10 Things That You Should Know About the NIH 2011 FCOI Regulation

1. RAD 303 10 Things That You Should Know About the NIH 2011 FCOI Regulation Bill McBlain, PhD University of Alberta NIH “Designated Official”

2. 10 things you should know aboutthe NIH 2011 FCOI Regulation • It exists! • When it was implemented! • The UofA is compliant! • There are things to do to be compliant with the Regulation! • There are a few important definitions! • The “Disclosure Report” differs from the “Disclosure and Consent Form!” • There are time-lines for on-going compliance! • Records must be kept! • Aspects of the Regulation are open to interpretation! • NIH FCOI Requirements must be met before Research Facilitators (RFs) or the Research Services Office (RSO) Central, Sign-Off!

3. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #1 1. It exists!

4. #1 cont’d 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/

5. #1 cont’d 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." 

6. #1 cont’d 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.

7. #1 cont’d 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 …

8. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #2 2. When it was implemented!

9. #2 cont’d Implementation: • August 24, 2012 • All applications and Notices of Award (NOAs) after that date must be compliant

10. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #3 3. The UofA is compliant!

11. #3 cont’d • 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/Conflict-of-interest-for-NIH-Public-Health-Service-and-Health-and-Human-Services-Funding-Procedure.pdf

12. #3cont’d UofA Conflict Policy and its Procedures Conflict Policy– Conflict of Interest & Commitment and Institutional Conflict (Policy) NEW Conflict of Interest for National Institutes of Health (NIH), Public Health Service (PHS) and Health and Human Services (HHS) Funding Procedure Conflict of Interest & Conflict of Commitment Reporting & Assessment Procedure Managing Conflict of Interest in Employment Procedure

13. #3cont’d 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

14. #3cont’d • 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

15. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #4 4. There are things to do to be compliant with the Regulation!

16. #4 cont’d “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

17. #4cont’d 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

18. #4 cont’d Training of Investigators:

19. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #5 5. There are a few important definitions

20. #5 cont’d 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.”

21. #5 cont’d “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.

22. #5 cont’d 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

23. #5 cont’d “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.)

24. #5 cont’d “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) But, I’ll summarize…

25. #5 cont’d “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.

26. #5 cont’d “SFI” cont’d-Exclusions from disclosure (brief summary): • Salaries and other remuneration from the UofA(the "Institution"). • Income from investment vehicles (e.g., mutual funds) where the Investigator does not control the investment decisions. • 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. • 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.

27. #5 cont’d 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…”

28. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #6 6. The “Disclosure Report” differs from the “Disclosure and Consent Form”!

29. #6cont’d • The UofA “Disclosure Report” is submitted in compliance with theConflict 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)

30. #6cont’d Conflict Policy– Conflict of Interest & Commitment and Institutional Conflict (Policy) 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 endof The Procedure

31. #6cont’d UofA requirements: • The Disclosure Reportrequests information on • non-financial conflicts of interest, • financial conflicts of interest, • conflicts of commitment, and • other conflict. • The Disclosure Report is submitted to the “Reporting Officer”. • The Disclosure and Consent Form is submitted to the UofA “NIH Designated Official”.

32. #6cont’d 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 …

33. #6cont’d The Disclosure and Consent Form includes: • Disclosure of SFIs for compliance with the NIH Regulation, and • “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).

34. #6cont’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. #6cont’d • 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.

36. #6cont’d • 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.

37. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #7 7. There are time-linesfor on-going compliance!

38. #7 cont’d • 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

39. #7 cont’d New NIH Requirements Added toUofA Procedures 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

40. #7 cont’d New NIH Requirements Added toUofA Procedures 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 orpublicly accessible by written response within five (5) business days: • FCOIs (including specified details) for senior/key personnel

41. #7cont’d • 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

42. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #8 8. Records must be kept!

43. #8 cont’d • 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).

44. #8cont’d • 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

45. 10 things you should know aboutthe NIH 2011 FCOI Regulation: #9 9. Aspects of the Regulation are open to interpretation!

46. #9cont’d • NIH Notice NOT-OD-13-004 • “…within the discretion afforded by the Final Rule, impose the $5,000 de minimisthreshold to reimbursed or sponsored travel disclosure…”

47. #9cont’d At the UofA, we will apply the de minimis$5,000 threshold for disclosure exclusions to: • reimbursed/sponsored travel, as well as to • income from seminars, lectures, or teaching engagements, and • 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 …)

48. #9cont’d 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

49. #9cont’d 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”

50. #9cont’d 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)