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

required research training

Northwestern's Research Conflict of Interest Training Module  Updated 2/15/16

One-Page Guide on Research COI Process for Investigators and Administrators

How do I disclose for the first time?

  1. Access eDisclosure and log in with your Northwestern NetID and password (or eDisclosure ID and password):eDisclosure
  2. Click "Disclose" button
  3. On the training page, open and read the training document; attest to having read and understood the contents of the training document by clicking the attestation checkbox
  4. Proceed through the disclosure by clicking "Continue" button
  5. Answer the disclosure questions "yes" or "no", providing the information required for "yes" responses
  6. Click Submit

How do I disclose on an ongoing basis?

  1. Access eDisclosure and log in with your Northwestern NetID and password (or eDisclosure ID and password):eDisclosure
  2. Click "Disclose"
  3. You will reach the training page; training is required every four years.  Your last training date will be noted on the page.  If you would like to re-attest to the training upon re-review of the training document, click the attestation checkbox, and your training date will be refreshed accordingly.  You may choose not to re-attest to the training and click "Continue" to proceed, unless your last training date was greater than 4 years prior to the present date, in which case you must review and attest to the training.
  4. Proceed through the disclosure by clicking "Continue" button
  5. For relationships with entities previously disclosed, you can refer to the table of existing disclosures at the bottom of the "Relationship(s) and/or Interest(s)" page to easily edit or remove the details of each relationship and/or interest.  
  6. For new relationships and/or interests with new entities, click the "Add Disclosure" button on the "Relationship(s) and/or Interest(s)" page
  7. Proceed through the disclosure by clicking "Continue" button
  8. Answer the disclosure questions "yes" or "no", providing the information required for "yes" responses
  9. Click “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 eDisclosure 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 on a specific project, 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 eDisclosure.   

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) related to one's Northwestern institutional responsibilities, 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 publicly-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 a $0 disclosure threshold for compensation and intellectual property interests. Please read each disclosure question carefully.

When Must I Submit a Disclosure?

Timing Disclosure Timeframe
Initial disclosure

Prior to submitting a research proposal or prior to engaging in research, as applicable:

  • Prior to submitting a proposal for sponsored research to entities subject to NU's COI requirements, which includes federal and industry sponsors as well as other sponsors with specific COI requirements or terms and conditions
  • Prior to contract execution for industry-sponsored projects that do not go through proposal and award process
  • Prior to engaging in research for any research involving human research participants, regardless of funding source
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

NOTE FOR FDA-REGULATED RESEARCH

Researchers involved in studies that are regulated by the Food and Drug Administration (FDA) -- meaning research studies involving drugs, devices, or biologics -- may be subject to additional disclosure requirements that the sponsor is responsible for administering.  The sponsor of an intended marketing application to the FDA is typically also the sponsor of the research project (e.g., a drug or device manufacturer).  This sponsor will solicit related financial interest disclosures from study PIs and Sub-Is via the FDA Form 1572.  The information required to be collected by the sponsor and disclosed by the PI and Sub-I to the sponsor is noted below. For more information, please refer to the FDA guidance available here

The following financial interests must be disclosed to the sponsor if the interests exist during the time the PI or Sub-I is carrying out the study and for one year following completion of the study:

FDA Disclosure Threshold        

Category of Financial Interests Required to be Disclosed to Sponsor
$0 any & all Compensation made to the investigator where the value of compensation could be affected by study outcome (e.g., compensation that could be higher for a favorable outcome than for an unfavorable outcome, compensation to the investigator in the form of equity interest in the study sponsor, or compensation tied to sales of the product, such as a royalty interest
$0 any & all A proprietary interest in the tested product, such as a patent, trademark, copyright, or licensing arrangement
$0 any & all Equity interest in the sponsor of a covered study if a non-publicly-traded entity
$50,000 Equity interest in the sponsor of a covered study if a publicly-traded entity
$25,000 Significant payments of other sorts, which are payments made by the sponsor of a covered study to the investigator or the investigator's institution to support the activities of the investigator exclusive of the costs of conducting the study

Resources

Training Resources
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

There is a COI session included in the quarterly ORI Research Administration Training Seminar.