Research Support Information Network (RESIN)

1. Research Support Information Network (RESIN) Presented by: Office of the Vice Chancellor for Research Date: October 4, 2016

2. Agenda • Updates & Timely Information from Research Support: Office of the VCR Travel URC  ORSP IRB Research Compliance Contract Administration OSPAN IACUC Library ORRA Compliance – Export Control  DLAM  TRI  BioVenturesCore Facilities

3. Community Scientist AcademyNicki Spencer, Prog. Manager, TRI • Background • Idea of a TRI CAB member • Inspired by LRPD Citizen’s Police Academy • Committee Make up • Format • Pre knowledge survey • Lesson • Small Groups • Guest researcher • Post knowledge survey

4. Community Scientist AcademyNicki Spencer, Prog. Manager, TRI • Main Goals of the CSA • Goal 1 - Build relationships, understanding and trust • Between the TRI and the Community • Goal 2 - Educate • Community members • The research process • Various ways to get involved with the TRI

5. Community Scientist AcademyNicki Spencer, Prog. Manager, TRI • Goal 3 - Create cadre of stakeholders for TRI • With increased knowledge and understanding • Additional info. • More info. • Who can influence TRI’s research • Steering committees, mentoring committees, review committees, research projects other leadership capacities

6. Community Scientist AcademyNicki Spencer, Prog. Manager, TRI • Key Goal - Building Relationships • Community Members • Understand the need for various research • Understand the timeline for research • More willing to participate in research process • Researchers • Understand the need for including community • More willing to include community • Access to more knowledgeable community members

7. Community Scientist AcademyNicki Spencer, Prog. Manager, TRI • Future Plans • Dates • Need for researchers • Need for committee members • Questions & Answers

8. BioVentures UpdateNancy M. Gray, PhD, Director • Formed as a subsidiary of ARHealth Ventures, a non-profit 501 (c) (3) • Will own and manage all intellectual property assets and related agreements and lease and manage the incubator facility • Oversight by Board of Directors (4 UAMS/5 Independent)

9. BioVentures UpdateNancy M. Gray, PhD, Director • Two Major Driving Factors • Ability to construct agreements that are more “industry friendly” • IP Revenue will no longer be “state dollars” • System IP policy still in effect • No impact on inventors or UA System share of revenue

10. BioVentures UpdateNancy M. Gray, PhD, Director • Definitive documents were signed and became effective October 1, 2016 • BioVentures, LLC begins operations - January 1, 2017 • After January 1, new disclosures and all IP assignments will be to BioVentures, LLC

11. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD • Federal Demonstration Partnership (FDP) • Cooperative initiative of federal granting agencies, institutional recipients of federal funds, and research policy organization • Purpose is to work collectively to identify, test, and implement new and more effective ways of managing federal research grant. • Goal is to improve productivity of research and the national research enterprise • Pilot new ways of managing grants before introducing the initiatives to the wider research community

12. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD GAO Review of Federal Research Grants • 4 Federal Funding Agencies • 9 Categories of Requirements • Involved research universities and stakeholder institutions – AAMC, COGR, Nat’l Science Board • Findings: OMB agency efforts resulted in some reductions to administrative workload and costs, still opportunities for further reductions while maintaining oversight and accountability.

13. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD Admin Topics • FY17 NIH Grants Policy Statement available October 31 • Uniform Guidance – needs more uniformity across federal agencies • Expanded Clearinghouse (Subawards) • 2nd cohort live • Web-based system now being developed

14. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD Application Updates • ASSIST can be used for both multi- and single-component applications, integrating into Grants.gov • New salary scale for post-doctoral fellows to accommodate new overtime rule (yr 0 increased to $47,484) • Elimination of most all appendix materials (if submitted with material that is not allowed or required, application will not be reviewed) • Post-submission materials limited to those resulting from unforeseen events (NOT-OD-16-130)

15. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD Clinical Trial Updates (coming 2017) • All NIH-funded investigators involved in clinical trials will be trained in Good Clinical Practice (GCP) • Expectation that all NIH-funded clinical trials will be registered and results submitted to ClinicalTrials.gov whether or not subject to FDAAA • Requires all applications involving one or more clinical trials to be submitted in response to a clinical-trial specific FOA

16. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD Compliance Updates • Culture of Safety (how to avoid new agency regulations) • IACUC—Interagency Collaborative Animal Research Education (ICARE) project and ICARE Academyto reduce non-compliance and self-imposed regulatory burden • COI • Survey coming to admin • Use of common vs individual management plans • What constitutes a unmanageable risk? • Disclosure for trainees

17. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD • IRB • Potential changes to Common Rule and unified consent forms (UAMS TBAPS form submitted) • single IRB required for domestic multisite projects (2017) • NCATS supported SMART IRB Authorization Agreement

18. The Federal Demonstration PartnershipSuzanne Alstadt, ORSP DirectorSteve Post, PhD Faculty Topics • “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century (2016)” available on NAS website • 3rd faculty workload survey—2017 • Broader inclusion of ERI faculty in funding process • Faculty-administrator engagement

19. TriNetXAmy Jo Jenkins, Sr. Project ManagerAnthony McGuire, Data Analyst, TRI • What is TriNetX? • TriNetX is a federated clinical data network of providers, pharmaceutical companies and contract research organizations (CROs) used to enhance clinical trial design and accelerate trial site and patient recruitment. • TriNetXmembership increases the flow of sponsored research to providers and enables pharmaceutical companies to find the right patients at the right sites for clinical trials.

20. TriNetXAmy Jo Jenkins, Sr. Project ManagerAnthony McGuire, Data Analyst, TRI • How does TriNetX work? • i2b2 is a scalable informatics framework that will enable clinical researchers to use existing clinical data for discovery research • TriNetX uses a separate local i2b2 instance from our current i2b2 • Data is inherently de-identified by utilizing i2b2

21. TriNetXAmy Jo Jenkins, Sr. Project ManagerAnthony McGuire, Data Analyst, TRI • How will we use TriNetX at UAMS?

22. TriNetXAmy Jo Jenkins, Sr. Project ManagerAnthony McGuire, Data Analyst, TRI • How will we use TriNetX at UAMS?

23. TriNetXAmy Jo Jenkins, Sr. Project ManagerAnthony McGuire, Data Analyst, TRI • Currently, all inquiries from Sponsors/CROs coming through TRI. • Forwarded to appropriate Research Liaison within ICE.

24. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • Do we need additional Behavioral Space? • Meeting of Behavioral Equipment Users • Survey of Behavioral Investigators • 3 Responders 

25. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • Let’s think about this together! • Presently we have most behavioral work being done in either Biomed 1 or 2 • What will happen if new users come • Do we have a sustainable plan for future growth?

26. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • DLAM is for housing animals • Housing space is becoming limited • We will not have the luxury of keeping these types of things in the animal facility: • Behavioral chambers • Metabolic chambers • Behavioral equipment • Telemetry equipment • Imaging equipment

27. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • Going Forward • How can we manage our animal housing space with increasing census numbers? • Sharing rooms among PIs • Caging efficiency • Reconfiguring rooms • Limiting usage to housing only

28. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • Information Sharing • SUGGESTIONS WELCOMED

29. Animal Facility Space andBehavioral Space? Mildred Randolph, D.V.M., Director, DLAM • Training on the Usage of Hazardous Agents in Biomedical Research • Friday, October 7, 2016, noon-1:30 p.m. • Walton Auditorium, 10th floor Cancer Institute • What are hazards? What is your responsibility as the PI? As a research associate? What are the compliance issues concerning the IACUC or IBC? • Facilitator/Trainer: Mr. Bill Greer, V.P. for Research, University of Michigan, Ann Arbor, MI

30. Institutional Commitment for Grants—Rules of EngagementLawrence Cornett, Ph.D., Vice Chancellor for Research • Issue: Applicants often will request “institutional commitment” with the knowledge and/or belief that this will improve chances for funding • What do we mean by “institutional commitment”? (usually $$, space, time) • Suggested process for requesting institutional commitment 30

31. Institutional Commitment for Grants—Rules of EngagementLawrence Cornett, Ph.D., Vice Chancellor for Research Types of Grants that “Require”* Institutional Commitment NIH Program Project/Center Grants (P Series) NIH Cooperative Agreement Grants (U series) NIH Shared Instrumentation Grants (S10) NSF EPSCoR Infrastructure Grants (Asset mechanism) *Require doesn’t mean absolutely need 31

32. Institutional Commitment for Grants—Rules of EngagementLawrence Cornett, Ph.D., Vice Chancellor for Research Types of Grants that Usually Don’t Need Institutional Commitment NIH Research Grants (R mechanism) NIH Training Grants (F series) NIH Career Development Grants* (K series) NSF Program Announcements Foundation Grants *NIH K series grants require significant time commitment from applicant 32

33. Institutional Commitment for Grants—Rules of EngagementLawrence Cornett, Ph.D., Vice Chancellor for Research • Institutional commitment can come from multiple sources • So, when asking for institutional commitment, start with your division director/chair and work upwards in the “org chart” • Chances for success increase if project aligns with institutional priorities • Be reasonable (e.g., $$ ask should not exceed IDCs from the grant) 32

34. Institutional Commitment for Grants—Rules of EngagementLawrence Cornett, Ph.D., Vice Chancellor for Research 33

35. Next RESIN • Next RESIN – After Summer break • November 1, 2016 @ 12:00 p.m. • Location - Walton Auditorium, Winthrop P. Rockefeller Cancer Institute, 10th floor • All RESIN presentations archived on the UAMS Research website • http://www.uams.edu/research/RESIN_Achive.asp