1. UPDATE For Business Managers 2013 http://research.illinois.edu University of Illinois at Urbana-Champaign

3. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Thank you for all you do to support disclosure and management of conflicts of interest at Illinois. We hope that this presentation is helpful. Your participation is very important Encouraging meetings of management oversight committees Encouraging awareness of issues Vigilance Ideas Welcome!

4. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu The University of Illinois Policy on Conflicts of Commitment and Interest was revised effective July 1, 2012 to accommodate new federal regulations in 42 CFR Part 50 Subpart F Please see http://research.uillinois.edu/coci/coci- policy Revisions were reviewed by the University Senates Conference, and approved by the University of Illinois Board of Trustees. Basic principles remain the same. University of Illinois Policy

5. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu A conflict of interest exists when an academic staff member is in a position to advance his/her own interest or that of others to the University’s detriment A conflict of commitment arises when the external activities of an academic staff member are so demanding of time or attention that they interfere with the individual’s responsibilities to the University Definitions

6. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Prior approval from supervisor for non-University activities Unit heads should not approve an activity unless satisfied that it benefits the institution and the employee and conflicts can be managed. Employee’s primary responsibility is to the University Annual Full Disclosure of non-University Activities Under University Policy, identification of conflicts is facilitated by our annual disclosure process in September, currently using the Report of Non-University Activities. The Unit Executive Officer and OVCR work with the academic staff member to identify and evaluate potential conflicts and to manage or eliminate them. What Activities Are Required By University Policy?

7. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu A Professor’s start-up company employs the Professor’s thesis students Students are involved in faculty consulting A spouse’s company sponsors faculty research University resources are used to support research for a company in which the employee has a financial interest Immediate family members are paid by a faculty grant Examples of Apparent COI

8. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Disclosure Monitoring Oversight committees or review panels Disclosure in publications and presentations Recusal from decisions Divesting financial interests Leave of absence or reduction in appointment Severing relationships COI Management Strategies

9. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu September 16, 2013: Notification to employees of form availability September 30, 2013: Completed forms turned into departments October 21, 2013: Reviewed forms and checklists forwarded from departments to colleges November 11, 2013: Reviewed forms and checklists due from colleges to OVCR Please see http://research.uillinois.edu/rnua RNUA Process 2013-2014

10. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Changes in RNUA Form 1. Simplified Part I – Single Yes/No

11. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu 2. Part II – no retrospective reporting and more room for explanation

12. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu 3. Part III - Affirmation Includes Links to PHS Disclosure Forms

13. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu 4. Part IV - Clearer Instructions Please see http://research.uillinois.edu/rnua/forms-instructions

14. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu 5. Part II Form – More space for explanation – two activities per page

15. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Your Assistance is Needed RNUA Forms – please make sure that forms are completed and that boxes are checked, signatures are in place, etc., before forwarding to the next level CHECKLISTS – please make sure that the checklist is completed before it is forwarded to the next level Did your expert in this area retire this year? Please call us if you have questions or need help with the process at 333-0034.

16. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Disclosure Financial interests – annual update process Travel – disclose at website Training Portal.research.Illinois.edu – one online option In person Updates to PHS 2013

17. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu The University’s Policy on Conflicts of Commitment and Interest focuses on disclosure of income-producing outside activities to identify conflicts of commitment or interest for all academic employees. www.research.uillinois.edu/policy/coci HHS Regulations focus on disclosure of significant financial interests and externally sponsored travel to identify conflicts of interest for PHS investigators. www.grants.nih.gov/grants/policy/coi/index.htm Comparing UI Policy To HHS Regulations

18. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Investigators A very broad definition “Any person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by the PHS” All academic employees, including students and residents PI, co-PIs, postdocs, RAs, fellows, emeritus faculty, research coordinators, others. Who is Covered By The HHS Regulations?

19. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Office of Global Affairs Office of the Assistant Secretary for Health Office of the Assistant Secretary for Preparedness and Response Agency for Health Care Research & Quality Agency for Toxic Substances and Disease Registry Centers for Disease Control and Prevention Food and Drug Administration Health Resources and Services Administration Indian Health Service National Institutes of Health Substance Abuse and Mental Health Services Administration HHS – Public Health Service Agencies

20. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Administration for Children and Families Alliance for Lupus Research American Cancer Society American Heart Association American Lung Association Arthritis Foundation Danforth Plant Science Center Juvenile Diabetes Research Foundation Lupus Foundation of America Susan G. Komen for the Cure Non-PHS Agencies That Follow Regulations

21. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Disclosure Financial interests At proposal submission (JIT) Within 30 days of change Travel Pre-travel Within 30 days of travel Training At proposal submission (JIT) Valid for 4 years What Activities Are Required By The HHS Regulations?

22. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Disclose all significant financial interests that appear to be related to your institutional responsibilities. These include financial interests held by immediate family members – parents, spouse, siblings, children. Payments from exempt sources do not require disclosure. Disclosure Requirements Non Exempt sources include non-profits international universities corporations Exempt sources include: U of I other US universities federal, state, or local government agencies

23. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Fillable PDF available at: www.research.illinois.edu/coi PHS Investigator Financial Interest Disclosure Form

24. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Disclose ANY externally reimbursed travel from a single source with an aggregate value ≥ $5000, unless exempt: The U of I, other U.S. academic institutions, federal, state or local government agencies are all exempt All travel covered by corporations, non-profit organizations, international universities or organizations must be disclosed Family travel expenses, including the travel of spouse and dependent children. Travel Disclosure

25. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Travel Disclosure Website Available at: www.phstraveldisclosure.research.illinois.edu

26. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Each PHS investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years For UI trainees OVCR Training Portal http://portal.research.illinois.edu For non-UI trainees OVCR Training Portal http://portal.research.illinois.edu Email phsdisclosure@illinois.edu for login informationphsdisclosure@illinois.edu Training

27. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Training And Disclosure Verification Fillable PDF available at: www.opsra.illinois.edu/forms.html List all project information on the first page

28. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Training And Disclosure Verification Fillable PDF available at: www.ospra.illinois.edu/forms.html List all project investigators on the second page

29. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu A WARD S TAGE OSPRA will confirm with OVCR that a signed verification form is on file prior to forwarding the award to Grants and Contracts. Funds cannot be expended until all PHS investigators on the project are trained and up to date with their disclosures. No anticipation accounts will be granted or award funds created until OSPRA has received an approved certification form from the OVCR. Training And Disclosure Verification

30. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu When do PIs need to verify? 1.Proposal submission (JIT) 2.Continuation 3.Renewal 4.Supplemental award 5.Change in Investigators Investigators MUST train and disclose before working on project Training And Disclosure Verification

31. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu The OVCR maintains records of training and disclosure. Data on completion of training and disclosure for faculty, staff and students is available from the OVCR through Box, uofi.box.com. Please contact phsdisclosure@illinois.edu to request access. Training And Disclosure Verification

32. OFFICE OF THE VICE CHANCELLOR FOR RESEARCH || UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN research.illinois.edu Office of the Vice Chancellor for Research Contacts: Melanie Loots, Ph.D. Linda K. Lee Drozt phsdisclosure@illinois.edu 217-333-0034 For More Information