Transcript Grant Coordinator Meeting

Grant Coordinator
Meeting
May 24 @ 1:30 pm
132 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
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.
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.
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.
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.
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 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.
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.
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.
For More Information…
Visit our website at http://www.clemson.edu/cfo/cashtreasury/cash-receipting/index.html
Contact:
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
Together
Towards Tomorrow
Session Objectives
 Communicate goals for Kuali Coeus
 Introduce Kuali Coeus Features
 Project timeline
 User engagement of research community in the
project
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
Kuali Coeus Overview
Kuali Coeus Elements
KC – Implementation Timeline
Phased Approach
Module Implementation
Phase I
-Project Planning
-Project
Governance
Committees
-Implementation
Plan
-Timeline
Phase II
Phase III
Proposal
-Proposal
Development
-Proposal Log
-Budgets
-Awards
-Grants.gov s2s
-Institutional
Phase IV
-IRB
-IACUC
-COI
-Interface KC
Awards to CUBS
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
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
Discovery
Go-Live
Post Go-Live
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
KC – Where Are We Now!!
Module Implementation
Phase I
-Project Planning
-Project
Governance
Committees
Phase II
Proposal
-Proposal
Development
-Proposal Log
-Budgets
-Institutional
-Timeline
Phase IV
-IRB
-IACUC
-COI
We Are Here!!
-Awards
-Implementation
Plan
Phase III
-Grants.gov s2s
-Interface KC
Awards to CUBS
User Involvement
2013
2014
2015
Institutional Proposal
Proposal Log
Configuration
Awards
Proposal Development
Bug Tracking
Workflow
Training
Documentation
System Testing
We Value Your
Email:
Bindu Rangaraju
[email protected]
864-650-1467
Export Control
Tami Hemingway
U.S. Export Controls
Laws and Regulations implemented
to further national security and U.S.
foreign policy
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 Officer
Tami Hemingway
656-4084
[email protected]
www.clemson.edu/research/compliance/export/
Avoiding Compliance
Pitfalls in Pre-Award
Tracy Arwood
Compliance 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 in
biomedical 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) microorganisms
• 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 Arwood
Compliance Office
Thank You for
Attending