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Grant CoordinatorMeeting
May 24 @ 1:30 pm132 Fluor Daniel Building
- 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 Pitfalls–Tracy Arwood
• Restructuring of EHS –Tracy Arwood
NIH Conflict of Interest Policy Status Update
Becca Hanus
Research Fund Policy for Research Subjects
Stephanie Wald
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.
Research Subjects
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.
Obtaining Research Subject Incentives
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.
Obtaining Research Subject Incentives – Cont.
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.
Research Subject Incentive - Restrictions
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 subject’s 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.
Distribution of Incentives
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.
Substantiation Process
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.
Repayment of Incentives
Visit our website at http://www.clemson.edu/cfo/cash-treasury/cash-receipting/index.html
Contact:
For More Information…
Questions
Faculty Gift Credit
Betsy Mudge
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
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
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
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
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
What if I want my gift included in the research annual report?
• Fill out form
Kuali Coeus Update
Bindu Rangaraju
Kuali Coeus Clemson’s New eRA
TogetherTowards Tomorrow
Session Objectives
Communicate goals for Kuali CoeusIntroduce Kuali Coeus FeaturesProject timeline User engagement of research community in
the project
Cradle to Grave SystemSimplify proposal generation, submission and
managementSystem-to-System SubmissionMake it possible to grow research at ClemsonEliminate the need for redundant effort in
departmentsEliminate need for shadow systemsReport generation capability through out the
life of the project
Project Goals
Kuali Coeus Overview
Kuali Coeus Elements
KC – Implementation Timeline
Phase II-Institutional Proposal
-Proposal Log
-Awards
Phased ApproachModule Implementation
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
KC - Implementation PlanOverall 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 capabilitiesTraining and Ongoing support for all users
Implementation Principles & ComponentsCampus Engagement
Engage Campus stakeholdersEngage faculty early, seek advice and guidanceGather feedback, document & validateBrainstorm solutions collaborativelyCommunicate
ProductConfigure product to meet reasonable campus needsEnable and promote consistency in processes and
reportingMinimal customization of the core productIntegrate with Peoplesoft Financials
Discovery Go-Live Post Go-Live
KC - Implementation Challenges
Be patient with staff through the implementation
We are all in this together, as a CommunityGive all implementers a virtual ‘Hug’:
Functional Staff, Departmental Staff and System Implementation TeamAnticipating a Kuality implementation
Phase II-Institutional Proposal
-Proposal Log
-Awards
KC – Where Are We Now!!Module Implementation
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!!
Institutional ProposalProposal Log
Awards
Proposal Development
Workflow
Bug Tracking
Configuration
User Involvement2013 2014 2015
Training
System Testing
Documentation
Acceptance Testing
User Function
Export Control
Tami Hemingway
Laws and Regulations implemented to further national security and U.S.
foreign policy
U.S. Export Controls
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
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)
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)
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
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
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
Restricted Parties
BIS• Denied Persons List• Entity List• Unverified List
DDTC• AECA Debarred List
OFAC• Specially Designated Nationals List
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.
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?
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
Post Award
• International Travel• Export controlled equipment or technology under
MTA, loan or purchase• Payments to a restricted entity• Anti Boycott Language
Contact
Export Control OfficerTami Hemingway
www.clemson.edu/research/compliance/export/
Avoiding CompliancePitfalls in Pre-Award
Tracy ArwoodCompliance Office
Compliance Review & Approval
• IRB – research with human subjects
• IACUC – research, teaching or testing with vertebrate animals
• IBC – research involving rDNA and biohazards (more?)
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
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
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
IRB Review Types
• Exempt (or administrative, etc.)
• Expedited
• Full Committee/Board Review
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
IACUC review
• Veterinary Consult
• Designated (Member) Review
• Full Committee
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
IBC Review Types
• Exempt
• Experiments that Require IBC Notice Simultaneous with Initiation
• Full Review
• Designated – for non-recombinant DNA research only
Other Things to Consider…
• Submission deadlines
• Collaborative/Sub-awards
• International
• Training
• Others???
Restructuring of EHS
Tracy ArwoodCompliance Office
Thank You forAttending