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UPDATE For Business Managers 2013

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

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UPDATE For Business Managers 2013

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

  2. Welcome! • 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

  3. University of Illinois Policy • 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.

  4. Definitions • 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

  5. What Activities Are Required By University Policy? • 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.

  6. Examples of Apparent COI • 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

  7. COI Management Strategies • 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

  8. RNUA Process 2013-2014 • 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

  9. Changes in RNUA Form 1. Simplified Part I – Single Yes/No

  10. 2. Part II – no retrospective reporting and more room for explanation

  11. 3. Part III - Affirmation Includes Links to PHS Disclosure Forms

  12. 4. Part IV - Clearer Instructions Please see http://research.uillinois.edu/rnua/forms-instructions

  13. 5. Part II Form – More space for explanation – two activities per page

  14. 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.

  15. Updates to PHS 2013 • Disclosure • Financial interests – annual update process • Travel – disclose at website • Training • Portal.research.Illinois.edu – one online option • In person

  16. Comparing UI Policy To HHS Regulations • 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

  17. Who is Covered By The HHS Regulations? • 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.

  18. HHS– Public Health Service Agencies • 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

  19. Non-PHS Agencies That Follow Regulations • 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

  20. What Activities Are Required By The HHS Regulations? • 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

  21. Disclosure Requirements 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. Exempt sources include: • U of I • other US universities • federal, state, or local government agencies Non Exempt sources include • non-profits • international universities • corporations

  22. PHS Investigator Financial Interest Disclosure Form • Fillable PDF available at: • www.research.illinois.edu/coi

  23. Travel Disclosure • 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.

  24. Travel Disclosure Website Available at: www.phstraveldisclosure.research.illinois.edu

  25. Training • 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 information

  26. Training And Disclosure Verification • Fillable PDF available at: • www.opsra.illinois.edu/forms.html • List all project information on the first page

  27. Training And Disclosure Verification • Fillable PDF available at: • www.ospra.illinois.edu/forms.html • List all project investigators on the second page

  28. Training And Disclosure Verification • Award Stage • 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. 

  29. Training And Disclosure Verification • When do PIs need to verify? • Proposal submission (JIT) • Continuation • Renewal • Supplemental award • Change in Investigators • Investigators MUST train and disclose before working on project

  30. Training And Disclosure Verification • 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.

  31. For More Information Office of the Vice Chancellor for Research Contacts: Melanie Loots, Ph.D. Linda K. Lee Drozt phsdisclosure@illinois.edu 217-333-0034

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