HS SPPO Contacts MeetingSeptember 21, 2017

• HS SPPO Updates & Reminders

• NIH Updates & Reminders

• Guest Speakers:

• Pam Tallarida, ePD Updates

• Brittany Whiting, Export Control

Agenda

HS SPPO Updates & Reminders

• Friday, October 20th:

• Phones will be forwarded to the Analysts’ voicemail STARTING NOON.

• Computers will be disassembled in the afternoon.

• Monday, October 23rd:

• The computers will be re-assembled, starting mid-morning.

• The phones will be moved and connected by morning.

• Tuesday, October 24th:

• HS SPPO will be back up and fully operational at our new location:

HS SPPO is Moving!!!

Medical Teaching Facility (MTF)2nd Floor, Room 275

• Streamlined HS SPPO proposal review process

• Departments now receive an email with a link to suggested corrections• Standardized notification email• Outlines areas of proposals that need corrections

• Benefits• Streamlined HS SPPO review process for departments• Retrieval form that fund managers can refer to when making corrections• Training opportunities for fund managers and departments

• Live Now!• Link to training presentation: https://edithealthsciences.ucsd.edu/vchs/research-

services/hssppo/news/Documents/1st%20August,%202017%20-%20HS%20SPPO%20On%20Base%20Dept.%20Presentation%20.pdf

Reminder:HS SPPO Updated Proposal Review Process

• Cloud Computing Services (research storage, managed services and cloud services) from Information Technology Services (ITS) or San Diego Super Computer (SDSC), or through direct contracts with Amazon Web Services or Microsoft Azure via Marketplace, will be exempt from the application of the indirect costs when acquired to support extramurally funded research (effective July 1, 2017).

• Here are the SDSC services that fall under this exemption waiver:• SDSC Cloud storage• Commvault• Project Storage• Triton Shared Computing Cluster (TSCC)

UC San Diego Cloud Computing F&A (IDC) Exemption

• Graduate Division has released the new tuition remission rates, beginning 10/1/17.

• Blink has been updated: http://blink.ucsd.edu/research/preparing-proposals/proposal-development/budgets/direct.html#Tuition-remission as well as the Budget Preparation Quick Guide as been updated: http://blink.ucsd.edu/_files/ocga/budgets/budget-preparation-rates-quick-reference-revised-sep-2017.pdf

Updated: UC San Diego Tuition Remission, 2017-2018

Updated UC San Diego Composite Fringe Benefit Rates

http://blink.ucsd.edu/research/preparing-proposals/proposal-development/budgets/direct.html#Fringe-benefit-rates

BUDGET LINE ITEM: NGN Charge $$$$ (Next Generation Network)

BUDGET JUSTIFICATION:

• UC San Diego Information and Technology Services (ITS) charges a flat per month fee for services to provide state-of-the-art technology infrastructure and services to the campus community. These charges are directly attributable and proportionally applied for the individual(s) included in the proposed budget on the project. These costs are not included in the campus' Facilities & Administration (F&A) rate as an indirect cost. UC San Diego auditors have determined that it is both equitable and consistent with the OMB Circular 2 CFR 200 provisions on cost allocability that the costs be assigned to FTE on grant and contract funds. Accordingly, an allocable portion of these NGN costs are included in this budget as direct project costs.

Updated: NGN Budget Justification Language

http://blink.ucsd.edu/research/preparing-proposals/proposal-development/budgets/direct.html#Other-expenses:-Next-Generation

BUDGET LINE ITEM: HS-TSC (Health Sciences Technology Services Charge) $$$$

BUDGET JUSTIFICATION:

• UC San Diego Health Information Services costs have been included to reflect costs associated with the increased level of security required for all personnel within UC San Diego Health, which includes UC San Diego School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, and the hospitals and clinics. These charges are directly attributable and proportionally applied for the individual(s) included in the proposed budget on the project.

Note: if you need more detailed budget language, the next slide contains this information.

Updated: HS-TSC Budget Justification Language

http://blink.ucsd.edu/research/preparing-proposals/proposal-development/budgets/direct.html#Other-expenses:-Health-Sciences

TO BE USED IN THE DETAILED BUDGET JUSTIFICATION:

• UC San Diego Health Information Services (IS) provides mandatory Information Technology Services to all of Health Sciences faculty and investigators, to include costs associated with the increased level of security required for all personnel within UC San Diego Health, which includes UC San Diego School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences and the hospitals and clinics. To mitigate the specific risk profile of this highly connected environment, UC San Diego Health Information Services ensures that all PIs who IS provides services to, whether they directly access patient information or not, operate in a highly secure desktop, application and server environment with dedicated and highly trained support. Charges are based on percent of FTE working on a grant and are charged on a monthly basis.

• These costs are not included in the campus' Facilities & Administration (F&A) rate as an indirect cost. UC San Diego auditors have determined that it is both equitable and consistent with the OMB Circular 2 CFR 200 provisions on cost allocability that the costs be assigned to FTE on grant and contract funds. Accordingly, an allocable portion of these Technology Services costs are included in this proposal as direct project costs.

Updated: HS-TSC Budget Justification Language (cont.)

NIH Updates & Reminders

NIH Update:Clinical TrialsNIH policy to improve its stewardship of clinical trials:• Requires that all applications involving one or more clinical trials be submitted in response to a

clinical trial-specific FOA – Effective for receipt dates on or after January 25, 2018.• Expects all NIH-funded investigators and staff who are involved in the conduct, oversight, or

management of clinical trials be trained in Good Clinical Practice (GCP) – Effective as of January 1, 2017.

• Expects all NIH-funded clinical trials are registered and that results are submitted to ClinicalTrials.gov whether or not subject to FDAAA – Applies to grants, contracts, and intramural clinical trials submitted on or after January 18, 2017.

See NOT-OD-17-043; NOT-OD-16-148; NOT-OD-16-149 for additional information:• NOT-OD-17-043: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-043.html• NOT-OD-16-148: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html• NOT-OD-16-149: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html

See the NIH Open Mike Blog Post “Continuing to Clarify the NIH Definition of a Clinical Trial:”• https://nexus.od.nih.gov/all/2017/09/08/continuing-to-clarify-the-nih-definition-of-a-clinical-trial/

Learn more at: https://grants.nih.gov/policy/clinical-trials.htm

NIH Initiatives to Enhance Clinical Trial Stewardship

Good Clinical Practice

Single IRBRegistration

on & Reporting

Clinical Trial

Review Criteria

Clinical Trial FOAs

New Application

Forms

Enhancing Clinical Trial Stewardship at NIH Accountability Transparency Efficiency Dissemination

Does your study…

Involve one or more human subjects?

Involve one or more interventions?

Prospectively assign human subject(s) to intervention(s)?

Have a health-related biomedical or behavioral outcome?

If “yes” to ALL of these questions, your study is considered a clinical trial!

Unsure how to answer the questions? We have a tool that can help:

• https://grants.nih.gov/ct-decision/

In the Coming Future, Did You Know that NIH Might Consider Your Human Subjects Research to be a Clinical Trial

It impacts whether you need to:

Respond to a clinical trial-specific FOA

Address additional review criteria specific for clinical trials

Register and report your clinical trial in ClinicalTrials.gov

Identifying Whether NIH Considers Your Study to be:a Clinical Trial is Crucial

How to determine if an FOA accepts clinical trials?

1. Refer to Section II. Award Information

2. Indicated in FOA title (new FOAs only)

Tip: Check your FOA at least 30 days before the due date for any updates!

Identifying the Right FOA is Key

• All clinical trial applications MUST be submitted to an FOA that allows clinical trials

Due Dates on orafter January 25, 2018

FOAs will include additional criteria:

Scored Review Criteria

Significance

Investigator

Innovation

Approach

Environment

Additional Review Criteria

Study Timeline & Milestones

Clinical Trial Specific Review Criteria

Read the FOA carefullyand be sure your

application addressesthe review criteria

appropriately

NIH has introduced two additional RPPRs, each one is outlined in the NIH RPPR Instruction Guide:

• Annual RPPR: used to describe a grant’s scientific progress, identify significant changes, report on personnel, and describe plans for the subsequence budget period or year.

• Final RPPR: Use as part of the grant closeout process to submit project outcomes in addition to the information submitted on the annual RPPR, except budget and plans for the upcoming year.

• Interim RPPR: Use when submitting a renewal (Type 2) application. If the Type 2 is not funded, the Interim RPPR will serve as the Final RPPR for the project. If the Type 2 is funded, the Interim RPPR will serve as the annual RPPR for the final year of the previous competitive segment. The data elements collected on the Interim RPPR are the same as for the Final RPPR, including project outcomes.

• NIH RPPR Instruction Guide: https://grants.nih.gov/sites/default/files/rppr_instruction_guide.pdf

• NOT-OD-17-022: NIH Implementation of Final Research Performance Progress Reports (Final RPPR): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-022.html

NIH ImplementationThree (3) RPPR Choices

Renewal Application Progress Report Policy Change

• In order to maximize public transparency, NIH will not maintain the current renewal application policy.

• NIHGPS Chapter 8.6.2 states that “whether funded or not” the progress report contained within the renewal application may serve in lieu of a separate final progress report.

• The change aligns NIH’s final performance reporting requirement with the requirements of other Federal research awarding agencies.

Interim vs. Final RPPR

RPPR Workflow Process

NIH requires recipients to report on Project Outcomes in Section I of the Interim and Final-RPPR. Therefore, in each scenario listed above, Project Outcomes must be provided by the recipient in order for the recipient to submit their final report in eRA Commons. Otherwise, eRA Commons will not allow recipients to submit the required report and recipients will be considered non-compliant.

If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision to withhold a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2.

Annual progress reports = RPPR format

Due dates

Non-SNAP - approximately 60 days before the start of the next budget period

SNAP - approximately 45 days before the start of the next budget period

Multi-year funded - on or before anniversary date

Searchable list to determine which progress reports are due: https://public.era.nih.gov/chl/public/search/progressReportByIpf.era

Reminder:Timely Progress Reports

Federal Financial Report (FFR) (SF-425) Expenditure Data

Annual (Non-SNAP Awards)

FFR submitted no later than 90 days after the end of the calendar quarter in which the budget period ended.

Final (SNAP and Non-SNAP Awards)

FFR submitted within 120 days following the end of the project period.

Reminder:Timely Financial Reporting

NOT-OD-17-098: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018

• NIH officially announces plans to eliminate Appendix materials related to clinical trials for applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2018. Clinical trial-related materials will be specified and required in the new PHS Human Subjects and Clinical Trials Information Form and no longer allowed in the Appendix unlessspecifically stated as required in the funding opportunity announcement (FOA).

• Restriction of Appendix materials is intended to rectify inequities in the peer review process that can arise from submission of inappropriate or excessive appendix materials by some applicants and consideration of Appendix materials in peer review by some, but not all, reviewers.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html

NIH Update:Clinical Trial-Related Materials Appendix Policy

NOT-OD-17-094: Clarification and Update: Salary Supplementation and Compensation on Mentored Research Career Development ("K") Awards

• The recipient institution may supplement the NIH or AHRQ salary contribution on "K" awards up to a level that is consistent with the institution's salary scale.

• For effort directly committed to the "K" award, salary supplementation is allowable, but must be from non-Federal sources (including institutional sources).

• For effort not directly committed to the "K" award, "K" award recipients may devote effort, with compensation, on Federal or non-Federal sources as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator), as long the specific aims of the other supporting grant(s) differ from those of the "K" award.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-094.html

NIH Clarification and Update:Salary Supplementation and Compensation on K Awards

NOT-OD-17-095: Additional Guidance on Full-Time Training for Ruth L. Kirschstein National Research Service Awards

• All Kirschstein-NRSA fellows and trainees are required to pursue their research training full time. Full-time is generally defined as devoting at least 40 hours per week to research training activities, or as specified by the awardee institution in accordance with its own policies.

• Fellows and trainees may spend on average, an additional 25% of their in part time research, teaching, or clinical employment, so long as those activities do not interfere with, or lengthen, the duration their NRSA training.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-095.html

NIH Additional Guidance:Full-time Training for NRSA Awards

NOT-OD-17-101 : Policy Supporting the Next Generation Researchers Initiative

• This notice announces a new policy designed to invest in the next generation of researchers; this policy implements, in part, Section 2021 of the 21st Century Cures Act. This policy supersedes previous notices on new and early stage investigators.

• Consistent with the directives of the 21st Century Cures Act, the Next Generation Researchers policy requires institutes and centers (ICs) to prioritize awards that will fund Early Stage Investigators (ESIs) and Early Established Investigators (EEIs).

• Meritorious R01-equivalent applications with ESI PD/PIs will be prioritized for funding. ICs will put this prioritization into effect starting in fiscal year (FY) 2017. The goal for FY 2017 will be to fund approximately 200 more ESI awards than in FY 2016.

• A meritorious application with a designated PD/PI EEI may be prioritized for funding if:• The EEI lost or is at risk for losing all NIH research support if not funded by competing awards this

year, OR• The EEI is supported by only one active award.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-101.html

NIH Update:Policy Supporting the Next Generation Researchers

NOT-OD-17-105: NIH Applications Must Be Complete & Compliant With NIH Policy and Application Instructions At Time Of Submission

• The purpose of this notice is to remind applicants, both sponsored programs officials as well as investigators, that to be fair to all concerned the NIH will consistently apply standards for application completeness and for compliance with all submission requirements and NIH policies.

• NIH (CSR) may withdraw any application identified during the receipt, referral, and review process that is incomplete or noncompliant with instructions in the SF424 (R&R) Application Guide, the Funding Opportunity Announcement, and relevant NIH Guide Notices.

• When a recipient is in doubt about this longstanding grants policy, contact Office of Policy for Extramural Research Administration or the Division of Receipt and Referral as listed below.

NIH Applications Completeness & Compliance with Policy

Office of Policy for Extramural Research Administration (OPERA)Office of Extramural Research (OER)Division of Grants PolicyTelephone: 301-435-0949Email: grantspolicy@od.nih.gov

Division of Receipt and ReferralCenter for Scientific Review (CSR)Telephone: 301-435-0715Email: csrdrr@mail.nih.gov

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-105.html

• Effective for receipt dates on or after January 25, 2018, ALL applications to the NIH MUST use the new Forms-E application packages in ASSIST ONLY. The downloadable SF424 Adobe Forms (AKA Legacy Forms) are being phased out.

• Please refer to NOT-OD-17-062 for more information.

• Note: Health Sciences will NOT utilize Workspace for any application to the NIH. HS SPPO will alert you to update your choice of application type if a Workspace application is received in lieu of an ASSIST application.

Coming Soon Reminder: Forms E Application Packages

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-062.html

Focus of changes:

Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms

Expansion and use of discrete form fields for clinical trial information to provide the level of information needed for peer review;

lead applicants through clinical trial information collection requirements

present key information to reviewers and agency staff in a consistent format

align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov

Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms

Focus of Changes for Forms E

PHS Human Subjects and Clinical Trials Information Form

Consolidates information from multiple forms

Incorporates structured data fields

Collects information at the study-level

Be sure you are using the correct application forms for your due date.

• FORMS-E will be available October 2017!

• For more information: https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm

Availability of FORMS-E Application Guides

Application guides for FORMS-E application packages will be posted to the How to Apply -Application Guide page no later than October 25, 2017.

Availability of FORMS-E Application Packages

NIH will begin posting new funding opportunity announcements (FOAs) with FORMS-E application packages on October 25, 2017.

• New FOAs posted before October 25, 2017 with initial due dates on or after January 25, 2018 will be posted without application forms. Application packages will be added to these FOAs by November 10, 2017.

FORMS-E Grant Application Forms and Instructions

The Final Rule – effective January 19, 2018 – is intended to enhance protections for human research participants, facilitate valuable research, and reduce burdens for investigators, research institutions, and Institutional Review Boards (IRBs).

Studies that have not undergone initial IRB review will be subject to the new Final Rule requirements.

Research ongoing on that date will continue to be subject to the current Common Rule requirements.

The single IRB requirement for cooperative research vs. multi-site studies takes effect three years later (January 20, 2020).

**The NIH policy on the use of single IRBs in multi-site studies takes effect in January 2018.**

Final Rule:Federal Policy for the Protections of Human Subjects

Effective for competing grant applications with receipt dates on or after January 25, 2018.

Domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH are expected to use a sIRB to conduct the ethical review required by the DHHS regulations for the Protection of Human Subjects.

Single Institutional Review Board (sIRB)

Costs – sIRB costs can be a direct or indirect charge to an NIH award as long as such costs are reasonable and consistent with the cost principles.

Exceptions to this policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal or state law, regulation or policy. Requests for exceptions that are not based on a legal, regulatory or policy requirement will be considered if there is a compelling justification for the exception.

FAQ’s for sIRB implementation and sIRB cost have recently been posted. Any questions should be sent to SingleIRBPolicy@mail.nih.gov

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html & https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-076.html

NIH Policy - Use of a Single IRB for Multi-Site Research

Domestic multi-site clinical trials will require a single IRB of record

Key Dates

Grants: Applications due on or after January 25, 2018

Contracts: Solicitations published starting January 25, 2018

Exceptions

sIRB not applicable for Career Development (K), Research Training (T), or Fellowship (F)

For more information: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm

Single Institutional Review Board (sIRB) Policy for Multi-site Research

ePD Updates: Effort ReportingPam Tallarida, Sr. Training & Client Support Analyst

Effort ReportingNovember 1, 2017

% Effort entry required effective 11/1/17

All EPD Proposals

Exceptions:• OCTA Sponsor Initiated Industry Funded Clinical Trials

• UCSD/UC PI-Initiated Clinical Trials not involving federal funding

Responsibilities by Role Aggregator (Proposal Creator)

Enters percent effort for first year of proposal using the decimal format 10% -> 0.10 100% -> 1.00

Enters percent effort broken down as: T (Total) – Only used for School of Medicine Personnel A (Academic) S (Summer) C (Calendar) – Only for General Campus 12 month appointees

Personnel to Add

Principal Investigator All other personnel with titles:

Professor (incl. Professor-in Residence, Clinical Professor, Adjunct Professor, Professor of Clinical X, Research Professor, Professor Emeritus)

Research Scientist

Project Scientist

Post Doc (only if PI)

Senior/Key Personnel Anyone responsible for the design, conduct or reporting of

research at UCSD

Principal Investigator

All other personnel with titles:Professor (incl. Professor-in Residence, Clinical Professor,

Adjunct Professor, Professor of Clinical X, Research Professor, Professor Emeritus)

Research Scientist

Project Scientist

Post Doc (only if PI)

Senior/Key Personnel

Anyone responsible for the design, conduct or reporting of research at UCSD

Non-Senior/Key Personnel Enter as Key Study Person if required for reporting

MSO Verify required effort has been entered before approving and routing for

chair approval

Aggregator makes additions/corrections

Rejects proposal missing effort information

IF NOT…. SPO

Rejects proposal missing effort information

Aggregator makes additions/corrections

Aggregator returns to SPO via “short map”

Reminder emails October 16th

October 31st

Export ControlBrittany Whiting,Export Control Officer

Export Control Red FlagsePD Questions & Special Review

Audience: HS ContactsPresenter: Brittany Whiting, Export Control Office (ECO)

9-21-17

• Identifies and manages export risks for national security & foreign policy reasons

• Supports faculty, staff and student research activities by:• Reviewing export transactions & obtaining export licenses from U.S. Government;• Evaluating travel to sanctioned countries and all shipments to foreign countries;• Developing technology control plans; and• Providing customized training

Export Control Office

Agenda

• Export Control Basics• ePD Export Control questions• COEUS Special Review for Export Control

Objectives

• Recognize red flags for export control risks in relation to sponsored research and unfunded agreements

• Gain an understanding of when to escalate to Export Control

• Ensure compliance with federal export control regulations

• Restricted Entities • prohibited payments, exports, collaborations

• Sanctioned Countries • Cuba, Iran, North Korea, Sudan & Syria

• Physical Exports • export restricted biologicals or technologies

• Deemed Exports • providing export restricted technology to foreign persons

in the United States, such as NDA info

Export Control Red Flags

National Security

EARITAR

OFAC

AFAEA

• Treasury• Sanctioned

Countries • Commerce• Dual Use

Items • State• Military

Items

• DOE/ NRC

• Nuclear Items

Foreign Policy

US Export Control Regulations

• Export Administration Regulations (EAR)• “Dual use” items are controlled by the Export Administration Regulations (EAR – 19 CFR 730-774)

administered by The Department of Commerce, Bureau of Industry & Security (BIS)

• International Traffic in Arms Regulations (ITAR) • Munitions & defense services are controlled under the International Traffic in Arms Regulations (ITAR)

are administered by the Department of State

• Office of Foreign Asset Control (OFAC) • Treasury’s Office of Foreign Assets Controls (OFAC) administers economic & trade sanctions • Research in or collaborations with any of the following countries, require review from Export Control:

Cuba, Iran, North Korea, Sudan, Syria

• AND OTHERS…DOE, NRC

The EXPORT CONTROL Questions:

WHO are we interacting with?

Restricted or Prohibited PARTY?

• The US Government issues various lists of individuals & entities both in the U.S. & abroad that have committed export violations or other serious offenses. • Terms & conditions require no debarred, disqualified

or ineligible persons• Part of funding awards, procurement and service

agreements

• Financial dealings or export transactions with Restricted or Prohibited parties is prohibited.• Terrorists• Weapons Proliferators• Export Violators• Drug Traffickers

How do you determine if there is a Restricted Party?

Restricted Party Screening in the Visual Compliance Tool

Transactions That Need Screening

• If you are conducting transactions with other persons, whether individuals or entities and whether in the U.S. or abroad, these restrictions apply to you. International transactions may include:o Collaborations – MTA’s, NDA’s, Licensing, Technology Transfero Payments for goods or services (cash, check, wire transfer, or other means)o Contributions and donations of funds, materials or support o Imports or export shipments either physical or electronico Access to export restricted data or ITAR equipment

• NDAs, Employees, students, visiting scholars in labs with access to restricted items, Sales and Service• All the parties to a transaction

Restricted Entities University Examples-not comprehensive

• BEIJING UNIVERSITY OF AERONAUTICS AND ASTRONAUTICS (BUAA) AKA BEIHANG UNIVERSITY-China

• NORTHWEST POLYTECHNICAL UNIVERSITY-Xian, China• SICHUAN UNIVERSITY- Chengdu, China• UNIVERSITY OF ELECTRONIC SCIENCE AND TECHNOLOGY OF CHINA - Chengdu, China• National University of Defense Technology- China• MALEK ASHTAR UNIVERSITY OF TECHNOLOGY- Tehran, Iran• BAQIYATTALLAH UNIVERSITY OF MEDICAL SCIENCES – Tehran, Iran• IMAM HOSSEIN UNIVERSITY- Tehran, Iran• BEN GURION UNIVERSITY (BGU)- Israel

Sanctioned Countries

OFAC Comprehensive Sanctions for imports, exports, financial transactions and services for

Cuba, Iran, North Korea, Syria and SudanContact ECO for transactions with any of these countries

• Other countries with non-comprehensive sanctions include: the Crimea region of Ukraine, Belarus, the Balkans, Central African Republic, Cote d’Ivoire, Iraq, Lebanon, Libya, Somalia, South Sudan, Venezuela, Yemen, Zimbabwe and the former Liberian Regime of Charles Taylor.

This list is not exhaustive

What is it?

Equipment & Materials Software

Technology or Technical Data

ITAR“Military items”

EAR Items“Dual use”

VS

How will it be used?Prohibited End Uses:

Nuclear (both civil & weapons), chemical & biological weapons, rockets & UAVs

Prohibited End Use Examples

• Service agreement for structural engineering for nuclear entity in South Korea to test rubber bearings for construction of nuclear facilities

• Confirmed with US government this was not a prohibited end use• Research collaboration by physics with an nuclear entity in Japan

• Review determined that entity was not tied to nuclear proliferation.• UAV use for service agreement with Australia

• ITAR export license was required and took 1 year to obtain• Award for NORTh Korean Govt officials to attend meetings at ucsd

• ofac license required for payment or services to DPRK

Does the Research or Activity involve: • DoD or Military contractor Funding (Navy, DARPA, Northrup Grumman, etc)• Military, Space, Encryption, Nuclear• A foreign entity?

• Collaboration with a foreign military or space agency?• Training foreign nationals?• Shipping/ transferring items to a foreign country?• Collaborating with foreign colleagues in foreign countries?• Working with a country subject to US sanctions?

• Cuba, Iran, North Korea, Syria and Sudan

Look for Red Flags

WHEN TO CONSIDER EXPORT CONTROLS AT UCSD

UCSD Partners in export control

Export Control Office

Contracts & Grants

Gifts

Purchasing

OIC

Shipping

Int’l Center & HR

Export Control

Faculty, Researchers & Administrators

Partnerships complimented by systems

• In addition to our Export Control partners, we’ve implemented checks, or “Gates,” in various systems across the campus where Export Controls may intersect University business.

• ePD Questions: • Directed at PIs / Research activities• Can identify risks early• Crosses multiple areas where Export Controls may

impact Research• Relies on Departmental proposal preparers / SPOs

Revised Export Control Questions

Q1. Are you working outside U.S., exporting items or working with a foreign entity? Please click MORE for additional information. Any country, Canada and Mexico included. Is there a budget for international shipping or travel? Is there

a foreign collaborator listed in the SOW or support letter? Q1A. Is there involvement of a Foreign entity (sponsor, sub-recipient, collaborator)? Q1.B. Which country will you be working with? Important note: Please separate the country names by a

comma. Q1C. Is there collaboration with or research in Cuba, Iran, North Korea, Syria, or Sudan? Requires

immediate review Q1D. Will any equipment, materials, software or technology be exported by UCSD in the course of this

project? In the budget, are there travel or shipping costs?

Q2. Is this research funded by the Department of Defense or any of its entities (Army, Navy, Air Force, DTRA, DARPA, etc.) either directly or indirectly like through a defense contractor or other research institution? The ITAR regulations changed and certain items funded by DOD are ITAR controlled unless in the award

the government indicates there is a civil use. Additionally Defense related funding may have publication, foreign national restrictions.

Q2a Did you include the DOD ITAR language in your statement of work? Q3. Does research involve encryption, military (ITAR) and/or space technology (e.g., satellites, explosives,

military training, military vehicles, vessels, and equipment)? If any of the words in this question regarding encryption, military (ITAR) and/or space technology (e.g.,

satellites, explosives, military training, military vehicles, Navy vessels, and military equipment) are present in the SOW or solicitation this should be answered yes. Examples include Israel ministry of defense, Australia Defence Science and Technology Group, NASA

Revised Export Control questions, cont

Q4. Does the proposed research involve access to export controlled information or technology such as government or 3rd party confidential information identified as export restricted?

Is there a NDA associated with this award? Or is there specific export restricted information identified in the solicitation?

Q5. Does the sponsor require prior approval on publications, indicate that project is export restricted or restricts the participation of foreign nationals?

Examples include distribution limited to “US government only”, “no foreign nationals”, “U.S. citizens only”, foreign national approval required. Publication approval required. This is ITAR restricted.

Revised Export Control questions, cont

• Handled the same as Conflict of interest (COI)• the Sponsored Projects Office will only create an award record in Coeus when the Export Control special

review line in the Institute Proposal module shows As “Approved”, “Managed” or “Not Required”. The Export Control Office updates Special Review approval statuses directly in the Coeus ePD and/or IP module

SPECIAL REVIEW

COEUS: Valid Approval Statuses for Export Control ReviewsStatus Definition

Pending Used when Export Control review is applicable.

Routed for Review* Used when a Sponsored Projects Office has routed the proposal and award to ECO at export@ucsd.edu for review

Approved* The award has been reviewed and approved by ECO which has verified that the proposal/award has no export license requirements.

Managed* ECO has identified export license requirements or technology control plan requirements. Research may proceed according to the terms of the license or control plan.

Not Approved* No research can occur due to U.S. export control regulatory restrictions that cannot be mitigated or managed.

Not Required Used when it is determined by the ECO that Export Control Approval is not required

* This value is not displayed to users in the web version of the Proposal Development module. Additionally, if a user tries to select any other approval status in Coeus Premium & submit the proposal to Routing, it will fail validation and required them to select a different value.

The SPO: last line of defense

• Gates established across campus• Department training is ongoing• SPO provides visibility to the export control office• Often the last gate before an award is accepted

and potentially unlicensed research activities begin• Once export control violations occur, UCSD is

subject to fines ($250k-$1M per violation), criminal prosecution (Prof Roth), and reputational damage

VideosTopics:University Research: 6 minutes, 45 secondsTraveling abroad: 4 minutes, 28 seconds ITAR: 7 minutes, 40 seconds Biological Agents: 5 minutes, 4 seconds OFAC: 3 minutes, 52 seconds

Who should watch them? • Students, post-docs, researchers • Staff – use as part of new hire training or watch when you

have a question• Faculty TO COMPLY WITH

EXPORT CONTROLShttp://blink.ucsd.edu/sponsor/exportcontrol/training.html

Export Control Office

• Brittany Whiting, Export Control Officer (858) 534-4175• Garrett Eaton, Sr. Export Analyst (858) 822-4136

export.ucsd.eduexport@ucsd.edu

Visual Compliance

Visual Compliance Restricted Party Screening Demo

Restricted Party Screening Tool

The highlighted fields need to be completed.

The comment needs to indicate the dept, PI & reason for screening

Example Screening Output

Example result of a clean screening with no matching records found

Example Screening OutputExample of a hit that needs escalation to: export@ucsd.edu

Escalations to Export Control

• If the visual compliance screening results in a hit, please email via Visual Compliance to export@ucsd.edu for review.

• Export Control will review and advise if an export license may be required depending on the entity and the interactions they will be having with UCSD.

Benefits of compliance:

2015 RESTRICTED PARTY SCREENING METRICS• 7,620 screenings

• 27 control plans implemented for visiting persons associated with restricted universities• 1 MTA stopped for restricted entity & export restricted biologicals• 1 Russian bank transfer stopped; routed to another bank• 1 import from Iran stopped for visiting scholar• 1 export license for restricted entity export in Pakistan

• Risk Mitigation of $7.5 M• 146 People doing screening

2015 BY THE NUMBERS

UC San Diego

Export Control Office

T: 858.534.4175 (Brittany Whiting)

T. 858-822-4136 (Garrett Eaton)

export.ucsd.edu

export@ucsd.edu

UC San Diego Health

Health Sciences SPO

T: 858.822.4109

hssppo.ucsd.edu

vchsgrants@ucsd.edu

UC San Diego

eRAP Help Desk

T: 858.534.9979

erap.ucsd.edu

blink.ucsd.edu/go/epd

eraphelp@ucsd.edu