Grant Coordinator Meeting

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Grant CoordinatorMeeting

• May 24 _at_ 130 pm
• 132 Fluor Daniel Building

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- Agenda -

• NIH Conflict of Interest Policy Status Update
  Chip Hood
• Research Fund Policy for Research Subjects
  Stephanie Wald
• Faculty Gift Credit Betsy Mudge
• Kuali Coeus Update Bindu Rangaraju
• Export Control Tami Hemingway
• Avoiding Compliance PitfallsTracy Arwood
• Restructuring of EHS Tracy Arwood
•  

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NIH Conflict of Interest Policy Status Update
Becca Hanus
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Research Fund Policy for Research Subjects
Stephanie Wald
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Research Subjects

• It is common in certain types of research to
  provide an incentive to individuals to
  participate in research studies.
• When participants are necessary for the success
  of the research project, an incentive may be
  offered provided they are included as part of the
  grant proposal and IRB approval was obtained.
• Research incentives given can typically range
  from 25 to 50.
• This policy is intended to provide guidance as to
  the appropriate acquisition and distribution of
  research subject incentives. We are proposing it
  as interim policy and will be subject to review
  next Fall.

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Obtaining Research Subject Incentives

• Incentives are available in the form of cash
  cards. Please allow two business days to process
  your request.
• Incentives may be obtained by completing a
  Research Subject Incentive Request Form and
  submitting it to the Cash and Treasury Services
  Department.
• Incentives should only be requested when
  disbursement of such funds is expected to
  commence within the current month. If the project
  continues throughout the year, multiple incentive
  requests should be made to provide for a
  reasonable and timely accounting of the funds.

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Obtaining Research Subject Incentives Cont.

• All request forms submitted must be signed by an
  authorized approver. Their signature indicates
  that the appropriate business officer is aware of
  the request and that documentation has been
  provided to them.
• A copy of the approval letter issued by the
  Institutional Review Board (IRB) must accompany
  the request.

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Research Subject Incentive - Restrictions

• All amounts received must be used for the purpose
  of providing an incentive to research subjects
  participating in an approved study.
• Incentives may not be used for any purpose other
  than the one outlined on the Research Subject
  Incentive Request Form.
• Unused cash cards cannot be used to pay research
  participants in subsequent, unrelated studies.
• Cash cards should be given as an incentive as
  opposed to other cash-like instruments.

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Distribution of Incentives

• Researchers are required to keep a Research
  Subject Incentive Distribution Log for all
  amounts disbursed. This log will maintain subject
  confidentiality by the use of identifiers.
• The Internal Revenue Service (IRS) requires
  Research Subject Incentives aggregating 600 or
  more paid to an individual during a calendar year
  to be reported on IRS Form 1099-MISC,
  Miscellaneous Income. If this should occur an
  additional reporting requirement is necessary.
  The subjects name, address, social security
  number, and payment amount must be sent to the
  Cash and Treasury Services Department no later
  than January 15th of the subsequent calendar
  year.

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Substantiation Process

• A Research Incentive Distribution Log along with
  all supporting documents should be submitted to
  the department for which the study was performed
  and the Cash and Treasury Services Department
  within 15 days of the completion of the study or
  by January 15th if the study exceeds one calendar
  year.
• Funds must be substantiated before any new
  advances will be issued.
• If no supporting documentation exists and the
  funds were not distributed to participants with a
  list, a memo of justification is required
  detailing why this documentation is not available
  and how the funds were spent.

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Repayment of Incentives

• Incentives distributed must be repaid no more
  than 30 calendar days from the issue date.
• Incentives are to be repaid through BuyWays by
  entering a voucher payable to Clemson University
  Cash and Treasury Services.
• Any unexpended/undistributed cash cards should be
  returned to the Cash and Treasury Services
  Department.

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For More Information

• Visit our website at http//www.clemson.edu/cfo/ca
  sh-treasury/cash-receipting/index.html
• Contact

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Questions
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Faculty Gift Credit
Betsy Mudge
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Background

• Faculty requested documentation of their role in
  fundraising
• February 2012 Members of Development, CUF,
  Provost Office, and Office of Institutional
  Research agreed on guidelines
• April 2012 Meeting with Provost and Deans
• May 2012 Implementation Date

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Guidelines

• Who receives credit?
• Faculty members who work with DOs to solicit
  gifts
• Faculty members who notify DOs in advance of
  gifts received
• Development Officer and Faculty member receive
  acknowledgement for 100 of closed amount

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Development Officer Responsibilities

• Record faculty name(s) on gift
• Up to 3 faculty members
• Cash, Gift-in-Kinds, and pledges
• Work with faculty to fill out forms and paperwork
  to book gift within 30 days of receipt
• Work in partnership with faculty member when
  soliciting and stewarding the gift

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Faculty Member Responsibilities

• Obtain appropriate approval before soliciting
  gift
• For unsolicited gifts, contact Development
  Officer within 30 days of receipt
• For gifts (cash, pledges, GIKs) of 10K and
  above, faculty members receive credit in RE and
  FAS

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When does it show up in FAS?

• May 1, 2012
• Begin documentation in RE (gift receiving system)
• August 2012
• Test download into FAS
• April 30, 2013
• Office of VP of Academic Affairs downloads data
  into FAS
• Faculty name, amount of gift, donor name

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What if I want my gift included in the research
annual report?

• Fill out form

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Kuali Coeus Update
Bindu Rangaraju
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Kuali Coeus Clemsons New eRA
Together Towards Tomorrow
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Session Objectives

• Communicate goals for Kuali Coeus
• Introduce Kuali Coeus Features
• Project timeline
• User engagement of research community in the
  project

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Project Goals

• Cradle to Grave System
• Simplify proposal generation, submission and
  management
• System-to-System Submission
• Make it possible to grow research at Clemson
• Eliminate the need for redundant effort in
  departments
• Eliminate need for shadow systems
• Report generation capability through out the life
  of the project

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Kuali Coeus Overview
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Kuali Coeus Elements
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KC Implementation Timeline
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Phased Approach
Module Implementation
Phase II -Institutional Proposal -Proposal
Log -Awards
Phase I -Project Planning -Project Governance
Committees -Implementation Plan -Timeline
Phase III -Proposal Development -Budgets -Grants
.gov s2s
Phase IV -IRB -IACUC -COI -Interface KC Awards
to CUBS
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KC - Implementation Plan

• Overall Goal Deliver an integrated research
  administration system that meets researcher and
  institutional needs
• Deliverables
• Processes that maintain compliance, increase
  efficiency and reduce administrative burden for
  all
• Reporting capabilities
• Training and Ongoing support for all users

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Implementation Principles Components

• Campus Engagement
• Engage Campus stakeholders
• Engage faculty early, seek advice and guidance
• Gather feedback, document validate
• Brainstorm solutions collaboratively
• Communicate
• Product
• Configure product to meet reasonable campus needs
• Enable and promote consistency in processes and
  reporting
• Minimal customization of the core product
• Integrate with Peoplesoft Financials

Go-Live
Post Go-Live
Discovery
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KC - Implementation Challenges

• Be patient with staff through the implementation
• We are all in this together, as a Community
• Give all implementers a virtual Hug
• Functional Staff, Departmental Staff and System
  Implementation Team
• Anticipating a Kuality implementation

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KC Where Are We Now!!
Module Implementation
Phase II -Institutional Proposal -Proposal
Log -Awards
Phase I -Project Planning -Project Governance
Committees -Implementation Plan -Timeline
Phase III -Proposal Development -Budgets -Grants
.gov s2s
Phase IV -IRB -IACUC -COI -Interface KC Awards
to CUBS
We Are Here!!
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User Involvement
Configuration
User Function
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• We Value Your
• Email
• Bindu Rangaraju
• Bindu_at_clemson.edu
• 864-650-1467

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Export Control
Tami Hemingway
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U.S. Export Controls

• Laws and Regulations implemented to further
  national security and U.S. foreign policy

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What is an export?

• Tangible Shipments outside of the U.S., its
  territories and possessions
• Release of technology or code to a non-U.S.
  person within the U.S. Deemed Export
• Providing a service to a non-U.S. person

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International Traffic in Arms Regulations

• ITAR controls items designed primarily for a
  military purpose as well as all satellites
• ITAR controlled items are found on the United
  States Munitions List (USML)

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Export Administration Regulations

• The EAR control items designed primarily for a
  civilian purpose but which may also be used in a
  harmful way Dual Use
• EAR controlled items are found on the Commerce
  Control List (CCL)

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Foreign Assets Control Regulations

• The FACR regulate U.S. sanctions and embargoes
  against specific countries or persons in
  furtherance of U.S. foreign policy
• General and specific licenses determine items
  that may be exported or imported to or from
  embargoed countries or with whom funds may be
  exchanged

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Fundamental research

• Basic and applied research in science and
  engineering conducted at accredited institutions
  of higher learning in the United States the
  results of which are ordinarily published

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Fundamental Research Exclusion

• Fundamental research results are not subject to
  export control regulations
• FRE does not apply to export controlled inputs
  used in the research
• Publication restrictions or restrictions on
  participation in the research based on
  citizenship will destroy the availability of this
  safe harbor

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Restricted Parties

• BIS
• Denied Persons List
• Entity List
• Unverified List
• DDTC
• AECA Debarred List
• OFAC
• Specially Designated Nationals List

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Anti Boycott compliance

• Applies primarily to the Arab League boycott of
  Israel
• Conduct that may be penalized
• Agreements to refuse or actual refusal to
• do business with or in Israel or with blacklisted
  companies.
• discriminate or actual discrimination against
  other persons based on race, religion, sex,
  national origin or nationality.
• furnish or actually furnish information about
  business relationships with or in Israel or with
  blacklisted companies.
• furnish or actually furnish information about the
  race, religion, sex, or national origin of
  another person.
• Implement letters of credit containing prohibited
  boycott terms or conditions.

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Export Control Assessment

• What is it?
• What do we want to do with it?
• Who is it going to?
• Where is it going to and what is the end use?

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Pre Award

• RFP/BAA (DOD, NASA, DOE, Private)
• Publication Restrictions (includes NDAs)
• Non-US person participation restrictions
• End Use/End User (chemical, biological, missile,
  nuclear WMD)
• Foreign funding/reviews
• Export Controlled deliverables anticipated
• SOW includes travel to embargoed country

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Post Award

• International Travel
• Export controlled equipment or technology under
  MTA, loan or purchase
• Payments to a restricted entity
• Anti Boycott Language

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Contact

• Export Control Officer
• Tami Hemingway
• 656-4084
• theming_at_clemson.edu
• www.clemson.edu/research/compliance/export/

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Avoiding CompliancePitfalls in Pre-Award

• Tracy Arwood
• Compliance Office

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Compliance Review Approval

• IRB research with human subjects
• IACUC research, teaching or testing with
  vertebrate animals
• IBC research involving rDNA and biohazards
  (more?)

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Human Subjects Research (HSR)

• 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 an investigator (whether professional or
  student) conducting research obtains
• Data through intervention or interaction with the
  individual, or
• Identifiable private information.

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Institutional Review Board - IRB

• Use of surveys, interviews, or focus groups
• Observation of public or private behavior
• Educational practices
• Use of existing data sets when identifiable
• Medical chart reviews

• Taste and food quality evaluation or consumer
  acceptance studies
• Clinical trials
• Collection of blood or biological specimens
• Studies of new drugs or medical devices

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IRB Review Types

• Exempt (or administrative, etc.)
• Expedited
• Full Committee/Board Review

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IACUC

• Use of live vertebrate animals inbiomedical
  teaching, biomedical research, agricultural
  teaching, agricultural research, or field studies
• Euthanasia methods
• Humane endpoints

• Hazardous agents
• Surgical or non-surgical procedures on animals
• Name of animal species
• Laboratory, research, or farm animals

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IACUC review

• Veterinary Consult
• Designated (Member) Review
• Full Committee

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IBC

• Recombinant DNA
• DNA molecules
• Biological hazards/infectious agents
• Chemical hazardous materials used with vertebrate
  animals
• Select agents and toxins
• DNA modified (exotic or non-exotic)
  micro-organisms

• Transgenic plants or animals
• Names of infectious agents, such as Salmonella,
  E. coli, Streptococcus, Ricin, or influenza virus
• Use of human blood, tissue, and any human bodily
  fluids
• Human cell lines
• Nanomaterials for these categories

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IBC Review Types

• Exempt
• Experiments that Require IBC Notice Simultaneous
  with Initiation
• Full Review
• Designated for non-recombinant DNA research
  only

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Other Things to Consider

• Submission deadlines
• Collaborative/Sub-awards
• International
• Training
• Others???

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Restructuring of EHS

• Tracy Arwood
• Compliance Office

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Thank You forAttending