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Sponsored Research COI Disclosure  |  Annual Faculty COI Disclosure  |  Annual Staff COI Disclosure

required sponsored research training document

Northwestern's Sponsored Research Conflict of Interest Training Module  Updated 3/5/2014

How do I disclose for the first time?

  1. Please click the following link and sign-in with your NetID & Password: Conflict of Interest Portal
  2. On the left-hand side of the screen, expand the “COI Training & COI Disclosure” menu bar
  3. Click “COI Training for Research”
  4. Open and read the PDF document
  5. Attest to having read and understood the contents of the training document
  6. Once the Attest button has been clicked, a link will appear on the bottom left-side for access to the “Sponsored Research COI Disclosure”
  7. Answer the COI disclosure questions
  8. Click “Sign” and “Submit”

How do I disclose on an ongoing basis?

  1. Please click the following link and sign-in with your NetID & Password: Conflict of Interest Portal
  2. On the left-hand side of the screen, expand the “COI Training & COI Disclosure” menu bar
  3. Select “COI Disclosure”
  4. If you have multiple roles in the COI system, you may be asked which disclosure type you would like to complete.  In this case, you are completing your “Research Disclosure”
  5. Check your reason for disclosure
  6. Answer the COI disclosure questions
  7. Click “Sign” and “Submit”

Who must disclose?

Investigators must meet research-related COI training and disclosure requirements.  Investigator includes individuals responsible for the design, conduct, or reporting of research, regardless of position or title.  The Principal Investigator of a project is responsible for making the determination of what named personnel are Investigators.

Tips:

  • Key Personnel are always considered Investigators by virtue of the definition of Key Personnel

  • Investigators may also include others (internal or external to Northwestern) who are independently responsible for research design, conduct, or reporting (i.e., individual(s) who have the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results and/or are likely to be authors on manuscripts or to present research findings)

  • Investigators are not administrative personnel or individuals who perform routine, pre-defined, or incidental tasks related to the project

All named individuals listed on the Personnel list in InfoEd are pulled into FASIS as Investigators; PIs/RAs/OSR/NUCOI have the ability to assign an individual a status of “not an Investigator” in the system based on the criteria above. 

If an RA, OSR, or NUCOI assign a status of "not an Investigator" for an individual, they must do so only under direction from the PI, whose responsibility it is to make this determination. 

Written documentation (e.g., an email) from the PI with this information (i.e. a specific individual not meeting the definition of Investigator) should be retained for record purposes.   

Click here for details of now to assign an individual “not an Investigator” in FASIS.   

What must be disclosed?

Any Significant Financial Interests (SFI), which means an external financial interest consisting of one or more of the following interests of an Investigator (and those of the Investigator’s spouse and dependent children), when combined for the 12 months preceding the disclosure date, from a single entity:

Nature of SFI Threshold Excluded (Do Not Disclose)
Compensation and/or other payments for service Exceeds $5,000* Compensation received less than $5,000, as well as any compensation received for lectures, seminars, teaching engagements, or service on advisory committees or review panels relating to federal, state, or local government agencies, an institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education, and compensation received from NU funds
Equity interests in a publicly-traded entity Exceeds $5,000* Interests in publicaly-traded entities valued at less than $5,000 as well as interests in any entity through personal retirement accounts and mutual funds
Equity interests in a non-publicly-traded entity 0 Interests in any entity through personal retirement accounts and mutual funds
Intellectual property rights and interests upon receipt of income related to such rights and interests Exceeds $5,000* Royalties received from NU funds, and unlicensed intellectual property that does not generate income
Sponsored or reimbursed travel

Applies to PHS-funded researchers only: Investigators who have any PHS funding or any funding from agencies following PHS COI regulations must disclose any reimbursed or sponsored travel
Exceeds $5,000 Travel administered through NU funds, and travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
* Investigators whose primary appointment is in the Feinberg School of Medicine (FSM) are subject to different reporting thresholds. Please read each disclosure question carefully.

When Must I Submit a Disclosure?

Timing Disclosure Timeframe
Initial disclosure post-August 24, 2012 Subsequent to the new COI requirements and new COI disclosure system effective 8/24/12, all investigators must submit an initial COI disclosure in the FASIS system prior to engaging in research sponsored by entities subject to NU's COI requirements 
Within 30 days of a new SFI Investigators must update their disclosure within 30 days of acquiring a new significant financial interest (SFI) meeting disclosure requirements

Annually

 Investigators must update their disclosure at least annually, even if acknowledging no change

Documents & Resources

Training Documents
FASIS Security Forms

To access the COI Monitor Compliance pages in FASIS, please complete and submit a Security Form for Research Administrators and other administrators who need access to compliance pages in FASIS: OSR/ASRSP/NUCOI Staff, or School COI Committee participants.

External Agency Resources

UPCOMING TRAINING EVENTS

There are no training events scheduled at this time. To request an in-person training, please contact nucoi@northwestern.edu. To request an in-person system training, please contact Chris Tondini at tondini@northwestern.edu.

Additionally, there is a COI session included in the quarterly ORI Research Administration Training Seminar.

Disclosure question detail

Click a topic below to see more details:

•  Questions #1 Remuneration

Remuneration:

With regard to any entity, a Significant Financial Interest (SFI) exists if the value of remuneration received by the Investigator (or the Investigator's spouse or dependent children) from a single entity within the 12 months preceding the 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).

SFIs do not include (i.e., do not disclose):

  • Remuneration that aggregates less than $5,000 from a single entity in the 12 months preceding disclosure (unless FSM faculty);
  • Salary, royalties, or other remuneration paid by Northwestern to the Investigator if the Investigator is currently employed or otherwise appointed by Northwestern;
  • Income from seminars, lectures, or teaching engagements sponsored by a Federal, state or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
  • Income from service on advisory committees or review panels for a Federal, state or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

If you respond “Yes”, please provide an explanation.


1) Related to your institutional responsibilities, did you receive remuneration from an entity which, when aggregated for that entity, exceeded $5,000* in the 12-month period prior to disclosure date?

* For Investigators whose primary appointment is in the Feinberg School of Medicine (FSM), the disclosure threshold is $0.

•  Questions #2 Equity

Equity Interests in Publicly Traded Entities:

With regard to any publicly traded entity, a Significant Financial Interest (SFI) exists if an Investigator (or the Investigator’s spouse or dependent children) has equity interests for which the value, when aggregated, exceeds $5,000* within the 12 months preceding the disclosure.  Equity interests include stock, stock options, or other ownership interests, and value is determined through reference to public prices or other reasonable measures of fair market value.

SFIs do not include (i.e., do not disclose):

  • Interests in publicly traded entities for which the aggregate value from a single entity is less than $5,000 within the 12 months prior to disclosure; or
  • Interests or income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

Equity Interests in Non-Publicly Traded Entities:

With regard to any non-publicly traded entity, a Significant Financial Interest (SFI) exists if an Investigator (or the Investigator’s spouse or dependent children) has any equity interests in such an entity within the 12 months preceding disclosure.  Equity interests include stock, stock options, or other ownership interests, and value is determined through reference to public prices or other reasonable measures of fair market value.

SFIs do not include (i.e., do not disclose):

  • Interests or income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.


2) Related to your institutional responsibilities, do/did you have equity interests that meet/met the below criteria in the 12-month period prior to disclosure date?

  • For private/non-publicly-traded entities, please disclose any equity (even if valued at $0 or value is unknown)
  • For publicly-traded entities, please disclose equity only if the aggregated value from a single entity exceeds $5,000*

* Investigators whose primary appointment is in the Feinberg School of Medicine (FSM) must disclose equity interests in publicly-traded entities for which the value of the interest exceeds $5,000 or for which the value of the interest is five percent (5%) or greater of any class of shares or other securities outstanding.

•  Question #3: Intellectual Property Rights & Interests

Intellectual Property Rights and Interests:

With regard to intellectual property rights and interests (e.g., patents, copyrights), a Significant Financial Interest (SFI) exists if an Investigator  (or the Investigator’s spouse or dependent children) holds or receives intellectual property rights, royalties from such rights, or agreements to share in royalties related such rights, within the 12 months preceding disclosure, for which the value exceeds $5,000*. Disclosure is required upon income (exceeding $5,000) received from such rights paid to the Investigator (or the Investigator’s spouse or dependent children). Since income may be received before a patent is issued, disclosure is required upon the filing of a patent application or the receipt of income related to the intellectual property interest, whichever is comes first.

SFIs do not include (i.e., do not disclose):

  • Intellectual property rights or interests that aggregate less than $5,000 for a single interest in the 12 months preceding disclosure (unless FSM faculty);
  • Unlicensed intellectual property that does not generate income;
  • Intellectual property rights assigned to Northwestern; or
  • Agreements to share in royalties related to intellectual property assigned to Northwestern.

3) Related to your institutional responsibilities, did you have intellectual property rights and interests for which income resulting from such interests, when aggregated for each interest, exceeds $5,000* within the past 12 months? 

* For Investigators whose primary appointment is in the Feinberg School of Medicine (FSM), the disclosure threshold for intellectual property rights and interests is $0.

•  Question #4: Travel

Sponsored Travel:

NOTE: Only Investigators with current PHS funding must respond to this question.  If an Investigator has ANY PHS funding, they must respond to this question.    

With regard to sponsored travel, a Significant Financial Interest (SFI) exists if an Investigator (or the Investigator’s spouse or dependent children) receives sponsored or reimbursed travel, if when aggregated, exceeds $5,000 from a single entity in the 12 months preceding disclosure. 

This includes travel that is paid on behalf of an Investigator (or the Investigator’s spouse or dependent children) rather than reimbursed directly to the Investigator, so that the exact monetary amount is not readily available or known.  In such situations, the Investigator must disclose a reasonable estimate of the value of the sponsored travel. 

SFIs do not include (i.e., do not disclose):

  • Reimbursed or sponsored travel that aggregates less than $5,000 from a single entity in the 12 months preceding disclosure;
  • Reimbursement of travel paid by or through the University or covered by a sponsored award through the University; or
  • Travel that is reimbursed or sponsored by a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, medical center, or a research institute that is affiliated with an institution of higher education.

4) Related to your institutional responsibilities, did you receive sponsored or reimbursed travel from an entity, which when aggregated for that entity, exceeds $5,000 in the 12-month period prior to disclosure date?

•  What is not included as a Significant Financial Interest according to this policy?

(1) Salary, royalties or other remuneration paid by or through the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University;

(2) Intellectual property rights assigned to the University and agreements to share in royalties related to such rights;

(3) Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;

(4) Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education; or

(5) Income from service on advisory committees or review panels for a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education.