Research Protections & Compliance Training: Ensuring Responsible Conduct of Research

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

2. 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

3. 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

4. “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

5. Circle of Compliance Research Compliance Ensures the ethical review of research

6. 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

7. 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 7

8. 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

9. 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

10. 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

11. 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 11

12. 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

13. 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 13

14. 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 14

15. Most Common US Agencies

16. 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) 16

17. 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 17

18. Dept of StateDirectorate of Defense trade controls (DDTC) International Traffic in Arms Regulations (ITAR) 22CFR Part120-130 • US Munitions List (USML) covers militaryarticles, 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. 18

19. 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. 19

20. 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. 20

21. 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

22. OFAC Application • 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 22

23. 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 • Don’t be fooled by their “Academic” names (Beihang University, SW Institute of Env Testing, Chinese Academy of Engineering Physics). 23

24. The “Lists” Denied Persons List (BIS) Unverified List (BIS) Entity List (BIS) Specially Designated Nationals List (OFAC) Debarred List (DDTC) Nonproliferation Sanctions (DDTC) 24

25. Types of Exclusions and Exemptions Exclusion – Outside the regulationsnot 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

26. 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

27. Areas of Concern 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 27

28. 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 28

29. 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

30. 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

31. 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) 31

32. Nine (9) Areas of RCR – 1st three

33. 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

34. Assure Data Reliability Access Management Maintain Data Integrity Data Retention DATA Management

35. 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

36. 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? DATA Management

37. 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/provost/Faculty_Handbook/section15.pdf • UMBC’s IP Policy • http://umbc.edu/policies/pdfs/iv-3.20.01%20intellectual%20property%20policy.pdf • NIH Data Sharing Policy • http://grants1.nih.gov/grants/policy/data_sharing/index.htm DATA Management

38. UMBC’sPolicy & ProceduresonConflicts of Interest

39. Because it is required by: • USM Policy • Maryland State Ethics Law • NSF and PHS Regulations Why Worry about a COI Policy on Research?

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

41. Forbid activity involving a COI, or • Manage COI so most activity involving a COI can be conducted. Two Approaches to Dealing with COI in Research

42. 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. What is a COI?

43. All Conflicts of Interest Financial COI Financial COI in Research Types of COI & Scopeof the Policy

44. 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 $ So, What Exactly is a COI in Research?

45. 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 General Policy Requirements

46. 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 What Must be Initially Disclosed?

47. At the Investigator’s Option: • Department Chair or Supervisor, or • Provost/Designee (Vice President for Research) To Whom Must Information be Disclosed?

48. 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 When does a Disclosure Need Further COI Review?

49. Remember:To get to this point, an Investigator must have a University RelationshipANDaPersonal Relationshipwith 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 How is COI Determined? QualitativeAspect

50. 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 Record Retention Policy