Basics of Preaward Research Administration Susan Wyatt Sedwick, Ph.D., CRA Associate Vice President

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Basics of Pre-award Research AdministrationSusa
n Wyatt Sedwick, Ph.D., CRAAssociate Vice
President for Research andDirector, Office of
Sponsored ProjectsThe University of Texas at
Austin
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Introductions

• Name
• Title
• Institution
• Experience in research administration
• Unique qualifications

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Strategy for Learning About Research
Administration
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Research Administration ResourcesWebsites and
Discussion Groups

• NCURA http//www.ncura.edu
• Neighborhoods
• SRA http//srainternational.org
• AUTM http//www.autm.net
• NACUBO http//www.nacubo.org
• COGR http//www.cogr.edu
• FDP http//thefdp.org
• FAR http//farsite.hill.af.mil
• CFR, FedReg, etc. http//www.gpoaccess.gov/nara
  /index.html
• Grants.gov - http//www.grants.gov/
• To subscribe to the Research Administrators
  listserv, send the message SUBSCRIBE RESADM-L
  your full name to listserv_at_hrinet.org

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Types of Agreements/Documents

• Sponsored Research Agreement
• Subcontracts/Subrecipient Agreement
• Service Agreement
• Consulting Agreement
• Teaming Agreement
• Consortium Agreement

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Types of Agreements/Documents cont.

• Material Transfer Agreements
• Uniform Biological Material Transfer Agreement
• clearly define material involved
• define proposed use for materials
• define ownership of materials and derivatives
• allow for publications and oral presentations
• Indemnification
• Testing Agreements/Laboratory Study Agreements
• Non-Disclosure Agreements/Confidential Disclosure
  Agreement
• Intellectual Property Agreements

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Model Documents

• http//www.utsystem.edu/ogc/IntellectualProperty/d
  bmock.htm

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Research Administration ResourcesOther Resources

• On-the-Job Training
• Institutional Policies and Procedures
• Agency (Sponsor) Guidelines

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Pre-Award AdministrationProposal Information

• Proposal Information
• Submission Details
• Personnel Information
• Project Information
• Intellectual Property
• Export Regulation Compliance
• Compliance Information
• Subcontract Information
• Budget Information
• Additional Space
• Renovation
• Cost Sharing/Matching

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Research AdministrationTypes of Offices

• Central Institutional Office
• Central School Office (i.e. Medical School)
• Departmental Office
• Combination Central/Departmental Office
• Office Function
• Specific divisions
• Cradle-to-Grave

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Sponsored Projects

• Supports the mission of the institution
• Increases the status of the institution
• Supports faculty activities
• Provides research experiences for students
• Augments infrastructure/equipment
• Advance knowledge

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Pre-Award FunctionsFacilitator and Gatekeeper

• Funding information
• Educational programming
• Proposal review and authorization
• Award negotiation
• Subcontract negotiation
• Certifications and representations
• Compliance assurance
• Risk management

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Research AdministrationResponsibilities of
Research Administrators

• Assist/Serve/Collaborate with Faculty
• Create a Positive Atmosphere
• Protect the Institution by Ensuring Compliance
• Ensure Appropriate Stewardship

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Terminology

• Direct costs
• Facilities and Administrative Costs (FA) aka
  indirect costs (IDC) or overhead
• Capital equipment
• Program Income
• Subawards

• Cognizant agency
• Subrecipient
• Vendor
• Consultant
• Pass-through Funds

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Legal and Regulatory Framework
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Sponsors

• Federal
• State
• Foundations/Not-for-profit organizations
• Industry
• Foreign

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Code of Federal and Domestic Assistance (CFDA)

• Important to track CFDA numbers
• http//www.access.gpo.gov/nara/cfr/cfr-table-searc
  h.html

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Federal Framework

• OMB Circular A-21 Cost Principles for Educational
  Institutions
• OMB Circular A-110 Uniform Administrative
  Requirements
• OMB Circular A-133 Audits of State, Local
  Governments and Non-profits Organizations
• Office of Management and Budget (OMB)
• http//www.whitehouse.gov/omb/circulars/index.html
  

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Federal Framework cont.

• OMB Circular A-87 Cost Principles for State,
  Local and Indian Tribal Governments
• OMB Circular A-122 Cost Principles for
  Non-profit Organizations
• OMB Circular A-102 Uniform Administrative
  Requirements for Grants and Cooperative
  Agreements with State and Local Governments

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Federal Framework cont.

• Federal Acquisition Regulations (FAR)
• http//farsite.hill.af.mil/VFFARA.HTM
• Defense FAR (DFARS)
• http//farsite.hill.af.mil/VFDFARA.HTM

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OMB Circular A-21

• Defines allowable and unallowable costs (see J.
  section)
• Defines methods of Facilities and Administrative
  (FA) cost rate identification and calculation
  (see sections E. through I.
• Appendices
• A. Cost Accounting Standards
• B. CASB Disclosures Statement (DS-2)

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OMB Circular A-21 cont.

• Cost Accounting Standards Board Cost Accounting
  Standards
• 501 Consistency in estimating, accumulating and
  reporting costs
• 502 Consistency in allocating costs incurred for
  the same purpose
• 505 Accounting for unallowable costs
• 506 Cost accounting period

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OMB Circular A-110

• Subpart B Pre-award Requirements
• Subpart C Post-award Requirements
• Subpart D Closeout Requirements

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OMB Circular A-110

• Subpart A Pre-Award Requirements
• SF 424 or other approved forms
• Debarment
• Preference for metric system and recycled
  materials
• Encourages agencies to allow annual submission of
  certifications and representations (certs and
  reps) on an annual basis

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OMB Circular A-110

• Subpart C Post-award Requirements
• Cost sharing and matching
• Program income
• Revisions requiring prior approval
• Expanded authorities
• Property management standards
• Procurement
• Reporting
• Records
• Early termination

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OMB Circular A-110

• Subpart D After-the-award Requirements
• Final reports
• Technical
• Financial
• Property
• patent
• Prompt payment by government
• Right to disallow cost in audit

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OMB Circular A-110

• Expanded Authorities
• 90 days pre-award costs
• One-time no cost extension (NCE) of up to 12
  months
• Carry forward unobligated balances to subsequent
  funding periods
• Budget revisions among line items not to exceed
  10 percent of the total budget

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OMB Circular A-133

• Applies to non-Federal entities that expend
  500,000 annually
• Single or program-specific audit annually
• Applies to pass-through funds

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Federal Acquisition Regulations (FAR)

• Incorporated into procurement contracts
• Part 52 states provisions and contract clauses
• Part 53 reproduces federal forms
• Parts 70 and up contains agency specific
  supplements
• Circular A-21 is incorporated in its entirety by
  reference as part 31.3

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Federal Demonstration Partnership (FDP)

• Central test bed for demonstration of
  reengineered processes and systems
• Increase productivity of federally supported
  research and education
• Provide for increased stewardship of federal
  funds
• Reduce administrative costs and burdens
• Currently in Phase IV
• Expanded authorities
• Faculty Burden Survey

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Research Business Models

• Subcommittee of the Committee on Science of the
  National Science and Technology Council (NSTC)
  charged with
• facilitating a coordinated effort across Federal
  agencies to address important policy implications
  arising from the changing nature of scientific
  research, and
• examining the effects of these changes on
  business models for the conduct of scientific
  research sponsored by the Federal government.
• http//rbm.nih.gov/

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Research Business Models cont.

• Facilitating multi-disciplinary research
• Acknowledge multiple PIs in proposals and data
  systems
• Identify models for stability of support
• Develop consistent support for GRA and post docs
• Facilitate collaboration between universities and
  federal labs
• Improving consistency of agency practice
• Develop standard formats for reporting, award
  notices and terms and conditions
• Promote FDP standard subcontract
• Harmonizing accountability
• Streamline A-133 monitoring
• Develop federalwide policies for misconduct and
  COI

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State Regulations

• Use of State resources
• Indirect costs recovery
• Use of facilities
• Intellectual property
• Office of Legal Counsel
• Indemnification
• Binding Arbitration
• Governing law

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Institutional Policies

• Cost sharing/matching contributions
• Determination of on- or off-campus rates
• Restrictions on use of foreign nationals
• Tuition remission
• Incentive funds

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Gift or Grant?

• Gift is motivated by charitable intent
• Gift is an irrevocable transfer of assets
• Gift is not generally subject to an exchange of
  consideration including preferential access to
  intellectual property or other contractual
  requirements although use of funds may be
  restricted
• Gift does not specify a period of performance
• Gift does not require financial reporting

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Types of Agreements

• Grant
• Cooperative Agreement
• Contract
• Teaming Agreement
• Memorandum of Understanding/Agreement
• Sponsored Research Agreement
• Other Agreements
• Material Transfer Agreement
• Non-disclosure Agreement
• Visiting Scientist Agreement

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Assistance Agreement or Contract

• Cooperative Agreement
• Idea may originate with recipient
• Substantial involvement between sponsor and
  recipient
• Grant
• Purpose is to transfer asset to accomplish a
  public purpose
• Idea originates with recipient
• No substantial involvement between sponsor and
  recipient

• Contract
• Procurement mechanism
• Purpose is to acquire property, service or direct
  benefit for sponsor
• Idea originates with sponsor

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Funding Announcements

• Grants/Coop. Agreements
• Program Announcement (Grants.gov, sponsor
  publication, or Federal Register)
• Request for Application (RFA)

• Contracts
• Request for Proposal (RFP)
• Request for Quotation (RFQ)
• Request for Bid (RFB)
• Broad Agency Announcement (BAA)

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Types of Award Actions

• Notice of Award
• Competitive renewal
• Non-competing renewal (continuation)
• Supplemental award
• Modification/Amendment
• No-cost extension (NCE)
• Subaward

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Types of Contracts

• Cost reimbursable
• Firm fixed price
• Time and materials
• Cost plus fixed fee

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Pre-award Administration
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Pre-award Overview

• Source of Funds
• Funding Instruments
• Proposal Preparation including Budgets
• Internal Review
• Electronic Research Administration
• Award Negotiations
• Other Agreements
• Subcontracts Process

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Sources of Funding

• Federal
• State or local government
• Industry
• Foundation
• Other universities and research institutes
• Private
• Foreign entities

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Federal Agency Websites

• U. S. Federal Agencies
• Centers for Disease Control http//www.cdc.gov
• Department of Agriculture http//www.usda.gov
• Department of Commerce http//www.doc.gov
• Department of Defense http//www.defenselink.mil
  
• Department of Education http//www.ed.gov
• Department of Energy http//www.doe.gov
• Department of Health Human Services
  http//www.hhs.gov
• Department of Transportation http//www.dot.gov
• Environmental Protection Agency http//epa.gov
• National Endowment for the Humanities
  http//neh.fed.us

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Federal Agency Websites cont.

• U. S. Federal Agencies(continued)
• National Institutes of Health
  http//www.nih.gov
• National Oceanic Atmospheric Administration
  http//www.noaa.gov
• National Science Foundation http//www.nsf.gov

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Non-government Sites

• Non-Government Sites
• Foundation Center http//www.fdncenter.org
• Foundations On-Line http//www.foundations.org/g
  rantsmakers.html
• American Cancer Society http//www.cancer.org
• American Heart Association http//www.americanhe
  art.org

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Other Websites

• Association of American Medical Colleges
  http//www.aamc.org
• Association of University Technology Managers
  http//www.autum.net
• Council on Governmental Relations
  http//www.cogr.edu
• Federation of American Societies for Experimental
  Biology http//www.faseb.org
• National Association of State Universities Land
  Grant Colleges http//www.nasulgc.org
• National Council of Universities Research
  Administrators http//www.ncura.edu

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Types of Proposals

• Preliminary Proposal
• Letter of Intent
• White Paper
• Preproposal with budget
• Full Proposal

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Budget Development

• Salaries Wages
• Institutional policy on salary recovery
• Effort commitment
• Personnel
• Summer salary
• Graduate students (salaries or stipends)
• Technical support
• Clerical support
• Undergraduate students
• Postdoctoral research associates
• Percent of effort
• Increases cost of living and merit-based
• NIH salary cap (186,600 effective 1/1/07)

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• Fringe Benefits (use currently negotiated rate)
• FICA
• Retirement
• Disability insurance
• Workers compensation
• Life insurance
• Unemployment insurance
• Health insurance
• Defined contributions

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Budget Development cont.

• Consultants
• Not an employee of your institution
• Proven professional of technical competence and
  provides this to your organization
• Is not controlled with regard to the manner of
  performance or the result of the service
• Considered a work for hire and does not retain
  any rights to the end product
• Reasonable allowable
• Letter of intent (confirmation)

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Budget Development cont.

• Equipment
• Definition (sponsor vs. institution)
• Obtain vendor quotes
• Installation costs
• Shipping costs
• Duty/US Custom fees (if purchased outside the US)
• Fabrication

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Budget Development cont.

• Travel
• trips X persons X days
• Airfare
• Ground transportation
• Lodging
• Meals
• Conference fees/registration
• Incidentals
• Domestic or foreign

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Budget Development cont.

• Patient Care Costs
• Inpatient outpatient care costs
• Other Direct Costs
• Materials Supplies
• Expendable
• Non-capital equipment

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Budget Development cont.

• Other Direct Costs
• Materials Supplies
• Publications
• Computer software
• Copying
• Communications
• Animal care costs
• Human subject care costs

• Shop charges
• Maintenance/service contracts
• Audio/visual services
• Lease of facilities
• Construction
• Renovation
• Remodeling costs

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Budget Development cont.

• Vendor/Professional Services Agreement
• The procurement of goods or services from an
  organization or individual which provides the
  goods and services to many different purchasers
  as part of its/their normal business operations
  within a competitive environment
• Not subject to the same compliance requirements
  as a subcontractor (if the source is Federal)

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Budget Development cont.

• Subcontracts (Partner)
• Performs substantive programmatic work under a
  grant or contract
• Bears responsibility for programmatic decision
  making and measurable performance requirement
• Must adhere to Federal compliance requirements if
  the source is a Federal award
• Retains intellectual property rights if a
  university
• Reasonable allowable

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Budget Development cont.

• Facilities Administrative (FA) Costs
• Calculated rate
• Federally negotiated rate (Cap on Administrative
  Costs 26) On-campus, Off-campus and others
• Federally negotiated uncapped rate
• Restrictions
• Waivers/contributions
• On subcontracts in accordance with institutional
  rate agreement

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Budget Development cont.

• Cost Sharing
• Cash
• In-kind
• Volunteer time
• Existing equipment
• Other
• Required
• Voluntary committed

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Budget Development cont.

• Summary of general points
• Include direct costs
• Include FA costs (indirect)
• Detailed (at least in first year)
• Include only allowable costs
• May include matching or cost sharing
• Remember Be consistent with sponsor policies
  and requirements.

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Budget Justification/Narrative

• Explains the budget in narrative form.
• Remember if proposed budget item is not justified
  appropriately, the reviewer will not understand
  why the item is necessary for the research
  project..
• If the reviewer does not understand the need for
  a budget item, then a recommendation can be made
  for that item to be deleted or funding reduced.
• Do not leave anything to the imagination. Good
  budget justifications provide the rationale for
  the budget item in the proposal

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Proposal Authorization

• Principal Investigator
• Co-Principal Investigator
• Department Chair/Director
• Dean/AVP/VP
• Center Director
• Account sponsors for cost sharing
• Research Office (i.e. OSP)

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Proposal Review Documents

• Guidelines
• Forms requiring a signature
• Abstract/statement of work
• Budget
• Budget Justification
• Cost sharing commitments
• Subcontract Information
• Checklist

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Proposal Review Checklist

• Correct forms
• Page limits
• Format restrictions
• All elements included
• Budget correct
• Correct rates used
• Subcontractor commitment letter
• Compliance Issues

• Cost sharing
• Signatures
• Certifications
• Correct number of copies
• Postmark/receipt date
• Address correct
• Mode of delivery

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Validation by Research Administrator

• SF 424
• Assurance information is correct
• Proposed dollar amounts are correct
• Proposed period of support is correct
• Institutional name/address correct
• Type of organization correct
• EIN (tax id) number correct
• Congressional district correct
• Duns number correct

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Validation by Research Administrator

• BUDGET PAGES
• Modular (not to exceed 250K)
• All modules the same
• modules different in any given year (if so, need
  to justify)
• cost sharing statement
• role and percent effort of all personnel on
  project listed

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Validation by Research Administrator

• Non-Modular
• Totals correctly and matches justification
• A21 items fully justified or removed
• Fringe benefit rates are correct and
  identified in justification
• Program income

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Validation by Research Administrator

• Correct indirect cost rate used
• Acceptable inflation rate used
• Salary cap recognized in all applicable years
• No salary on federal grants, if PI or faculty on
  project already has K award.
• Budgets over 500K of direct costs must have prior
  approval letter from NIH
• Cost sharing authorization
• Approval for cost sharing / IDC waiver

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Validation by Research Administrator

• Letter of Intent
• Face page
• Budget/budget justification
• Checklist/certifications/assurances
• Indirect cost rate agreement
• Scope of Work
• Current and Pending (effort commitments)

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NIH Checklist

• NIH Checklist
• Indirect costs calculation correct
• DHHS agreement date correct

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Other Information (Primarily Non-Federal Agencies

• Indirect cost rate agreement
• Auditors report
• Tax-exempt memo
• Financial reports
• Representations Certification (Reps/Certs)
• Patents Publications (private agencies)

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Compliance Reviews

• Animal use
• Human research participants
• Recombinant DNA (rDNA)
• Radiation/Radioisotopes
• Biosafety (infectious agents, select agents,
  toxins, etc.
• Export controls

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Successful Grantsmanship

• Good match for project and program
• Target the proposal
• Contact with Program Officer
• Follow the guidelines
• Compelling abstract
• Multiple funding sources
• Concise
• Honor submission limitations
• Collaboration with researchers outside your
  institution

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Characteristics of Successful Proposals

• Compelling Abstract
• Innovation
• Relevance
• Uniqueness
• Demonstrated competence
• Adequate facilities resources

• Literature search
• Absence of jargon
• Realistic budget
• Justified costs
• Timeline
• Related to solicitation
• Enthusiasm

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Unfunded Proposals

• PI should obtain review and resubmit
• Contact Program Officer for clarification of any
  review items not fully understood
• PI should analyze publications and research plan
• Encourage PI to have a senior faculty member
  review the protocol

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Electronic Research Administration

• NSF Fastlane
• Other systems
• Grants.gov
• Problems for Mac users
• PureEdge forms Adobe
• Revised deadlines after forms are issued
• Duns Number
• System2System Interface

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Other Electronic Research Administration Systems

• National Institutes of HealthNIH Commons
• U.S. Army Medical Research Material Command
• American Heart Association
• American Cancer Society
• State government initiatives

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Negotiation of Federal Awards

• Reduction in proposed budget
• May require revised
• research plan
• other support
• budget
• budget justification
• Updated assurances
• Cost sharing issues
• Conflict of Interest certification
• Most current FA rate agreement

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Negotiations with Industry

• Publication restrictions
• Intellectual property rights
• Confidentiality
• Budget including FA rates
• Conflicts of Interest
• Indemnification
• Governing law
• Insurance clauses
• Binding Arbitration
• Coordination with Legal and Technology Management
• If Clinical Study, IRB approval

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Negotiations with Industry cont.

• Contract Review
• Insurance clauses
• Governing law
• Binding arbitration
• Indemnification
• Publication restrictions
• Intellectual property ownership
• FAR clauses
• Coordination with Legal Counsel Technology
  Development offices
• Confidentiality

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Other Agreements

• Clinical trial Agreements
• Usually reimbursed on a per patient basis
  including a fixed FA rate of 10-30 TDC
• Ownership of data and patient records
• Confidentiality of patient records
• Publication Rights
• Patent Rights/Ownership of Intellectual Property
• Indemnification
• Internal Review Board (IRB) process

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Subawards

• Agency approval generally required
• Check to see that FA agreement and assurances
  are current
• Flowdown of required provisions from prime award
  to subaward
• FDP subaward

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Research Compliance
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Effective Compliance Strategies

• Institutional commitment
• Standards of conduct
• Roles and responsibilities with high level
  compliance officer
• Policies and procedures
• Educational programs
• Assessment and audits
• Assessing and mitigating risks
• Violations are evidence of compliance

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Risks of Non-compliance

• False Claims Act
• Exceptional or high risk status
• U.S. Sentencing Guidelines Chapter 8
• Effective compliance
• Self reporting
• Confidential/Anonymous Reporting
• Office of Extramural Research Administration
  (OPERA) site visits
• Office of Inspector General

86
Compliance Guidance

• COGRs Managing Externally Funded Research
  Programs A Guide to Effective Management
  Practices
• Responsible Conduct of Research (RCR)
• NCURAs publications
• Regulation and Compliance
• Managing Federal Grants
• Sponsored Programs Administration
• A Guide to Effective Strategies and
  Recommended Practices

87
Ethics in Research

• Scholarly Misconduct
• Falsification
• Plagiarism
• Improper use of information
• Manipulation of results
• Material failure to comply with rules and
  regulations
• Inappropriate behavior as it relates to
  misconduct, i.e. retaliation
• Process for review, inquiry, investigation and
  adjudication

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When is IRB review needed?

• Research involving human subjects or use of data
  on human subjects including survey research that
  will be conducted on this campus and/or conducted
  by university staff, students or faculty and
  might be published must be reviewed.

89
Federal Regulations

• 45 CFR 46 DHHS Protection of Human Subjects
• Subpart A Common Rule
• Subpart B Pregnant women, fetuses and neonates
• Subpart C Prisoners
• Subpart D Children
• 21 CFR 56 FDA Clinical Investigations

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Definitions

• Research means a systematic investigation,
  including research development, testing and
  evaluation, designed to develop or contribute to
  generalizable knowledge.
• Human Subject means a living individual about
  whom the investigator conducting research obtains
  (a) data through intervention or interaction with
  the individual or (b) identifiable private
  information (45 CFR 46.102F). Private information
  must be individually identifiable (i.e., the
  identity of the subject is or may readily be
  ascertained by the investigator or associated
  with the information) in order for obtaining the
  information to constitute research involving
  human subjects.
• Vulnerable Subjects/Participants mean individuals
  who lack the capacity to provide informed consent
  or whose willingness to participate in research
  may be subject to undue influenced or coercion.
  Vulnerable subjects include, for example,
  children, prisoners, individuals with emotional
  or cognitive disorders/impairments, and
  economically or educationally disadvantaged
  persons.
• Third Party Risk

91
Levels of IRB Review

• Exempt
• Minimal risk
• Expedited
• Minimal risk (vulnerable populations)
• Full Board
• Data collection using video or audio taping
• Investigational device or product
• Invasive procedures or higher risk research
  involving vulnerable populations
• Deception

92
Exemptions

• Evaluation of normal educational practices
• Educational tests, surveys and public
  observations unless subjects could be identified
  or beyond reasonable risk
• Public officials or candidates for public office
• Existing data, documents, records and
  pathological or diagnostic specimens
• Evaluation of public service programs
• Taste and food quality

93
Foundation of Protection of Human Research
Participant Protections

• Belmont Report
• Respect for persons
• Autonomy
• Additional protections for those with diminished
  capacities
• Informed consent
• Beneficence
• Maximize benefits/minimize harm
• Justice
• Research should be related to the participant
  pool

94
Other Considerations

• Federal-wide assurance
• Association for the Accreditation of Human
  Research Protection Programs (AAHRPP)

95
Use of Animals in Research

• International
• Federal
• State
• Local
• Institutional
• Voluntary
• Accreditation

96
Regulatory Framework

• Animal Welfare Act
• Administered by USDA
• Alternatives are desirable
• Minimize pain and discomfort/psychological
  well-being
• Invasive procedures
• Excludes mice, rats, birds and horses and
  livestock used for agricultural purposes
• Includes live and dead warm-blooded animals
• USDA inspections

97
PHS Policy on the Human Care and Use of
Laboratory Animals

• Definition of laboratory animals includes any
  live vertebrate animal used or intended for use
  in research, research training, experimentation
  or biological testing
• Appropriate care and use in PHS sponsored
  research
• Annual assurance
• IACUC
• Mandated education

98
ILAR Guide for the Care of Use of Laboratory
Animals

• Basis for Association for Assessment and
  Accreditation of Laboratory Animal Care
  International (AAALAC )accreditation standards
• Extensive review
• Annual report/re-evaluation every three years
• Professional judgment
• Definition of lab animal includes any vertebrate
  animal used in research, teaching or testing

99
Biosafety

• Recombinant DNA (rDNA)
• Radioisotopes
• Infectious agents
• Material transfers
• USA Patriot Act
• Registration of laboratories
• Select agents and toxins
• Restricted persons/background checks
• Public Health Security and Bioterrorism
  Preparedness and Response Act

100
Health Information Portability and Protection Act
of 1996

• Requirements for the protection of identifiable
  health information
• Protects identifiable health information that is
  transmitted or maintained in any form or medium
  (electronic, oral, or paper) by a covered entity
  or its business associates, excluding certain
  educational and employment records

101
US Patriot Act

• Registration of laboratories
• Bioterrorism provisions
• Select agents and toxins
• Surveillance and privacy
• Information Available to the Public
• Restricted Persons

102
Conflict of Interest

• Financial and Commitment
• Requires disclosure to the annually of outside
  interests
• Requires review by Objectivity In Research
  Committee specific to a particular proposal
• Management plan is used to manage or eliminate
  potential or perceived conflicts
• Institutional conflicts
• Use of human subjects

103
Terms

• Investigator
• PI/responsible for the design, conduct and
  reporting of research
• Includes spouse and dependent children
• Research
• Significant Financial Interest
• gt 10,000/5 equity interest
• Does not include salaries, royalties or other
  remuneration from applicant institution including
  SBIR and for service on advisory
  committees/review panels, etc.

104
Institutional Responsibilities

• Written and enforced policies and procedures
• Subrecipient monitoring
• Review of individual projects
• Requiring updates at least annually or when
  changes occur
• Enforcement
• Recordkeeping

105
Managing or Eliminating Conflicts

• Public disclosure
• Monitoring
• Disqualification
• Divestiture
• Severance of relationship

106
Institutional Conflict of Interest

• Equity interest in start-up companies
• Use of human research participants

107
Export Controls, Embargoes and Sanctions

• Regulations
• EAR Export Administration Regulations US
  Department of Commerce Bureau of Industry and
  Security
• ITAR International Traffic in Arms Regulations
  US Department of State Office of Defense Trade
  Controls
• OFAC US Department of Treasury - Office of
  Foreign Assets Control
• There are others

108
Regulatory Framework

• EAR - Export Administration Act
• ITAR - Arms Export Control Act
• OFAC - Trading with the Enemy Act International
  Emergency Economic Powers Act and others

109
Risk for Universities

• Collaborations/discussions with foreign national
  collaborators and students especially when
  involving proprietary information
• Taking or shipping items or transferring
  technology that is controlled to a foreign
  country or foreign national
• Performing defense services
• Visiting scientists
• Travel to foreign countries including fieldwork
• Technology transfer
• Faculty start up companies

110
Deemed Exports

• Deemed Export foreign national with access to
  information restricted by EAR/ITAR.
• Applies to research assistants and students
• Applies to visiting foreign researchers
• Applies to U.S. citizens visiting a foreign
  country
• Does not apply to U.S. Citizens, permanent
  residents and those with US asylum protection

111
Exclusions and Exceptions

• Exclusions
• Information in the Public Domain
• Fundamental research
• University-based research in the US
• Educational Exclusion
• Catalog courses and instructional labs (EAR) and
  general math and science taught (ITAR)
• Foreign patent applications

• EAR
• Temporary (TMP)
• ITAR
• If ordered under federal contract 126.4 (c)

112
EAR Controls

• Controls are specific to the item or technology
  Country Groups
• Terrorist Supporting Countries
• Cuba
• Iran
• North Korea
• Sudan
• Syria

113
ITAR Controls

• Prohibited Countries Belarus, Cuba, Iran, North
  Korea, Syria, Venezuela and Vietnam
• Arms Embargoes Burma, China, Liberia, Somalia
  and Sudan
• Bona fide Employee Exception
• Policy to deny licenses
• ¹Section 126.1 of the ITAR (22 CFR 126.1)

114
OFAC Sanctions

• Balkans
• Belarus
• Burma
• Côte divoire
• Cuba
• Iran

• Iraq
• Liberia
• North Korea
• Sudan
• Syria
• Zimbabwe

115
Foreign Travel

• Not just a sponsored research issue
• Remote access to information/email
• Entity and individual screening
• Traveling with equipment including laptops
• Travel programs

116
Licensing/Documentation

• Licensing requirements can cause delays
• Licenses are agency specific
• Technical Assistance Agreements (ITAR)
• Technology Control Plans
• Exceptions require documentation/ transaction
  logs and reports
• Coordination with the responsible office
• Ongoing assessment
• Audit

117
Violations and Penalties

• Civil Fines and forfeitures
• Criminal Fines and incarceration
• Loss of export privileges
• Bad press
• Voluntary disclosures and compliance efforts
  mitigate penalties

118
Compliance is a Team Effort

• Sponsored Projects
• Non-sponsored/ institutional research
• Tech Transfer
• Academic Units
• Legal Counsel
• Accounting
• Revenue Accounts
• Development
• Gift Accounts

• Payroll Office
• International Programs
• Shipping
• Travel
• Internal Audit
• Purchasing/Inventory
• Excess Property
• Public Affairs

119
Effective Export Controls Compliance Strategies

• Commitment from the top
• Awareness and educational program
• Designated official (empowered official)
• Expert legal counsel
• Self-assessment
• Consider limiting performance of controlled
  research in separate, secure areas
• Promote compliance through education
• Focus on compliance
• Good recordkeeping and documentation of
  decision-making process
• Encourage prompt disclosure

120
QUESTIONS

• sedwick_at_austin.utexas.edu