Office of Research and Economic Development Research Administration Meeting October 24 th 2017

1. Office of Research and Economic DevelopmentResearch Administration Meeting October 24th 2017

2. Office of Research and Economic Development Research Administration Meeting AGENDA • Welcome and Introductions • Youth Event Training • Pre-Award • Office of Postdoctoral Scholar Services • Research Integrity • Budget and Cost Analysis • Laboratory Animal Research • Research Management Solutions • Research Information Systems • Closing Remarks

3. Project Organizational Chart Office of Research and Economic Development Vice President’s Office Update Welcoming Remarks • Introduction of Office of Research and Economic Development Team • Introduction of New Attendees • Future Research Administrators Meeting for 2018 • Tuesday, April 10th 2018 • Tuesday, October 9th 2018 • Slides will be posted on the Office of Research and Economic Development website after meeting

4. Project Organizational Chart Office of Research and Economic Development Youth Event Training • Requirements related to youth events • Demonstration of website • Questions & Answers

5. Project Organizational Chart Office of Research and Economic Development Pre Award Update Pre-Award Structure Update

6. Project Organizational Chart Office of Research and Economic Development Pre Award Update Deadline Reminders • Generally 5 business days prior to sponsor’s deadline BUT • 8 business days prior to sponsor deadline if: • Center (P grants) and large research team applications • Remember - route proposal to Department, Dean, Center Director with sufficient time to obtain their approval on the electronic Proposal Routing Approval Form (ePRAF) in order to adhere to the institution’s deadline reminder. • If an award is received for a proposal not previously approved by ORED, the award will NOT be processed until all requisite approvals are in place in accordance with institutional policies and procedures; OREDmay reject an award if is not in furtherance of the University’s mission or the project cannot be viably performed at FIU • Electronic submissions need to be submitted no later than Noon on the deadline date to address any e-submission errors. This applies to all deadlines, including sponsor deadlines that may fall after 5:00 PM.

7. Project Organizational Chart Office of Research and Economic Development Pre Award Update ePRAF Updates PI Split of Returned F&A Thisis the Facilities & Administrative (F&A) percentage that will be shared among the project team members if determined by the PI. This value will default to 100% for the principal investigator. Adjust the distribution of F&A amongst team members.

8. Project Organizational Chart Office of Research and Economic Development Pre Award Update ePRAF Updates Faculty Fellowship Question 28

9. Project Organizational Chart Office of Research and Economic Development Pre Award Update ePRAF Updates Timely Workflow Approvals -- Reminder Review your approval inbox by proposal deadline, to ensure any concerns are addressed prior to submission. Clinical Trials Form -- Reminder Question #29 Is this project a clinical trial? If "Yes", please attach the ePRAF Clinical Trials Form 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/.

10. Project Organizational Chart Office of Research and Economic Development Pre Award Update Award Related Reminders IRB/IACUC/IBC/IRE Approvals • Approvals are required to be in place before award can be released • Project ID or AWD should be listed under the funding section of Topaz • Partial release is an option for work that is severable from that requiring IRB/IACUC/IBC/IRE approval but budget being released should be a true reflection of work needing the approval • Partial release requires approval of Assistant Vice President for Research PHS Financial Conflict of Interest (FCOI) Compliance • PHS and NSF Investigator Report of Financial Interests in Research Form must be on file for each new award before funds can be released • Conflict of Interest (COI) training is valid for only 4 years of receipt of CITI certificate • Reminder: Investigator - the principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or of proposed research, which may include, for example, collaborators or consultants.

11. Project Organizational Chart Office of Research and Economic Development Office of Postdoctoral Scholar Services • Office of Postdoctoral Scholar Services • Introduction of office • Other remarks

12. Project Organizational Chart Office of Research and Economic Development Research Integrity Update • Dual Use Research of Concern (DURC) • Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or material. • Institutional Review Entity (IRE) • A committee that provides oversight of potential DURC. • The IRE evaluates research involving specific types of agents/toxins to determine if a risk mitigation plan is needed. • PI Responsibilities • Submit an IRE Assessment Application if the proposed research will involve one or more of the agents/toxins listed on the next slide. • http://research.fiu.edu/ire/

13. Project Organizational Chart Office of Research and Economic Development Research Integrity Update

14. Project Organizational Chart Office of Research and Economic Development Research Integrity Update • NIH Certificate of Confidentiality (CoC) Updates • Effective October 1, 2017: CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016 • The CoC will be issued as a term and condition of award • There will be no physical certificate issued • The term “identifiable sensitive information” is very broad. • All CoCs issued in the past or in the future, regardless of funding sources, must comply with the requirements of the CoC policy, especially the new disclosure requirements and restrictions. • To obtain a CoC for a non-NIH funded project, the PI will still be required to apply for a CoC. • http://research.fiu.edu/irb/certificates-of-confidentiality/

15. Project Organizational Chart Office of Research and Economic Development Research Integrity Update • NIH Single IRB Process • Effective Date: January 25, 2018 • Requirement to use a single IRB for NIH funded studies in which the sites are all using the same IRB research protocol. • Exceptions: VA sites; international sites; site involving tribal nations. • http://research.fiu.edu/irb/single-irb/ • IRB Reliance Requests • All requests to use an external IRB (with the exception of WIRB) must now be submitted via the new TOPAZ “IRB Reliance Request Form”. • If the request to use an external IRB is approved, FIU investigators will need to maintain their FIU study in the TOPAZ system by submitting amendments, renewals, and adverse events after they have been approved by the external IRB. • http://research.fiu.edu/irb/irb-reliance-requirements/

16. Project Organizational Chart Office of Research and Economic Development Budget and Cost Analysis Introduce Personnel • Michael Dudley – University Graduate School • Maria Ortega – Recharge Centers • Michelle Zaldivar – Non-Sponsored Project IDs, Expenses Effort Reporting update

17. Project Organizational Chart Office of Research and Economic Development Laboratory Animal Research Florida International UniversityMARC Pavilion Wednesday, October 25, 20179:00 am - 1:00 pm Topics: Comparing Mouse Models for Obesity and Diabetes Research, Generating Mouse Models Using CRISPR/Cas Technology, Modeling HIV, Ebola and Other Infectious Diseases in Humanized Mice

18. Project Organizational Chart Office of Research and Economic Development Laboratory Animal Research Ordering • The Office for Laboratory Animal Research mission is to facilitate the animal related research and teaching programs at FIU. • It is ACF’s responsibility for managing and administering a program of laboratory animal care that complies with the federal Animal Welfare Act, the Guide, the Public Health Service Policy on Humane Care and Use of laboratory Animals and the USDA Regulations. • The functions of the ACF are daily animal care, veterinary services, and provisions for research services, surgical assistance and monitoring the care and use of animals. The ACF serves as the purchasing and receiving agent for all animals, medical gases and drugs. Cost of purchase plus any applicable fees, charges, and/or freight are recharged to the appropriate budget entity. 

19. Project Organizational Chart Office of Research and Economic Development Research Management Solutions

20. Project Organizational Chart Office of Research and Economic Development Research Management Solutions Individual Memberships Three steps need to occur to justify the purchase of an individual membership versus a departmental/institutional membership: • Request an email or memorandum from the organization stating that they do not have Departmental/Institutional classification of memberships and only offer individual memberships.  • Request a memorandum from the Dean, Vice President or Budget Manager of your department that describes how a membership to the specific organization is essential to the individual employee’s statutory duties and responsibilities.  • Submit both documents as back up for the purchase. In the event that the organization does offer institutional/departmental memberships but an individual membership will be more beneficial, please include those benefits in the memorandum from the Dean, Vice President or Budget manager.  In this case, step 1 can be bypassed.

21. Project Organizational Chart Office of Research and Economic Development Research Information Systems New Graduate School Website (gradschool.fiu.edu)

22. Project Organizational Chart Office of Research and Economic Development Research Information Systems Recent Enhancements to FIU Research Site • Research Facilities (research.fiu.edu/facilities) • Technologies Available for Licensing (http://research.fiu.edu/technology/technologies/)

23. Project Organizational Chart Office of Research and Economic Development Research Information Systems Reporting Update • New Innovation Dashboards on Accountability website • Centers & Institutes Reporting Enhancements • Monthly Reporting Process

24. Project Organizational Chart Office of Research and Economic Development Research Information Systems Vivo@FIU • Technology Fee approved for Vivo Discovery System @ FIU • Currently in the project planning phase. More announcements coming soon.

25. Project Organizational Chart Office of Research and Economic Development Closing Remarks / Adjournment Closing Remarks • Introduction of Donna Kiley, Director of Post-Award • Hurricane Irma Damages • Questions • Adjournment