RAD 303
10 Things That You Should
Know About the NIH 2011
FCOI Regulation
Bill McBlain, PhD
University of Alberta NIH “Designated Official”
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
1
Research Services Office
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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!
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“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation
NIH 2011 FCOI Regulation
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1. It exists!
“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation: #1
NIH 2011 FCOI Regulation
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#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/
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#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."
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#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.
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NIH 2011 FCOI Regulation
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#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 …
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NIH 2011 FCOI Regulation
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2. When it was
implemented!
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10 things you should know about
the NIH 2011 FCOI Regulation: #2
NIH 2011 FCOI Regulation
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#2 cont’d
Implementation:
• August 24, 2012
• All applications and Notices of Award (NOAs) after that date must
be compliant
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NIH 2011 FCOI Regulation
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3. The UofA is
compliant!
“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation: #3
NIH 2011 FCOI Regulation
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#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/Co
nflict-of-interest-for-NIH-Public-Health-Service-and-Health-andHuman-Services-Funding-Procedure.pdf
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#3 cont’d
UofA Conflict Policy
and its Procedures
Conflict Policy –
Conflict of Interest &
Commitment and
Institutional Conflict
(Policy)
NEW
Conflict of Interest &
Conflict of Commitment
Reporting & Assessment
Procedure
Research Services Office
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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
Research Administration Day June 5, 2013
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NIH 2011 FCOI Regulation
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#3 cont’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
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NIH 2011 FCOI Regulation
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#3 cont’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
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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4. There are things to do
to be compliant with
the Regulation!
“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation: #4
NIH 2011 FCOI Regulation
15
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#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
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#4 cont’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
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#4 cont’d
Training of Investigators:
Content
• NIH FCOI Regulation
• UofA Policy and FCOI Procedure
• Disclosure of SFIs
When
• Prior to NIH-funded research
• Every four years, and
• If:
o FCOI Procedure changes
o Investigator new to UofA
o Investigator non-compliance
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NIH 2011 FCOI Regulation
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5. There are a few
important definitions
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10 things you should know about
the NIH 2011 FCOI Regulation: #5
NIH 2011 FCOI Regulation
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#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.”
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#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.
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NIH 2011 FCOI Regulation
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#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
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NIH 2011 FCOI Regulation
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#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.)
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#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)
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NIH 2011 FCOI Regulation
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#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.
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#5 cont’d
“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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“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#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 NIHfunded 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…”
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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6. The “Disclosure
Report” differs
from the “Disclosure
and Consent Form”!
“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation: #6
NIH 2011 FCOI Regulation
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#6 cont’d
• 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)
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
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#6 cont’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 end
of The Procedure
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NIH 2011 FCOI Regulation
Research Administration Day June 5, 2013
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#6 cont’d
UofA requirements:
• The Disclosure Report requests information on
non-financial conflicts of interest,
2. financial conflicts of interest,
3. conflicts of commitment, and
4. other conflict.
1.
• The Disclosure Report is submitted to the “Reporting Officer”.
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
• The Disclosure and Consent Form is submitted to the UofA “NIH
Designated Official”.
31
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#6 cont’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 …
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NIH 2011 FCOI Regulation
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#6 cont’d
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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NIH 2011 FCOI Regulation
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NIH 2011 FCOI Regulation
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#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
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#6 cont’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.
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NIH 2011 FCOI Regulation
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#6 cont’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.
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NIH 2011 FCOI Regulation
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7. There are time-lines
for on-going
compliance!
“Top 10” Research Administration Day 2013
10 things you should know about
the NIH 2011 FCOI Regulation: #7
NIH 2011 FCOI Regulation
37
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NIH 2011 FCOI Regulation
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#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
38
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#7 cont’d
New NIH Requirements Added to UofA Procedures
UofA
• No requirement to
report to any external
body
• No training obligation
UofA/NIH
• Reports provided to NIH for
FCOIs, management plans, noncompliance, 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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NIH 2011 FCOI Regulation
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#7 cont’d
New NIH Requirements Added to UofA 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 or publicly accessible by
written response within five (5)
business days:
“Top 10” Research Administration Day 2013
NIH 2011 FCOI Regulation
• FCOIs (including specified details)
for senior/key personnel
40
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#7 cont’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
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NIH 2011 FCOI Regulation
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8. Records must be
kept!
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10 things you should know about
the NIH 2011 FCOI Regulation: #8
NIH 2011 FCOI Regulation
42
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#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).
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#8 cont’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
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NIH 2011 FCOI Regulation
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9. Aspects of the
Regulation are open to
interpretation!
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10 things you should know about
the NIH 2011 FCOI Regulation: #9
NIH 2011 FCOI Regulation
45
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#9 cont’d
• 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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#9 cont’d
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 …)
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#9 cont’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
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#9 cont’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”
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#9 cont’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)
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10 things you should know about
the NIH 2011 FCOI Regulation: #10
10. NIH FCOI requirements
must be met before
Research Facilitators, or
the Research Services
Office Central, sign-off!
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#10 cont’d
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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#10 cont’d
Steps for Compliance
with the Procedure
Training
Disclosure
of SFIs
Investigator
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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
Research Administration Day June 5, 2013
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#10 cont’d
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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NIH 2011 FCOI Regulation
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#10 cont’d
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
Disclosure of SFI
Compliance with Institutional Policy
Investigator
Compliance with Regulations
Reporting to NIH
Institutional Policy
Implementation
Evaluation of SFI
Identification of FCOI
Management
Institution
PHS regulation 42 CFR Part 50, Subpart F and 45 CFR Part 94
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NIH
Oversight
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Research Administration Day June 5, 2013
10 11 things you should know about
the NIH 2011 FCOI Regulation: #10 11
11. Working with the
UofA NIH Designated
Official requires a prepayment in the currency
of cookies and/or
chocolate!
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