internal Audit
     AUDITOR OBJECTIVES
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       Federal Auditors:
       -compliance with federal regulations
       -protection of federal assets and public
       -periodic after-the-fact assurance to the   federal
       government

       Federal Investigators:
       -criminal violations of federal law
     INTERNAL AUDIT
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        Independent, objective assurance and
        consulting activity designed to add value by
        evaluating the control structure of university
        operations.

        - Periodic
        - After-the-fact or current assurance to
        management
     CONTROLS
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        All those mechanisms needed to provide
         reasonable assurance that organizational
         objectives are accomplished. Key controls include:
          Authorization/Approvals

          Separation   of duties
          Access to assets/security

          Reconciliations

          Reviews

          Documentation
     AUDITOR OPINIONS
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         Auditors interpret the regulations in
          determining whether actions are
          appropriate.

         Auditor interpretations differ, just like those
          of:
           Lawyers

           Tax   accountants
     OIG WORK PLANS DEVELOPMENT
23




           Follow the money
           Follow the issues

           Read the news

           Whistleblowers

           Throw darts?
     OIG WORK PLANS – HOT TOPICS
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          Effort reporting
          Export controls
          Cost principles/direct costing
          Conflicts of interest



                         Yet to come:
       federal stimulus monies regulatory compliance?
     Top 3 THINGS TO REMEMBER
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       1. Lots of federal regulation comes with federal
          funding – important to protect the public
          interest
       2. Lots of auditors – to provide assurance that the
          regulations are followed; interpretations may
          vary
       3. Follow university policy and the guidance of
          your centralized university resources and you
          have the best chance of staying out of trouble
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SMALL BUSINESS
SUBCONTRACTING PLANS
TRAINING MODULE V – COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009

Amber Williams, Small Business Liaison Officer
Procurement Service Center
     SMALL BUSINESS SUBCONTRACTING PLANS
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         What are they?
          Statement of goals for subcontracting to
          small business concerns

         When are they required?
          Federal Contracts where award is equal to
          or greater than $550,000;
          original or modified award
          Per FAR 52.219.9
     SMALL BUSINESS CONCERNS
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      •   Small Business
      •   Small Disadvantaged Business
      •   Woman-Owned Small Business
      •   Historically Black Colleges/Universities & Minority
          Institutions
      •   HUBZone Small Business
      •   Veteran-Owned Small Business
      •   Service-Disabled Veteran-Owned Small Business
     PLAN DEVELOPMENT
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     •   CU’s Small Business Program
         – https://www.cu.edu/psc/purchasing/sbp/


     •   Contact us:
         – Small.Business@cu.edu

         – Pamela Andrade, Assistant Small Business Liaison
           Officer (Asst. SBLO)
           • 303.315.2827 or Pamela.Andrade@cu.edu
         – Amber Williams, SBLO
           • 303.315.6356 or Amber.Williams@cu.edu
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FUNDAMENTALS OF
COMPLIANCE:
CONFLICTS OF
INTEREST & COMMITMENT
TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21st 2009

Jean Wylie, Compliance Director,
Conflicts of Interest/Commitment
     CONFLICT OF INTEREST:
31




       exist ―when an employee’s financial or personal
       considerations may compromise, or have the
       appearance of compromising, an employee’s
       personal judgment in administration, management,
       instruction, research, and other professional and
       academic activities.‖

                         APS on Conflicts of Interest and Commitment
     CONFLICT OF COMMITMENT:
32




      ―refers to situations in which outside relationships
      or activities adversely affect, or have the
      appearance of adversely affecting, an
      employee’s commitment to his/her University
      duties.‖


                          APS on Conflicts of Interest and Commitment
     PERCEPTION IS REALITY
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      Conflict of interest/commitment programs deal with
      situations in which an employee’s judgment or
      commitment to the University could be compromised.
      It is the potential for compromise that is the most
      likely to cause harm.
     WHAT DOES A CoI/C PROGRAM DO?
34




           Identify
           Manage, reduce, eliminate

           Notify
     IDENTIFY
35


        Disclosure of External Professional Activities (DEPA) (both CoI
         and CoC)
         -    Annual FOR ALL TENURE-TRACK AND RESEARCH
         FACULTY
              (at employment and the beginning of the calendar year)
         -    On-line (CU Connect, Academics & Research tab)
         -    Review by CoI/C director
             Determine no conflict; or,
             Needs further review

        Disclosure to OCG and HRC (CoI)

        Application for Approval of Regular and Periodic Consulting
         Activities (CoC)
         (http://www.colorado.edu/facultyaffairs/atoz/ofaindex.html
         -    Review/Approval by Unit Head
     WHERE IS THE ―LINE‖ - CoI?
36




         Income of >$10,000/year (self, family member)
          from a business that is related to one’s University
          activities
         Equity interests >$10,000 or 5% in a business that
          is related to one’s University activities
         Service to company (e.g. Board of Directors)
         Intellectual property rights
     WHERE IS THE ―LINE‖ – CoC?
37




         Not remunerative scholarship
         1/6th rule (generally > 19.5 days/semester)
         Interference with ―paramount obligations to
          students, colleagues, and the primary missions
          of the University.‖
     MANAGE, REDUCE, ELIMINATE
38




        CoI/C director gathers information from discloser
        Provides analysis to unit head & discloser
          Is there a conflict, and, if so, why is it a conflict

          Suggestions of how to manage, reduce, eliminate

        Unit head determines if conflict, and how to manage
        Unit head and discloser sign MOU, send to dean
        Dean makes decision, notifies discloser and CoI/C
     NOTIFY
39



         NIH
           notify that conflicts have been identified before
            submission of proposal
           notify that conflicts have been managed before
            funds disbursed
         NSF
           notify of any conflicts that institution cannot
            manage
         CU
           administration gets annual report
     EXAMPLES (generic)
40


           Professor Zen receives $15,000/year for consulting for a
            company that has also given a large gift to support his
            research program. Several students are supported by that
            gift.
           Is this a conflict of interest?
            -      Yes – it involves issues of scientific integrity and
            relationships with students.
           How would it be managed?
                   1. Disclosure to journals and in public presentations
                   where results are presented
                   2. Disclosure to students and committee members (if
                   applicable).
           Is this a conflict of commitment?
            -      No - not as presented
     EXAMPLES #2 (generic)
41




         Professor Yang receives >$10,000/year as an editor
          of a prestigious journal; he spends one day/month on
          this activity.
         Is this a conflict of interest?
                No, this is remunerated scholarship. It does not
             need to be reported on the DEPA.
         Is this a conflict of commitment?
                No, not as reported.
     EXAMPLE #3 (generic)
42



        Professor Xavier has a contract to conduct a large survey of
         satisfaction of hearing aid users for a company in which she
         owns a substantial share.
        Is this a conflict of interest?
         - Yes – it involves issues of scientific integrity, and protection
         of human subjects.
        How would it be managed?
             1.      Disclosure to journals and in public presentations
             2.      Disclosure to subjects
             3.      Possible scientific oversight of conduct of project.
        Is this a conflict of commitment?
         - No - not as described.
     EXAMPLE #4 (generic)
43


        Professor Wren is assisting a small start-up company for
         free, in an area related to his University work. He is
         spending approximately 20 hours/week helping to get it
         up and going. He does most of the work on nights and
         weekends, but at times needs to be on site for a day or
         two every week.
        Is this a conflict of interest?
         - No.
        Is this a conflict of commitment?
         - Yes. His effort exceeds the 1/6th rule. (The 1/6th rule
         applies 24/7 during the appointment year.)
        How would it be managed?
         1. Leave for some period of time;
         2. Reduction of the appointment percentage.
     INFORMATION AND HELP
44



        (http://www.cu.edu/policies/Academic/coninterest.ht
         ml)
        http://www.colorado.edu/VCResearch/ORI/coic.html
        http://www.colorado.edu/facultyaffairs/atoz/one-
         sixth-rule.pdf.
        Jean Wylie, Compliance Director
          Jean.Wylie@colorado.edu or 303.492.3024

        Russell Moore, Associate VC for Research
          Russell.Moore@colorado.edu or 303.492.2899
                                           45




RADIATION SAFETY
TRAINING MODULE V: COMPLIANCE ISSUE
THURSDAY, MAY 21ST 2009

Michelle Law, Radiation Safety Officer
Department Environmental Health & Safety
     RADIATION SAFETY
46




        Responsible for reviewing safety of research
         involving:
          Radioactive Materials (Approx 125 PIs using Unsealed &
           Sealed Sources)
          Radiation Producing Machines (Approx 35 X-rays)
          Lasers (Under Development)
        Personnel:
          Full-time Radiation Safety Officer (RSO)
          Full-time Alternate RSO (ARSO)
          2 Radiation Safety Specialists, 1 Part-Time Student
          10 Committee Members (UCB and UCCS)
     RADIATION SAFETY
47




         Physical Safety
           Protectionof personnel, environment, and property
           License Review, Equipment, Cradle to Grave

         Administrative Safety
                     from Regulatory Citations
           Protection

           Developing/modifying procedures as needed
     RADIATION SAFETY
48


         Training
           Initial Training for Unsealed materials in our office

           Other training is available on-line or by request
              Unsealed Refresher Training
              Sealed Source Training & Refresher
              X-ray Training & Refresher
         New Requirements
           Security

           Previously Exempt Materials (NORM)
49   RADIATION SAFETY
     Contact Information
     Environmental Health and Safety
     (303) 492-6025
     Radiation Safety Office
     (303) 492-6523
     Michelle.Law@colorado.edu
     www.colorado.edu/radsafety
                                       50




ANIMAL RESOURCES

TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009
Albert R. Petkus, Director
Animal Resources
     LAB ANIMAL REGULATIONS
51


        National Regulations require an Institutional Animal
         Care and Use Program and an Animal Care and
         Use Committee (IACUC)
        Animal Welfare Act
        NIH Office of Laboratory Animal Welfare OLAW
     ANIMAL RESOURCES PROVIDES:
52


        Training as mandated by the IACUC
        Regulatory compliance thru inspections and record
         maintenance
        Veterinary services such as disease diagnoses,
         necropsy services, treatments and animal colony
         health programs
        Heath reports for shipping animals to other
         institutions
        Managing quarantine programs for incoming
         animals
     IACUC RESPONSIBILITIES
53


        Review of all Animal Use Protocols for all research
         and teaching applications
        Semi-annual facility inspections and animal
         program review
        Investigates all concerns involving animal program
        Maintains USDA registration and assurance
         contract with NIH Office of Laboratory Animal
         Welfare (OLAW)
     ANIMAL RESOURCES CONTACT INFO
54




     http://www.colorado.edu/VCResearch/AnimalResources/index.html

       Albert R. Petkus, DVM, ACLAM
       Director, Animal Resources
       University of Colorado - Boulder
       UCB 345
       Boulder CO 80309
       ph 303 492-3411
       fax 303 492 -2967
       albert.petkus@colorado.edu
     ANIMAL RESOURCES CONTACT INFO
     (cont’d)
55

     Silvia N. Iorio
     Program Coordinator/IACUC Administrator
     Institutional Biosafety Committee
     University of Colorado-Boulder
     Muenzinger Psychology - Room E227
     Campus Box UCB 345
     Boulder, CO 80309
     303 492-8187 office
     303 492-2967 fax
     Silvia.Iorio@colorado.edu
      IACUC meetings occur on the 3rd Wednesday of every month. Deadline for
     Animal Care and Use Protocol submission is one and one-half weeks (Monday)
                               prior to IACUC meeting
                                       56




HUMAN RESEARCH COMMITTEE
(HRC)
TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009

 Joseph Rosse
 Research Integrity Officer
57   YOUR ETHICAL RESPONSIBILITIES

     Research with human subjects
     HUMAN RESEARCH COMMITTEE (HRC)
58




        Federally mandated
        Reviews research involving human subjects to
         ensure that research is conducted ethically and
         safely
     DOES THIS REQUIRE REVIEW?
59


        Sleep lab experiments to test effects of fatigue on
         motor performance
        Surveys of Boulder homeowners about the Xcel
         SmartGrid
        Analysis of student test scores and course grades
        Interviews of elected officials about their views on
         energy conservation
        Analysis of political affiliations of CU faculty
        Student Opinions about CU
     WHAT IS RESEARCH?
60




      A systematic investigation, including research
      development, testing, and evaluation, designed to
      develop or contribute to generalizable knowledge.
       Systematic: a process for data to be considered
        valid, thus able to be generalized so that the
        activity might be considered research.
       Designed to: a deliberate intent to create or add
        to generalizable knowledge.
       Generalizable: relevant to more than the particular
        circumstance that produces it and intended to be
        shared for a broader audience.
     WHAT IS HUMAN SUBJECT?
61




         A living individual about whom an investigator
         conducting research obtains:
        Data through intervention or interaction with the
         individual, or
        Identifiable private information.
                                                  45CFR46.102(f)
     DOES THIS REQUIRE REVIEW?
62


        Sleep lab experiments to test effects of fatigue on motor
         performance (Intervention)
        Surveys of Boulder homeowners about the Xcel SmartGrid
         (Interaction)
        Analysis of student test scores and course grades (Identifiable
         Private Data)
        Interviews of elected officials about their views on energy
         conservation (Trick question!)
        Analysis of political affiliations of CU faculty (Depends)
        Student Opinions about CU (Probably not ―research‖)
     APPROVAL PROGESS
64



        Class projects not resulting in publication
            Instructor applies to the HRC for approval
        Honors theses, other independent research that may
         result in publication
          Requires individual approval
          Refer to the HRC website for instructions and forms
          HRC website:
           http://www.colorado.edu/VCResearch/HRC/index.html
     CITI TUTORIAL
65


        CITI tutorial:
         http://www.colorado.edu/VCResearch/HRC/EducationalTools.html

        Complete the ―Students in Research‖ module for
         class projects
        For independent research complete the ―Social
         Behavioral Research‖ or ―Biomedical Research‖
         module, as appropriate
66   SUBMITTING TO THE HRC

     On-line system – IRB Manager
     HRC STAFF
67



        Melissa Diemer                    Claire Dunne, PhD, CIP
         Program Coordinator               HRC Administrator
         Melissa.Diemer@Colorado.EDU
         303-735-3702                     Erin Coons, CIP
                                           Quality Assurance
        Amanda Whitson                    Coordinator
         Social / Behavioral Panel
         Coordinator                      Joseph Rosse, PhD
                                           Director, Office of Research
        Richard Husser                    Integrity
         Biomedical Panel
         Coordinator
                                                      68




INSTITUTIONAL BIOSAFETY
COMMITTEE COMPLIANCE
TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009

Denise A. Donnelly, Institutional Biosafety Officer
Department of Environmental Health & Safety
     INSTITUTIONAL BIOSAFETY COMMITTEE
69




        The Institutional Biosafety Committee (IBC) is
        responsible for reviewing all University
        research and teaching activities involving the
        use of biohazards, recombinant DNA
        molecules, select agents, or bloodborne
        pathogens.
     INSTITUTIONAL BIOSAFETY COMMITTEE
70


                          Who Are We?
      IBC Membership includes:
         No fewer than five members with the appropriate
          expertise in recombinant DNA technology
         Institutional Biosafety Officer
         At least one individual with expertise in animal
          containment principles for rDNA research involving
          animals
         At least one individual with expertise in plant, plant
          pathogen, or plant pest containment principles for rDNA
          research involving plants
         At least two members not otherwise affiliated with the
          institution, community members
     INSTITUTIONAL BIOSAFETY COMMITTEE
71




     Biohazards consist of the following:
      Infectious/pathogenic agents classified in the following

       categories: Risk Group 1, 2, 3, or 4 bacterial, fungal,
       parasitic, viral, rickettsial or Chlamydia agents or,
      Plants, animals or derived wastes which contain or may
       contain pathogenic hazards (including
       xenotransplantation tissue) or,
      Human and nonhuman primate tissue, body fluid, and
       cell culture (primary or continuous) or,
     INSTITUTIONAL BIOSAFETY COMMITTEE
72




     Biohazards consist of the following:
      Pathogenic microorganisms that are present in human

       blood and can cause disease in humans. These
       pathogens include, but are not limited to, hepatitis B
       virus (HBV) and human immunodeficiency virus (HIV)
       or,
      Administration of hazardous materials to animals and

       their associated tissues and body fluids or,
     INSTITUTIONAL BIOSAFETY COMMITTEE
73




     Biohazards consist of the following:
      Select Agents - specifically regulated pathogens and
       toxins as defined in Title 42, CFR, Part 73, Title 9 CFR
       121, and Title 7 CFR 331. These agents have the
       potential to pose harm to human health, animal health
       or products, and/or plant health or products or,
      Other agents that have the potential for causing
       disease in healthy individuals, animals, or plants.
     INSTITUTIONAL BIOSAFETY COMMITTEE
74




      Recombinant DNA Research
       Must comply with the NIH Guidelines for Research
        Involving recombinant DNA Molecules
       http://www4.od.nih.gov/oba/rac/

        guidelines/guidelines.html
     INSTITUTIONAL BIOSAFETY COMMITTEE
75




                                   Institutional
       Human                      Animal Care &
      Research                    Use Committee
      Committee   Institutional      (IACUC)
        (HRC)      Biosafety
                   Committee
                      (IBC)
                                  Radiation
                                    Safety
                                  Committee
                                    (RSC)
     INSTITUTIONAL BIOSAFETY COMMITTEE
76




     Responsibilities of Biosafety Officer:
        Member of the IBC
        Member of the IACUC
        Review HRC Applications
        Develop and Manage Campus Biosafety Program
     INSTITUTIONAL BIOSAFETY COMMITTEE
77



     Campus Biosafety Program consists of:
        Compliance with Federal, State, local, and funding
         agency laws and requirements
        Compliance lab inspections
        Training – Biological Lab Safety, Biosafety Cabinet,
         rDNA Research Compliance, Bloodborne Pathogen,
         Packaging & Shipping of Biological Materials
        Management and disposal of biological waste
        Import/Export of biological, animal, and plant
         materials
     INSTITUTIONAL BIOSAFETY COMMITTEE
78


                     IBC Contact Information
     IBC Chair
     Dr. Gretchen H. Stein   gretchen.stein@colorado.edu
     (303) 492-5229

     Biosafety Officer
     Denise A. Donnelly      denise.donnelly@colorado.edu
     (303) 492-7072

     IBC Administrator
     Sherril Potter          sherril.potter@colorado.edu
     (303) 492-3721
                                                   79




RESEARCH MISCONDUCT
TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21st 2009
 Joe Rosse
 Research Integrity Officer & Empowered Official
     What is Research Misconduct?
80


        The Federal Big Three
          Fabrication*

          Falsification*

          Plagiarism

        Other serious deviations from accepted practices
        CU adds:
          Authorship   disputes
     What Research Misconduct is NOT
81




         Honest error
           vs.   intentional or reckless
         Honest differences of opinion or interpretation
         Anything not involved in proposing, conducting, or
          reporting research
         Violations of other policies (e.g., fiscal misconduct,
          conflict of interest)
     Investigation of Research Misconduct
82




         Concerns may be addressed to Research Integrity
          Officer (Joe Rosse)
         Standing Committee on Research Misconduct will
          conduct inquiry
         Normally a very confidential process
                                       83




EXPORT CONTROLS

TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21st 2009

 Joe Rosse & Linda Morris
 Office of Research Integrity
     EXPORT CONTROLS
84



     U.S. has various regulations dealing with exports of
     technology or related information based on concerns
     about:
              National Security
                Defense-related technology
                ―Dual-Use‖ technology

              National/Foreign Policy
                Embargoed  countries
                Banned groups or individuals
     EXPORT CONTROLS RESTRICTIONS
85


     As a contractor/recipient of Federal grants, these
     export restrictions also apply to CU
            Physical exports - rare
              Laptop    computers usually not a problem
            ―Deemed exports‖ – more common
              Transfer of knowledge to foreign nationals, even if
               the transfer occurs in U.S.
                Via   documents, emails, even site visits
                          with foreign scientists or students is most
              Collaboration
               common example
     EXPORT CONTROLS RESTRICTIONS
86




         Financial transactions with embargoed
          countries
           Balkans, Belarus, Burma, Cuba, Democratic
            Republic of Congo, Iran, Iraq, Ivory Coast,
            Liberia, N. Korea, Sudan, Syria, Zimbabwe
           Travel ban with Cuba

         Transacations with people/companies on
          various Denied Parties Lists
     EXPORT CONTROLS IMPLICATIONS
87




        Exports—physical or ―deemed‖—may require a license,
         depending on:
            Type of technology
            What the other nation is
            Whether an exemption applies
              Fundamental research/public domain
              Education
              Laptop computer/PDA/cell phone

        Where you travel and who you talk with may be restricted
        Check with Linda Morris to determine
                                       88




CONTRACTOR CODE OF
BUSINESS ETHICS
FAR 52.203-13
TRAINING MODULE V: COMPLIANCE ISSUES
THURSDAY, MAY 21ST 2009
Kathleen R. Lorenzi
Office of Contract and Grants
     AS PRESCRIBED IN FAR Part 3.1004(a)
     INSERT THE FOLLOWING CLAUSE:
89


     FAR 52.203-13, Contractor Code of Business Ethics and
     Conduct (December 2008)
     • Applies to all federal contracts and subcontracts over $5M (yes, we have
       contracts this large)

     Basic Requirements:
         •   Written Code of Conduct
         •   Provide copies of the Code and training to employees
         •   Ongoing business ethics and conduct awareness program
         •   Internal Control System
         •   Internal reporting mechanism
         •   Corrective Measures
         •   Disciplinary Action for improper conduct

     FAR 52.203-14, Display of Hotline Posters
         DECEMBER 24, 2008, THIS CLAUSE WAS REVISED TO
         INCLUDE A NUMBER OF VERY IMPORTANT CHANGES:
90

•    Definitions have been added;
     •    Agent – any individual, including a director, officer, employee or
          independent contractor authorized to act on behalf of the
          organization.

     •    Full Cooperation – disclosure to the Government of the information
          sufficient for law enforcement to identify the nature and extent of the
          offense and the individuals responsible for the conduct. Includes
          providing timely and complete responses to Government auditors and
          investigators requests for documents and access to employees with
          information.

     •    Principal – officer, director, agent, owner, partner, or person having
          primary management or supervisory responsibilities within a business
          entity.
     THE CONTRACTOR SHALL:
91




       Exercise due diligence to prevent and detect
        criminal conduct;

       Promote   an organizational culture that encourages
        ethical conduct and a commitment to compliance
        with the law.

       Expanded  the criteria for a business ethics
        awareness and compliance program
92


        ―The Contractor shall timely disclose, in writing, to the Office
         of the Inspector General with a copy to the Contracting
         Officer, whenever, in connection with the award, performance
         or closeout of this contract or any subcontract there under, the
         Contractor has credible evidence that a principal, employee,
         agent or subcontractor of the Contractor has committed:
              A violation of federal criminal law involving fraud, conflict of
               interest, bribery, or gratuity violations found in Title 18 of the US
               Code, or
           •   A violation of the civil False Claims Act (31 USC 3729-3722) (can
               prove ―intent‖ or ―a reckless disregard for accuracy‖)‖
     *** By the way, there is no definition, guidance or case law as yet to define:
                                 •   Credible evidence
                                   •  Timely disclose
     • Defined the minimum content of an internal control
       system:
        • Assignment of responsibility at a high level in the
          organization to ensure effectiveness of the program

        • Reasonable efforts not to designate a principal who
          cannot comply

        • Periodic reviews of the company business practices,
          procedures, policies and internal controls for compliance
          to include:
            • Monitoring and auditing to detect criminal conduct
            • Evaluate the effectiveness of the program and
               general awareness
            • Assess the risk of criminal conduct and modify
93
               program to minimize this risk.
• Defined the minimum content of an internal control
  system, continue:

     • Internal reporting mechanism – allows for anonymity or
       confidentiality of employees who may report suspected
       incidences of misconduct

     • Disciplinary action for improper conduct or for failing to
       take reasonable steps to prevent or detect improper
       conduct

     • Timely Disclosure in writing to the OIG of credible evidence
       of a violation

     • Full cooperation with Government agencies
94
     THE UNIVERSITY OF COLORADO SYSTEM
95



       •   Code of Conduct
       •   Principles of Ethical Behavior:

            •   Responsible Conduct
            •   Respect for Others
            •   Conflicts of Interests
            •   Research and Academic Integrity
            •   Stewardship of University Property
            •   Contributing to a safe workplace
            •   Privacy and Confidentiality
            •   Open and effective communications
            •   Reporting suspected misconduct
 THE UNIVERSITY OF COLORADO AT BOULDER HAS ALL THE ELEMENTS
 OF A CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT
 PLACE
96



      Compliance at UC Boulder:
         •   Financial Management
         •   Human Resources
         •   Office of Contracts and Grants
         •   Purchasing Service Center
         •   Environmental Safety and Health
         •   Information security
         •   Export controls
         •   Research Integrity
         •   Conflicts of Interest
         •   Research Compliance (human subjects, IACUC, etc.)
         •   Hotline at System
         •   Training available from each area
     INFORMATION
97


     Hotline – EthicsPoint
     • System directory under ETHICSPOINT
     • https://secure.ethicspoint.com/domain/en/report_custom.asp?clie
       ntid=14973
     • Hot Line 800-677-5590

     Websites
     • Research Policies and Procedures
       http://www.colorado.edu/VCResearch/researchpolicies.html
     • Research Integrity and Regulatory Compliance
       http://www.colorado.edu/VCResearch/ORI/index.html
     CONTACT INFORMATION
98


        Randall Draper - OCG        Al Petkus – LAR
         (303) 492-2695               (303) 492-4311
        Kathleen Lorenzi – OCG      Claire Dunne – HRC
         (303) 492-2692               (303) 735-5014
        Pat Dodson – SPA            Denise Donnelly – EHS
         (303) 492-2620               (303) 492-7072
        Amber Williams - PSC        Joe Rosse – ORI
         (303) 315-6356               (303) 735-5809
        Jean Wylie – COI            Linda Morris – ORI
         (303) 492-3024               (303) 492-2889
        Michelle Law – EHS          Jean Stewart – Int. Audit
         (303) 492-6523              (303) 837-2201
99   THANK YOU FOR ATTENDING

								
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