Financial Conflict of Interest 2010 NIH Regional Seminar Slide 2
2 Financial Conflict of Interest (FCOI) Regulations 42 CFR Part 50
Subpart F (grants and cooperative agreements) 42 CFR Part 50
Subpart F (grants and cooperative agreements) 45 CFR Part 94
(contracts) 45 CFR Part 94 (contracts) These regulations went into
effect on October 1, 1995 Slide 3 3 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. 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. Slide 4 The Regulation Compliance (including accurate
& timely reporting) Institutional Policy
ImplementationManagementOversight Institution DisclosureCompliance
Investigator Oversight Education & Outreach NIH Slide 5 Who is
Covered? Each Institution that applies for NIH grants or
cooperative agreements for research Each Institution that applies
for NIH grants or cooperative agreements for research Domestic,
foreign, public, private (not Federal)Domestic, foreign, public,
private (not Federal) Any Investigator, as defined by the
regulation, participating in the research Any Investigator, as
defined by the regulation, participating in the research SBIR/STTR
Phase I applications are exempt (current regulation) SBIR/STTR
Phase I applications are exempt (current regulation) 5 Slide 6 6
What is an FCOI? A significant financial interest that could
directly and significantly affect the design, conduct, or reporting
of NIH funded research Slide 7 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 Slide 8 8 Institutional Responsibilities
Maintain a written, enforced policy that complies with the
regulation andMaintain a written, enforced policy that complies
with the regulation and inform Investigators of the policy, the
regulation, and their reporting responsibilities inform
Investigators of the policy, the regulation, and their reporting
responsibilities Establish enforcement mechanisms and provide for
sanctions where appropriateEstablish enforcement mechanisms and
provide for sanctions where appropriate Maintain records for at
least three years from date of submission of final expenditures
reportMaintain records for at least three years from date of
submission of final expenditures report Slide 9 9 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. Slide 10 10
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: 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 Institutions policy ORSubrecipient
Investigators to comply with the Institutions policy OR
Subrecipient Institutions to provide assurances to the grantee
Institution that will enable it to complySubrecipient 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. Slide 11
11 Institutional Responsibilities Certify in each application for
funding: Certify in each application for funding: There is in
effect a written and enforced administrative process to identify
and manage, reduce or eliminate conflicting interestsThere 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
interestReport 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.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.
Slide 12 12 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.Director,
Office of Acquisitions
http://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asp
http://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asphttp://oamp.od.nih.gov/AcquisitionOffices/chief_cos1.asp
Slide 13 13 Institutional Responsibilities eRA Commons FCOI Module
eRA Commons FCOI Module Enables grantees to report identified FCOIs
to NIH through the eRA CommonsEnables grantees to report identified
FCOIs to NIH through the eRA Commons Mandatory use began
7/1/09Mandatory use began 7/1/09 NIH Guide Notice: NOT-OD-09-072
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-072.html
NIH Guide Notice: NOT-OD-09-072
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-072.html
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-072.html
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-072.html
Slide 14 14 eRA Commons FCOI Module/reporting tool System allows
institutions to: System allows institutions to: Initiate and send a
new FCOI report electronically through the eRA CommonsInitiate and
send a new FCOI report electronically through the eRA Commons
Search previously created recordsSearch previously created records
Edit a previously submitted recordEdit a previously submitted
record Respond to a request for additional informationRespond to a
request for additional information Rescind a previously submitted
recordRescind a previously submitted record View history of
actionsView history of actions To prepare, institutional Signing
Officials must assign FCOI roles to users in eRA Commons. 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
More information on the FCOI Module can be found at
http://era.nih.gov/services_for_applicants/other/fcoi.cfm
http://era.nih.gov/services_for_applicants/other/fcoi.cfm Slide 15
Summary of FCOI Reporting Requirements 1. 1. At the time of
application: Investigators must submit known significant financial
interests to the Institution. 2. 2. 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. 3. 3. 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. Slide 16 16 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 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
Investigators spouse and dependent children Includes Investigators
spouse and dependent children Slide 17 17 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 Slide 18 18 Significant Financial Interest Anything of
monetary value, including but not limited to: Anything of monetary
value, including but not limited to: Salary or other payments for
services (e.g., consulting fees or honoraria)Salary or other
payments for services (e.g., consulting fees or honoraria) Equity
interests (e.g., stocks, stock options or other ownership
interests)Equity interests (e.g., stocks, stock options or other
ownership interests) Intellectual property rights (e.g., patents,
copyrights and royalties from such rights)Intellectual property
rights (e.g., patents, copyrights and royalties from such rights)
Slide 19 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
Investigators spouse and dependent children over the next 12 months
are not expected to exceed $10,000 Significant Financial Interest
Exclusions Slide 20 20 Significant Financial Interest Exclusions An
equity interest that when aggregated for the Investigator and the
Investigators spouse and dependent children meets both of the
following tests: An equity interest that when aggregated for the
Investigator and the Investigators 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 ANDDoes 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 entityDoes not
represent more than a 5% ownership interest in any single entity
Slide 21 21 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 Slide 22 22 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 Institutions 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. Slide 23 23 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. Slide 24 24 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
Slide 25 Recent Environment Since the existing rules were
promulgated in 1995: Since the existing rules were promulgated in
1995: biomedical and behavioral research has grown in
complexitybiomedical and behavioral research has grown in
complexity interactions among Government, research institutions,
and the private sector have increasedinteractions among Government,
research institutions, and the private sector have increased public
scrutiny has grownpublic scrutiny has grown All these factors have
raised the question whether a more rigorous approach is required
All these factors have raised the question whether a more rigorous
approach is required 25 Slide 26 26 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 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.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 Federal Register (Vol. 74, No. 88) May 8, 2009
60-day comment period closed July 7, 2009 60-day comment period
closed July 7, 2009 78 comments received and considered78 comments
received and considered All comments are posted at:
http://www.regulations.gov/search/Regs/home.html#docke
tDetail?R=NIH-2008-0002 All comments are posted at:
http://www.regulations.gov/search/Regs/home.html#docke
tDetail?R=NIH-2008-0002
http://www.regulations.gov/search/Regs/home.html#docke
tDetail?R=NIH-2008-0002
http://www.regulations.gov/search/Regs/home.html#docke
tDetail?R=NIH-2008-0002 Slide 27 27 Advanced Notice of Proposed
Rulemaking (ANPRM) Asked for comment on various topics including:
Asked for comment on various topics including: Expanding the scope
of regulation and disclosure of interests;Expanding the scope of
regulation and disclosure of interests; Definition of Significant
Financial Interest;Definition of Significant Financial Interest;
Identification and management of conflicting interests by
institutions;Identification and management of conflicting interests
by institutions; Assuring institutional compliance;Assuring
institutional compliance; Requiring institutions to provide
additional information;Requiring institutions to provide additional
information; Broadening the regulations to address institutional
conflict of interestBroadening the regulations to address
institutional conflict of interest Slide 28 28 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. Slide 29 29
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 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 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?)
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?)
Slide 30 Notice of Proposed Rulemaking (NPRM) Submit comments on
Regulations.gov [Docket Number: NIH-2010-0001] or see notice for
further submission options and instructions Submit comments on
Regulations.gov [Docket Number: NIH-2010-0001] or see notice for
further submission options and instructions [email protected]
for questions about the proposed rule NO COMMENTS PLEASE
[email protected] for questions about the proposed rule NO
COMMENTS PLEASE [email protected] See NIH Guide to Grants and
Contracts (NOT-OD- 10-099), at
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-10-099.html
See NIH Guide to Grants and Contracts (NOT-OD- 10-099), at
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-10-099.html
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-10-099.html
http://grants.nih.gov/grants/guide/notice- files/NOT-OD-10-099.html
NIH will carefully consider comments in drafting the Final Rule NIH
will carefully consider comments in drafting the Final Rule 30
Slide 31 Major proposed changes to the regulations Significant
Financial Interest (SFI) definition Significant Financial Interest
(SFI) definitionCURRENT: -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 or institutions
of higher education 31 Slide 32 32 Major proposed changes to the
regulations (cont.) Investigator disclosure requirements
Investigator disclosure requirementsCURRENT: -Only SFIs related to
PHS-funded research as determined by the Investigator PROPOSED:
-SFIs include financial interests that are related to an
Investigators institutional responsibilities -Institutions
responsible for determining whether SFI relates to PHS-funded
research and is a FCOI Slide 33 Major proposed changes to the
regulations (cont.) Public disclosure Public disclosureCURRENT: -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 ( $250K) 33
Slide 34 Major proposed changes to the regulations (cont.)
Management of an identified FCOI by the InstitutionManagement of an
identified FCOI by the InstitutionCURRENT: - 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 Slide 35 Major
proposed changes to the regulations (cont.) Management of an
identified FCOI by the Institution (cont.) Management of an
identified FCOI by the Institution (cont.) Key elements of the
Institutions management plan The role and function of the
conflicted Investigator in the research project The role and
function of the conflicted Investigator in the research project The
rationale for including the conflicted Investigator in the research
project The rationale for including the conflicted Investigator in
the research project The conditions of the management plan The
conditions of the management plan How the management plan will
safeguard objectivity in the research project How the management
plan will safeguard objectivity in the research project
Confirmation of the Investigators agreement to the management plan
Confirmation of the Investigators agreement to the management plan
How the management plan will be monitored to ensure Investigator
compliance How the management plan will be monitored to ensure
Investigator compliance Other information as needed Other
information as needed 35 Slide 36 Major proposed changes to the
regulations (cont.) Management of an identified FCOI by the
Institution (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 Slide 37 Major proposed changes to the
regulations (cont.) Information on an identified FCOI reported by
the Institution to PHS Awarding Component Information on an
identified FCOI reported by the Institution to PHS Awarding
ComponentCURRENT: -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 Institutions
management plan 37 Slide 38 Major proposed changes to the
regulations (cont.) Timing of reporting of an identified FCOI to
the PHS Awarding Component Timing of reporting of an identified
FCOI to the PHS Awarding ComponentCURRENT: -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 Slide 39 39 Major proposed changes to the regulations
(cont.) Scope of the regulation Scope of the regulationCURRENT:
-Does not cover Small Business Innovation Research/Small Business
Technology Transfer Research (SBIR/STTR) Phase I applications
PROPOSED: -Includes SBIR/STTR Phase I applications Slide 40 Major
proposed changes to the regulations (cont.) Investigator training
Investigator trainingCURRENT: -No requirement PROPOSED: -FCOI
training required for Investigators before engaging in PHS-funded
research, and every two years thereafter 40 Slide 41 Major proposed
changes to the regulations (cont.) HHS authority to inquire about
FCOI HHS authority to inquire about FCOICURRENT: -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
Institutions determination of a FCOI 41 Slide 42 42 Information OER
FCOI Web Site OER FCOI Web Site
http://grants.nih.gov/grants/policy/coi/http://grants.nih.gov/grants/policy/coi/http://grants.nih.gov/grants/policy/coi/
Mailbox for inquiries Mailbox for inquiries
[email protected]@[email protected]
Mailbox for inquiries about the NPRM Mailbox for inquiries about
the NPRM
[email protected]@[email protected]
Slide 43 43 Questions? Diane Dean Director, Division of Grants
Compliance and Oversight, OPERA/OER [email protected] 301-435-0930
Kathy Hancock Assistant Grants Compliance Officer, Division of
Grants Compliance and Oversight, OPERA/OER [email protected]
301.435.1962
