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
1
Learning Outcomes
Understand the importance of Research
Protections & Compliance
 Understand and Appreciate how essential your
role is in UMBC’s Research Protections &
Compliance
 Learn about valuable campus resources
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2
Overview
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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 - Data Management
RCR - Conflict of Interest (COI)
RCR - Research Misconduct
“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
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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
Circle of Compliance
Administration
Compliance
Units
Research
Compliance
Researchers
Compliance
Committees
Ensures the ethical review of research
WHAT ARE EXPORT CONTROLS?
•
•
•
•
Regulations that control distribution of
certain exports to FN’s and foreign
countries
Have been around since the 1940s
Extend beyond research
Need license before you can export
WHAT IS AN EXPORT?
•
Transfer of Controlled:
Technology
Information
Equipment
•
To:
–
–
•
Software
Source Code
Services (ITAR)
A non-U.S. entity or individual, wherever located (Deemed export )
Anyone outside the U.S., including U.S. citizens
By Any Means:
–
–
–
–
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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
7
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.
8
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.
–
9
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
10
APPLICATION
• Applies to following UMBC areas:
* Research
* MTA, CDA, LA
* Shipping
* Foreign Travel
* Foreign Students
* Purchasing
* Human Resources
* Visiting Faculty – Foreign Nationals
* International Education
• 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
11
WHY IS THIS IMPORTANT?
•
•
•
Protect National Security & US foreign
obligations
Combat Terrorism
Prevent spread of weapons of mass
destruction (nuclear, chemical, biological,
missiles, etc)
12
WHY IMPORTANT
LIABILITY 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
13
WHY IMPORTANT
UNIVERSITY VIOLATIONS
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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
14
MOST COMMON US AGENCIES
Department of
State
Department of
Commerce
Export Admin
Regulations
(EAR)
Bureau
of
Industry
and
Security
(BIS)
Trade
Protection
Regulates commercial goods
& Services with potential
military application
(Dual Use)
Commerce Control List (CCL)
International
Traffic in Arms
Regulations
(ITAR)
National
Security
Export of articles, services
& related technical data
that are military in nature
US Munitions List (USML)
Department of
Treasury
Directorate
of Defense
Trade
Controls
(DDTC)
Office of
Foreign Assets
Control (OFAC)
Trade
Embargos
Sanctions against:
Foreign Countries & Gov
Terrorists, Narcotics, War
Criminals, Weapons
Proliferators
DEPT OF COMMERCE
BUREAU 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)
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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
17
DEPT OF STATE
DIRECTORATE 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:
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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
21
OFAC APPLICATION

Prohibits:

Travel to embargoed countries
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
(Balkans, Burma, Cote d’Ivoire, 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

22
EAR & ITAR
END USER CONTROLS/PROHIBITIONS
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
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

Don’t be fooled by their “Academic” names (Beihang
University, SW Institute of Env Testing, Chinese Academy of
Engineering Physics).
23
THE “LISTS”
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Denied Persons List (BIS)
Unverified List (BIS)
Entity List (BIS)
Specially Designated Nationals List (OFAC)
Debarred List (DDTC)
Nonproliferation Sanctions (DDTC)
24
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
25
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.
26
AREAS OF CONCERN
TRAVEL
 Travel to embargoed countries
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

(Balkans, Burma, Cote d’Ivoire, 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
27
AREAS OF CONCERN

Shipping equipment to a foreign country
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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
28
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 party’s proprietary
information
 International sponsors, subcontractors
29
29
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
 MTA’s and NDA’s
30
30
PLAN FOR MANAGING EC
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Sponsored Programs
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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
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Established EC Official & Legal - Dean & Dave
Work with Functional Departments (shipping, travel, etc)
Execute EC Policy – Draft routed
Outreach and training program
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–
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http://www.umbc.edu/research/ORPC/_
•
•
•
(found at
Schedule times at College faculty meetings
Add EC component to DRATT
On agenda for Departmental Mtgs (BRA, RAG, etc)
31
Nine (9) Areas of RCR – 1st three
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 NDA’s, MTA’s, LA’s, MOU’s
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?
DATA MANAGEMENT
Assure Data Reliability
Access Management
Maintain Data Integrity
Data Retention
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.
DATA MANAGEMENT
Questions:
1) Can the investigator use the students report for his report
to the sponsor?
2) What went right & wrong in maintaining Data Integrity ?
3) What if there was new Intellectual Property developed?
4) What should the PI do now?
DATA MANAGEMENT
Resources:
1) ORPC Web page RCR/Research Integrity
http://my.umbc.edu/groups/compliance/documents/166
2) Faculty Handbook, Section 15 – Faculty Rights and ResponsibilitiesResearch http://www.umbc.edu/provost/Faculty_Handbook/section15.pdf
3) UMBC’s IP Policy
http://umbc.edu/policies/pdfs/iv-3.20.01%20intellectual%20property%20policy.pdf
4) NIH Data Sharing Policy
http://grants1.nih.gov/grants/policy/data_sharing/index.htm
UMBC’S
POLICY & PROCEDURES
ON
CONFLICTS OF INTEREST
WHY WORRY ABOUT A COI POLICY ON
RESEARCH?
Because it is required by:
• USM Policy
• Maryland State Ethics Law
• NSF and PHS Regulations
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.
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.
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.
TYPES OF COI & SCOPE
OF THE POLICY
All Conflicts of Interest
Financial COI
Financial COI in
Research
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
• Consulting Agreements
• License Agreements
• Equity Holdings
• Other UMBC Agreements
• Fees, Royalties & Other $
GENERAL POLICY REQUIREMENTS
For situations in which both a Personal Relationship and
a University Relationship exists for an Investigator . . .
The Policy requires:
1. Disclosure of Certain Financial
Interests
2. Review of Those Disclosures
3. Management or Elimination of
the Conflict of Interest Situation
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
TO WHOM MUST INFORMATION BE
DISCLOSED?
At the Investigator’s Option:
• Department Chair or Supervisor, or
• Provost/Designee (Vice President for Research)
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
Research
or Product Development)
•
Conflicts of Interest
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.
Quantitative
Aspect
Qualitative
Aspect
• 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
RECORD RETENTION POLICY
No COI:
COI Exists & Managed:
• Records kept for 3
years
• Forward to Provost for
Review
• Destroyed
thereafter
• Records kept for 3
years after end of COI
• Confidential
(to the extent
permitted by law)
• Public Record
REVIEW/APPROVAL PROCESS
Disclosure of COI
(as determined by
Chair)
Review by
Provost or
Designee
COI
Committee
IRB
UMBC
Counsel
COI
Management
Plan
COI Statement
Approval
President
Approval
Appeal
Investigator
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
WHERE IS THE POLICY DOCUMENT?
www.umbc.edu/research
Resources
Research Compliance
Conflict of Interest and Commitment
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
What has to be reported?

Any potential violation that involves
 Fabrication
 Falsification
 Plagiarism
Research misconduct does not include
honest error or differences of opinion.
Examples of misconduct
UMBC Policies and procedures for responding to allegations of scientific misconduct

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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)
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.
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.

REPORTING MISCONDUCT
Disclosure by
Complainant
VPR Consults with
Complainant and Legal
File ?
Let Supervisor Provost &
Respondent Know
Inquiry
Committee
Record
Collection
Continue?
Disciplinary Action
Investigation
Committee
Appeal
Final Decision - Provost
Report to
External Entities
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

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

Websites
UMBC’s 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.html
Questions??
Office for Research Protections and Compliance
compliance@umbc.edu
http://www.umbc.edu/research/ORPC
410-455-2737