1. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 Things That You Should Know About the NIH 2011 FCOI Regulation Bill McBlain, PhD University of Alberta NIH “Designated Official” 1 RAD 303

2. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 1.It exists! 2.When it was implemented! 3.The UofA is compliant! 4.There are things to do to be compliant with the Regulation! 5.There are a few important definitions! 6.The “Disclosure Report” differs from the “Disclosure and Consent Form!” 7.There are time-lines for on-going compliance! 8.Records must be kept! 9.Aspects of the Regulation are open to interpretation! 10.NIH FCOI Requirements must be met before Research Facilitators (RFs) or the Research Services Office (RSO) Central, Sign-Off! 10 things you should know about the NIH 2011 FCOI Regulation 2

3. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #1 3 1. It exists!

4. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 What is it? Published in 2011, the US National Institutes of Health (NIH) Financial Conflict of Interest (FCOI) Regulation (“Final Rule” of the U.S. Department of Health & Human Services [HHS]) provided an update to the predecessor 1995 NIH FCOI Regulation. On August 25, 2011, HHS entered into the Federal Register (Vol. 76, No. 165, Part IV), the Final Rule “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service [PHS] Funding is Sought and Responsible Prospective Contractors” (42 CFR Part 50 Subpart F for grants and cooperative agreements and 45 CFR Part 94 for contracts, respectively). http://grants.nih.gov/grants/policy/coi/ #1 cont’d 4

5. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Purpose of the Regulation "This regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest." #1 cont’d 5

6. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Application of the Regulation The Regulation applies to all members of the University community who are applying for and/or receiving funding from or participating in a research project funded by NIH and/or other PHS sources HHS and/or any other research-funding source which has adopted the HHS Final Rule at 42 CFR Part 50 Subpart F and 45 CFR Part 94. #1 cont’d 6

7. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Other agencies are adopting this Regulation: U.S. Centers for Disease Control & Prevention (CDC) U.S. Food and Drug Administration (FDA) Agency for Health Care Research & Quality (AHRQ) U.S. Department of National Defense American Heart Association American Cancer Society Juvenile Diabetes Research Foundation Etc. … and others in the future … #1 cont’d 7

8. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #2 8 2. When it was implemented!

9. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Implementation: August 24, 2012 All applications and Notices of Award (NOAs) after that date must be compliant #2 cont’d 9

10. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #3 10 3. The UofA is compliant!

11. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 The UofA added a NEW Procedure to its Conflict Policy in order to be in compliance with the Regulation: https://policiesonline.ualberta.ca/PoliciesProcedures/Procedures/Co nflict-of-interest-for-NIH-Public-Health-Service-and-Health-and- Human-Services-Funding-Procedure.pdf https://policiesonline.ualberta.ca/PoliciesProcedures/Procedures/Co nflict-of-interest-for-NIH-Public-Health-Service-and-Health-and- Human-Services-Funding-Procedure.pdf #3 cont’d 11

12. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #3 cont’d 12 Conflict of Interest & Conflict of Commitment Reporting & Assessment Procedure Managing Conflict of Interest in Employment Procedure Conflict of Interest for National Institutes of Health (NIH), Public Health Service (PHS) and Health and Human Services (HHS) Funding Procedure Conflict Policy – Conflict of Interest & Commitment and Institutional Conflict (Policy) NEW UofA Conflict Policy and its Procedures

13. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 The NIH/PHS/HHS Procedure has Forms linked to it for: Disclosure and Consent Form for Significant Financial Interests of Investigator Disclosure and Consent Form for Significant Financial Interests of Spouse of Investigator Disclosure and Consent Form for Significant Financial Interests of Dependent Child of Investigator #3 cont’d 13

14. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 The University of Alberta is included in the Federal Demonstration Partnership (FDP) Institutional Clearinghouse list of institutions compliant with the new NIH/PHS/HHS Regulation. http://sites.nationalacademies.org/PGA/fdp/PGA_070596 #3 cont’d 14

15. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #4 15 4. There are things to do to be compliant with the Regulation!

16. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “To Do” List (Partial) for Compliance: Appointment by Institution (UofA) of a “Designated Official” Training of “Investigators” Investigators’ Disclosure of Significant Financial Interests (SFIs) Determination if SFI is related to the research If so, determination if SFI constitutes a Financial Conflict of Interest (FCOI) Written agreements for sub-grants #4 cont’d 16

17. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 UofA Designated Official Bill McBlain, PhD NIH Designated Official & Conflict Review Officer (Interim) 2-51 South Academic Building (780) 246-6887 bill.mcblain@ualberta.ca #4 cont’d 17

18. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #4 cont’d 18 Training of Investigators: ContentWhen NIH FCOI Regulation UofA Policy and FCOI Procedure Disclosure of SFIs Prior to NIH-funded research Every four years, and If: o FCOI Procedure changes o Investigator new to UofA o Investigator non-compliance

19. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #5 19 5. There are a few important definitions

20. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Conflict of Interest “A situation in which there is OR may be perceived to be a divergence between the private financial benefit or financial interest or personal benefit of a person, family member, or an outside party, and that person’s obligations to the University, such that an impartial observer might reasonably question whether related actions to be taken or decisions made by the person would be influenced by consideration of the person’s own interests.” #5 cont’d 20

21. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “Investigator” "... means the project director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.” …where “responsible for” = degree of independence. #5 cont’d 21

22. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 NOTE: Depending on their role in the project, the following people, amongst others, could be Investigators: Students/Post-Doctoral Fellows Technicians Research Associates Project Managers Study Nurses Third parties from whom you purchase services #5 cont’d 22

23. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “NIH/PHS/HHS” National Institutes of Health (NIH) and/or other Public Health Service (PHS) sources and/or Health and Human Services (HHS) and/or any other research funding source which has adopted the US Department of HHS Final Rule at 42 CFR Part 50 Subpart F and 45 CFR Part 94…. (Other funding sources which have adopted the aforementioned HHS Final Rule include those listed by the US Federal Demonstration Partnership.) #5 cont’d 23

24. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “Significant Financial Interest (SFI)” A Financial Interest of the Investigator (or spouse or dependent child[ren], as applicable), that reasonably appears to be related to the Investigator’s Institutional responsibilities. The rest of the SFIs definition is too long and detailed for this slide presentation! There are also exclusions to disclosure. (Please see the Procedure for more information) #5 cont’d 24

25. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “SFI” cont’d - Some summary points: For publicly traded entities, there is an annual aggregated minimum threshold of $5,000 for disclosure of the listed types of remuneration, equity interests, etc. For non-publicly traded entities (e.g., many spin-off companies), there is the same $5,000 minimum threshold for the disclosure of remuneration but this threshold does not apply to equity interests which must be reported regardless of real or estimated value. Any reimbursed or sponsored (see definition) travel related to the Investigator's Institutional Responsibilities must be disclosed if the aggregated monetary value exceeds $5,000 per entity paid to the specific Investigator in the previous 12 months. #5 cont’d 25

26. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 “SFI” cont’d - Exclusions from disclosure (brief summary): 1. Salaries and other remuneration from the UofA (the "Institution"). 2. Income from investment vehicles (e.g., mutual funds) where the Investigator does not control the investment decisions. 3. Reimbursed/sponsored travel, income from seminars, etc., and/or for service on advisory/review panels when the source of funding is a US federal, state, or local government agency, a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with a US institution of higher education. 4. Income from seminars, lectures, teaching and/or income from service on advisory committees, review panels, etc., when the source of funding is a non-US equivalent of the entities listed in #3 above, and where the annual aggregated monetary value paid to the individual Investigator per entity is less than $5,000. #5 cont’d 26

27. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 A Financial Conflict of Interest (FCOI) “A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of NIH- funded research.” An FCOI is very often a good thing! e.g., in the case of Commercialization/Spin-Off Companies “…from bench to bedside and back again…” #5 cont’d 27

28. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #6 28 6. The “Disclosure Report” differs from the “Disclosure and Consent Form”!

29. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 The UofA “Disclosure Report” is submitted in compliance with the Conflict of Interest and Conflict of Commitment Reporting and Assessment Procedure. The UofA “Disclosure and Consent Form” is submitted in compliance with the Conflict of Interest for NIH/PHS/HHS Funding Procedure (“The Procedure” for this presentation) #6 cont’d 29

30. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #6 cont’d 30 Conflict of Interest & Conflict of Commitment Reporting & Assessment Procedure  Disclosure Report Form Managing Conflict of Interest in Employment Procedure Conflict of Interest for NIH/ PHS/HHS Funding Procedure  Disclosure and Consent Form Linked from the end of The Procedure Conflict Policy – Conflict of Interest & Commitment and Institutional Conflict (Policy)

31. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 UofA requirements: The Disclosure Report requests information on 1. non-financial conflicts of interest, 2. financial conflicts of interest, 3. conflicts of commitment, and 4. other conflict. The Disclosure Report is submitted to the “Reporting Officer”. The Disclosure and Consent Form is submitted to the UofA “NIH Designated Official”. #6 cont’d 31

32. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 For both the “Conflict of Interest and Conflict of Commitment Reporting and Assessment Procedure” and the “Conflict of Interest for National Institutes of Health (NIH), Public Health Service (PHS) and Health and Human Services (HHS) Funding Procedure”… … Disclosure is the key step … #6 cont’d 32

33. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 The Disclosure and Consent Form includes: 1. Disclosure of SFIs for compliance with the NIH Regulation, and 2. “Consent for Collection and Disclosure of Personal Information,” for UofA compliance with Alberta’s “FOIPP Act” (for cases where an SFI is reviewed by NIH or when a Financial Conflict of Interest declaration must be declared to the NIH and made accessible to the public). #6 cont’d 33

34. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #6 cont’d Disclosure of SFIs Most Investigators complete the Disclosure and Consent Form(s) on-line and then save, print, initial, and sign them prior to scanning and e-mailing a PDF version to the UofA Designated Official: bill.mcblain@ualberta.ca

35. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Principal Investigator (PI) must ensure that all research team “Investigators” who will work on the NIH/PHS/HHS-funded research project are also trained and have disclosed SFIs for themselves (and their spouse and dependent children, if applicable) and have granted consent for the release of such information. #6 cont’d 35

36. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Disclosure and Consent Forms for the Investigator’s Spouse and Dependent Child(ren), as applicable, must be submitted regardless of whether the spouse/dependent child(ren) holds Significant Financial Interests. #6 cont’d 36

37. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #7 37 7. There are time-lines for on-going compliance!

38. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Disclosures of SFIs At the time of application Within 30 days of acquisition of a new SFI Annually Declarations of FCOIs to NIH Prior to expenditure of funds Within 60 days of their identification Annually … all with a Management Plan #7 cont’d 38

39. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #7 cont’d UofA No requirement to report to any external body No training obligation UofA/NIH Reports provided to NIH for FCOIs, management plans, non- compliance, retrospective reviews & mitigation activities Training obligation prior to being engaged in NIH-funded research, every 4 years, and under other designated circumstances 39 New NIH Requirements Added to UofA Procedures

40. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #7 cont’d UofA No requirement for public accessibility to FCOI information UofA/NIH NIH requires that the following be publicly accessible on a website: FCOI Policy The following must be on a web site or publicly accessible by written response within five (5) business days: FCOIs (including specified details) for senior/key personnel 40 New NIH Requirements Added to UofA Procedures

41. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 For FCOIs, information to be made publicly accessible. For “senior/key personnel,” the following information is included: Investigator’s name Investigator’s title and role with respect to research project Name of entity in which the SFI is held Nature of the SFI Approximate dollar-value (range) or statement that the SFI is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value #7 cont’d 41

42. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #8 42 8. Records must be kept!

43. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 PDF electronic file of Disclosure and Consent Forms for Investigators (and spouse/dependent child[ren], as applicable). WORD/EXCEL document for each Principal Investigator, summarizing SFIs of the PI + other Investigators on the research team (along with those of the spouse and dependent child[ren], as applicable). #8 cont’d 43

44. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Some numbers (approximate), to date: Investigators trained Disclosure and Consent Forms: Principal Investigators Other Investigators Total (including those for spouses and dependent children) SFIs FCOIs #8 cont’d 44

45. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #9 45 9. Aspects of the Regulation are open to interpretation!

46. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 NIH Notice NOT-OD-13-004 “…within the discretion afforded by the Final Rule, impose the $5,000 de minimis threshold to reimbursed or sponsored travel disclosure…” #9 cont’d 46

47. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 At the UofA, we will apply the de minimis $5,000 threshold for disclosure exclusions to: 1. reimbursed/sponsored travel, as well as to 2. income from seminars, lectures, or teaching engagements, and 3. income from service on advisory committees or review panels. (where the latter two are funded from a government, post-secondary Institution, or health sciences centre source and the annual aggregated amount paid to the specific Investigator per entity does not exceed $5,000 – details to follow …) #9 cont’d 47

48. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 U15 Letters Interpretation of “a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.” NIH FAQ: Must be U.S. entities! NIH asked to re-consider this interpretation #9 cont’d 48

49. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 NIH Reply to U15 Exclusion is based in United States Code, 20 U.S.C. 1001(a) “Approach discussed in the Notice … should provide the most flexibility with the least amount of administrative burden” #9 cont’d 49

50. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Interpretations NIH Notice NOT-OD-13-004 U15 Letters FOIPP (Third Party consent, if needed, to be handled by Designated Official)  Revised UofA Procedure (June, 2013) #9 cont’d 50

51. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 things you should know about the NIH 2011 FCOI Regulation: #10 51 10. NIH FCOI requirements must be met before Research Facilitators, or the Research Services Office Central, sign-off!

52. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 UofA Designated Official ensures that: 1. Training is completed and that 2. Disclosure and Consent Forms have been submitted … typically confirmed via a communication with RF/RSO #10 cont’d 52

53. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 #10 cont’d 53 Training Disclosure of SFIs Designated Official’s Review of SFIs: Related to Research? FCOI? No FCOI: Disclosure filed; no further action FCOI Exists: Declaration Management Plan Report Records Designated Official Steps for Compliance with the Procedure Investigator

54. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Please remember: Financial Conflicts of Interest (FCOI) are very often a good thing! e.g., in the case of Commercialization/Spin-Off Companies “…from bench to bedside and back again…” #10 cont’d 54

55. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 Also remember the “1984” NIH FCOI Regulation: HHS authority applies before, during, or after an award with regard to any Investigator disclosure of financial interests, regardless of whether or not the disclosure resulted in the Institution’s determination of an FCOI. #10 cont’d 55

56. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 NIH FCOI Regulations Framework Compliance with Regulations Reporting to NIH Institutional Policy Implementation Evaluation of SFI Identification of FCOI Management Institution Disclosure of SFI Compliance with Institutional Policy Investigator Oversight NIH PHS regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94 56

57. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 10 11 things you should know about the NIH 2011 FCOI Regulation: #10 11 57 11. Working with the UofA NIH Designated Official requires a pre- payment in the currency of cookies and/or chocolate!

58. “Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation “Top 10” Research Administration Day 2013 We appreciate your help in evaluating this presentation! The RAD evaluation form is accessible online. Click here or click on the blue checkmark below (right-click the hyperlink(s) and click Open Hyperlink to activate).Click here Online Evaluation Form 58