New PHS Financial Conflict of Interest
(FCOI) Regulatory Requirements
Investigator Responsibilities
Campus-Wide Overview
2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
1
Section 1
INTRODUCTION
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
2
Note!!!
• This presentation applies only to Public Health Service (PHS)
regulations. All definitions & requirements are for OUHSC
faculty/staff who have or are applying for a Public Health
Service (PHS) award.
• Other Conflict of Interest policies also apply to all faculty, staff,
and students. Those policies may be found at this site.
 http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interest-fcoi/regentspolicy-conflict-of-interest/
 It is the responsibility of al faculty, staff, and students to be familiar
with and in compliance with all applicable state law and University
policies
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
3
Purpose of the Updated Regulation
• The regulation is aimed at ensuring that the design, conduct,
or reporting of research funded under PHS grants and
cooperative agreements will not be biased by any conflicting
financial interest of the investigators responsible for the
research.
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
4
Summary of Regulatory Changes: Key Changes
Blue indicates change from 1995 regulations
• Requirement that institution determines if a disclosed
financial interest is related to the employee’s institutional
responsibilities (change from study responsibilities only)
 OUHSC PHS Investigator discloses all Significant Financial Interests
(SFIs)
• PHS definition: de minimis threshold for disclosure is lowered
(to $5K), includes any equity, and scope of outside
compensation subject to disclosure is broadened (now includes
non-profit organizations)
• Disclosure for financial interests in the previous 12 months
(new timetable)
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
5
Summary of Regulatory Changes: Key Changes , cont.
Blue indicates change from 1995 regulations
• Travel, reimbursed or covered, must be disclosed to
institution regardless of dollar amount (new)
• Paid authorship, royalties, copyrights, textbooks, must be
disclosed to institution (new)
• Mandatory training requirement every 4 years for
investigators (new)
• Timely disclosure of any changes in significant financial
interest must occur within 30 days (new)
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
6
Section 2
KEY DEFINITIONS
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
7
Key Definitions: Public Health Service (PHS)
• Includes











August 24, 2012
National Institutes of Health (NIH)
Centers for Disease Control & Prevention (CDC)
Food & Drug Administration (FDA)
Agency for Healthcare Research & Quality (AHRQ)
Health Resources & Services Administration (HRSA)
Indian Health Service (IHS)
Substance Abuse & Mental Health Services Administration (SAMHSA)
Agency for Toxic Substances & Disease Registry (ATSDR)
Administration for Children and Families (ACF)
Centers for Medicare & Medicaid Services (CMS)
Federal Occupational Health (FOH)
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
8
Key Definitions: Investigator
• “Project Director/Principal Investigator (PD/PI) as well as any
other person, regardless of title or position, who is
responsible for the design, conduct, or reporting of research
or proposed for such funding
 Applies to sub-investigators, sub-recipients, sub-grantees,
collaborators, subcontractors, or consortium members
 Includes state flow-through if originating source is a PHS agency
PD/PI is responsible for identifying all individuals who might be
considered an Investigator on a PHS award
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
9
Key Definitions: Investigator, cont.
You are considered an Investigator if you are:
• A Principal Investigator (PI)/Project Director (PD)
• Senior/Key Personnel
• All significant contributors or collaborators if responsible for design,
conduct or reporting of research
• Designated by the PI/PD as responsible for design, conduct or
reporting of research
 This could include administrative staff if the PD/PI determines that they
could influence the design, conduct, or reporting of research
It is the PI’s responsibility to identify all Investigators as defined by the PHS regulations
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
10
Key Definitions: Institutional Responsibilities
• An Investigator’s “professional responsibilities on behalf of the institution”
• Examples include but are not limited to







Research
Research consultation
Teaching
Professional practice
Speaking Engagements
Institutional committee memberships
Service on panels such as Institutional Review Boards or Data and Safety
Monitoring Boards
Only disclose Significant Financial Interests related to an
Investigator’s institutional responsibilities
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
11
Definition: Significant Financial Interest (SFI)
Blue indicates change from 1995 regulations
• Payments from a publicly traded entity over the 12 months
preceding the disclosure that, when aggregated, exceeds
$5,000 as of the date of the disclosure
 Includes salary and any payment for services not otherwise identified
as salary such as
• Equity interest includes any stock, stock option, or other ownership
interest, as determined through reference to public prices or other
reasonable measures of fair market value;
• Intellectual Property rights and interests and any payment for services,
salary, consulting fees, honoraria, paid authorship
Includes spouse and dependent children!!!
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
12
Definition: Significant Financial Interest (SFI) cont.
Blue indicates change from 1995 regulations
• Payments from a non-publicly traded entity in the twelve
months preceding the disclosure that, when aggregated,
exceeds $5,000
 Investigator holds any equity interest (e.g., stock, stock option, or
other ownership interest)
 Includes non-profits (such as foundations)
• Intellectual property rights and interests (e.g., patents,
copyrights), upon receipt of income related to such rights and
interests
• Investigators also must disclose the occurrence of any
reimbursed or sponsored travel regardless of amount
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
13
Key Definitions: SFI – Excluded Sources – No disclosure
Required
You do NOT have to disclose if the SFI comes from the following sources:
• Salary, royalties, or other remuneration from current institution
• Agreements to share in royalties related to Intellectual Property Rights
assigned to OUHSC
• Mutual funds and retirement accounts with no investigator control of
investment
• Income from teaching engagements sponsored by a federal, state, or local
government agency, an institution of higher education, an academic
teaching hospital, a medical center or an academic research institute
• Income from service on committees or review panels for a federal, state, or
local government agency, institution of higher education, an academic
teaching hospital, a medical center, or an academic research institute.
If your SFI comes from any other source, you must disclose
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
14
Key Definitions: Financial Conflict of Interest (FCOI)
• An interest that could directly and significantly affect the
design, conduct or reporting of the research
• Conflict of interest is a situation in which financial or other
personal considerations:
 may compromise,
 may involve the potential for compromising
 may have the appearance of compromising
an employee’s objectivity in meeting University duties or
responsibilities, including research activities
• Determined by OUHSC
 The Investigator does NOT determine FCOI, only discloses SFI
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
15
Key Definitions: SFI vs. FCOI
• A significant financial interest (SFI) is defined by the PHS criteria on
slides 12 & 13
 All PHS Investigators must disclose all SFIs
• A Significant Financial Interest (SFI) is not always an FCOI
• The designated Institutional official* determines if an FCOI exists
when a SFI could directly and significantly affect the design,
conduct, or reporting of the PHS-funded research
* Designated Institutional Official is the OUHSC Vice President for Research
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
16
Section 3
DISCLOSURE PROCESS
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
17
SFI Disclosure Process
An Investigator must disclose to the institution all significant
financial interests (SFIs) (and those of his/her spouse and
dependent children)
RELATED TO HIS/HER INSTITUTIONAL RESPONSIBILITIES at the
time the research proposal is submitted to the grant awarding
agency
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
18
SFI Disclosure Process
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
19
Significant Financial Interest (SFI) Disclosure Process
1. Project Director/Principal Investigator (PD/PI) is responsible for
his/her own SFI disclosure and determines who meets the
definition of “Investigator” on their project


The PD/PI identifies all other individuals, regardless of title or position,
who he/she identifies as responsible for the design, conduct, or reporting
of research or proposed for such funding
It is the PD/PI’s responsibility, in conjunction with department assistance,
to notify and secure disclosures from the identified Investigators
2. The designated Investigators complete the Significant Financial
Interests Form (SFIF)
 Project-based form – one form for each project for each designated
Investigator (completed form may be duplicated for multiple projects)
 If the Investigator has no SFIs, no further action is required
 If the Investigator has one or more SFIs, he/she completes the SFI
Attachment (1 per SFI entity)
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
20
SFI Disclosure Process, cont.
3. The identified Investigators send the completed SFIF and, if
applicable, the SFI attachments to ORA (hscora@ouhsc.edu)
 All disclosures must be received by ORA before an application can be
approved for submission
4. A copy of the SFIF is forwarded to the Vice President for
Research (OUHSC Institutional Official) for review
 Institutional Official evaluates every PHS-research-related SFI in the
context of each PHS project to determine if the interest creates a
Financial Conflict of Interest (FCOI)
 May involve the Investigator in that review process
5. If the Institutional Official determines there is no FCOI, the
process is complete
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
21
SFI Disclosure Process, cont.
6. If the Institutional Official determines there is an FCOI, then
he will work with the investigator to create a FCOI
management plan.



Within 60 days of receipt of disclosure
Application may be submitted without management plan as long as
all SFIs for all designated Investigators have been disclosed
The original disclosure along with the decision is kept in the proposal
file and will be used to verify at the Just-in-Time (JIT) and award
stages
7. The Institutional Official reports details of FCOI and
management plan to funding agency
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
22
SFI Disclosure Process: When to Disclose SFI?
• No later than at the time of application for PHS-funded
research
• Within thirty days of discovering or acquiring a new Significant
Financial Interest
• At least annually, in accordance with the specific time period
during the period of award.
Disclosure includes spouse and dependent children
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
23
Section 4
TRAINING, TRAVEL, PAID AUTHORSHIP
& PUBLIC DISCLOSURE
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
24
Training
• Funding cannot be released until all designated Investigators
have successfully completed the OUHSC FCOI training
 The PD/PI must designate all Investigators on ORA Routing Form, or
notify ORA of personnel changes
 ORA verifies completion of training prior to award set-up
• All Investigator(s)designated by the PD/PI should take the
mandatory training as soon as possible
 Must repeat training every 4 years
 Or immediately if designated an Investigator by a PD/PI.
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
25
Travel Disclosure
• All Investigators must complete Travel Supplemental
Disclosure Form (TSDF) for
 any reimbursed travel or
 any sponsored travel
• i.e. paid on behalf of the Investigator and not reimbursed to the
investigator so that the exact monetary value may not be readily available
• One form per travel event
• Disclosure must occur within 30 days of reimbursement or
travel event if sponsored travel
Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
26
Paid Authorship
• All Investigators must disclose paid authorship not covered in
the SFI exclusion list as part of the Significant Financial
Interest Disclosure.
 Within 30 days of occurrence (if greater than >$5,000)
OR
 When the aggregate from a single entity exceeds >5,000
Exclusions! It’s not as bad as you think. Remember the SFI Excluded Sources
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
27
Public Accessibility of FCOI Information
OUHSC must make publicly available certain information about
FCOIs that were identified involving investigators by responding
to requests within 5 business days.
Remember! An FCOI is not an SFI. OUHSC is not obligated to disclose SFIs
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
28
For Reference Only
DETAILED REGULATION CHANGES
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
29
Definition of Investigator
1995
• Anyone involved in the design,
conduct, and reporting of the
research
2012
• Project Director/Principal
Investigator as well as any
other person, regardless of title
or position, who is responsible
for the design, conduct, or
reporting of research funded
by the PHS, or proposed for
such funding, which includes
subawardees and may include
collaborators or consultants
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
30
Significant Financial Interests (SFI) Threshold
•
•
1995
De minimis threshold of $10,000
for disclosure generally applies to
payments aggregated for the
Investigator and the Investigator’s
spouse and dependent children
Equity: An equity interest that
exceeds $10,000 in value or more
than a 5% ownership interest in
any single entity
•
2012
De minimis threshold of $5,000 for
disclosure applies to any
remuneration received from the
entity aggregated together with
the value of any equity interest.
•
Includes any equity interest in
non-publically traded entities
•
OUHSC may apply higher
standards for what constitutes an
SFI
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
31
SFI Reporting Period
•
1995
In the next 12 months
•
2012
In the previous 12 months
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
32
Which SFIs Need to be Disclosed Once Threshold is Met?
•
•
1995
Only those SFI the Investigator
deems related to the PHS-funded
research
OSR-100
•
•
•
2012
All SFI related to the
Investigator’s institutional
responsibilities
Annual disclosure
Updates required within 30 days
of change or occurrence
(travel/paid authorship)
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
33
Excluded from Disclosure Requirement
•
•
1995
Income from seminars, lectures,
or teaching engagements
sponsored by public or nonprofit
entities; income from service on
advisory committees or review
panels for public or nonprofit
entities
An equity interest that when
aggregated for the Investigator
and the Investigator’s spouse and
dependent children meets both of
the following tests: does not
exceed $10,000 in value and does
not represent more than a 5%
ownership interest in any single
entity.
•
•
2012
Income from seminars, lectures,
or teaching engagements, or
service on advisory committees or
review panels sponsored by a
Federal, state, or local
government agency, an Institution
of higher education, an academic
teaching hospital, a medical
center, or a research institute that
is affiliated with an Institution of
higher education.
Income or service for any other
type of organization must be
reported.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
34
Types of SFI Excluded
•
1995
Excludes income from investment
vehicles such as mutual funds and
retirement accounts as long as the
Investigator does not directly
control the investment decisions
made in these vehicles
2012
•
Same
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
35
SBIR/STTR Phase I
1995
•
Excluded
2012
•
•
Excluded
Phase II is included
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
36
Intellectual Property (IP)
•
1995
Royalties are included among the
“payments” subject to the $10,000
threshold.
•
•
2012
The threshold of $5,000 applies to
licensed IP rights (e.g., patents,
copyrights), royalties from such rights,
and agreements to share in royalties
related to licensed intellectual property
rights.
Excluded


Unlicensed IP that doesn’t generate income
IP rights assigned to the Institution and
agreements to share in royalties related to
such rights
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
37
Paid Authorship*
1995
•
Not included
2012
•
•
Included
Doesn’t include academic textbooks,
etc.
Remember – SFI disclosure doesn’t necessarily mean FCOI
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
38
Travel Reimbursements and Sponsored Travel
1995
•
Not included
•
•
2012
Disclose the occurrence of ANY
reimbursed travel or sponsored
travel related to institutional
responsibilities
NOT required to disclose travel
that is reimbursed or sponsored
by a federal, state, or local
government agency, an Institution
of higher education, an academic
teaching hospital, a medical
center, or a research institute that
is affiliated with an Institution of
higher education.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
39
Sub-recipients and Reporting of Identified FCOIs
•
1995
Institutions must take reasonable
steps to ensure that Investigators
working for sub-recipients comply with
the regulations by requiring those
Investigators to comply with the
institution’s policy, or by requiring the
entities to provide assurances to the
institution that will enable the institution
to comply
•
•
2012
Incorporate as part of a written
agreement terms that establish
whether the FCOI policy of the
awardee Institution or that of the subrecipient will apply to sub-recipient
Investigators, and include time periods
to meet disclosure and/or FCOI
reporting requirements
Sub-recipient Institutions who rely on
their FCOI policy must report identified
FCOIs to the awardee Institution in
sufficient time to allow the awardee
Institution to report the FCOI to NIH to
meet reporting obligations.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
40
FCOI Training
•
1995
No requirement
•
2012
Each Investigator must complete
training prior to engaging in
research related to any PHSfunded grant or contract and at
least every four years, and
immediately under the following
circumstances:
 If institutional FCOI policies
change in a manner that affects
Investigator requirements
 An Investigator is new to an
Institution
 An Institution finds an Investigator
noncompliant with Institution’s
FCOI policy or management plan.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
41
Information on an identified Financial Conflict of Interest (FCOI) reported by the
Institution to NIH
•
1995
Grant/Contract number, PI, name
of Investigator with FCOI, whether
FCOI was managed, reduced, or
eliminated
2012
Requirements in 1995 regulations,
plus:
•
•
•
Name of the entity with which the
Investigator has a FCOI;
Nature of FCOI, e.g., equity,
consulting fees, travel
reimbursement, honoraria;
Value of the financial interest $04,999; $5K-9,999; $10K-19,999;
amts between $20K-$100K by
increments of $20K; amts above
$100K by increments of $50K or
statement that a value cannot be
readily determined
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
42
Information on an identified Financial Conflict of Interest
(FCOI) reported by the Institution to NIH, con’t
2012
 A description how the financial interest relates to PHS-funded
research and the basis for the Institution’s determination that the
financial interest conflicts with such research
• Role and principal duties of the conflicted Investigator in the research
project
• Conditions of the management plan
• How the management plan is designed to safeguard objectivity in the
research project
• Confirmation of the Investigator’s agreement to the management plan
• How the management plan will be monitored to ensure Investigator
compliance
• Other information as needed.
 Annual Report with status of the FCOI and changes to the
management plan
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
43
Public Accessibility
1995
• No requirement
•
•
2011
Make information available concerning
identified FCOIs held by senior/key
personnel via a publicly accessible Web site
or by a written response to any requestor
within 5 business days of a request, and
update such information as specified in the
rule.
This information will include at a minimum
the Investigators name, title, and role; the
name of the entity in which the SFI is held;
the nature of the SFI; and the approximate
dollar value of the SFI, or a statement that
the interest is one whose value cannot be
readily determined through reference to
public prices or other reasonable measures
of fair market value.
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
44
FAQs and Resources
NIH
• 42 CFR 50 Subpart F
 http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm
• NIH FCOI Page
 http://grants.nih.gov/grants/policy/coi/index.htm
• NIH FAQs – New and Updated (3/21/2012)
 http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
OUHSC
• Office of Research FCOI Page
 http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interestfcoi/
• Board of Regents Policy
 http://research.ouhsc.edu/forms-policies/financial-conflicts-of-interestfcoi/regents-policy-conflict-of-interest/
August 24, 2012
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements Training
45
Contact Information
Office of Research Administration
Phone: (405)271-2090
Email: hscora@ouhsc.edu
website: http://research.ouhsc.edu
PHS Financial Conflict of Interest (FCOI) Regulatory Requirements
46