Grant Coordinator Meeting May 24 @ 1:30 pm 132 Fluor Daniel Building.

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

We Value Your

Email:Bindu [email protected]

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

[email protected]

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