VUMC Core Managers Meeting VUMC Office of Research

VUMC Core Managers Meeting VUMC Office of Research December 13, 2017

Agenda • Announcements and FYI • Export Compliance Presentation • Sky. VU Impact on VUMC Cores • i. Lab Updates • Q&A 2

School of Medicine Cores: Accolades from Biomedical Sciences Advisory Board 2017 BSAB Agenda Eric P. Skaar, Ph. D. , M. P. H. Learn more about the Board: www. vumc. org/oor/people/biomedical-science-advisory-board

FYI VUMC Strategic Directions BRET Business Module ABRF National Meeting i. Lab User Conference SOM Core Managers Retreat 5

VUMC Strategic Directions https: //ww 2. mc. vanderbilt. edu/strategic-directions/

BRET Management & Business Principles Module Great opportunity! • Receive business-oriented help, develop new approaches for your core • Be part of helping the next generation of scientists • Contact Anthony. Tharp@Vanderbilt. edu to participate and for more information • Other SOM cores have participated: Flow Cytometry Shared Resource VICC Innovative Translational Research Shared Resource https: //medschool. vanderbilt. edu/career-development/business-and-management-principles-scientists

Registration now open: https: //conf. abrf. org/registration-information 8

i. Lab/CORES User Group Conference February 26 -28, 2018 City of Hope – Comprehensive Cancer Center in Los Angeles • Intended for Institutional and Core Facility Directors and Managers who currently use or are planning to use the i. Lab/CORES platform. • IT personnel will benefit from the conference's specialized breakout sessions. • If you are unsure whether you should attend, please contact us at ilabusergroupconf@agilent. com Office of Research will pay the meeting registration fee for attendees from VUMC cores – contact Jessie Pirtle for assistance. More information about the agenda and other details: http: //mailchi. mp/ilabsolutions/ilab-solutions-complimentary-webinarpublicationtracker-2408877? e=c 03713 e 366 9

School of Medicine Core Managers Retreat • Currently planned for September 2018 • SOM-wide: VUMC and VU Basic Sciences cores • Topics under consideration: • Long term strategic planning • Metrics of success • S 10 grants and NSF instrument grants • Leadership skills and professional development • SOP writing • Marketing Stay Tuned!

Export Compliance Adam Riddick

Introduction to Export Compliance Fundamentals of Export Controls & What you need to know… Facilitator: Adam Riddick, MBA Export Compliance Manager VUMC Export Compliance (VUMC EC) vumc. export@vanderbilt. edu (615)-875 -7577 https: //ww 2. mc. vanderbilt. edu/globalsupport/50084

Think Export Control Laws don’t affect you?

What are “export controls” and their intent? The term "export controls" typically refers to a specific set of regulations overseen by several U. S. Government agencies, that implement federal laws put in place to: • protect national security interests • promote foreign policy, and • in some cases, to control short supplies Export controls protect national security and economic interests by regulating not only the movement of physical items across international borders, but also the sharing of controlled data, software, or research results by any means with a non-U. S. entity or individual anywhere. Exports: Can be physical, electronic, verbal, or even visual

U. S. Export Control Laws and Regulations

U. S. Federal Agencies charged with Export Control Oversight All regulations are sections within an overall body of regulations, published annually by the NARA, known as the Code of Federal Regulations or the CFR. U. S. Department of Commerce Bureau of Industry and Security EAR: 15 CFR 730 -774 EAR Export Administration Regulations U. S. Department of State U. S. Department of Treasury Directorate of Defense Trade Controls Office of Foreign Assets Control ITAR: 22 CFR 120 -130 FACR: 31 CFR 501 -598 FACR Foreign Asset Controls Regulations ITAR International Traffic in Arms Regulations

Four important questions: 1 2 3 4 1. What is it? • i. e. - Information, technical data, schematics, devices, equipment, materials, viruses, fungi, bacteria, etc. 2. Where is it going? 3. Who is it going to? • Are they a U. S. Person or non-U. S. Person? • Are they inside or outside the U. S. ? 4. What are they going to use it for?

Countries of Concern Contact VUMC EC immediately when exports to any of the following locations could occur: Cuba Iran Sudan, Republic of (North) Syria North Korea Extensive list of additional countries with specific export compliance concerns: https: //ww 2. mc. vanderbilt. edu/globalsupport/50095

Restricted Party Screening (RPS) & Denied Persons Lists (DPL) RPS is the process of screening potential denied parties involved in any export transaction for the purpose of complying with U. S. Export Control Laws. • Denied persons, Specially Designated Nationals (SDN), and unverified or debarred parties DPLs are published by various offices of both the U. S. Government and international sources. They include: • lists of persons, businesses, corporations, entities, etc. that are denied for export purposes. No person, business, or institution can deal with such a party; regardless of where they appear in the transaction.

Why is compliance with export control regulations important? 1. 2. 3. 4. Federal Law National Security Institutional Reputation Loss of Federal Funding Who is responsible? • The regulations stipulate that each individual is responsible for their export activities • Knowingly or Unaware • Intentional or Unintentional

What’s not controlled*? • • • Information in the public domain Educational information (textbooks, etc. ) Information excluded under the Fundamental Research Exclusion (FRE)* Artistic or non-technical publications Basic marketing descriptions * All transactions to the following countries must be reviewed regardless of content: • Cuba, Iran, Sudan, Syria, North Korea

Case Study: Reece-Roth, University of Tennessee • John Reece-Roth: • emeritus professor of electrical engineering, taught and researched at Tennessee for nearly 30 years • worked as a consultant on a U. S. defense research project • Prosecuted for violating the Arms Export Control Act (AECA) • AECA: Prohibits disclosing sensitive technology to foreign countries or non. US persons • Convicted in Knoxville (2008) of: • using graduate students from China and Iran on restricted U. S. Air Force research • taking a laptop with restricted files to China • Found guilty on 18 counts of conspiracy, fraud, and multiple violations of the AECA

Case Study: Reece-Roth, University of Tennessee • Defense contract stipulated the project was subject to export controls • licensing required to export information to foreign nationals or countries • A license he would not have received for Chinese or Iranian students • University of Tennessee was not found ultimately accountable • UT’s Export Compliance Office was not informed of Reece-Roth’s actions; however, when made aware, immediately attempted to prevent violations • UT’s warnings ignored, thus Reece-Roth and his protégé were held responsible • UT did lose the government contract and defense funding

What are some transactions that may trigger export compliance oversight? ü ü ü ü ü Shipping equipment and/or biological materials to a foreign country? Hosting Foreign Visitors on campus? Collaborating with international colleagues in foreign countries? Exposing foreign nationals to research labs? Training of foreign national students on research protocols or equipment? Working with a foreign country subject to US embargo? Dealing with publication restrictions? Dealing with participation restrictions of foreign students? Hiring a Foreign National? Traveling overseas to attend or present at a conference? Click here for the Export Compliance Checklist

How do you determine if export compliance requirements apply to your work? ü The VUMC Export Compliance website: https: //ww 2. mc. vanderbilt. edu/globalsupport/50084 Here you will find information about: • International Travel • International Shipping • Collaborating with Colleagues/Institutions Abroad • Bringing Foreign Visitors to VUMC ü VUMC Export Compliance office: Director: Julie Lankford, MBA - (615) 343 -2542 Export Compliance Manager: Adam Riddick, MBA - (615) 875 -7577 vumc. export@vanderbilt. edu

Export Compliance Best Practices • Where research is being conducted • Domestic or foreign • Who is working on the project (including at VUMC or via subcontract) • What are the project terms and conditions? • Are there restrictions? • When? • Communicate early and often with your faculty, staff, and the VUMC Export Compliance office Ø VUMC faculty and staff share responsibility for export compliance

��！ grazie! obrigado! ich danke Ihnen! ! ﻟﻚ ﺷﻜﺮﺍ gratias tibi! cảm ơn bạn! Thank you! спасибо! ευχαριστώ! לך !תודה ありがとう！ je vous remercie! gracias!

Key Terms associated with Export Controls • Export - Shipment of articles or related technology/technical data out of the United States or providing export-controlled technical data or technology to restricted parties anywhere, including within the United States. • Deemed Export - A release of technology or source code that is subject to the Export Administration Regulations (EAR) to a foreign national. Such release is "deemed" to be an export to the home country or countries of the foreign national. • U. S. Person – One whom is either a: • U. S. Citizen • Naturalized Citizen • Permanent Resident (Green Card Holder) • Foreign National* - Any person who is not a citizen or a lawful permanent resident of the United States. *Note: This definition includes representatives of foreign corporations, associations, and governments.

Key Terms associated with Export Controls • Technical Data** - ITAR-specific - 22 CFR § 120. 10 Refers to information required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance, or modification of a defense article (military specific). • Technology** - EAR-specific - 15 CFR § 772 Refers to specific information necessary for the development, production, or use of a controlled product. **Note: These definitions do not include information concerning general scientific, mathematical or engineering principals commonly taught in schools, colleges and universities, or information in the public domain.

Sky. VU Impact on VUMC Cores • Expected Transition: January 1, 2018 • All VU cost centers will be converted to a new Co. A or POET number. • The new numbers will be systematically updated in both VUMC C. O. R. E. S. and i. Lab • After initial conversion, VU users will need to request new numbers be added to either VUMC CORES or i. Lab • Webform: https: //www. vumc. org/oor/vu-cost-center-change-use-vumc-core-groups-ilab-vumc-cores

Sky. VU Impact on VUMC Cores • Co. A Numbers: Used for all unrestricted activity • Example: • 125. 05. 12560. 6250. 000. 0. 0 • POET Numbers: Used for grants, contracts, cores, faculty funds, gifts and endowments • Example of converted VU cost centers: • AA_######_### • Example of a new project number: • ######_###

i. Lab Updates • PO Functionality Updates • Current Behavior: POs are added per single user per core facility used. • Upcoming Feature Development: • Phase 1: POs can be shared across members of a lab • Phase 2: POs can be shared across all VUMC core groups

CORES & i. Lab System Roles & Responsibilities Core Manager Office of Research Core Administrator VUMC/VU User Support: User Support to Core: VUMC-VU User Account Support: - Guide users on registration. - Guide users on payment number activation. - Guide users on access to activated payment numbers. - Escalate customer support issues to Cores. Email@Vanderbilt. edu. - Direct VU users with registration questions to Cores. VU@Vanderbilt. edu - Advise core manager on user registration, customer payment information activation and lab member access to payment numbers. - Escalate customer support issues to Cores. Email@Vanderbilt. edu. - Direct VU users with registration questions to Cores. VU@Vanderbilt. edu - Approve access for member’s to VUMC PI Lab Groups. - Review access requests received in the Default (VUMC) Lab Group and move user to appropriate Lab Group. - Approve access for Admin (VUMC) Lab and grant user access to specific departments. - VU user account management is provided by the VU OCGA (Cores. VU@Vanderbilt. edu) External User Support: Core Workflow Support: -Complete OOR webform to request updates to external user account or to request new external user accounts. -Forward request for VA payment number activation to Cores. Email@Vanderbilt. edu -Create or Approve non- VA or VU purchase orders on behalf of external users. Process Customer Requests: - For project based cores, monitor View All Request tab and process new requests for services. - For instrument based cores, monitor reservations module and approve reservation requests. - Provide quotes to customers Core Billing: - Enter service charges and confirm calendar usage monthly. - Troubleshoot and resolve ‘red flag’ billing errors. - Create a draft billing event monthly. Invoice Management - Advise users on viewing invoices. - Submit OOR webform to update payment number on pre-invoice (or, Advise user to update invoice directly in i. Lab). - Invalid payment number resolution upon notification by Office of Research Invoice Dispute Resolution - Review any disputed charges and issue refunds as needed. i. Lab Site Updates - Add new instrument calendars - Add new services or project requests - Add or update custom forms - Understand core staff’s i. Lab workflow and troubleshoot issues. - Escalate system issues to Cores. Email@Vanderbilt. edu. Core Billing Support: - Confirm core has submitted draft billing event. External User Account Support: - Process external user account requests. - Create POs on behalf of external users upon request. - Create and manage VA POs. User Support: Invoice Management: - Monitor the Cores. Email@Vanderbilt. edu and resolve escalated customer support issues. - Advise core on invoice review and refund process - Distribute invoices to external users. - Submit OOR webform to mark external invoices as paid. Centralized Billing: i. Lab Site Updates - Advise on site updates (instrument calendars, project requests, custom forms) - Confirm all draft billing events have been created. - Collaborate with core to resolve billing errors on pre-invoices. - Create invoices - Submit invoice files to VUMC Finance for upload to the ledger. - Submit VU invoices to VU Finance for payment. - Submit VA invoices to VA for payment. Invoice Management Support: - Distribute invoices to external users - Mark external invoices as paid upon request - Mark VUMC & VU invoices as paid Transition Support: - Host weekly i. Lab Clinics - Conduct monthly in-person training sessions - Publish online user guides, FAQs, and other resources. - Collaborate with i. Lab to improve system functionality and available features. i. Lab Site Updates: - Add Images to i. Lab sites and calendars - Update rates

Questions? 34

VUMC Core Managers & Directors Reception Please join us at the Medical Student Lounge located on the 3 rd Floor.