Office of Research and Economic Development Research Administration Meeting October 9 th 2018

1. Office of Research and Economic DevelopmentResearch Administration Meeting October 9th 2018

2. Office of Research and Economic Development Research Administration Meeting AGENDA • Welcome and Introductions • Environmental Health and Safety (EH&S) • Office of the Vice President • Pre-Award • Post-Award • Research Integrity

3. Project Organizational Chart Office of Research and Economic Development Research Administration Meeting Welcoming Remarks • Introduction of New Attendees • Future Research Administrators Meeting for 2019 • Future meetings will be held on the 3rd floor of the MARC building in the StartUP conference room. • Date to be announced • Slides will be posted on the Office of Research and Economic Development website after the meeting

4. EH&S and ORED: Changing the Culture of Safety Tamece Knowles Assistant Director, Dept. of EH&S

5. EH&S Overview Mission • To support and guide the university community in protecting our people, environment and property while assuring regulatory compliance Goal • Change the Culture of Safety at FIU - shift from reactive to proactive • Community engagement (roundtables, safety events) • Education (workshops, seminars, safety initiatives) • Visibility (safety walkthroughs, safety presentations, committee presence)

6. EH&S Overview

7. EH&S Overview Industrial General Safety Laboratory Safety • High Risk Work (Hot work, Confined space, etc.) • Pressure vessels • Electrical Safety • Machine Guarding • Vehicle and Powered Industrial trucks • Fall protection • Event Safety • Infrastructure Safety • Indoor Air Quality • Ergonomic Assessments • Laboratory and Chemical Safety • Controlled Substances • Biologics and Animal Research • Nanotechnology • Radiation and Laser Safety • Industrial Hygiene • Limited Spill Response • Lab Decommission • Material Transportation/Export • Risk Assessments • Compliance Inspections Environmental Compliance Life Safety Fire • Air and water pollution • Storm water • Industrial waste • Operating permits • Hazardous Waste • Spill Prevention and Control • Grease and oil • Above ground storage tanks • Inspections and maintenance of Fire extinguishers • Evacuation response support and logistics for new buildings • Limited Emergency Response • Fire Drills • Fire Prevention and State Fire Marshall liaison • Fire Safety for Events

8. EH&S and ORED

9. EH&S and ORED Office of Research Integrity (ORI) • EH&S representation on various compliance committees (IBC, IACUC, DURC, and Lab Safety) • Lab compliance and safety issues – identification, reporting, and escalation • Workshop/Training Collaborations – IBC rDNA • Bi-weekly meetings to stay abreast of concerns and upcoming research projects Pre-Award • Safety review and approval of new proposals • Provides opportunity for EH&S to capture new hazards, new researchers, and identify areas of concern

10. EH&S and ORED Research Services • New labs and researchers • Lab renovations • Lab decommissions • Acquisition and relocation of lab equipment • Interns and minors working in research labs – review and approval • Weekly meetings to discuss ongoing issues or upcoming projects

11. EH&S and ORED Shift the culture of safety at FIU REACTIVE PROACTIVE

12. Contact Us! Campus Support Complex, 146 Phone: 348-2621 Email: ehs@fiu.edu Website: https://ehs.fiu.edu

13. Faculty Research Incentive Plan

14. Faculty Research Incentive Plan (FRIP) • Provides incentives for obtaining external research funding, patents and certain faculty awards which furthers FIU efforts to achieve BOG Emerging Preeminence and Preeminence designation, as well as maintain the already achieved Carnegie Research 1 designation • Paid in full or in part as a bonus and/or transferred the faculty member’s FRIP account to support research at faculty discretion unless expressly specified in program components

15. FRIP Components paid annually in October based on prior fiscal year • Bonus/Research Account Based on Grants a) Principal Investigators (PIs) will receive 5% of the F&A produced by their grants. PIs can decide to share the F&A component of the bonus with the Co-Is in the respective grants b) Faculty will receive 10% of the salary savings amount produced by effort charged* to externally funded grants *Academic Year effort for faculty with 9-month assignments and calendar year effort for faculty with 12-month assignments

16. FRIP Components paid annually in October based on prior fiscal year 2. Bonus/Research Account for Assistant Professors Obtaining Grants Assistant Professors receiving grants as PI in the amounts of $30,000 to $75,000 in a given fiscal year will receive a one-time payment of $3,500 for the first grant

17. FRIP Components paid annually in October based on prior fiscal year 3. BOG Recognized High Value Faculty Awards and Fellowships** Faculty members receiving one of the designated BOG Recognized High Value Faculty Awards will receive at one time payment of $2,000 upon initial receipt of the award/fellowship **Includes only American Council of Learned Societies (ACLS) Fellows, Beckman Young Investigators, Burroughs Wellcome Fund Career Awards, Cottrell Scholars, Fulbright American Scholars, Getty Scholars in Residence, Guggenheim Fellows, Howard Hughes Medical Institute Investigators, Lasker Medical Research Awards, MacArthur Foundation Fellows, Andrew W. Mellon Foundation Distinguished Achievement Awards, National Endowment for the Humanities (NEH) Fellows, National Humanities Center Fellows, National Institutes of Health (NIH) MERIT, National Medal of Science and National Medal of Technology, NSF CAREER awards (excluding those who are also PECASE winners), Newberry Library Long‐term Fellows, Pew Scholars in Biomedicine, Presidential Early Career Awards for Scientists and Engineers (PECASE), Robert Wood Johnson Policy Fellows, Searle Scholars, Sloan Research Fellows, and Woodrow Wilson Fellows

18. FRIP Components paid annually in February based on prior calendar year 4. Patenting Incentives (paid out as bonus only) • For each patent disclosure FIU submits during the calendar year to the USPTO for a non-provisional patent, the inventor group will share equally $700 • For each FIU patent received from the USPTO during the calendar year, the inventor group will share equally $2,000

19. Project Organizational Chart Office of Research and Economic Development Pre-Award NIH F31 NRSA TUITION POLICY • Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2018 • Notice Number: NOT-OD-18-175 • You may find the NRSA tuition policy here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-175.html • Undergraduate and Predoctoral Trainees and Fellows: For institutional training grants (T32, T34, T35, T90, TL1, TL4) and individual fellowships (F30, F31), an amount per predoctoral trainee or fellow equal to 60% of the actual tuition level at the applicant institution, up to $16,000 per year, will be provided. Calculation Example: • FIU current Tuition: $379.95 x 24 credits = $9118.80 therefore the formula would be applied: • $9119 x .60 = $5,471. This is how much NIH would fund. If 60% of the actual tuition costs exceeds $16k, NIH provide the maximum of $16k.

20. Project Organizational Chart Office of Research and Economic Development Pre-Award eRA Enhancements: New Features for Human Subject System As part of NIH efforts to comply with 21st Century Cures requirements to enhance accountability and transparency in NIH clinical research, NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in once place. Notice Number: NOT-OD-18-179: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-179.html

21. Project Organizational Chart Office of Research and Economic Development Pre-Award eRA Enhancements: New Features for Human Subject System CONT’D

22. Project Organizational Chart Office of Research and Economic Development Pre-Award CESU Program Master Cooperative Agreement Agreement entered into between the United States Department of the Interior, National Park Service (NPS) and The Florida International University Board of Trustees All new task orders need to use the MTDC method for F&A calculation at the agreed upon 17.5% rate. CESU Funded Projects: 1. Department of Interior (DOI) 2. National Park Service (NPS) 3. U.S. Army Corps of Engineers (USACE) 4. The United States Fish and Wildlife Services (USFWS)

23. Project Organizational Chart Office of Research and Economic Development Pre-Award FASTLANE/RESEARCH.GOV UPDATES • New Award Letter Format • Simple Design, Easy to Read, Logical Layout, Standardized text • Time Frame • NCE – March 2018 • Other Administrative, No Funds Action – June 2018 • Increases/Supplements- November 2018 • New Award- March 2019 • PIs will be copied in the e-mails

24. Project Organizational Chart Office of Research and Economic Development Pre-Award AWARD PROCESSING COMPLEXITIES • Approval of T&C of Award • Budget • Approval/Re-budgeting • Tuition Waiver • IRB/IACUC/IBC/IRE • New Award, Existing Awards • Financial Conflict of Interest • PHS Agencies/Flow-Through/Non-PHS but adopted & NSF • PHS and NSF Investigator Report of Financial Interests in Research Form • FCOI CITI Training • NIST/IT SECURITY/FAR CLAUSES • Attempt to negotiate out • Sensitive Data/CUI Data Questionnaire • Review and approval by UTS • Export Control • Review by Don Fisher • Technology Control Plan (TCP) • E-Verify • Phonecall with HR • E-Verify Guidelines form

25. Project Organizational Chart Office of Research and Economic Development Pre-Award SUBAWARD PROCESSING & OTHER AGREEMENT COMPLEXITIES • Subawards • Agency Prior Approval (New Subawards, NSF, NIH Foreign) • IRB/IACUC/IBC/IRE • Negotiations • Other Agreements (MTA, DUA, Collaboration, etc.) • Completed request form • IRB/IACUC/IBC/IRE • Negotiations • IT Review and Approval

26. Project Organizational Chart Office of Research and Economic Development Post-Award • Change to the Procurement Policy on July 1, 2018 • 2CFR200 Procurement Standards – Uniform Guidance requires changes to the procurement policy • Communicated to research community and project managers through listserve June 15, 2018 • Included in the controllers Newsletter 2017-2018 Volume 12

27. Project Organizational Chart Office of Research and Economic Development Post-Award

28. Project Organizational Chart Office of Research and Economic Development Post-Award • Certified Research Administrator (CRA) • Study session for exam May 2019 • Commence March 2019 • Sessions are once a week for 1 ½ hours for 10 weeks • Organized around the CRA Body of Knowledge • Designed to assist in targeting study areas to prepare for the CRA exam • 250 multiple choice questions – testing time 4 hours • Passing 70% or 175 correct multiple choice questions • Eligibility requirements for the exam • Bachelor’s Degree and 3 years experience • Associates Degree and 5 years experience • No degree and 6 years experience with additional approval • Email Donna.Kiley@fiu.edu if interested in joining the study session in March 2019

29. Project Organizational Chart Office of Research and Economic Development Post-Award • Office of Research & Economic Development’s Research Administrators Certificate Course (RACC) • Final Stages Updating Sessions 2 B&C – Post Award Administration • Completion date January 2019 • https://professionaldevelopment.fiu.edu >Login > Enroll > Browse by Department > Division of Research > Select Online Session 2: Post-Award Administration

30. Project Organizational Chart Office of Research and Economic Development Research Integrity • New Employees in ORI • Elizabeth Juhasz, IRB Coordinator • Mario Sanchez, Research Integrity Coordinator • New Responsible Conduct of Research Training Workshop • The Research Clinic – An interactive training video that educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct

31. Project Organizational Chart Office of Research and Economic Development Research Integrity • Invertebrate Research • A new section called “Use of Invertebrates” has been added to the IACUC Exemption Form. • The IACUC Exemption Form can now be used for three different purposes: • Research involving an animal carcass/biospecimen; • Research involving observational field studies; or • Research involving invertebrates • Higher level invertebrates (octopi, squid, lobsters) may require additional questions to be answered • 5 year approval term • Note: Amendments are still required for any proposed changes

32. Project Organizational Chart Office of Research and Economic Development Research Integrity • Some Species of Invertebrates May Require Permits • Florida Fish and Wildlife Conservation Commission (FWC) • http://myfwc.com/wildlifehabitats/profiles/invertebrates • National Oceanic & Atmospheric Administration (NOAA) • https://www.fisheries.noaa.gov/invertebrates • Florida Department of Agriculture • https://www.freshfromflorida.com/Divisions-Offices/Plant-Industry/Business-Services/Plant-Pest-Permits/Arthropod-Plant-and-Plant-Pest-Permits • https://www.freshfromflorida.com/Business-Services/Aquaculture/Ornamental-Fish-and-Invertebrates

33. Project Organizational Chart Office of Research and Economic Development Research Integrity • Revised Common Rule (Upcoming IRB Changes) • Revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) become effective on January 21, 2019. • Significant number of changes. Major areas affected include: • Exemptions, continuing review, informed consent, clinical trials, activities considered as research, and single IRB review. • Overview of how FIU is planning to implement the Revised Common Rule changes.

34. Project Organizational Chart Office of Research and Economic Development Research Integrity • New and Revised Exemption Categories • Category 3 has been replaced with a new category for benign behavioral interventions • Several other Exemption categories have been revised • Continuing Review • Annual review will no longer be required for Expedited protocols (with the exception of FDA regulated studies). • FIU’s tentative plan is to require for investigators to renew their Expedited protocols every 3 years (subject to change) • Informed Consent • Include a concise summary of essential study information • Disclose plans for conducting future research with collected information or biospecimens • Disclose what will happen with biospecimens (commercial purposes, results shared, genome sequencing, etc.)

35. Project Organizational Chart Office of Research and Economic Development Research Integrity • Clinical Trials • The Office for Human Subject Protections (OHRP) has adopted the same revised clinical trials definition that is being used by the NIH. • Investigators conducting clinical trials will be required to post a copy of their consent form online. • Activities No Longer Considered Research • Scholarly/journalistic activities that focus on specific individuals; • Public health surveillance activities from a public health authority; • Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and • Certain activities in support of intelligence, homeland, security, defense, or other national security missions • Single IRB Review • As of January 19, 2020 all multi-site research that is federally funded—not just NIH-funded—must rely on a single IRB.

36. Project Organizational Chart Office of Research and Economic Development Research Integrity • Freeze on New Submissions • Considerable preparation will be required for a smooth transition to the Revised Common Rule. • A freeze period on new IRB protocol submissions has been tentatively scheduled for January 1, 2019 – January 20, 2019. • Investigators submitting grants involving human subjects need to take this timeframe into account. • Special requests to submit protocols during this timeframe will be considered on a case-by-case basis for funding-related deadlines. • Pending Submissions • All pending submissions will need to have IRB approval by January 16, 2019. • A projects is considered as “pending” if they have been submitted to the IRB, but have not yet received final IRB approval.

37. Project Organizational Chart Office of Research and Economic Development Research Integrity • Projects Due for Renewal in January/February 2019 • Investigators with protocols expiring during the months of January or February 2019 will need to submit their renewal applications early to help avoid any lapses in their IRB approvals. • Existing IRB-Approved Projects • All active projects that were previously approved under an Expedited or Full Board review category will be transitioned to the Revised Common Rule regulatory requirements. • This transition will occur at the time of the project’s next amendment or renewal submission (after January 21, 2019). • More Information • For the latest updates on FIU’s transition to the Revised Common Rule, please visit the following web page: http://research.fiu.edu/irb/revised-common-rule/

38. Project Organizational Chart Office of Research and Economic Development Closing Remarks / Adjournment Closing Remarks • Questions • Adjournment • Don’t forget to sign the sign-in sheet