Conflicts of Interest (COI) Basic Course
Terms and Conditions
Please select the module(s) that your organization would like to use.
Module Name
Description
Module 1: Financial Conflicts
of Interest: Overview,
Investigator Responsibilities,
and COI Rules
Module 2: Institutional
Responsibilities as They Affect
Investigators
Module 3: OrganizationSpecific Policies (basic level)
Modules 1 and 2 will provide training on
the PHS/NIH regulations related to
financial conflicts of interest (PHS
regulations on Responsibility of
Applicants for Promoting Objectivity in
Research for which PHS Funding is
Sought [2 C.F.R. Part 50, Subpart F] and
Responsible Prospective Contractors [45
C.F.R. Part 94]) that were revised in
2011. These modules will serve as the
core training for this course.
Modules 1 and 2 are mandatory.
Module 3 is an optional organizationspecific module that the CITI Program
can create using the information you
provide.
Does your
Yes:
organization
want to
create an
organizationspecific
module?
Does your
Yes:
organization
want to
make
Module 4
mandatory
for the
learner?
Does your
Yes:
organization
want to
make
Module 5
mandatory
Module 4: Conflicts of
Commitment and Conscience
Module 4 is an optional module available
to all learners that provides training on
conflicts of commitment, conscience,
and institutional conflicts of interest. If
your organization prefers, the CITI
Program system can make the module
mandatory for the learner.
Module 5: Institutional
Conflicts of Interest
Module 5 is an optional module on
institutional conflicts of interest that is
primarily designed for institutional
administrators. If your organization
prefers, the CITI Program system can
make the module mandatory for the
learner.
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No:
No:
No:
for the
learner?
As a part of the CITI Program’s COI Basic Course, your organization has the option of creating Module 3,
which will provide learners with information about your organization’s COI policies.
If you do not wish to add Module 3, please proceed to Part 8 of this form.
Submission Criteria
Information about your organizational policies must be submitted to the CITI Program in a finalized form.
Your organization is responsible for the accuracy of the information sent to the CITI Program. The
information should be thoroughly reviewed by your organization prior to submission.
The CITI Program will only accept content that is presented in a (.doc, .rtf, or .docx) format.
The CITI Program CANNOT accept:
a. PDFs, handwritten, scanned, or faxed materials
b. Documents that are not final or include notes, comments, strikethroughs or any other type of editorial
feedback
If you wish to display images, videos, graphs, charts, and case studies, please be sure to include the intended
location within the module and the presentation style (for example, hyperlink, image within module, etc.) for
each supplemental learning material. It is the responsibility of the organization to ensure that all supplemental
learning materials and hyperlinks within the module remain active and updated.
How To Submit Your Completed Content
All organization-specific content must be sent via e-mail to citisupport@med.miami.edu as a finalized
document. You will be sent a unique case number to confirm the receipt of your content. Please retain this case
number for your records.
Expected Completion Timeframe
Upon receiving your form, your request will be placed in the CITI Program support queue for the next
available technician to set up. Requests will be handled based on the order in which they are received.
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The CITI Program will work to process your request in an expedient manner. Keep in mind that the timeframe
for the completion of your COI Course will be in direct relation to when organization-specific content is
submitted. Please note: if your organization-specific module is greater than 5,000 words or has multiple
supplemental learning tools, this may require a longer time until the content upload is completed.
To check the status of your request, contact the CITI Program Help Desk at (305) 243-7970 or
citisupport@med.miami.edu with your case number.
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Approval Policy
Once your setup is complete, a CITI Program representative will contact your organization’s delegated
administrator (that you assign on the last page of this form) for final approval.
In order for the course to be available to your learners, the delegated administrator must provide written
consent via e-mail within seven (7) business days. Additional instructions on approval will be provided at that
time.
During this time, it is the organization’s responsibility to review the module’s content for accuracy. The
CITI Program is not responsible for the content provided and uploaded to create the module. The
organization providing the content must check for accuracy. Please note: Only your delegated
administrator can approve your organization-specific module before it goes live.
Updates to the Organization-specific Module
As with all other customized modules, your organization is responsible for notifying the CITI Program about
any changes to the module’s content, including links. The delegated administrator within your organization
should, at a minimum, review the module annually and notify the CITI Program accordingly.
Fees
All requests to add or modify the organization-specific module (Module 3) will be subject to our current
custom module programming fee(s) of $100/per hour. There will be no fee(s) for CITI Program subscribers to
add modules 1, 2, 4, or 5 to their existing curriculum.
New subscribers will be subject to the CITI Program’s subscription fee in order to have access to the COI
Basic Course.
Acceptance
I agree to all terms and conditions [ ]
___________________________________________________________
Please Print Name Above to Indicate Approval
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Module Set-Up Information
Name of Organization
Please provide the name of your organization. If your organization is already affiliated with the CITI Program,
provide the name as it appears on your organization’s page. If you represent a new organization, the CITI Program’s
Billing Office will contact you as a part of the set-up process. Access to the COI Basic Course is part of the
organizational base subscription fee.
Organization Name:
Is your organization currently
Yes: No: If “No,” please be aware that a member of the CITI Program’s
affiliated with the CITI Program?
Billing Office will contact you within five (5) business days of
receiving this form.
Please Provide Your Contact Information
Name:
Position in the
Organization:
Phone:
Fax:
E-mail:
Will this person be
responsible for reviewing
and updating the
information in the
Organization-specific
Module?
Will this person be
responsible for payment,
if the organization is not
already affiliated with the
CITI Program?
Yes:
No: (If “no,” please provide name and contact of person responsible for ongoing
updates.)
Name:
Phone:
E-mail:
Yes:
No: (If “no,” please provide name and contact of person responsible for payment.)
Name:
Phone:
E-mail:
Please Indicate The Person Responsible For The COI Program At Your Organization
If there is more than one individual, please copy and complete one table per individual.
Name:
Position in the Organization:
Phone:
Fax:
E-mail:
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Module Content Information
Part 1
Introduction
Introduce your organizational policies. This section may also contain a statement from your organization’s
official. The CITI Program has provided some recommended sections that should be included in the custom
module; however, your organization may provide additional content as appropriate. Sample items include:




A summary of the organization’s commitment regarding COIs
The organizational training policy regarding financial conflicts of interest (FCOIs)
A general overview of the organization’s training requirements for investigators, staff, and students
A description of the policies for awardees versus sub-awardees, and note if there are any
requirements for non-PHS funded investigators and staff
 An overview of re-training requirements (e.g., four-year minimum or more often if required by the
organization)
 Organizational plan to comply with the 2011 Final Rule (revised PHS regulations)
Provide your introductory paragraph text below:
Learning Objectives
It is important to provide measurable learning objectives that represent the focus of this organizationspecific module. The learning objectives should incorporate strong action verbs. For example:
By the end of this module, you should be able to:

Discuss the regulatory definitions associated with financial conflicts of interest (FCOIs) as defined
by the 2011 Final Rule (revised PHS regulations)
 Describe the organization’s policies related to COIs
 Identify the individuals responsible for the COI Program at your organization
Provide your learning objectives below:
Please use a separate row for each objective. Space for three (3) learning objectives has been provided;
however, additional objectives may be included.
Learning Objective 1:
Learning Objective 2:
Learning Objective 3:
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Part 2
Organizational Policies and Procedures
This section is intended to provide general statements regarding your organizational policies and procedures
that serve as an overview. In addition, it is recommended that this section include commentary regarding the
organization’s response to the requirement that the FCOI policy be available via a publicly accessible
website (unless the organization has no current web presence). This section should also contain an overview
of your organization’s definitions as they relate to the FCOI policy and procedures.
An in-depth review of portions of the organizational policies and procedures will follow in subsequent
sections. The CITI Program encourages you to have learners visit your website directly via the links
(provided in this section) to your policies and procedures. This will also allow learners to bookmark the
website(s). Referring the learners to your organization’s website(s) as the primary source for the review of
policy/procedure information also means that any changes to those policies/procedures do not have to be
communicated back to the CITI Program unless they are no longer consistent with the overview statements
listed here. URLs should be provided as a list at the end of the section, but you may reference the URLs by
name of page within the body of the narrative. When you provide the URL, please put the name of the
page, as you would like it to appear in the section.
Provide the general statements regarding your organizational policies and procedures below:
Definitions
The CITI Program will insert the following standard definitions presented by the NIH; however, if your
organization defines any of the following differently, please insert your revised definition in the space that
follows.
The CITI Program recommends that you include the following information within this section:






What is your organization’s definition of FCOI?
What is your organization’s definition of significant financial interest (SFI)?
What is your organization’s definition of “employee’s institutional responsibilities?”
Investigator means the project director or principal investigator and any other person, regardless of
title or position, who is responsible for the design, conduct, or reporting of research funded by the
National Institutes of Health (NIH), or proposed for such funding, which may include, for example,
collaborators or consultants.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of the
organization, and as defined by the organization in its policy on financial conflicts of interest, which
may include for example: activities such as research, research consultation, teaching, professional
practice, institutional committee memberships, and service on panels such as Institutional Review
Boards or Data and Safety Monitoring Boards.
Significant Financial Interest (SFI) is (1) A 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:
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(i) With regard to any publicly traded entity, a significant financial interest exists if the
value
of any remuneration received from the entity in the twelve months preceding the disclosure
and the value of any equity interest in the entity as of the date of disclosure, when
aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary
and any payment for services not otherwise identified as salary (e.g., consulting fees,
honoraria, paid authorship); 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;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the
value of any remuneration received from the entity in the twelve months preceding the
disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator's
spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other
ownership interest); or
(iii) 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 (i.e., that
which is paid on behalf of the Investigator and not reimbursed to the investigator so that the exact
monetary value may not be readily available), related to their institutional responsibilities, provided,
however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored
by excluded sources provided in regulation.
 A financial conflict of interest (FCOI) is an SFI that could directly and significantly affect the
design, conduct, or reporting of NIH-funded research.
 Senior/key personnel means the project director/principal investigator (PD/PI) and any other person
identified as senior/key personnel by the organization in the grant application, progress report, or
any other report submitted to the PHS by the organization under the regulation.
If relevant, please provide your organization’s modified definitions below:
Title of
Web Page
Title of
Web Page
Title of
Web Page
Title of
Web Page
URL
URL
URL
URL
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Part 3
Investigator Disclosure Requirements
This section is intended to provide the learner with a detailed review of the organizational policies and
procedures associated with investigator disclosure requirements. The CITI Program has provided some
guiding instructions and questions to consider as your organization develops the narrative portion for this
section.

Describe the organizational policy on SFI reporting requirements (include, for example, the
thresholds for reporting SFI).
 What is the mechanism of disclosure?
 What are the elements of the disclosure?
 When and how often are investigators required to disclose?
 To whom or to what office does the investigator disclose the SFI?
 Is there a web form for employees to complete? (Location of the web form, provide the URL.)
 What phone number can employees call for assistance with completing the disclosure form?
 How long should records be maintained?
Provide the narrative related to your organization’s disclosure requirements below:
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Part 4
Organization Assessment Responsibilities
This section is intended to provide the learner with a detailed description of the process the organization
uses to assess SFIs. The CITI Program suggests, at a minimum, the inclusion of information related to the
following:
 How does your organization determine whether SFIs are related to research? (Describe the process.)
 How does your organization determine if the research-related SFIs create an FCOI?
 How does you organization address sub-recipient investigators?
Provide the narrative describing your organization’s assessment responsibilities and procedures
below:
Organizational Management Plan for FCOIs
This section is intended to provide the learner with an overview of management plans as they relate to the
2011 Final Rule (revised PHS regulations) as well as important information associated with the
organization’s management plan. The following questions are suggested for inclusion in your organization’s
narrative.
 What is a management plan?
 Who at your organization will develop the management plan?
 What are the required elements of your organization’s management plan?
 Who reviews and approves the FCOI management plans?
Provide the narrative describing your organization’s assessment responsibilities and procedures
below:
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Part 5
Organizational Reporting Requirements
Organizations must report FCOIs of their employees to the NIH via the eRA Commons FCOI Module. This
section is intended for your organization to describe this process. Note that annual reporting is required as
well as reporting during the period of award within sixty (60) days of identifying a new FCOI.
Describe the elements that at minimum will be reported to the PHS. It is recommended that bullets
be used to list the items, which will be reported.

FCOI Disclosure (Public Accessibility)
FCOIs of senior/key personnel discovered during the assessment process must be either displayed on the
organization’s website or made available by a written response to any requestor within five (5) business
days of a request. Consider including the following:

How the information will be made available? (Will it be posted on a website? If so, provide the
URL. If it will be provided via written response, detail that process.)
 The elements that will be displayed on the website. (2011 Final Rule/revised PHS regulations
require that at a minimum the investigator’s name, title, and role with respect to the research project
be listed along with 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.)
Address the organization’s disclosure policy and procedures below:
Part 5A
SFI/FCOIs Identified Post Disclosure (Retrospective Review)
If the organization discovers a SFI/FCOI that was not identified in the disclosure and assessment process,
the organization is required to conduct a retrospective review to determine if the SFI is an FCOI and if the
FCOI has led to the collection and/or the reporting of biased data. The purpose of this section is to provide
the learner with information related to the organization’s policy and procedures related to SFI/FCOIs
identified post disclosure. The CITI Program recommends inclusion of information related to the following
questions.


How does your organization define “retrospective review”?
The regulatory requirement is that the review be within 120 days. Is the organizational policy the
same?
 Who will conduct the retrospective review at your organization?
 What are the required elements of the retrospective review?
 What other elements might the retrospective review include?
Please provide the narrative related to SFI/FCOI identified post disclosure procedure, including
retrospective review, for the organization below:
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Part 5B
Identification of Bias
If the retrospective review concludes that the research may have been biased as a consequence of the
unreported FCOI, the organization is required to submit a mitigation report to the PHS. This section is
intended for you to describe the mitigation reporting. The CITI Program recommends inclusion of
information related to the following questions:


How does your organization define “institutional mitigation report”?
What are the elements of the mitigation report at the organization? (Note that the 2011 Final
Rule/revised PHS regulations require that the report address the impact of the bias on the research
project and the actions the organization has taken, or will take, to eliminate or mitigate the effect of
the bias.)
 Who will review and approve the mitigation report?
Describe your organization’s mitigation reporting process here:
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Part 6A
Additional Information
If needed, provide any additional information related to your organization’s conflict of interest policies for
your learners.
Please provide the additional information below:
Part 6B
Summary
This section is intended to provide concluding comments for your organization’s learners along with any
additional information. The CITI Program recommends the following:



A summary statement that provides an overview of the content presented in the module
Additional organizational links
Links to external sources (PHS and other entities)
A statement directing learners to the quiz/assessment (if your organization elects to quiz/assess learners, see
next section).
Provide the summary narrative below:
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Part 7
Quiz/Assessment
Does your organization want to quiz your investigators on the materials included in this
module?
Yes:
No:
If Yes:
If No:

Nothing further is required in this
It is recommended that five (5) multiplesection. Note that the CITI
choice questions be provided.
Program will include an attestation
o 4-5 potential responses for each
notice (“I have reviewed this module
question, but only one true correct
and the applicable institutional
answer.
documents”) that learners must
o Feedback to the learner describing
check at the end of the module to
why the correct answer is correct.
complete the process.
o Avoid negative constructions of
questions (for example using
“except” or double negatives).
o Questions should be answerable
based on either the content within the
module or that appears as a direct
result of links within the module. It is
not advisable to quiz or assess on
links on secondary pages.
Provide questions, answer choices, and feedback here (you may copy the rows for as many
questions as your organization would like to provide; remember to mark the correct
answer):
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
Question Stem:
Answer Choice 1:
Answer Choice 2:
Answer Choice 3:
Answer Choice 4:
Feedback for learner:
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Part 8
Learner Group Set-Up Information
Delegated Administrator
Please provide the contact information of your delegated administrator. This is the person who
will be contacted to approve the final course.
Name of
Delegated
Administrator
E-mail Address
CITI Program Member ID #
Located on top left corner of
screen when logged into
citiprogram.org
The CITI Program default settings for the COI Course are listed below. If you would like to
customize the settings, please provide your information in the chart labeled Custom Settings.
Course Name That
Appears To Your
Learners:
Passing Score:
Default Settings
Conflicts of Interest (COI) Basic Course
80%
Expiration:
4 years
Enrollment
Question
Answer 1:
Answer 2:
Would you like to take the Conflicts of Interest (COI) Basic Course?
Yes (learner is enrolled in the course)
No (no action taken from response)
Custom Settings –
If you do not edit this section, the default settings above will apply.
Course Name That
Appears To Your
Learners:
Passing Score:
Expiration:
Enrollment
Questions
Answer 1:
Answer 2:
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End of Form