Office of Research and Economic Development Research Administration

Office of Research and Economic Development Research Administration Meeting October 24 th 2017 Page 1 1

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

Office of Research and Economic Development Project Organizational Chart 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 10 th 2018 • Tuesday, October 9 th 2018 • Slides will be posted on the Office of Research and Economic Development website after meeting Page 3

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

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

Office of Research and Economic Development Project Organizational Chart 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 (e. PRAF) 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; ORED may reject an award if is not in furtherance of the University’s mission or the project cannot be viably performed at FIU 1. 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. Page 6

Office of Research and Economic Development Project Organizational Chart Pre Award Update e. PRAF Updates PI Split of Returned F&A This is 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. Page 7

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

Office of Research and Economic Development Project Organizational Chart Pre Award Update e. PRAF 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 e. PRAF Clinical Trials Form available at http: //research. fiu. edu/forms/proposalpreparation/e. ICFAttachment. 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/. Page 9

Office of Research and Economic Development Project Organizational Chart 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. Page 10

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

Office of Research and Economic Development Project Organizational Chart 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/ Page 12

Office of Research and Economic Development Project Organizational Chart Research Integrity Update Agents/Toxins • • • • Page 13 Avian influenza virus (highly pathogenic) Bacillus anthracis Botulinum neurotoxin (no exempt quantities) Burkholderia mallei Burkholderia pseudomallei Ebola virus Marburg virus Reconstructed 1918 Influenza virus Rinderpest virus Toxin-producing strains of Clostridium botulinum Foot-and-mouth disease virus Francisella tularensis Variola major virus Variola minor virus Yersinia pestis Categories of Experiments • • Enhances the harmful consequences of the agent or toxin. Disrupts the immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin. Alters the host range or tropism of the agent or toxin. Enhances the susceptibility of a host population to the agent or toxin. Generates or reconstitutes an eradicated or extinct agent or toxin listed above.

Office of Research and Economic Development Project Organizational Chart Research Integrity Update • NIH Certificate of Confidentiality (Co. C) Updates • Effective October 1, 2017: Co. Cs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016 • The Co. C 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 Co. Cs issued in the past or in the future, regardless of funding sources, must comply with the requirements of the Co. C policy, especially the new disclosure requirements and restrictions. • To obtain a Co. C for a non-NIH funded project, the PI will still be required to apply for a Co. C. • http: //research. fiu. edu/irb/certificates-of-confidentiality/ Page 14

Office of Research and Economic Development Project Organizational Chart 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-reliance-requirements/ Page 15

Office of Research and Economic Development Project Organizational Chart 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 Page 16

Office of Research and Economic Development Project Organizational Chart Laboratory Animal Research Florida International University MARC Pavilion Wednesday, October 25, 2017 9: 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 Page 17

Office of Research and Economic Development Project Organizational Chart 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. Page 18

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

Office of Research and Economic Development Project Organizational Chart 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. Page 20

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

Office of Research and Economic Development Project Organizational Chart 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/) Page 22

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

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

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