Financial Conflict of Interest
2010 NIH Regional Seminar
Financial Conflict of Interest
(FCOI) Regulations

42 CFR Part 50 Subpart F (grants and cooperative
agreements)

45 CFR Part 94 (contracts)
These regulations went into effect on October 1, 1995
2
What is the Purpose of the
Regulation?

This regulation is aimed at ensuring
that the design, conduct, or
reporting of research funded under
NIH grants and cooperative
agreements will not be biased by any
conflicting financial interest of the
Investigators responsible for the
research.
3
The Regulation
Oversight
Education & Outreach
NIH
Institutional Policy
Implementation
Management
Oversight
Compliance
(including accurate
& timely reporting)
Institution
Disclosure
Compliance
Investigator
Who is Covered?

Each Institution that applies for NIH
grants or cooperative agreements for
research
• Domestic, foreign, public, private (not
Federal)


Any Investigator, as defined by the
regulation, participating in the
research
SBIR/STTR Phase I applications are
exempt (current regulation)
5
What is an FCOI?

A significant financial interest that
could directly and significantly
affect the design, conduct, or
reporting of NIH funded research
6
Institutional Responsibilities
Institutions must establish standards to
ensure there is no reasonable expectation
that the design, conduct, or reporting of
NIH funded research is biased by a
conflicting financial interest of an
Investigator
Institutional Responsibilities
• Maintain a written, enforced policy that
complies with the regulation and

inform Investigators of the policy, the regulation,
and their reporting responsibilities
• Establish enforcement mechanisms and
provide for sanctions where appropriate
• Maintain records for at least three years from
date of submission of final expenditures
report
8
Institutional Responsibilities

Designate an Institutional Official to
• solicit & review disclosure statement from each
Investigator planning to participate in NIH-funded
research
• Provide guidelines to identify conflicting interests
• Take action to ensure they are managed, reduced, or
eliminated

By the time an application is submitted, assure
that the Institutional Official has received a
financial disclosure statement from each
Investigator who is planning to participate in the
NIH-funded research.
9
Institutional Responsibilities

If NIH-funded research is performed through
“subgrantees, contractors, or collaborators,”
[aka subrecipients] the grantee Institution
must take reasonable steps to ensure
compliance by either requiring:
• Subrecipient Investigators to comply with the
Institution’s policy OR
• Subrecipient Institutions to provide assurances to
the grantee Institution that will enable it to
comply
Subrecipients should report identified FCOIs to the
grantee Institution. Grantee Institution reports to NIH.10
Institutional Responsibilities

Certify in each application for funding:
• There is in effect a written and enforced
administrative process to identify and manage,
reduce or eliminate conflicting interests
• Report existence of an FCOI prior to
expenditure of funds under an award and
within 60 days of identification of a new
conflicting interest
• Agree to make information available upon
request regarding all conflicting interests
identified by the Institution and how those
interests have been managed, reduced, or
eliminated.
11
Institutional Responsibilities



Reports of an identified Financial Conflict of
Interest include:
• grant and/or contract number,
• PD/PI or contact PD/PI,
• name of Investigator with the FCOI, and
• an indication whether the conflict has been
managed, reduced or eliminated.
For grants, all FCOI reports must be submitted
through the eRA Commons FCOI Module.
For contracts, reports should be sent to the
appropriate Director, Office of Acquisitions.
http://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asp
12
Institutional Responsibilities

eRA Commons – FCOI Module
• Enables grantees to report identified
FCOIs to NIH through the eRA
Commons
• Mandatory use began 7/1/09

NIH Guide Notice: NOT-OD-09-072
http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-09-072.html
13
eRA Commons FCOI
Module/reporting tool

System allows institutions to:
• Initiate and send a new FCOI report electronically
through the eRA Commons
• Search previously created records
• Edit a previously submitted record
• Respond to a request for additional information
• Rescind a previously submitted record
• View history of actions

To prepare, institutional Signing Officials must assign
FCOI roles to users in eRA Commons.

More information on the FCOI Module can be found at
http://era.nih.gov/services_for_applicants/other/fcoi.cfm
14
Summary of FCOI
Reporting Requirements
1.
2.
3.
At the time of application:
Investigators must submit known
significant financial interests to the
Institution.
Prior to the expenditure of funds: The
Institution must report an identified
financial conflict of interest to the NIH
and assure that it has been managed,
reduced, or eliminated.
FCOI identified after the initial report:
The Institution must report to the NIH
within 60 days of identification and
assure that it has been managed,
reduced, or eliminated.
Definition of Investigator


The Principal Investigator (PI) AND
any other person who is responsible
for the design, conduct, or reporting
of NIH-funded research, or proposed
for such funding
Includes Investigator’s spouse and
dependent children
16
Investigator Responsibilities

Submit financial disclosure statements
which is a listing of Significant Financial
Interests
• that would reasonably appear to be affected by
the research for which you are seeking
funding, and
• in entities whose financial interests would
reasonably appear to be affected by the
research

Comply with all Institutional requirements
17
Significant Financial Interest

Anything of monetary value,
including but not limited to:
• Salary or other payments for services
(e.g., consulting fees or honoraria)
• Equity interests (e.g., stocks, stock
options or other ownership interests)
• Intellectual property rights (e.g.,
patents, copyrights and royalties from
such rights)
18
Significant Financial Interest
Exclusions





Salary, royalties, or other remuneration from the
applicant Institution
Ownership interests in the Institution, if the
Institution is an applicant under the SBIR program
Income from seminars, lectures, or teaching
engagements sponsored by public or non-profit
entities
Income from service on advisory committees or
review panels for public or non-profits entities
Salary, royalties, or other payments that when
aggregated for the Investigator and the
Investigator’s spouse and dependent children over
the next 12 months are not expected to exceed
$10,000
Significant Financial Interest
Exclusions

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 as
determined through reference to public prices
or other reasonable measures of fair market
value AND
• Does not represent more than a 5% ownership
interest in any single entity
20
SFI vs. FCOI


A Significant Financial Interest (SFI) is
not always an FCOI
An FCOI exists when a designated
Institutional official reasonably
determines that an SFI could directly
and significantly affect the design,
conduct, or reporting of the NIH-funded
research
21
NIH Responsibilities
• NIH may request information regarding all
conflicting interests identified by the Institutions
and how those interests have been managed,
reduced, or eliminated to protect research from
bias.
• If the failure of an Investigator to comply with
the Institution’s conflict of interest policy has
biased the design, conduct, or reporting of the
NIH-funded research, the Institution must
promptly notify NIH of the corrective action
taken or to be taken. NIH will consider the
situation and, as necessary, take appropriate
action, or refer the matter to the Institution for
further action, which may include directions to
the Institution on how to maintain appropriate
objectivity in the funded project.
22
NIH Responsibilities

NIH may at any time inquire into the
Institutional procedures and actions
regarding conflicting financial interests in
NIH-funded research, including a
requirement for submission of, or review
on site, all records pertinent to
compliance. NIH may decide that further
corrective action is needed or that the
Institution has not managed, reduced, or
eliminated the conflict in accordance with
requirements. If necessary, NIH may
suspend funding until the matter is
resolved.
23
NIH Responsibilities

In any case in which an NIH-funded
clinical research project whose purpose is
to evaluate the safety or effectiveness of a
drug, medical device, or treatment has
been designed, conducted, or reported by
an Investigator with a conflicting interest
that was not disclosed or managed in
accordance with the regulation, the
Institution must require the
Investigator(s) involved to disclose the
conflicting interest in each public
presentation of the results of the research
24
Recent Environment


Since the existing rules were promulgated in
1995:
• biomedical and behavioral research has grown
in complexity
• interactions among Government, research
institutions, and the private sector have
increased
• public scrutiny has grown
All these factors have raised the question
whether a more rigorous approach is required
25
Advanced Notice of Proposed
Rulemaking (ANPRM)

NIH Requests Comments on Proposed Amendment of
Regulations on the Responsibility of Applicants for
Promoting Objectivity in Research for which Public Health
Service Funding is Sought and Responsible Prospective
Contractors” –
• Published May 8, 2009 in the NIH Guide to Grants and
Contracts: NOT-OD-09-099.

Federal Register (Vol. 74, No. 88) May 8, 2009

60-day comment period – closed July 7, 2009
• 78 comments received and considered

All comments are posted at:
http://www.regulations.gov/search/Regs/home.html#docke
tDetail?R=NIH-2008-0002
26
Advanced Notice of Proposed
Rulemaking (ANPRM)

Asked for comment on various topics including:
• Expanding the scope of regulation and
disclosure of interests;
• Definition of “Significant Financial Interest”;
• Identification and management of conflicting
interests by institutions;
• Assuring institutional compliance;
• Requiring institutions to provide additional
information;
• Broadening the regulations to address
institutional conflict of interest
27
ANPRM response



Several professional societies (e.g.
AAU/AAMC) and institutions that conduct
research provided comments.
All the questions raised in the ANPRM
were addressed in the comments.
Many of the comments addressed the
definition of Significant Financial Interest
and what information should be provided
to the funding agency.
28
Notice of Proposed Rulemaking
(NPRM)



NIH carefully considered and analyzed comments
submitted in response to the ANPRM and on
behalf of the Department of Health and Human
Services and the Public Health Service prepared
an NPRM which proposes changes to the
regulations
The NPRM was published in the Federal Register
on May 21, 2020 for Public Comment until July
20, 2010
NIH is soliciting comments on all aspects of the
NPRM; in addition, preamble highlights certain
topics for which comments are specifically
solicited, e.g., definitions (SFI, “institutional
responsibilities”), public disclosure requirement;
elements of FCOI reports, Institutional conflict of
interest policy requirement?)
29
Notice of Proposed Rulemaking
(NPRM)

Submit comments on Regulations.gov [Docket
Number: NIH-2010-0001] or see notice for
further submission options and instructions

FCOI-NPRM@mail.nih.gov for questions about the
proposed rule – NO COMMENTS PLEASE

See NIH Guide to Grants and Contracts (NOT-OD10-099), at http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-10-099.html

NIH will carefully consider comments in drafting
the Final Rule
30
Major proposed changes to the
regulations

Significant Financial Interest (SFI) definition
CURRENT:
- De minimis threshold of $10,000 for disclosure generally applies
to payments or equity interests over the next 12 months
- Exclusions include income from seminars, lectures, or teaching,
and service on advisory committees or review panels, for public or
nonprofit entities
PROPOSED:
- De minimis threshold of $5,000 for disclosure generally applies to
payments and/or equity interests 12 months preceding the
disclosure and the value of any equity interest as of the
date of disclosure
- Includes any equity interest in non-publicly traded entities
- Exclusions include income from seminars, lectures, or teaching,
and service on advisory or review panels, for government agencies
31
or institutions of higher education
Major proposed changes to the
regulations (cont.)

Investigator disclosure requirements
CURRENT:
- Only SFIs related to PHS-funded research as determined by
the Investigator
PROPOSED:
- SFIs include financial interests that are related to an
Investigator’s institutional responsibilities
- Institutions responsible for determining whether SFI relates
to PHS-funded research and is a FCOI
32
Major proposed changes to the
regulations (cont.)

Public disclosure
CURRENT:
- No requirement
PROPOSED:
- Make FCOI policy available via a publically assessable web
site
- Before spending funds for PHS-supported research, an
Institution shall post on a publicly accessible web site
information on certain SFIs that the Institution determines are
related to the PHS-funded research and are FCOI (< $20K;
<$50K; ,$100K;<$250K and >$250K)
33
Major proposed changes to the
regulations (cont.)
• Management of an identified FCOI by the
Institution
CURRENT:
-
Manner of compliance with regulation not specified (manage, reduce or
eliminate are indicated as options)
PROPOSED:
-
For all identified FCOI, Institutions must develop and implement a
management plan (may include reduction or elimination of the SFI)
34
Major proposed changes to
the regulations (cont.)

Management of an identified FCOI by the
Institution (cont.)
−
Key elements of the Institution’s management plan







The role and function of the conflicted Investigator in the
research project
The rationale for including the conflicted Investigator in the
research project
The conditions of the management plan
How the management plan will 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
35
Major proposed changes to
the regulations (cont.)

Management of an identified FCOI by the
Institution (cont.)
CURRENT:
- No requirement
PROPOSED:
− If FCOI is one that was not disclosed or reviewed in a timely
manner, the Institution must also implement a mitigation
plan which shall include review and determination as to
whether any PHS-funded research conducted prior to
identification and management of the FCOI was biased
36
Major proposed changes to the
regulations (cont.)

Information on an identified FCOI reported by the
Institution to PHS Awarding Component
CURRENT:
-
Grant/Contract number
Project Director/Principal Investigator (PD/PI) or Contact PD/PI
Name of Investigator with FCOI
Whether FCOI was managed, reduced, or eliminated
PROPOSED:
- Current requirements, plus:
- Value of the financial interest $0-4,999;$5K-9,999; $10K-19,999;
amounts between $20K-$100K by increments of $20K or statement
that a value cannot be readily determined
- Nature of FCOI, e.g., equity, consulting fees, travel reimbursements,
honoraria, and description of how FCOI relates to PHS-funded
research
- Key elements of the Institution’s management plan
37
Major proposed changes to the
regulations (cont.)

Timing of reporting of an identified FCOI to
the PHS Awarding Component
CURRENT:
- Prior to the Institution's expenditure of any funds under the
award
- Within 60 days for any interest that the Institution identifies as
conflicting subsequent to the Institution's initial report under
the award
PROPOSED:
- Current requirements, plus annual updates on any
previously-identified FCOI for the duration of the research
project
38
Major proposed changes to the
regulations (cont.)

Scope of the regulation
CURRENT:
- Does not cover Small Business Innovation Research/Small
Business Technology Transfer Research (SBIR/STTR) Phase I
applications
PROPOSED:
- Includes SBIR/STTR Phase I applications
39
Major proposed changes to the
regulations (cont.)

Investigator training
CURRENT:
- No requirement
PROPOSED:
- FCOI training required for Investigators before engaging in
PHS-funded research, and every two years thereafter
40
Major proposed changes to the
regulations (cont.)

HHS authority to inquire about FCOI
CURRENT:
- The HHS may at any time inquire into the Institutional
procedures and actions regarding conflicting financial interests
in PHS-funded research
PROPOSED:
- Clarifies that HHS authority applies before, during, or after an
award with regard to any Investigator disclosure of financial
interests, whether or not the disclosure resulted in the
Institution’s determination of a FCOI
41
Information

OER FCOI Web Site
• http://grants.nih.gov/grants/policy/coi/

Mailbox for inquiries
• FCOICompliance@mail.nih.gov

Mailbox for inquiries about the NPRM
• FCOI-NPRM@mail.nih.gov
42
Questions?
Diane Dean
Director, Division of Grants Compliance and Oversight, OPERA/OER
diane.dean@nih.gov
301-435-0930
Kathy Hancock
Assistant Grants Compliance Officer,
Division of Grants Compliance and Oversight, OPERA/OER
kathy.hancock@nih.gov
301.435.1962
43