Office of Research and Economic Development Research Administration Meeting May 8 th 2018

1. Office of Research and Economic DevelopmentResearch Administration Meeting May 8th 2018

2. Office of Research and Economic Development Research Administration Meeting AGENDA • Welcome and Introductions • Pre-Award • Post-Award • Research Integrity • StartUP FIU/Commercializing Research • Closing Remarks

3. Project Organizational Chart Office of Research and Economic Development Vice President’s Office Welcoming Remarks • Introduction of New Attendees • Future Research Administrators Meeting for 2018 • Tuesday, October 9th 2018 • Slides will be posted on the Office of Research and Economic Development website after meeting

4. ePRAF Updates • ePRAF credit for centers and/or institutes • The Departmental Credit section in the ePRAF has been revised to become the Center and Institute section and has the following new question: “If this proposal is associated with a Center or Institute, please enter it below. If no response is provided this project will default to the PI’s Home Department for account setup and reporting purposes.” • In the ePRAF’s new format, multiple centers/institutes can be selected if the project involves multiple centers/institutes. • The ePRAF will no longer have references to primary department credit. Credit to the PI’s Home Department, regardless of center/institute association, will be done automatically through the HR system, which associates the PI’s home department with the ePRAF. • Grant Types Added • Faculty Fellowship • Postdoctoral Fellowship • Student Fellowship Project Organizational Chart Office of Research and Economic Development Pre-Award

5. NIH Salary Cap • At this time, NIH has not received a FY 2018 appropriation, and is operating under a Continuing Resolution, the "Continuing Appropriations Act, 2018" (Public Law No: 115-56), that applies the terms and conditions of the Consolidated Appropriations Act, 2017. • The Consolidated Appropriations Act, 2017, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management has recently released new salary levels for the Executive Pay Scale. Effective January 7, 2018, the salary limitation for Executive Level II is $189,600. • The NIH 12 month appointment salary cap for applications submitted will be $189,600.   The NIH salary cap for nine month appointments will be prorated to $141,655. Project Organizational Chart Office of Research and Economic Development Pre-Award

6. Fringe Benefit Rates • The Office of Financial Planning has updated the fringe benefit rates for the 2018-2019 fiscal year, therefore the fringe benefit rates used at proposal stage have been revised as follows: • The internal budget sheet used at proposal stage has been revised to reflect these changes in the fringe benefit rates. Project Organizational Chart Office of Research and Economic Development Pre-Award

7. National Science Foundation (NSF) • NSF has changed FastLane and Research.gov account create and maintenance process for faculty and staff. As of March 26, 2018 all users will need to create and self-manage accounts, including personal information and role requests, via research.gov. • New Functionality • Allow users to create and self-manage accounts, including personal information and role requests; • Eliminate the need for organizational Administrators to create accounts and maintain profile information for their users, allowing Administrators to focus on managing roles for their organizations through a dashboard with functions to approve, disapprove, assign, and remove roles; and • Replace the existing FastLane and Research.gov account management functions. • Existing NSF Accounts • Existing NSF account holders, including Grants.gov and Application Submission Web Service (ASWS) users, will be migrated to the new account management system through a simple, one-time operation when initially signing in to FastLane or Research.gov. Account holders will be required to verify information to transfer it to the new system. Each user will have one NSF ID per the Proposal & Award Policies & Procedures Guide (NSF 18-1). Project Organizational Chart Office of Research and Economic Development Pre-Award

8. National Science Foundation (NSF) • PAPPG 18-1 Revisions • Chapter I.E.6, Foreign Organizations • Chapter II.C.1.e, Collaborators & Other Affiliations Information • Chapter II.C.2.g, Budget and Budget Justification • Chapter II.C.2.d, Project Description • Chapter II.C.2.d(iii), Results from Prior NSF Support • Chapter II.C.2.g(viii), Indirect Costs Project Organizational Chart Office of Research and Economic Development Pre-Award

9. NIH Changes for Application Submissions and Impacts on Clinical Trials • New Application Forms Set “E” • New PHS Human Subject & Clinical Trials Information Form • Clarification on the Research Strategy Attachment • Incorporation of updated appendix policy • Incorporation of recent grants.gov changes to the R&R Budget and SBIR/STTR information forms. • Discontinue use of supplemental instructions for all competing applications and progress reports. • New Funding Opportunity Announcements • 2018 all applications involving one or more clinical trials need to be submitted through a Funding Opportunity Announcement (FOA) specifically designed and designated for clinical trials. • NIH Definition of a Clinical Trial • In an effort to assist PIs in determining whether their proposed project is an NIH defined clinical trial (which would require submission of their project via a clinical trial specific FOA) the NIH has provided detailed guidance on their website at https://grants.nih.gov/policy/clinical-trials/definition.htm . Project Organizational Chart Office of Research and Economic Development Pre-Award

10. Grants.gov Applications • On December 31st, 2017 grants.gov retired the grants.gov legacy downloadable forms and the submission is now through grants.gov Workspace. This is a web based application process. • ORED pre-award staff will prepare the applications in grants.gov on behalf of the PI’s. • The principal investigators will not need to have grants.gov accounts. The application package will be sent to the PI’s prior to submission for final review and approval for submission. Project Organizational Chart Office of Research and Economic Development Pre-Award

11. ePRAF Updates • Revised/New Questions • Revised Question #30: Is this project a clinical trial? If "Yes" and if you are submitting an application to an agency other than NIH, please attach the ePRAF Clinical Trials Form for Non-NIH Applications available at http://research.fiu.edu/forms/proposal-preparation/eICFAttachment.docx. Please note that the NIH requires all staff involved in the conduct, oversight and management of NIH funded clinical trials to receive Good Clinical Practice (GCP) training. Additional details on CITI based GCP training to meet this NIH requirement is available at http://research.fiu.edu/irb/training-requirements/. • New Question #36: Do you anticipate that the research proposed in this project will lead to commercialization activities or industry collaboration? If so please provide additional details in the comment box • New Question #37: Does this project involve collaboration with StartUP FIU or the Office of Technology Management and Commercialization? • Revised Question #23: Will the proposed project involve or potentially involve classified or sensitive research? • New Question #24: Will the proposed project involve or potentially involve sensitive data (i.e. Protected Health Information, Controlled Unclassified Information, Personally Identifiable Information)? Project Organizational Chart Office of Research and Economic Development Pre-Award

12. NIST 800-171 • NIST 800-171 is a special publication from the National Institute of Standards and Technology which provides requirements for protecting the Controlled Unclassified Information (CUI). • The requirements applies to all components of nonfederal information systems and organizations that process, store, or transmit CUI, or provide security protection for such components. • List of CUI Categories and Subcategories can be found on the National Archives website at https://www.archives.gov/cui/registry/category-list Project Organizational Chart Office of Research and Economic Development Pre-Award

13. NIST 800-171 Cont’d • ORED Implementation at Award Time • Review of ePRAF and Award document for any reference to NIST 800-171 • If NIST 800-171 is applicable to award, PI must complete the “Sensitive Data/CUI Data Questionnaire” and return to the Pre-Award Rep (http://research.fiu.edu/forms/#administrative) • UTS will assess the project and the workstation of the PI and give the final approval Project Organizational Chart Office of Research and Economic Development Pre-Award

14. Data Use Agreements • Data Use Agreement Types • De-identified Data • Limited Data Set (Refers to PHI that excludes 16 categories of direct identifiers) • Full Identification Human Data • PI must complete the “Sensitive Data/CUI Data Questionnaire” and return to the Pre-Award Rep (http://research.fiu.edu/forms/#administrative) • UTS will assess the project and the workstation of the PI and give the final approval Project Organizational Chart Office of Research and Economic Development Pre-Award

15. Notice of Award – Clinical Trial designation The NIH has updated the Notice of Award to indicate whether projects (either new or continuation) are considered clinical trails. This is fond under the special terms and conditions of the award action and will indicate “Clinical Trail Indicator: Yes” or “Clinical Trail Indicator: No.” Project Organizational Chart Office of Research and Economic Development Pre-Award

16. IRB Approval Memo • In an effort to streamline awards that require HIPAA compliance, ORI will be including one of the two statements below on the approval memos: • HIPAA Privacy Rule: N/A • HIPAA Privacy Rule: Satisfied Project Organizational Chart Office of Research and Economic Development Pre-Award

17. Letter of Agreement (LOA) process with FIU Foundation • Letter of Agreement • When FIU Foundation (FIUF) receives funding related to research activities, they transfer the funding to ORED via our established process through a Letter of Agreement (LOA). However, FIUF will not sign off on the LOA until they have the cash is on hand. • Pre-Award • Pre-Award can always be requested in order to begin work on the project • Improvements • We are currently working on improving our process with FIUF and will keep you posted. Project Organizational Chart Office of Research and Economic Development Pre-Award

18. 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 • FIU’s quote threshold will be lowered to $10,000 (from $15,000) and will require 2 quotes • Update to the Sole Source Form on the Controllers website • (Joint communication from ORED and Controllers with details of changes prior to July 1, 2018)

19. Project Organizational Chart Office of Research and Economic Development Post-Award • Human Resources Forms • HR form submission deadline https://hr.fiu.edu/wp-content/uploads/sites/61/2017/05/Payroll_Calendar_2018.pdf • Forms must be received at least 48 hours prior to the upcoming HR deadline in order to allow adequate handling time & ensure that they are approved/submitted to HR within the deadline. • ORED cannot approve forms that do not contain the required departmental approvals • Forms must be filled out properly • ORED managers only approve Sponsored project ID’s

20. Project Organizational Chart Office of Research and Economic Development Post-Award • Purchasing items for assembly of Equipment • When ordering items needed for assembly of a piece of equipment on a sponsored award contact purchasing so that they can code the expenditure as equipment (and not supplies or materials) • Eliminates the need for numerous cost transfers

21. Project Organizational Chart Office of Research and Economic Development Research Integrity • Proposed Delay of Revisions to the Common Rule • On April 19, 2018, the HHS announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”). • If the proposed delay is passed, the new compliance date of the revisions to the Common Rule would be January 21, 2019. • More information will be provided to the FIU research community as it becomes available. • For the latest updates and an overview of the major changes, please visit: http://research.fiu.edu/irb/revised-common-rule/

22. Project Organizational Chart Office of Research and Economic Development Research Integrity • New HIPAA Policies for Research Studies • Use of Protected Health Information for Research Purposes (Policy #2370.520) • Addresses when research is subject to HIPAA requirements and the different ways in which PHI can be accessed or disclosed for research purposes. • Obtaining Authorization or Waiver of Authorization to Conduct Research (Policy #2370.515) • Addresses the requirements for obtaining Authorization or Waiver of Authorization through the IRB when using PHI for research purposes. • Authorization Template is available on the FIU IRB website • A Waiver of Authorization is requested directly in the protocol application

23. Project Organizational Chart Office of Research and Economic Development Research Integrity • New HIPAA Policies for Research Studies (Continued) • Certification for Research Using Decedent Protected Health Information (Policy #2370.521) • Addresses the requirements for obtaining PHI from decedents for research purposes. • Requires that a “Certification for Research on Decedents’ Only PHI Form” be completed and submitted to the Covered Entity’s HIPAA Security Administrator • Certification of Review Preparatory to Research (Policy #2370.510) • Addresses the requirements for obtaining PHI for reviews preparatory to research (e.g., developing a research protocol) • Requires that a “Certification of Review Preparatory to Research Form” be completed and submitted to the Covered Entity’s HIPAA Security Administrator

24. Project Organizational Chart Office of Research and Economic Development Research Integrity • HIPAA Resources for Researchers • FAQs, policies and forms relating to the use of PHI in research studies are available on the following web page: • http://research.fiu.edu/irb/privacy-practices-and-hipaa/ • CITI Health Information Privacy and Security (HIPS) Training is required when using PHI for research purposes. See the following web page for further guidance on CITI Training: • http://research.fiu.edu/irb/training-requirements/ • Additional guidance on conducting research with PHI can be viewed at the following web page: • https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html

25. Project Organizational Chart Office of Research and Economic Development Research Integrity • FIU Clinical Trials Web Page Updates • New resources have been added to the FIU IRB Clinical Trials web page including new instructions and tips for registering clinical trials: http://research.fiu.edu/irb/clinical-trials/ • Responsible Conduct of Research (RCR) CITI Training • The CITI Program has added a new module to the RCR training course curriculum. The new module is called “Reproducibility of Research Results” • Good Clinical Practice (GCP) CITI Training • The CITI Program has added a Social and Behavioral GCP training course option. This course is ideal for researchers conducting clinical trials that do not involve FDA regulated drugs or devices.

26. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

27. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

28. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

29. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

30. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

31. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

32. Project Organizational Chart Office of Research and Economic Development StartUP FIU/Commercializing Research

33. Project Organizational Chart Office of Research and Economic Development Closing Remarks / Adjournment Closing Remarks • Questions • Adjournment