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

Financial Conflict of Interest in Research Policy

Johnson & Wales University (JWU) employees and, as may be required by agreement or policy, agents,

consultants, representatives, and other affiliated individuals will strive to safeguard the university’s financial,

legal, and reputational standing and their own credibility and reputations, by promoting objectivity while

engaged in research activities.

JWU’s Procedures for Identifying and Addressing Financial Conflict of Interest in Research (the “Procedures”),

which are based on federal regulations published at 42 CFR Part 50, Subpart F, are intended to honor that

commitment through the management of financial conflicts of interest (FCOIs) that may arise during research

activities supported by federal agencies including, without limitation, the National Science Foundation (NSF)

and the U. S. Department of Health & Human Services (HHS), which includes the Public Health Services’

Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health

Resources and Services Administration (HRSA), the National Institutes of Health (NIH), and the Substance

Abuse and Mental Health Services Administration (SAMHSA).

Many private foundations also require their grantees to abide by the regulations cited above. Unless otherwise

directed by law or university policy, individuals employed by or affiliated with JWU who intend on seeking

funding from, or who are engaged in research funded by, such foundations will also be required to follow the

Procedures.



Financial Conflict of Interest in Research Procedures

Terms and Authority

With the exception of terms defined in these Procedures, capitalized terms are defined in 42 C.F.R. § 50.603 and

elsewhere in the Public Health Services (PHS) FCOI regulations.

If Research is supported by a non-PHS agency or organization with its own requirements governing disclosure,

management, and reporting of financial conflicts of interest, and if those requirements are not specifically

addressed in these Procedures, then the more restrictive requirements must be followed unless otherwise

required by law, university policy, or specific award provisions.

Investigator Responsibilities

Learning/Training

1. Prior to seeking or engaging in any federally sponsored Research, every Investigator must review and

become familiar with JWU’s FCOI Policy and FCOI regulations.

2. Prior to seeking or engaging in any federally sponsored Research, every Investigator must successfully

complete the following courses [or other federally compliant courses approved by the Institutional Official,

whose responsibilities are described at 42 C.F.R. §50.604(d)] through the Collaborative Institutional

Training Initiative (CITI):

a. Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (ID 15070)

b. Institutional Responsibilities as They Affect Investigators (ID 15072)

These courses shall be referred to as Mandatory Training.

3. Every Investigator shall complete Mandatory Training at least every four years and, additionally, any time

a. JWU revises its FCOI Policy in any manner that affects the requirements to which the Investigator

is subject;

b. an Investigator is new to JWU; or

c. JWU finds that an Investigator is not in compliance with JWU’s FCOI Policy or Management Plan

(discussed below).

Disclosure of Significant Financial Interests

4. A Disclosure of Significant Financial Interests (“Disclosure”) shall include all Significant Financial Interests

of the Investigator (and also those of the Investigator’s spouse, domestic partner, and/or dependent children)

that:

a. reasonably appear to be related to the Investigator’s Institutional Responsibilities; or

b. involve any reimbursed or sponsored travel related to the Investigator’s Institutional

Responsibilities (including at minimum the purpose of the trip, the identity of the

sponsor/organizer, the destination, and the duration).

5. Each Investigator must submit a Disclosure using JWU’s Disclosure of Significant Financial Interests

form(s)as follows:

a. Prior to submitting an application for federallysponsored Research

b. Within 30 days of acquiring (e.g., through purchase, marriage, or inheritance) or discovering a new

Significant Financial Interest

c. At least annually, in accordance with the specific time period prescribed by JWU (within one week

Financial Conflict of Interest in Research Procedures

Page 2 of 4

before the anniversary of the original official award). Such annual disclosure shall include

i. any information that was not disclosed initially to JWU (with an explanation as to why it

was not previously disclosed); and

ii. updated information regarding any previously disclosed Significant Financial Interest (e.g.,

the updated value of a previously disclosed equity interest).

Review and Monitoring Process

6. In keeping with 42 C.F.R. § 50.604(d), JWU has designated as its Institutional Official its provost (or the

provost’s designee) to solicit and to review Disclosures from each Investigator who is planning to participate

in, or is participating in, federallysponsored Research. The Institutional Official may enlist the assistance of

other university personnel as appropriate.

7. JWU has established a committee to review FCOIs (“FCOI Review Committee”) and to assist the

Institutional Official as appropriate at any time in the Review and Monitoring Process. The FCOI Review

Committee shall include the provost, the chief financial officer, and the general counsel.

8. Promptly after submission of a Disclosure, the Institutional Official shall confirm that a Significant Financial

Interest exists and, if so, whether an FCOI exists. An FCOI will exist when the Institutional Official

determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or

reporting of federallysponsored Research.

9. If the Institutional Official determines that an FCOI exists, the Institutional Official shall determine whether

the FCOI can be managed and, if so, shall develop (or require the Investigator to develop) and implement a

written Management Plan within the meaning of 42 C.F.R. § 50.604(g). The Institutional Official may

require the Investigator to supplement the Disclosure with additional information as reasonably necessary.

10. Before any federally

 sponsored Research goes forward, the affected Investigator must agree to and sign the

Management Plan, and the FCOI Review Committee must, by a majority vote, approve the Management Plan.

11. A Management Plan shall include, at minimum, one or more of the following steps in keeping with FCOI

regulations and the nature of the FCOI:

a. Public disclosure of the FCOI (e.g., when presenting or publishing the Research)

b. For Research involving human subjects, disclosure of the FCOI directly to the subjects

c. Appointment of an independent monitor

d. Modification of the plan of Research

e. Change of personnel or personnel responsibilities or disqualification of the affected Investigator

from participation in all or a portion of the Research

f. Reduction or elimination of the Significant Financial Interest (e.g., sale of the relevant equity

interest)

g. Severance of relationships that create the FCOI

h. A plan for ongoing monitoring of the Investigator

12. For awards issued by the National Science Foundation (NSF), and in accordance with Chapter IX.A. of the

NSF’s Proposal & Award Policies & Procedures Guide, if the reviewer(s) determine(s) that imposing

conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts

that may arise from a Significant Financial Interest are outweighed by interests of scientific progress,

technology transfer, or the public health and welfare, then the reviewer)s) may allow the research to go

forward without imposing such conditions or restrictions.

Financial Conflict of Interest in Research Procedures

Page 3 of 4

13. The Institutional Official shall monitor compliance with the Management Plan and shall collaborate with

the FCOI Review Committee to determine and impose remedies for noncompliance, which might include

(among other remedies) suspending or terminating the Research.

14. If at any time the Institutional Official or any member of the FCOI Review Committee discovers that an

Investigator failed appropriately to disclose a Significant Financial Interest, the Investigator will be required

to complete, sign, and submit a Disclosure. Assessment of the Disclosure will proceed in the manner outlined

above.

15. If at any time the Institutional Official or any member of the FCOI Review Committee discovers that an

FCOI was not disclosed or managed appropriately, the FCOI Review Committee will, within 120 days of

discovery, complete a retrospective review of the affected Investigator’s activities to determine whether any

of the Research was biased in design, conduct, or reporting. The Institutional Official and the FCOI Review

Committee may request additional information from the affected Investigator as reasonably necessary. The

retrospective review will include the following at minimum:

a. Project number, if any, assigned by the Institutional Review Board

b. Project title

c. Name and contact information for Principal Investigator

d. Name of the affected Investigator (if different from the Principal Investigator)

e. Name of the entity with which the Investigator has an FCOI

f. Reason(s) for the retrospective review

g. Detailed methodology used for the retrospective review

h. Findings of the retrospective review

i. Conclusions of the retrospective review

16. Based on the outcome of the retrospective review, the Institutional Official may develop or implement a

Management Plan (if one does not exist) or modify the Management Plan (if one exists); take steps to

mitigate bias; and take other steps, which might include (among other things) the following:

a. Require the Investigator to complete additional training

b. Undertake additional audits or monitoring

c. Require that subjects be notified and/or be asked to sign updated consent forms

d. Impose sanctions or require additional remedies to be determined based on the circumstances

e. Suspend or terminate the Research

In the case of clinical Research related to a drug, medical device, or treatment, the Investigator must disclose

the FCOI in all public presentations of the Research results and request that previous publications be

amended to include the disclosure.

Subrecipients

17. JWU shall ensure all subrecipients’ compliance with the FCOI regulations by entering into a written

agreement with each subrecipient specifying whether JWU’s FCOI policy or the applicable policy of the

subrecipient shall apply to subrecipient Investigators. Among other things, the agreement shall specify when

subrecipients shall report FCOIs to JWU, such that JWU may satisfy its reporting requirements.

Reporting to Sponsor(s)

18. Should any FCOI or noncompliance require reporting to a federal sponsor, the Institutional Official shall

report it in accordance with the FCOI regulations. If the funding for the Research is a subaward from a prime

federal sponsorship awardee, reports shall be made to the prime awardee such that the prime awardee may

Financial Conflict of Interest in Research Procedures

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fulfill its reporting obligations to the federal sponsor prior to the expenditure of any federal funds and within

60 days of any subsequently identified FCOI.

19. For awards issued by NSF, and in accordance with Chapter IX.A. of the NSF’s Proposal & Award Policies &

Procedures Guide, JWU will notify NSF’s Office of the General Counsel if JWU finds that it is unable to

satisfactorily manage a conflict of interest and if JWU finds that research will proceed without the imposition

of conditions or restrictions because imposing them would be either ineffective or inequitable, and the

potential negative impacts that may arise from a Significant Financial Interest are outweighed by interests

of scientific progress, technology transfer, or the public health and welfare.

20. If JWU identifies an FCOI and eliminates it prior to the expenditure of any federal funds, JWU will not be

required to submit an FCOI report to the applicable federal agency.

Public Accessibility

21. Prior to the expenditure of federal funds, JWU will ensure public accessibility of information, via response

to a requestor within five business days of the request, about any Significant Financial Interest that meets

the following criteria:

a. The Significant Financial Interest was disclosed and is still held by the Investigator;

b. A determination has been made that the Significant Financial Interest is related to the federally -

funded Research; and

c. A determination has been made that the Significant Financial Interest is an FCOI.

The information to be made available shall be consistent with the requirements of PHS regulations.

Confidentiality

22. To the extent permitted by law, all Disclosures, Management Plans, and related information will be

confidential. However, JWU may make such information available to the agency funding an Investigator’s

Research or to a requestor of information concerning an FCOI related to federalfunding or to the primary

entity that made the funding available JWU, if requested or required.

Record Retention

The Institutional Official will retain all disclosure forms, conflict management plans, and related documents for

a period of at least three years from the date the final expenditure report is submitted to the federal agency or to

the prime awardee or such longer period as JWU policy or applicable law may require.

Related Documents:

 Conflict of Interest and Commitment Policy

 Policy on Pursuit and Administration of Grants and Cooperative Agreements

 Disclosure of Significant Financial Interests (SFIs) form

Policy Contact(s):

 Policy issues or concerns should be directed to the

provost or the provost’s designee.

 Grant compliance issues should be directed to the director of grants & sponsored program

administration.

Originally Issued: July 8, 2019

Policy Owner: Provost

Grants & Sponsored Program Administration – 4.4.2019

Part A

Disclosure of Significant Financial Interests (SFIs)

vestigator information:

Name

Campus

E-mail address

College

Preferred phone #

Department

Role in the project



Principal Investigator



Project Director



Other Senior/Key Personnel

Employer

(if not JWU)

Project information:

Title

Beginning date

Click or tap to enter a date.

Ending date

Click or tap to enter a date.

Sponsor (if any)

Type of Disclosure:

Choose an item.

Most recent date financial conflict of interest (“FCOI”) training was completed: Click or tap to enter a date.

Disclosures:

Please respond to the questions below to di

sclose SFIs as defined in 42 C.F.R. §50.603 that may reasonably

appear to relate to your Institutional Responsibilities, also as defined in 42 C.F.R. §50.603.

Publicly Traded Entity

• Have you, your spouse/domestic partner, or your dependent child received any income or payment

for services from any publicly traded entity in the past 12 months that exceeds $5,000 in the

aggregate and that may reasonably appear to relate to your Institutional Responsibilities?

 Yes

 No

• Do you, your spouse/domestic partner, or your dependent child own stock, stock options, or any

other ownership interest in any publicly traded entity that exceeds $5,000 in value in the aggregate

and that may reasonably appear to relate to your Institutional Responsibilities? (Equity interest

does not include interests in mutual funds and retirement funds in which you do not directly

control investment decisions.)

 Yes

 No

Non-Publicly Traded Entity

• Have you, your spouse/domestic partner, or your dependent child received any income or payment

for services from any non-publicly traded entity in the past 12 months that exceeds $5,000 in the

aggregate and that may reasonably appear to relate to your Institutional Responsibilities?

 Yes

 No

• Do you, your spouse/domestic partner, or your dependent child own stock, stock options, or any

other ownership interest in any non-publicly traded entity that exceeds $5,000 in the aggregate and

that may reasonably appear to relate to your Institutional Responsibilities?



Yes

 No

Intellectual Property

• Have you, your spouse/domestic partner, or your dependent child received any payments in the

past 12 months for any intellectual property rights or interests (e.g., patents, copyrights assigned or

licensed to a party other than JWU) exceeding $5,000 and that may reasonably appear to relate to

your Institutional Responsibilities?

 Yes

 No

Disclosure of Significant Financial Interests (SFIs) – Part A

Page 2

Grants & Sponsored Program Administration – 4.4.2019

Travel

• Have you, your spouse/domestic partner or your dependent child received any travel

reimbursement or been sponsored for travel (i.e., travel expenses paid and not reimbursed so that

the exact monetary value may not be readily available) within the last 12 months when such travel

related to your Institutional Responsibilities? (This does not include travel sponsored or

reimbursed by a federal, state, or local government agency, a U.S. institution of higher education or

an affiliated research institute, an academic teaching hospital, or a medical center.)

 Yes

 No

If you answered “Yes” to any of the questions above, please complete Part B of this form.

INVESTIGATOR CERTIFICATION:

• I have read, understand, and will comply with JWU’s Conflict of Interest and Commitment Policy and

Financial Conflict of Interest Policy.

• The information provided above and in any attachments hereto (a) reflects any and all of my SFIs related to

my Institutional Responsibilities and (b) truthfully, completely, and accurately reflects my SFIs to the best of

my knowledge.

• I agree to comply with any conditions or restrictions imposed by JWU for the purpose of managing, reducing,

or eliminating actual or potential conflicts of interest in connection with this grant. If I am unable to comply, I

understand that JWU may decline the grant or terminate the PHS-funded Research.

Signature

Date

Name (please print)

PRINCIPAL INVESTIGATOR/PROJECT DIRECTOR CERTIFICATION:

The following people (or roles) meet the definition of Investigator for the above project, and I certify that they all

will comply with the disclosure requirements of the JWU Financial Conflict of Interest Policy:

Signature

Date

Name (please print)

____________________

IF “YES” TO ANY OF THE QUESTIONS ABOVE, INSTITUTIONAL OFFICIAL CERTIFICATION:

_____ No Financial Conflict of Interest appears to exist.

_____ A Financial Conflict of Interest may exist. No Research may go forward until the requisite Management

Plan is in place, and the sponsor has been notified.

Signature

Date

Name (please print)

Grants & Sponsored Program Administration – 4.4.2019

Part B

Disclosure of Significant Financial Interests

Please complete this page for each entity in which you have a Significant Financial Interest (“SFI”). Use a

different page for each person (i.e., you, your spouse/domestic partner, or dependent child) who has an SFI.

For further guidance, please see JWU’s Financial Conflict of Interest Policy and

42 C.F.R. Part 50, Subpart F.

Investigator information:

Name

Campus

E-mail address

College

Preferred phone #

Department

Information of person with SFI (if different from above):

Name

Campus

Email address

College

Preferred phone #

Department

Entity in which the Investigator (or Investigator’s spouse/domestic partner or dependent child) has an SFI:

Name

Address

Website

Form of compensation



Salary



Fees (e.g., honoraria, consulting, authorship, etc.)



Stock, stock option, or other ownership interest



Intellectual property interest



Other: ______________________________________________________________________________

Approximate value of compensation

Description of compensation

Description of relationship to the entity

and/or work performed for it

Relationship of work to Institutional

Responsibilities, including Research



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