“Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation

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Research Services OfficeTogether we make it happen Research Administration Day June 5, 2013

NIH 2011 FCOI Regulation

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1310 Things That You Should Know About the NIH 2011 FCOI RegulationBill McBlain, PhDUniversity of Alberta NIH “Designated Official”

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RAD 303

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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 aboutthe NIH 2011 FCOI Regulation

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10 things you should know aboutthe NIH 2011 FCOI Regulation: #1

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1. It exists!

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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/

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http://grants.nih.gov/grants/policy/coi/

http://grants.nih.gov/grants/policy/coi/

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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."

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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.

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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 …

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2. When it was implemented!

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Implementation:• August 24, 2012• All applications and Notices of Award (NOAs) after that date must

be compliant

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3. The UofA is compliant!

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• 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

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https://policiesonline.ualberta.ca/PoliciesProcedures/Procedures/Conflict-of-interest-for-NIH-Public-Health-Service-and-Health-and-Human-Services-Funding-Procedure.pdf




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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

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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

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• 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

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http://sites.nationalacademies.org/PGA/fdp/PGA_070596

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4. There are things to do to be compliant with

the Regulation!

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“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

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UofA Designated Official

Bill McBlain, PhDNIH Designated Official & Conflict Review Officer (Interim)2-51 South Academic Building(780) [email protected]

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mailto:[email protected]

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Training of Investigators:

Content When• NIH FCOI Regulation• UofA Policy and FCOI Procedure• Disclosure of SFIs

• Prior to NIH-funded research• Every four years, and• If:o FCOI Procedure changeso Investigator new to UofAo Investigator non-compliance

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5. There are a few important definitions

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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.”

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“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.

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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

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“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.)

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“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)

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BUT, I’LL SUMMARIZE…

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“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.

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“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.

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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…”

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6. The “Disclosure Report” differs

from the “Disclosure and Consent Form”!

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• 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)

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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

Conflict Policy –

Conflict of Interest & Commitment and Institutional

Conflict (Policy)

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UofA requirements:

• The Disclosure Report requests information on1. non-financial conflicts of interest,2. financial conflicts of interest,3. conflicts of commitment, and4. other conflict.

• The Disclosure Report is submitted to the “Reporting Officer”.

• The Disclosure and Consent Form is submitted to the UofA “NIH Designated Official”.

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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 …

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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).

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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:

• [email protected]

mailto:[email protected]

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• 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.

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• 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.

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7. There are time-lines for on-going compliance!

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• 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

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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

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New NIH Requirements Added to UofA Procedures

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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

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New NIH Requirements Added to UofA Procedures

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• 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

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8. Records must be kept!

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• 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).

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• 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

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9. Aspects of the Regulation are open to

interpretation!

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• 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…”

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At the UofA, we will apply the de minimis $5,000 threshold for disclosure exclusions to:

1. reimbursed/sponsored travel, as well as to2. 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 …)

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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

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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”

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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)

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10. NIH FCOI requirements must be met before Research Facilitators, or the Research Services Office Central, sign-off!

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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

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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

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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…”

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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.

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NIH FCOI Regulations Framework

Compliance with RegulationsReporting to NIH

Institutional PolicyImplementationEvaluation of SFIIdentification of FCOIManagement

Institution

Disclosure of SFICompliance with Institutional Policy

Investigator

Oversight

NIH

PHS regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94

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10 11 things you should know aboutthe NIH 2011 FCOI Regulation: #10 11

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11. Working with the UofA NIH Designated Official requires a pre-payment in the currency of cookies and/or chocolate!

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• 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).

Online Evaluation Form

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https://docs.google.com/a/ualberta.ca/forms/d/1bsxDl60nYc1WchvGMogDKFWHW89u99GJRsKJg0avU8I/viewform

https://docs.google.com/a/ualberta.ca/forms/d/1bsxDl60nYc1WchvGMogDKFWHW89u99GJRsKJg0avU8I/viewform

Documents

“Top 10” Research Administration Day 2013 Research Services Office Together we make it happen Research Administration Day June 5, 2013 NIH 2011 FCOI Regulation