Export Control

1
Departmental Research Administrators Training
Track
Research Protections Compliance Part II of II

• Export Control
• Responsible Conduct of Research (RCR)
• Data Management
• Conflict of Interest
• Research Misconduct

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Learning Outcomes

• Understand the importance of Research Protections
  Compliance
• Understand and Appreciate how essential your role
  is in UMBCs Research Protections Compliance
• Learn about valuable campus resources

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Overview

• Research Protections Compliance is
• Being aware of rules and regulations
• Understanding what compliance means
• Showing and Sharing with others how to Do the
  right thing
• How do you fit in?
• Be aware of the concepts and components of
  Research Compliance
• Know why it is important for you and
  investigators to be aware of the issues and
  challenges related to
• Export Control RCR - Conflict of Interest
  (COI)
• RCR - Data Management RCR - Research
  Misconduct

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Doing the right thing

• The Reputation of a thousand years may be
  determined by the conduct of one hour.
  Japanese Proverb
• The Office of Research Integrity says research
  staff should understand the purpose of being
  responsible and having proper conduct in
  research activities
• Follow institutional procedures for acting
  responsibly
• Understand what is means to be a responsible
  researcher
• Have an awareness of the core areas of
  responsible conduct of research

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Circle of Compliance
Research Compliance
Ensures the ethical review of research
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What Are Export CONTROLS?

• Regulations that control distribution of certain
  exports to FNs and foreign countries
• Have been around since the 1940s
• Extend beyond research
• Need license before you can export

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What is an Export?

• Transfer of Controlled
• Technology Software
• Information Source Code
• Equipment Services (ITAR)
• To
• A non-U.S. entity or individual, wherever located
  (Deemed export )
• Anyone outside the U.S., including U.S. citizens
• By Any Means
• Actual shipment outside the US
• Visual inspection in or outside the US
• FAX PHONE EMAIL FACE to FACE
• Tours of labs
• Training sessions
• Computer data

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What is a Deemed Export?

• The transfer, release or disclosure of Technical
  Data or Technology to a foreign national within
  the United States (includes university campuses).
  
• A transfer is the same as exporting it to the
  home country of foreign national.

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Who are U.S. Persons?

• U.S. citizens
• Aliens who are Lawful Permanent Residents
  (Green Card holders)
• Other Protected Individuals
• designated an asylee or refugee
• a temporary resident under amnesty provision
• Any entity incorporated to do business in the
  U.S.

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Who are Foreign Persons?

• Everyone else
• Any foreign interest or any US Person effectively
  owned or controlled by a foreign interest
• Includes foreign businesses not incorporated in
  the U.S., persons representing Foreign Persons,
  any foreign government
• Includes H1B Work Visa, F1 Study Visa, J1
  Training Visa, E1 Investors Visa, TN Work Visa,
  L1 Intra-Company Transfer Visa, K and V Fiancée
  Visas
• EAR does not use the term foreign person -
  instead it refers to foreign national- they
  mean the same thing

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Application

• Applies to following UMBC areas
• Research Purchasing
• MTA, CDA, LA Human Resources
• Shipping Visiting Faculty Foreign
  Nationals
• Foreign Travel International Education
• Foreign Students
• Export control laws apply to all activities
  not just sponsored research projects
• Your award does not have to cite the regulations
  for export controls to apply

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Why is this important?

• Protect National Security US foreign
  obligations
• Combat Terrorism
• Prevent spread of weapons of mass destruction
  (nuclear, chemical, biological, missiles, etc)

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Why ImportantLiability and Violations

• Individual institutional penalties
• Large fines jail time (500K Civil 1M
  Criminal)
• Multiple violations/finding for same occurrence
• Not just you - Could result in UMBC wide
• All settlements public
• Draconian compliance and reporting
• Loss of export privileges (exporting is not a
  right)
• Adverse impact on federal awards

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Why importantUniversity Violations

• U of Tenn Roth Fine Jail time ITAR.
• UCLA - Supported a conference in Iran OFAC
• UC Santa Cruz civil enforcement action 5 yr
  look-back rule
• Texas Tech - Butler - Select Agent export to
  Tanzania 2 yrs in prison 37,400 fine
• Voluntary disclosure helps

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Most Common US Agencies
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Dept of CommerceBureau of Industry security

• Export Administration Regulations (EAR)
• (15 CFR 734-774)
• The Commerce Control List (CCL) covers
  commodities, technology software identified by
  an Export Control Classification Number (ECCN).
• Goods and Services having a dual use
  (commercial with military application)

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EAR Commerce Control List (CCL)

• Category 0 - Nuclear Materials, Facilities
  Equipment (and Miscellaneous Items)
• Category 1 - Materials, Chemicals,
  Microorganisms, and Toxins
• Category 2 - Materials Processing
• Category 3 Electronics
• Category 4 Computers
• Category 5 (Part 1) Telecommunications
• Category 5 (Part 2) - Information Security
• Category 6 - Sensors and Lasers
• Category 7 - Navigation and Avionics
• Category 8 Marine
• Category 9 - Propulsion Systems, Space Vehicles
  and Related Equipment

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Dept of StateDirectorate of Defense trade
controls (DDTC)

• International Traffic in Arms Regulations (ITAR)
  22CFR Part120-130
• US Munitions List (USML) covers military
  articles, services and related technical data
• Prior Authorization required for
• Sending or taking out of U.S. in any manner
• Disclosing (including oral or visual disclosure)
• Transferring to foreign person, whether in U.S.
  or abroad. 
• Performing a defense service on behalf of, or for
  the benefit of, a foreign person, whether in the
  U.S. or abroad.
• Certain info controlled even if in public domain
  Defense Services.

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ITAR US Munitions List (USML)

• 121.3 Aircraft and related articles
• 121.4 Amphibious vehicles
• 121.5 Apparatus and devices under Category IV(c)
• 121.6 Cartridge and shell casings
• 121.7 Chemical agents
• 121.8 End-items, components, accessories,
  attachments, parts, firmware, software and
  systems
• 121.9 Firearms
• 121.10 Forgings, castings and machined bodies
• 121.11 Military demolition blocks and blasting
  caps
• 121.12 Military explosives and propellants
• 121.13 Military fuel thickeners.
• 121.15 Vessels of war and special naval
  equipment.
• 121.16 Missile Technology Control Regime Annex.

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Dept of Treasury Office of Foreign Assets
Control

• The Office of Foreign Assets Control (OFAC)
• 31 CFR 500-599
• Based on US foreign policy and national security
  goals. They cover economic and trade sanctions
  against targeted foreign countries, terrorists,
  international narcotics traffickers, and those
  engaged in activities related to the
  proliferation of weapons of mass destruction.

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OFAC Application

• OFAC license required for services to or from
• Countries, entities, or individuals
• Covers Sanctions and Embargos
• May apply when ITAR EAR do not
• Multiple lists must be checked (applies to
  entities and individuals even if their country is
  not listed)
• Covers some practices (ie proliferation of WMD)
• Restrictions vary by country
• Some exemptions apply for academic collaboration

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OFAC Application

• Prohibits
• Travel to embargoed countries
• (Balkans, Burma, Cote dIvoire, Cuba, DRC, Iran,
  Iraq, Liberia, Lebanon, Libya, North Korea,
  Somalia, Sudan, Syria, and Zimbabwe)
• Sanctions against Countries, Entities,
  Individuals
• Research, field-work, or instruction
• Surveys or interviews
• Trade Importing merchandise
• Furnishing anything of value (ie materials,
  payments, services, honoraria, training)
• Collaborating, presenting or training

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EAR ITAR End User Controls/Prohibitions

• Separate from USML CCL, ITAR EAR prohibit
  exports to, or export collaborations with,
  certain designated entities or countries
  identified as export violators both in and
  outside the U.S.
• So, CCL and USML may say no license is required
  in general, but you need to also check their
  lists to determine if more stringent restrictions
  apply to the entity or country
• Dont be fooled by their Academic names
  (Beihang University, SW Institute of Env Testing,
  Chinese Academy of Engineering Physics).

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The Lists

• Denied Persons List (BIS)
• Unverified List (BIS)
• Entity List (BIS)
• Specially Designated Nationals List (OFAC)
• Debarred List (DDTC)
• Nonproliferation Sanctions (DDTC)

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Types of Exclusions and Exemptions

• Exclusion Outside the regulations not subject
  to the regulations
• Exemption - License not required for item or
  activity as defined within the regulations
• Public Domain Exclusion (ITAR,EAR,OFAC)
• Fundamental Research Exclusion (ITAR, EAR)
• Education Exclusion (ITAR, EAR)
• License Exception TMP (Temporary Exports)
• Full-Time Employee Exemption (ITAR)
• Must be used correctly failure may result in an
  export control violation

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Areas of Concern

• Equipment Use
• No License required if FN use of controlled
  equipment is routine. Must not include
  information beyond what is publically available.
• A license may be required if FN is "using" the
  controlled equipment in such a way as to access
  technical information beyond what is publicly
  available. Applies even if Fundamental Research.

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Areas of Concern

• TRAVEL
• Travel to embargoed countries
• (Balkans, Burma, Cote dIvoire, Cuba, Dem. Rep of
  Congo, Iran, Iraq, Liberia, Lebanon, Libya, North
  Korea, Somalia, Sudan, Syria, and Zimbabwe)
• Taking equipment (laptops, etc.), out of the
  country may require a license for equipment or
  controlled technology loaded on equipment
• Available license exceptions (must stay under
  effective control)
• TMP temporary exports - Good for 1 yr
• BAG personal baggage

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Areas of Concern

• Shipping equipment to a foreign country
• A license is required to ship if controlled by
  ITAR to any foreign country (few exemptions).
• A license may be required to ship equipment
  controlled under the EAR out of the US depending
  on what the equipment is, where it is being sent,
  who will be using, and for what purpose (many
  exceptions)
• Process to classify equipment and obtain a
  license under EAR may take several months
• There is a presumption under OFAC that any and
  all shipments of equipment and provision of
  services to countries under sanction or persons
  in those countries are ILLEGAL.
• Collaborating with foreign colleagues in foreign
  countries
• Teaching foreign persons how to use items in
  research (Defense Service)
• Controlled software use in classes

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Areas of Concern

• Sponsor publication approval or foreign national
  restrictions
• Contracts with DoD, NASA, DHS, Intel Agencies
• Proprietary technology research with industry or
  government
• Accepting another partys proprietary information
• International sponsors, subcontractors

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Areas of Concern

• Non-sponsored research at university
• Collaborating w/ country subject to US sanctions
• Projects in your garage
• Attending closed mtgs conferences DD2345
• Faculty start-up companies (no FRE)
• Providing services (not research)
• Protecting students
• Consulting work
• MTAs and NDAs

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Plan for managing EC

• Sponsored Programs
• Export Control Flow Chart and Questionnaire
  created
• Questions are being added to Routing sheet
• Practical EC training to OSP planned
• UMBC Community
• Created EC information web site (found at
  http//www.umbc.edu/research/ORPC/_
• Established EC Official Legal - Dean Dave
• Work with Functional Departments (shipping,
  travel, etc)
• Execute EC Policy Draft routed
• Outreach and training program
• Schedule times at College faculty meetings
• Add EC component to DRATT
• On agenda for Departmental Mtgs (BRA, RAG, etc)

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Nine (9) Areas of RCR 1st three
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DATA Management

• Data Are a collection of facts, measurements,
  or observations acquired through a scientifically
  designed method
• Final Research Data - Recorded factual material
  commonly accepted in the scientific community as
  necessary to document and support research
  findings.
• Multiple Institutions - Might require NDAs,
  MTAs, LAs, MOUs
• Contractual obligations - to share data
  (NIH/NSF) Key to work it out in advance
  internally, (student/mentor/advisor) as well as
  externally (UMBC entity)
• UMBC IP Have inventions been reported before
  you share or make public?
• Export Controls Can you share the data with
  Foreign Collaborators?

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DATA Management
Assure Data Reliability Access
Management Maintain Data Integrity Data
Retention
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DATA Management
Case Study A student works in a lab where
practices and procedures for keeping research
records have not been reviewed or enforced. Each
person in the lab has their own style of keeping
research data. The student often uses yellow
post-it-notes to record data. After several
months of research the student prepares a report
for a paper and presents it to the PI. Upon
review the PI requests a copy of the lab notebook
to review the supporting data associated with a
particular graph. The student hands the PI the
post-it-notes, but admits he can no longer find
the particular note that supports the graph in
question.
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DATA Management

• Questions
• Can the investigator use the students report for
  his report to the sponsor?
• What went right wrong in maintaining Data
  Integrity ?
• What if there was new Intellectual Property
  developed?
• What should the PI do now?

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DATA Management

• Resources
• ORPC Web page RCR/Research Integrity
• http//my.umbc.edu/groups/compliance/documents/166
  
• Faculty Handbook, Section 15 Faculty Rights and
  Responsibilities-Research http//www.umbc.edu/pr
  ovost/Faculty_Handbook/section15.pdf
• UMBCs IP Policy
• http//umbc.edu/policies/pdfs/iv-3.20.0120intelle
  ctual20property20policy.pdf
• NIH Data Sharing Policy
• http//grants1.nih.gov/grants/policy/data_sharing/
  index.htm

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UMBCsPolicy ProceduresonConflicts of
Interest
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Why Worry about a COI Policy on Research?

• Because it is required by
• USM Policy
• Maryland State Ethics Law
• NSF and PHS Regulations

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Why Worry about a COI Policy on Research?
But also because A policy on COI protects
individual investigators and the university from
others calling into question the integrity of
research results when an investigator could be
perceived to benefit financially from the results
of the research.
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Two Approaches to Dealing with COI in Research

1. Forbid activity involving a COI, or
2. Manage COI so most activity involving a COI can
   be conducted.

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What is a COI?
In General A situation in which the potential
exists for a secondary interest (e.g., a
personal financial interest) to influence
judgment associated with a primary interest
(e.g., research and teaching) Even if the
influence is not real, but could be perceived to
be real.
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Types of COI Scopeof the Policy
All Conflicts of Interest
Financial COI
Financial COI in Research
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So, What Exactly is a COI in Research?
COI Requires TWO Relationships with the same
Company by the same Individual
University Relationships
Personal Relationships
Faculty, Staff, Students
Individual Family

• Research Agreements
• License Agreements
• Other UMBC Agreements

• Consulting Agreements
• Equity Holdings
• Fees, Royalties Other

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General Policy Requirements
For situations in which both a Personal
Relationship and a University Relationship exists
for an Investigator . . .

• The Policy requires
• Disclosure of Certain Financial Interests
• Review of Those Disclosures
• Management or Elimination of the Conflict of
  Interest Situation

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What Must be Initially Disclosed?

• When you have, or plan to have, a University
  relationship with a company in which you or a
  Family Member have any financial interest
• OR, when you (or a Family Member) have, or plan
  to have, a financial interest in a company that
  could reasonably appear to be affected by your
  research

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To Whom Must Information be Disclosed?

• At the Investigators Option
• Department Chair or Supervisor, or
• Provost/Designee (Vice President for Research)

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When does a Disclosure Need Further COI Review?

• When the disclosure meets the thresholds of a
  Relevant Interest or Significant Financial
  Interest
• See Exhibit A of the COI Procedures for the
  definitions of these terms
• Financial Disclosure Statement Form Exhibit C

• Consulting
• Corporate Research
• Gifts
• Corporate Financial Interests
• Federal Grants (Related to Researchor Product
  Development)
• Conflicts of Interest

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How is COI Determined?
Remember To get to this point, an Investigator
must have a University Relationship AND a
Personal Relationship with the same Company.

• COI Exists if the Personal Relationship is
• A Relevant Interest State Law(1,000
  Threshold) or
• A Significant Financial Interest
  Federal(10,000 Threshold)
• Judgment of the Reviewer based on the Disclosure
  of the Individual

Quantitative Aspect
QualitativeAspect
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Record Retention Policy

• No COI
• Records kept for 3 years
• Destroyed thereafter
• Confidential (to the extent permitted by law)

• COI Exists Managed
• Forward to Provost for Review
• Records kept for 3 years after end of COI
• Public Record

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Review/Approval Process
Disclosure of COI (as determined by Chair)
Review by Provost or Designee
COI Committee
COI Management Plan
IRB
COI Statement
UMBC Counsel
Approval
President Approval
Appeal
Investigator
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UMBC COI Management

• Public Disclosure Legending Publications
• Graduate Students Oversight
• Post-doctoral Fellows Notification
• Equity Trigger Dates/Restrictions
• Management/Employment Restrictions
• Consulting Reporting Inventions
• Agreements with UMBC Recusal

See Exhibit B Guidelines for Managing COI in
Research Development
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Where is the Policy Document?
www.umbc.edu/research
Resources
Research Compliance
Conflict of Interest and Commitment
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Research Misconduct

• Responsibility of the entire academic community.
• Scholars work in an environment in which there is
  an important sense of trust. Published material
  is assumed to have been obtained during an
  author's investigations. Falsification or
  fabrication of such data is intolerable. 1
• Everyone at UMBC (faculty, staff, administrators
  and students) who are paid or unpaid, engaged in
  research, scholarly writing, and the creation of
  works of art have the responsibility of
  maintaining standards to assure the highest
  ethical conduct of research and detection of
  abuse
• 1 UMBC Policies and procedures for responding to
  allegations of scientific misconduct

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What has to be reported?

• Any potential violation that involves
• Fabrication
• Falsification
• Plagiarism
• Research misconduct does not include honest error
  or differences of opinion.

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Examples of misconduct UMBC Policies and
procedures for responding to allegations of
scientific misconduct

• Fabrication (making up data or results and
  recording or reporting them)
• Falsification (manipulating research materials,
  equipment, or processes, or changing or omitting
  data or results such that the research is not
  accurately represented in the research record)
• Plagiarism (taking another person's ideas,
  processes, results, or words without giving
  appropriate credit)
• Misrepresenting authorship (taking credit of
  authorship improperly or excluding others from
  correct authorship)
• Violation of generally accepted research
  practices (improperly manipulating results)
• Failure to comply with federal requirements
  (substantial, repeated, or willful violations
  involving the use of funds, care of animals,
  human subjects)
• Inappropriate behavior in relation to misconduct
  (false accusations of misconduct, withholding or
  destroying evidence of misconduct, failing to
  report or looking the other way)
• Misappropriation of Funds or Resources (using for
  personal gain)

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Who has to report?

• Reporting possible violations is a shared
  responsibility, and it is the duty of the
  faculty, staff members, and students to resolve
  issues arising from such alleged misconduct. 

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Consequences

• Weakens the integrity of scientific endeavors and
  erodes the public trust
• UMBC will use due care to protect privacy of
  complainant. Anonymity of complainant cannot be
  assured.
• Materials collected will be kept confidential
  during the process. All participants will be
  treated with justice, fairness and with
  sensitivity to their reputations.

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Reporting Misconduct
Disclosure by Complainant
VPR Consults with Complainant and Legal
File ?
Let Supervisor Provost Respondent Know
Record Collection
Inquiry Committee
Continue?
Disciplinary Action
Report to External Entities
Investigation Committee
Appeal
Final Decision - Provost
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Overall, where do you fit in and how you can help

• Be aware of this procedure and alert researchers
  if you become aware of situations
• Encourage researchers to be aware of policies and
  procedures
• Know who to contact on campus with questions

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Points To Remember

• Be aware of rules and regulations
• Understand what compliance means while helping
  others to do the right thing
• Your role is in University research compliance is
  important

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Websites

• UMBCs Policy Procedures for Handling
  Allegations of Misconduct
• http//www.umbc.edu/policies/pdfs/iii-1.10.01.pdf
  
• USM Policy on Misconduct
• http//www.usmh.usmd.edu/regents/bylaws/SectionIII
  /III110.html 
• Office of Research Integrity policies and
  procedures
• http//ori.hhs.gov/policies/
• UMBC RCR training
• http//www.umbc.edu/research/ORPC/rcr_training.htm
  l

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Questions??

• Office for Research Protections and Compliance
• compliance_at_umbc.edu
• http//www.umbc.edu/research/ORPC
• 410-455-2737