Forum for Deans, Heads and Chairs Mitra Dutta, PhD Vice Chancellor for Research

1. Forum for Deans, Heads and Chairs • Mitra Dutta, PhD • Vice Chancellor for Research • UIC Distinguished Professor

2. OVERVIEW of the OFFICE OF THE VICE CHANCELLOR FOR RESEARCH

3. Research DevelopmentServices (RDS) AND Office of Research Services (ORS) To be presented during the 3:00pm session.

4. Total DollarsAwarded – FY 2008- FY 2012 Millions *2010 includes ARRA awards

5. Office for the Protection of Research Subjects (OPRS)

6. Goals 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

7. Human Subjects • living individual(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)

8. Getting Started – Includes information about: “Human Subjects Research” “Key Research Personnel” Investigator Training requirements The role of the UIC IRB The types of protocol review, including: • Determinations • Exemptions • Expedited IRB Review • Convened (full) IRB review • Others: Amendments, CR, Prompt Reports Decision Trees (e.g. medical record review research) Research at the Jesse Brown VAMC Tips for obtaining informed consent Helpful links

9. Contact Us • West Side Office: Room 203B, AOB, • 1737 West Polk Street • Phone 312-996-1711 • Email: uicirb@uic.edu • East Side Satellite Office (M,W 2 – 4 pm) • Room 3108A, BSB • Phone 312-996-7742 • URL: www.research.uic.edu/protocolreview/irb

10. Office ofAnimal Care and Institutional Biosafety (OACIB)

11. 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 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. Animal Care Committee (ACC) Oversight for all use of all live vertebrate animals in • Research • Testing • Teaching OLAW/NIH USDA AAALAC SPONSOR GUIDE ILAR DEA IDPR

12. 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 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 Infectious agents/toxins Select Agents (EHSO) OBA CDC USDA

13. Web Sites Office of Animal Care and Institutional Biosafety ACC:www.research.uic.edu/protocolreview/acc/index.shtml IBC:www.research.uic.edu/protocolreview/ibc/index.shtml Controlled Substances:www.research.uic.edu/protocolreview/cs/index.shtml Meeting Dates Forms Education/Training Policies/Guidance FAQs Online Resources Contact Information

14. 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

15. Contact Us • West Side Office: Room 203B, AOB, • 1737 West Polk Street • Phone 312-996-1711 • Email: uicirb@uic.edu • East Side Satellite Office (M,W 2 – 4 pm) • Room 3108A, BSB • Phone 312-996-7742 • URL: www.research.uic.edu/protocolreview/irb

16. Conflictof Interest (COI)

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

18. Conflict of Interest 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.

19. Conflict of Interest 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.

20. Conflict of Interest 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)

21. Conflict of Interest 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.

22. Contact US Jacquelyn Jancius, COI Director Phone: 312-996-4070 Email: coi@uic.edu Scott MacEwen COI Coordinator Phone: 312-996-3642 Email: coi@uic.edu www.research.uic.edu/conflict

23. ResearchIntegrity

24. Research misconduct at top-tier research institutions raise public concerns about policing scientific integrity • 1970s • William Summerlin, Memorial Sloan-Kettering Cancer Center • the painted mice • 1980 • Elias Alsabati, six different US research intitutions • >80 plagiarized and fraudulent papers • Marc Straus, Boston University • falsified patient eligibility for clinical trials • Vijay Soman, Yale Medical School • falsified and fabricated data • plagiarized a rival’s paper • John Long, Massachusetts General Hospital • falsely represented monkey cells as human

25. Fraud in Biomedical Research March 1981 Congressional Oversight Hearings Al Gore, Jr. , Chair, Investigations and Oversight Committee of the House Science and Technology Committee Philip Handler, President of NAS: “The system succeeds in policing itself” Donald Frederickson, Director of NIH: [no congressional mandate for regulation of research]…is necessary, for the natural sciences contain ultimate correctives for any debasement of the knowledge derived from research.”

26. Integrity in Research and Publication • Goal promote compliance with the highest scholarly standards • Purpose provide impartial fact-finding and fair adjudication of allegations of research misconduct • Policy UI Policy and Procedures on Integrity in Research and Publication http://www.vpaa.uillinois.edu/policies/Integrity-Policy.pdf UI Policy incorporates federal regulations and PHS guidelines 42 CFR 93 (rev. 2005) http://www.gpo.gov/fdsys/pkg/CFR-2006-title42-vol1/pdf/CFR-2006- title42-vol1-part93.pdf

27. 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

28. Integrity in Research and Publication Research Misconduct includes fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. • Fabrication: making up data or results and recording or reporting them • Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. • Plagiarism: appropriation of another person’s ideas, processes, results or words without giving appropriate credit • Does not include honest error or difference of opinion

29. Integrity in Research and Publication Research Misconduct also includes, but is not limited to, the following: • intentionally misleading or deliberately false reporting of credentials and related information • abuse of confidentiality with respect to unpublished materials • misappropriation of research materials • evasion, or intentional failure to comply after notice with research regulations, such as those governing conflict of interest/commitment, human subjects, laboratory animals, new drugs, radioactive materials, genetically altered organisms, and safety • any other conduct that constitutes a serious deviation from accepted ethical guidelines and professional standards in scholarship and research

30. Integrity in Research and Publication • Any member of the University community who has information related to potential Research Misconduct has a duty to report such information to the Respondent’s Unit Executive Officer, or to the RIO • Members of the University community shall cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and Investigations. • Institutional members, including Respondents, have an obligation to provide evidence relevant to Research Misconduct allegations to the RIO or other institutional officials.

31. Contact US Mark D. Grabiner, PhD Associate Vice Chancellor for Research and Research Integrity Officer Phone: 312-996-2757 Email: grabiner@uic.edu Website: www.vpaa.uillinois.edu/Policies/integrityresearch/index.cfm

32. Research Resources Center (RRC)

34. Assures accessibility of shared resources to all researchers in the UIC community • Serves >1,000 investigators, $160M 013 grants • $8 M operating budget, 35-40% subsidy • 60 staff; full-time PhD lab directors in each facility • Faculty Academic Directors • East and West Campus central facilities

35. Contact US William Hendrickson Director, RRC Phone: 312-996-5600 Email: whend@uic.edu Website: http://www.rrc.uic.edu/

36. Biologic Resources Laboratory(BRL)

37. 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

38. Biologic Resources Laboratory • UIC’s Animal Care and Use Program has been continually accredited by AAALAC International since 1970. • Oldest and most successful training programs for laboratory animal veterinarians • Active professional staff • Professional organizations • Teaching • Research • Service

39. Biologic Resources LaboratoryProgram Scope • 137,000 sq. ft. • 10 satellite facilities • House over 20 species • Ave. daily census 32,000 animals • Mice 30,000 • Primates 175

40. Biologic Resources LaboratoryProgram Scope • Staff - 64 • 11 vets – 5 board certified, 6 post-docs • 8 veterinary technicians • 37 husbandry staff • 6 administrative staff • 1enrichment specialist • 1 machinist

41. Biologic Resources LaboratoryAnimal Based Research Scope • 275 investigators • 700 active research protocols • Types of studies • Cancer • Immunotherapy • Radiobiology • Infectious disease • TransplantationHeart Disease • Diabetes • Neurologic disease • Retinal diseases

42. Biologic Resources Laboratory • Main phone number 312-996-7040 • Website http://www.brl.uic.edu/ • Key contacts • Fee schedule • Animal per diem rate • Diagnostic lab services • Surgery services • Jeffrey Fortman, Director Biologic Resources Lab • 312-996-1220 • jdf@uic.edu

43. Questions?