Export ControlResponsible Conduct of

Research (RCR):* Data Management

* Conflict of Interest * Research Misconduct

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Departmental Research Administrators Training Track

Research Protections & CompliancePart II of II

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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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

“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

Circle of Compliance

Research Research ComplianceCompliance

Ensures the ethical review of research

• 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

• 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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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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– 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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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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• 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

• Protect National Security & US foreign obligations

• Combat Terrorism• Prevent spread of weapons of mass

destruction (nuclear, chemical, biological, missiles, etc)

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• 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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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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Department of Commerce

Export Admin Regulations

(EAR)

Trade Protection

Regulates commercial goods & Services with potential

military application (Dual Use)

Commerce Control List (CCL)

Bureau of

Industry and

Security (BIS)

Department of State

Department of Treasury

International Traffic in Arms

Regulations (ITAR)

Office of Foreign Assets Control (OFAC)

Directorate of Defense

Trade Controls (DDTC)

National Security

Export of articles, services & related technical data

that are military in nature

US Munitions List (USML)

Sanctions against:Foreign Countries & GovTerrorists, Narcotics, War

Criminals, Weapons Proliferators

Trade Embargos

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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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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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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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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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 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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Prohibits: Travel to embargoed countries

(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

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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).

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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)

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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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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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TRAVEL Travel to embargoed countries

(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

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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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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

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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

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• 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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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?

Assure Data Reliability

Access Management

Maintain Data Integrity

Data Retention

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.

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?

Resources:

1)ORPC Web page RCR/Research Integrityhttp://my.umbc.edu/groups/compliance/documents/166

2)Faculty Handbook, Section 15 – Faculty Rights and Responsibilities-Research http://www.umbc.edu/provost/Faculty_Handbook/section15.pdf

3)UMBC’s IP Policyhttp://umbc.edu/policies/pdfs/iv-3.20.01%20intellectual%20property%20policy.pdf

4)NIH Data Sharing Policyhttp://grants1.nih.gov/grants/policy/data_sharing/index.htm

Because it is required by:

• USM Policy

• Maryland State Ethics Law

• NSF and PHS Regulations

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.

1.Forbid activity involving a COI, or

2.Manage COI so most activity involving a COI can be conducted.

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.

All Conflicts of Interest

Financial COI in Research

Financial COI

University RelationshipsFaculty, Staff, & Students

• Research Agreements

• License Agreements

• Other UMBC Agreements

Personal RelationshipsIndividual & Family

• Consulting Agreements

• Equity Holdings

• Fees, Royalties & Other $

COI Requires TWO Relationships with the same Company by the same Individual

The Policy requires:

1. Disclosure of Certain Financial Interests

2. Review of Those Disclosures

3. Management or Elimination of the Conflict of Interest Situation

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

• 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

At the Investigator’s Option:

• Department Chair or Supervisor, or

• Provost/Designee (Vice President for Research)

• 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

• 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

Remember: To get to this point, an Investigator must have a University Relationship AND a Personal Relationship with the same Company.

Quantitative Aspect

QualitativeAspect

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

Disclosure of COI (as determined by

Chair)

Review by Provost or Designee

COI Management

Plan

COI Committee

President Approval

COI Statement

Investigator

UMBC Counsel

IRB

Appeal

Approval

• 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

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

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.

Disclosure by Complainant

VPR Consults with Complainant and Legal

Let Supervisor Provost & Respondent Know

Inquiry Committee

Investigation Committee

Continue?

Final Decision - Provost

File ?

Record Collection

Disciplinary Action Report to External Entities

Appeal

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

WebsitesUMBC’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