Effective: September 23, 2025
- Introduction........................................................................................................................... 2
- Applicability........................................................................................................................... 2
- Definitions............................................................................................................................. 2
- Significant Financial Interest (SFI) Disclosure Requirements ................................................ 5
- Review of SFI Disclosures .................................................................................................... 5
- Relatedness of SFIs to PHS/NIH-Funded Research and FCOI ............................................. 6
- Management of SFIs that Pose an FCOI .............................................................................. 7
- Monitoring Investigator Compliance ...................................................................................... 7
- Public Accessibility of the FCOI Policy and FCOIs Held bySenior/Key Personnel…………7
- Reporting Identified Financial Conflicts of Interest.............................................................. 8
- Training Requirements for Investigators...........................................................................10
- Noncompliance With FCOI Policy and Corrective Actions ................................................10
- Clinical Research Requirements......................................................................................11
- Subrecipient Requirements..............................................................................................11
- Maintenance of Records ..................................................................................................12
- Enforcement Actions for Investigator Noncompliance ......................................................12
- Useful FCOI and NIH Resources .....................................................................................12
- Point Of Contact ..............................................................................................................13
1) Introduction
The purpose of this policy is to ensure that research funded by the National Institutes of Health
(NIH) is designed, conducted, and reported objectively and without bias resulting from
Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are 42 CFR Part
50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible
Prospective Contractors”, which set requirements for promoting objectivity in Public Health
Service (PHS)–funded research for grants, cooperative agreement, and research contracts,
respectively. The regulations do not apply to Phase I applications or awards. This policy
implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for Orthopaedic
Trauma Association, Inc (“OTA”).
2) Applicability
This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for
grants and cooperative agreements issued by the NIH. This policy applies to individuals who
meet the regulatory definition of “Investigator” (as defined below) who are planning to
participate in or who participate in PHS/NIH-funded research.
3) Definitions
For the purpose of these policies and procedures, the following definitions apply:
Financial Conflict of Interest (FCOI): A significant financial interest that could directly
and significantly affect the design, conduct, or reporting of PHS-funded research.
Financial Interest: Anything of monetary value, whether or not its value is readily ascertainable.
Institutional Responsibilities: The professional activities an Investigator performs on behalf
of OTA including research, development, publication, consulting, administration, institutional
committee memberships and/or panels, or any other duties defined by their role at the
company.
Designated Official (DO): The individual appointed by OTA to solicit and review disclosures of
significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this
policy, and develop management plans for identified FCOI.
Institution: Any public or private organization, domestic or foreign (excluding a federal agency)
that is applying for or receives, PHS/NIH research funding.
Investigator: The Project Director (PD) or Principal Investigator (PI), and any other person,
regardless of title or position, who is responsible for the design, conduct, or reporting of
research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. The institution determines who is responsible for the design,
conduct, or reporting of PHS/NIH-funded research. OTA will consider the individual's role,
rather than the title, of those involved in the research and the degree of independence with
which the individual works when determining who is responsible for the design, conduct, or
reporting of the PHS-funded research.
Manage: means taking action to address a financial conflict of interest, which can include
reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
Research: Implies a systematic investigation, study, or experiment designed to develop or
contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). As used in the regulation, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.
PHS-Funded Research: Any activity supported by a Public Health Service (PHS) Awarding
Component through a grant, cooperative agreement, or contract, whether funded under the
PHS Act or other statutory authority.
PHS: The Public Health Service of the U.S. Department of Health and Human Services, and
any components of the PHS to which the authority involved may be delegated, including the
National Institutes of Health (NIH).
NIH: The biomedical research agency within the Public Health Service (PHS) that funds and
conducts research to improve health and advance scientific knowledge.
Senior/Key Personnel: The PD/PI and any other individual identified as senior/key personnel
by the Institution in a grant application, progress report, or other submission to PHS/NIH. For
this policy, the term applies specifically to the public accessibility requirement, which mandates
disclosure only of financial conflicts of interest held by these senior/key personnel, as described
in Section 9.
Significant Financial Interest (SFI):
- A domestic or foreign financial interest consisting of one or more of the following
interests of the Investigator, and those of the Investigator’s spouse, and dependent
children, that reasonably appears to be related to the Investigator’s institutional
responsibilities performed on behalf of OTA, and that consists of one or more of the
following:- (i) Publicly traded entity: An SFI exists if the total of remuneration received
from the entity in the previous 12 months and the value of any equity interest in
the entity on the disclosure date exceeds $5,000. Remuneration includes salary
and payments for services (e.g., consulting fees, honoraria, paid authorship).
Equity interest includes stock, stock options, or other ownership interests
measured by public prices or other reasonable market value. - (ii) Non-publicly traded entity: An SFI exists if the aggregated value of
remuneration received from the entity in the 12 months preceding the disclosure
exceeds $5,000, or if the Investigator (or their spouse or dependent children)
holds any equity interest in the entity (e.g., stock, stock options, or other
ownership interest). - (iii) Intellectual property: An SFI exists if receipt of income related to
intellectual property rights or interests (e.g., patents, copyrights), exceeds
$5,000 during the 12 months preceding the disclosure, related to such rights
and interests.
- (i) Publicly traded entity: An SFI exists if the total of remuneration received
- Investigators must disclose any reimbursed or sponsored travel related to their
institutional responsibilities with a value exceeding $5,000. Such travel includes trips
paid on behalf of the Investigator rather than reimbursed directly, where the exact cost
may not be known. The disclosure must cover the previous 12 months and include, at
minimum, the purpose, sponsor or organizer, destination, and duration of each trip.
The disclosure requirement does not apply to travel that is reimbursed or sponsored by
the following:
• a federal, state, or local government agency located in the United States,
• a United States Institution of Higher Education,
• an academic teaching hospital,
• a medical center, or
• a research institute affiliated with a United States Institution of Higher Education - The term “significant financial interest” does not include, and therefore
investigators are not required to disclose, the following types of financial interests:
• Salary, royalties, or other remuneration paid by OTA to the Investigator if
the Investigator is currently employed or otherwise appointed by OTA,
including intellectual property rights assigned to OTA and any agreements
to share royalties related to those rights.
• Income from investment vehicles such as mutual funds and retirement
accounts, provided the Investigator does not directly control the investment
decisions for those vehicles.
• Income from seminars, lectures, or teaching engagements sponsored by a
U.S. federal, state, or local government agency, a U.S. institution of higher
education, an academic teaching hospital, a medical center, or a research
institute affiliated with a U.S. institution of higher education.
• Income from service on advisory committees or review panels for a U.S.
federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated
with a U.S. institution of higher education.
Foreign Financial Interests: Investigators must disclose all foreign financial interests (which
include income from seminars, lectures, or teaching engagements, income from service on
advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000). - Significant Financial Interest (SFI) Disclosure Requirements Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy.
The disclosure will not be limited to an Investigator’s research responsibilities or their
funded research as this is too narrow in scope and not consistent with the 2011 regulation.
The Investigator SFI Disclosures will be retained by the Institution as part of the record
maintenance requirements.
Investigators are required to disclose SFIs at the following times:
At the time of application: The PI and all other individuals who meet the definition of
“Investigator” must disclose their SFIs to the DO(s). Any new Investigator who joins the
project after the NIH application has been submitted or during the course of the research must
also disclose their SFI(s) to the DO(s) promptly and before participating in the project, using
the SFI Disclosure Form.
Annual disclosure: Each Investigator participating in research under an NIH award must
submit an updated SFI disclosure at least annually (on or before July 1) during the award
period. The annual disclosure must include: (1) any new information that was not previously
disclosed to OTA under this policy, including SFIs associated with NIH-funded projects
transferred from another institution; and (2) updated details for any previously disclosed SFI,
such as changes in the value of an equity interest.
New SFIs during the award: Each Investigator participating in PHS/NIH-funded research must
submit an updated SFI disclosure within 45 days of discovering or acquiring a new SFI (e.g.,
through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 45 days of each occurrence.
5) Review of SFI Disclosures
The Designated Official(s) will conduct reviews of SFI disclosures. The Designated Official(s) will
review any SFI that have been identified in a disclosure; these interests will be compared to each
PHS/NIH research application and/or award on which the Investigator is identified as responsible
for the design, conduct, or reporting of the research to determine if the SFI is related to the
PHS/NIH-funded research and, if so, whether the SFI creates a Financial Conflict of Interest (FCOl)
The SFI disclosures will be reviewed as described below:
Prior to the issuance of a new award and before any expenditure of any awarded funds
(e.g., during Just-in-Time stage): The DO will review the Investigator’s SFIs before NIH
issues a new award. If an FCOI is identified, an FCOI report will be submitted to NIH via
the eRA Commons FCOI Module prior to any expenditure of funds.
Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide
updated information on any previously disclosed SFIs (e.g., revised value of an equity
interest). The DO will review these updates to determine whether changes to an existing
management plan are needed. Any modifications will be reflected in the next Annual FCOI
report submitted to NIH, if applicable.
Ad hoc basis during award period: If a new Investigator joins a project or an existing
Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days:
(1) review the disclosure;
(2) determine whether the SFI is related to the PHS/NIH-funded research;
(3) determine whether an FCOI exists; and, if so,
(4) implement, on at least an interim basis, a management plan.
An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.
6) Relatedness of SFIs to PHS/NIH-Funded Research and FCOI
The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and
determining when they constitute a FCOI.
Relatedness Test: The DO determines whether an Investigator’s SFI is related to research
under an NIH award. An SFI is considered “related” when the DO reasonably determines that:
• The SFI could be affected by the PHS/NIH-funded research, or
• The SFI is in an entity whose financial interests could be affected by the
PHS/NIH-funded research.
INVESTIGATOR INVOLVEMENT: The DO may consult with the Investigator when
assessing whether an SFI is related to the research.
Designated Official FCOI Determination: An FCOI exists when the DO reasonably determines
that the SFI could directly and significantly affect the design, conduct, or reporting of the
PHS/NIH- funded research (“significantly” meaning that the financial interest would have a
material effect on the research).
7) Management of SFIs that Pose an FCOI
When an FCOI is identified, the DO will determine and implement management strategies to
ensure the research is conducted objectively. Examples of management conditions include, but
are not limited to:
1. Public disclosure of the FCOI (e.g., in publications or presentations, to study
personnel, to the IRB, IACUC, or Data Safety Monitoring Board). While public
posting of FCOIs is required only for senior/key personnel, the DO may require
disclosure of any Investigator’s FCOI as a condition of a management plan.
2. For human subject’s research, disclosure of the FCOI to participants in
the informed consent document
3. Appointment of an independent monitor to protect against bias in the design,
conduct, and reporting of the research
4. Modification of the research plan
5. Change of personnel roles or removal from portions of the research
6. Reduction or elimination of the financial interest (e.g., divesting equity)
7. Severance of relationships creating the conflict
The DO will communicate the determination and the management plan in writing to the
Investigator, the PD/PI, and the appropriate supervisor.
No expenditures on an NIH award may occur until the Investigator has met all disclosure
requirements and agreed in writing to comply with the management plan. The DO will submit
an FCOI report to NIH via the eRA Commons FCOI Module.
8) Monitoring Investigator Compliance
OTA will monitor Investigator compliance with the management plan for the duration of the
NIH award.
FCOIs are made in publications, presentations, and other communications. Investigators must
also disclose the FCOI in writing to study personnel and provide a copy of this disclosure to the
DO for recordkeeping.
9) Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key
Personnel
FCOI Policy: A copy of this FCOI policy is available on OTA public website, as required by
Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement.
Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH
award, OTA will ensure public accessibility, either by posting on a publicly accessible
website or by providing a written response, within fifteen (15) business days to requests for
information about any SFI that meets all three of the following criteria:
• The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and
any other individual identified by OTA as senior/key personnel in the
application, progress report, or other NIH submission).
• OTA has determined that the SFI is related to the NIH-funded research.
• OTA has determined that the SFI constitutes an FCOI.
When applicable, OTA will make available at least the following information:
• Investigator’s name
• Investigator’s title and role with respect to the research project
• Name of the entity in which the SFI is held
• Nature of the SFI
• Approximate dollar value of the SFI in the following ranges: $0–$4,999;
$5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by
increments of $20,000; amounts above $100,000 by increments of $50,000; or a
statement that the value cannot be readily determined by public prices or
reasonable fair market value measures
The written response will note that the information provided is current as of the date of the
correspondence and is subject to updates on at least an annual basis and within 60 days of the
institution’s identification of a new FCOI, which should be requested subsequently by the
requestor.
If OTA uses a publicly accessible website to meet this requirement, the information will be
updated at least annually and within 60 days of:
• Receiving or identifying an additional SFI of Senior/Key Personnel related
to the NIH-funded research that was not previously disclosed, or
• A new SFI being disclosed by Senior/Key Personnel joining the project and
determined by the DO to be related and an FCOI.
Information on SFIs subject to public accessibility will remain available for at least three years
from the most recent update.
10) Reporting Identified Financial Conflicts of Interest
Prior to spending any funds under an NIH-funded award, OTA will submit an identified FCOI
report to NIH, in accordance with NIH regulations, for any Investigator’s SFI determined to be
an FCOI. OTA will also ensure that the Investigator has agreed to and begun implementing the
associated management plan.
OTA will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in
the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH.
FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e.,
no award means no FCOI report, and no FCOI means no FCOI report).
The NIH eRA Commons FCOI Module User Guide, available at the following location,
provides instructions for preparing and submitting FCOI reports.
https://www.era.nih.gov/files/fcoi_user_guide.pdf
Initial (Original) FCOI Reports
• Prior to the expenditure of funds: If an FCOI is identified at the time a new NIH
award is issued, the FCOI SO will submit an “Original” FCOI report (2011 FCOI)
through the eRA Commons FCOI Module before any funds are spent. The report
must include all information required under 42 CFR 50.605(b)(3) or as outlined in
the NIH FAQ.
• Within 60 days during the award: If an FCOI is identified during the award period
(e.g., a new SFI is disclosed or a new Investigator joins the project), the Institution
must submit an Original FCOI report within 60 days of identifying the FCOI.
Annual FCOI Reports: For the duration of an award, including any extensions with or without
funds, the Institution must submit an annual FCOI report to NIH. This report will indicate
whether each previously reported FCOI is still being managed or no longer exists and describe
any changes to the management plan, if applicable.
• The annual report must be submitted at the same time as the Research Performance
Progress Report (RPPR) or multi-year progress report, and at the time of any grant
extension, following NIH guidance (see NIH’s FAQ H.2). NIH creates the
opportunity for the FCOI SO to submit the Annual report 75 days prior to the next
budget period start date for continuation awards. NIH will notify the Institution by
an email when an annual report is due.
• Annual FCOI reports are not required at grant closeout.
Revision (or Mitigation) FCOI Reports: After completing a retrospective review, the
Institution will submit a Revision report to NIH if new information about the FCOI is
discovered, or a Mitigation report if the review finds that bias has occurred.
Types of FCOI Reports Summary Chart for NIH:
Required FCOI Reports to NIH via eRA Commons FCOI Module
REPORT CONTENT REQUIRED WHEN
New FCOI
Report
Grant number; PI; name of
entity with FCOI; nature of
Prior to the
expenditure of funds
(Initial
submission)
FCOI; value of the financial
interest (in required
on a new award;
within 60 days of
increments); description of
how the financial interest
relates to the research; key
identifying any new
FCOI during the
award period.
elements of the management
plan
Annual Status of the FCOI (whether it Submitted annually at
FCOI Report is still being managed or no
longer exists) and any changes
to the management plan, if
the same time as the
annual progress report,
multi-year progress
applicable. report, or at the time of
a grant extension.
Revised
FCOI Report
If applicable, updates to a
previously submitted FCOI
report to describe actions that
will be taken to manage the
FCOI going forward or to
revise the original report.
Following a
retrospective review
when noncompliance
with the regulation is
identified, if
applicable.
Mitigation
Report
Project number; project title;
contact PI/PD; name of
Investigator with FCOI; name
of entity with FCOI; reason for
review; detailed methodology,
findings, and conclusions.
After a retrospective
review when bias is
found.
11) Training Requirements for Investigators
Each Investigator will be informed of OTA’s FCOI Policy and trained on their responsibility to
disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50
Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded
research, at least once every four years, and promptly (as described below) when any of the
following occur:
• OTA revises this policy or related procedures in a way that affects Investigator
requirements.
• An Investigator is new to OTA research under an NIH award (training must
be completed before participating in the research).
• OTA determines that an Investigator has not complied with this policy or with a
management plan issued under it (training must be completed within 30 days as
directed by the DO).
To meet the NIH training requirement, OTA requires Investigators to complete the NIH
FCOI Training Tutorial. All investigators must print a certification of completion at the
end of training and retain it for audit purposes.
Also, OTA suggests investigators to acquaint themselves with the NIH Virtual Seminar presentation
on FCOI compliance from the following location:
https://www.youtube.com/watch?v=D292YZ6BX24.
12) Noncompliance With FCOI Policy and Corrective Actions
If OTA identifies an SFI that was not disclosed, reviewed, or managed in a timely manner,
the DO will, within 60 days: review the SFI; determine whether it is related to NIH-funded
research; determine whether it constitutes an FCOI; and, if so, implement an interim
management plan describing actions that have been and will be taken to manage the FCOI
going forward. OTA will also submit an FCOI report to NIH via the eRA Commons FCOI
Module.
In cases of noncompliance, including:
• Failure by the Investigator to disclose an SFI that is later determined to constitute an
FCOI
• Failure by the institution to review or manage an FCOI
• Failure by the Investigator to comply with an established management plan
OTA will, within 120 days of identifying noncompliance:
1. Conduct a retrospective review of the Investigator’s activities and the NIH-funded
research to determine whether the research, or any part of it, was biased in the
design, conduct, or reporting.
2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or
NIH’s FAQ I.2Q.
If bias is found, OTA will promptly notify NIH and submit a mitigation report as required by 42
CFR 50.605(a)(3)(iii) or as described in NIH’s FAQ I.3 to NIH via the FCOI Module.
The report will include:
• The impact of the bias on the research project, and
• The plan of action or corrective steps taken to eliminate or mitigate the effect of the bias.
OTA will thereafter submit FCOI reports annually to NIH as required by the regulations and the
terms and conditions of the award. Depending on the circumstances, OTA may implement
additional interim measures regarding the Investigator’s participation in the research until the
retrospective review is complete. If no bias is found, no further action is required.
13) Clinical Research Requirements
If HHS determines that one of its funded clinical research project evaluating the safety or
effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an
Investigator with an unmanaged or unreported FCOI, OTA will require the Investigator to
disclose the conflict in every public presentation of the research results and to request an
addendum to previously published presentations.
14) Subrecipient Requirements
A subrecipient relationship exists when federal funds flow from or through OTA to another
individual or entity that will carry out a substantive portion of a PHS-funded research project
and is accountable to OTA for programmatic outcomes and compliance. Subrecipients (e.g.
collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees)
are subject to OTA’s terms and conditions. OTA will take reasonable steps to ensure that all
subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart
F. OTA will include in each written agreement with a subrecipient terms specifying whether
OTA’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient
Investigators (see NIH Grants Policy Statement Section 15.2.1 on Written Agreements).
• If the subrecipient’s FCOI policy applies:
The subrecipient institution must certify in the agreement that its policy complies with
federal FCOI regulations. The agreement will specify the timeframe for the
subrecipient to report identified FCOIs to OTA in time for OTA to meet NIH
reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient
identifying an FCOI). Typically, this means requiring subrecipients to report FCOIs to
OTA within 50–55 days of identification. OTA’s DO will then submit the subrecipient
FCOI report to NIH through the eRA Commons FCOI Module.
• If the subrecipient cannot certify compliance:
The agreement will specify that OTA’s FCOI Policy applies. In this case, subrecipient
Investigators must disclose their SFIs to OTA. The SFI disclosure must include SFIs
that are directly related to the subrecipient’s work for OTA. The agreement will allow
sufficient time for OTA to review, manage, and report any resulting FCOIs. When an
FCOI is identified, OTA will implement a management plan, monitor compliance by
the subrecipient Investigator, and submit the required FCOI report to NIH via the eRA
Commons FCOI Module.
15) Maintenance of Records
OTA will maintain records of all Investigator financial interest disclosures, OTA’s review and
response to those disclosures (whether or not they resulted in a determination of an FCOI), and
any actions taken under this policy or through retrospective review. These records will be
retained for at least three years from the date of submission of the final expenditures report, or
for longer periods as specified in 45 CFR 75.361 for specific situations. OTA will retain these
records for each competitive segment as required by regulation.
16) Enforcement Actions for Investigator Noncompliance
Compliance with this policy is a condition of employment and/or participation for all
applicable Investigators. Investigators who fail to comply may be subject to disciplinary
action, which can include termination of employment or contract, formal warning letter or
official notice of disciplinary action, restrictions on the use of research funds, and/or
disqualification from further participation in any PHS/NIH-funded research, as deemed
appropriate.
17) Useful FCOI and NIH Resources
· NIH e-mail address for FCOI-related inquiries: fcoicompliance@mail.nih.gov
· FCOI Regulation 42 CFR Part 50 Subpart F - Promoting Objectivity in Research
· Financial Conflict of Interest
· FCOI Training
· Frequently Asked Questions (FAQs)
· NIH “Welcome Wagon” Letter: Information for New Recipient Organizations
18) Point Of Contact
If you have a question related Financial Conflict of Interest Policy of OTA or would
like to disclose an SFI or potential FCOl contact: schober@ota.org