DDDH Orientation

1. DDDH Orientation Mitra Dutta, PhD Vice Chancellor for Research

2. Office of the Vice Chancellor for Research Institutional Official (IO) is the University point of contact with various agencies, the signatory for the Federal-wide Assurance (FWA), and bears ultimate responsibility for ensuring University compliance with the federal requirements. OVCR • Research Infrastructure • Research Compliance • Research Development

3. Office of the Vice Chancellor for Research • Office of Research Services (ORS) – search for director in process • Office for the Protection of Research Subjects (OPRS) – Jim Fischer • Office of Animal Care & Institutional Biosafety (OACIB) – Mary Bowman • Conflict of Commitment & Interest (COCI) – Jacqueline Jancius • Clinical Trials Office (CTO) – Assistant Vice Chancellor Lisa Pitler • Associate Vice Chancellor/Research Integrity Officer – Mark Grabiner • Associate Vice Chancellor for Research – Luisa DiPietro • Associate Vice Chancellor for Research – Martha Daviglus • IT/Communications – Jacqueline Berger • Research Development Services (RDS) – Tony Halford • Research Resources Center (RRC) - Bill Hendrickson • Biologic Resources Laboratory (BRL) – Jeff Fortman

4. Office Connected to but not reporting to OVCR • Office of Technology Management (OTM) • since 2004 – reports to OVPR in UA • Grants & Contracts • Reports to OBFS • Research Parks – UIRP LLC – URO • reports to a BOM and ultimately to UI BoT; VCRs and VCAS are voting members • Illinois Ventures LLC – URO • reports to a BOM and ultimately to UI BoT; VCR voting member • UILABS Not URO • separate Board

5. Various Compliance Visits FY13-14 • FDA • OHRP-NIH • ORI • VHA Office of Research Oversight • VHA Data Security and Privacy Oversight • USDA – annual unannounced visit • Office of Laboratory Animal Welfare – NIH • DEA • NIH- Biosafety • AAALAC • DOD • BARDA • AAHRPP • NSF • HRSA • Annual A-133 audit with OBFS

6. Office of the Vice Chancellor for Research • Partner with UIUC and UIS to develop and launch a new electronic research administration (ERA) tool • START myResearch (http://web.uillinois.edu/start_myresearch) (Systemwide Tools for Administration of Research and Training) • PI Portal launched • KualiCoeus – open source software being used for development of the new ERA • Pre-award module being developed • IRB and IACUC modules being determined

7. Office of Research Development Services (RDS)

8. Research Development Services • Searchable databases • Limited Submissions • Internal Funding

9. Internal Funding Opportunities • OVCR Pilot Grants • Develop new pilot data • OVCR Pilot Grants for Architecture, Arts, and Humanities • Jumpstart new architectural, artistic, or humanities scholarship • Chancellor’s Discovery Fund for Multidisciplinary Research • Initiate multidisciplinary research • Ignite Proposal Development Program • Craft a major external proposal • Bridge Funding Program • Bridge gaps between grants

10. Office of research services (ORS)

11. Office of Research Services • The Office of Research Services (ORS) is the central University office responsible for all pre-award and non-financial post-award sponsored project activities for the Chicago, Rockford and Peoria campuses of the University of Illinois. • RDS and ORS supports faculty from development to award stage.

12. ORS Responsibilities • Review proposal submissions including budgets • Provide technical assistance on electronic research administration • Negotiate and execute all award documents/contracts • Monitor sponsor guidelines and policy updates • Ensure compliance with sponsor and University guidelines and policies • Conduct educational outreach (workshops, seminars and open forums)

13. Sponsors and Activities • Sponsors may include, federal, state, municipalities, foundations, private sector (e.g. associations, international, bio-medical, pharmaceuticals). • Types of activities may include: Research, Instruction, Public Service, Technical Testing, Clinical Trials, SBIR/STTRs, Data Use Agreements, Non-Disclosure and Confidentiality Agreements, Collaborative Agreements, Material Transfer Agreements.

14. ORS Authority • ORS is the authorized institutional representative for sponsored project activity and provides institutional endorsements on proposal submissions. • ORS has delegated Board of Trustees signature authority to bind the university on sponsored research agreements and award acceptance.

15. ORS on the Web • UIC Office of the Vice Chancellor for Research – Sponsored Programs • Preparing a Proposal • Award/Contract Processing & Acceptance • Award Administration • Award Closeout • UIeRA Pre-Award System • Forms & Contract Templates • Policies • Education & Training • I'm Looking for... • https://research.uic.edu/sponsored_programs

16. Office for the protection of research subjects (OPRS)

17. Goal of the UIC Human Subjects Protection Program • To ensure a comprehensive Human Subjects Protections Program (HSPP): • Utilizing the highest ethical and professional standards • Affording the highest possible protections for our human subjects • Minimize risk to subjects; and • Maximize benefits of the research. • Human Subjects • livingindividual(s) about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information. 45CFR46.102(f)

18. Office of animal care and institutional biosafety (OACIB)

19. Animal Care Committee (ACC) Office for Animal Care and Institutional Biosafety OACIB provides administrative support for the review and approval of research protocols (experiments) involving animals, recombinant and synthetic DNA and infectious agents, and ensures compliance with regulations related to the use of controlled substances in animal research. The goal of the office is to facilitate the protocol writing/review process and navigation of the regulatory issues to ensure compliance with the regulations for the protection and welfare of animals, protection and safety of investigators, and the University. Animal Care Committee (ACC) Oversight for all use of all live vertebrate animals in • Research • Testing • Teaching OLAW/NIH USDA AAALAC SPONSOR GUIDE DEA IDPR

20. Institutional Biosafety Committee (IBC) Office for Animal Care and Institutional Biosafety OACIB provides administrative support for the review and approval of research protocols (experiments) involving animals, recombinant and synthetic DNA and infectious agents, and ensures compliance with regulations related to the use of controlled substances in animal and laboratory research. The goal of the office is to facilitate the protocol writing/review process and navigation of the regulatory issues to ensure compliance with the regulations for the protection and welfare of animals, protection and safety of investigators, and the University. Institutional Biosafety Committee (IBC) Oversight of all research involving rDNA/Synthetic Infectious agents/toxins Select Agents (EHSO) OBA CDC USDA OSHA

21. Office of Animal Care and Institutional Biosafety Regulations Pertaining to Research • Animals • rDNA • Infectious Agents • Toxins- Biological • Controlled Substances • Select Agents • Humans • Chemicals • Radionucleotides • X-rays/Irradiators • Lasers • Embryonic Stem Cells • Conflict of Time/Commitment • Conflict of Interest • Import/Export • Material Transfer

22. Conflict of interest (COI)

23. Conflict of Interest • The Changing Environment • Federal regulations • University Policy • Main Points • COI Defined • COI and RNUA • Reporting and Managing Conflicts

24. What is financial conflict of interest? “A ‘conflict of interest’ arises when an academic staff member is in a position to influence either directly or indirectly University business, research, or other decisions in ways that could lead to gain for the academic staff member, the staff member's family, or others to the detriment of the University's integrity and its missions of teaching, research, and public service.” • “Family" is defined as one's spouse or domestic partner, parents, siblings and children. • Conflicts reside in a situation, and do not imply improper behavior.

25. Who is covered by the policy? “All paid academic staff members, whether part time or full time, of the University of Illinois. The academic staff includes the faculty ranks of professor, associate professor, assistant professor (and all of the foregoing whose appointments contain such terms as 'research,' 'adjunct,' 'visiting,' or 'clinical'), instructor, and lecturer, as well as academic professionals and postdoctoral associates.” • Any paid, non-0% appointment. • Students, including medical residents, are not considered academic staff.

26. Report of Non-University Activities (RNUA) • Annual Reporting of Non University Activities is the implementation of conflict of interest policies and regulations for both conflict of interest and conflict of commitment. • All academic staff complete the form, even if there are no outside activities to disclose. • 24/7 during the contract period. • Resolution always begins with RNUA disclosure and sometimes involves a combination of conflict management techniques.

27. PHS FCOI Regulations (2011) • These regulations require HHS, PHS, and NIH Investigators and senior/key research personnel to: • Disclose significant financial interests (SFIs) at the time of proposal submission • Disclose sponsored or reimbursed travel at the time of proposal submission • Update disclosures within 30 days of any newly acquired or discovered SFIs • Manage Financial Conflicts of Interest (FCOI) prior to execution of an award or continuing review • Complete mandatory University training on Financial Conflicts of Interest (FCOI)

28. How to Report and Manage COI • Unit Executive Officer • Holds primary responsibility for working with the academic staff members to manage conflicts. • UIC Conflict Review Committee (CRC) • Advisory to the Vice Chancellor for Research. • Reviews RNUA-management plans and other management plans as needed • COI-Human Subject Research (COI-HSR) Committee • Expedited review of COI disclosures on IRB protocols • Makes recommendations to the IRB.

29. Research Integrity

30. Research Integrity at UIC • Goal: • promote compliance with the highest scholarly standards • Purpose: • provide impartial fact-finding and fair adjudication of allegations research misconduct • Policy: • UI Policy and Procedures on Integrity in Research and Publication http://research.uic.edu/node/1437/policies/policies • PHS Policies on Research Misconduct • 42 CFR 50 and 93 (rev. 2005) http://ori.hhs.gov/sites/default/files/42_cfr_parts_50_and_93_2005.pdf

31. 1985 Health Research Extension Act (Section 493) • HHS regulation requires that institutions establish: • process to review allegations research misconduct • report investigation of alleged research misconduct to the federal government

32. Research resources center (RRC)

33. Research Resources Center

34. Research Resources Center • Assures accessibility of shared resources to all researchers in the UIC community • Serves >1,000 investigators, $160M 013 grants • $8 M operating budget, 45% subsidy • 60 staff; full-time PhD lab directors in each facility • Faculty Academic Directors • East and West Campus central facilities

35. Biologic resources laboratory (BRL)

36. Biologic Resources Laboratory • UIC’s Centralized Animal Research Facility • Oversight of the institution’s animal care and use program • Support research • Daily care and husbandry of all laboratory animals • Procurement of all animals • Ensure animal welfare • Ensure compliance with regulatory agencies • Ensure the health status of animal colonies • Train students, staff, and faculty

37. Program Scope • UIC’s Animal Care and Use Program has been continually accredited by AAALAC International since 1970. • 137,000 sq. ft. • 10 satellite facilities • House over 20 species • Ave. daily census 32,000 animals • Mice 30,000

38. OVCR Contact Information Main Phone: 312-996-4995 Main Website: http://research.uic.edu • RDS: http://research.uic.edu/funding • ORS: http://research.uic.edu/sponsored_programs • OPRS: http://research.uic.edu/compliance/irb • OACIB: http://research.uic.edu/compliance/acc • COI: http://research.uic.edu/compliance/coi • Integrity: http://research.uic.edu/compliance/research-integrity • RRC: http://www.rrc.uic.edu • Phone: 312-996-5600 • BRL: http://www.brl.uic.edu/ • Phone: 312-996-7040