Appplication of the Conflict of Interest in Research Policy
The Conflict of Interest in Research policy requires training and disclosure before initiating and throughout the life a project. Questions about whether a specific project falls under the Conflict of Interest in Research policy should be referred to firstname.lastname@example.org.
Below is general information related to the Conflict of Interest in Research policy. More detailed information is available on these pages:
- Proposal preparation guidance for research administrators - requirements from federal sponsors, subrecipients, and research administration tools
- Disclosure instructions and guidance for Investigators - what, when and how to disclose
- Considerations for research involving human participants - FDA regulations, review requirements, managing conflicts when research involves human participants
What research is covered?
- All federally funded research
- All industry-sponsored research
- Research sponsored by foundations or other organizations with COI terms and conditions
- All research involving human participants and submitted to the IRB, regardless of funding source
See the list of Sponsors with COI Requirements for a list of foundations known to have COI requirements.
Who is required to follow this policy on the project?
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.
- 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
If an individual who is named on a project does not meet the definition of Investigator, that individual can be marked as "not an Investigator" on the COI Compliance Page in eDisclosure. Instructions for doing so are on the Manage Investigator Status page.
Click here for details of how to assign an individual “not an Investigator” in eDisclosure.
Training is required every four years. Training can be completed in the eDisclosure system and is built into the disclosure process. To complete training:
- Log into eDisclosure using your NetID and password
- Click the "Complete Training" on the left side of the screen
- Review the pdf training module, and check the box to attest to having completed training
- Click "OK"
Should an individual ever wish to reference the training modules outside of eDisclosure, they are available below:
Northwestern's Research Conflict of Interest Training Module
(For use by all researchers internal and external to Northwestern except researchers that are faculty with primary appointments in the Feinberg School of Medicine and/or primarily affiliated with Northwestern Memorial Hospital (NMH), Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie), and the Shirley Ryan Ability Lab (SRALab))
FSM/Affiliate Research Conflict of Interest Training Module
(For use by researchers that are faculty with primary appointments in the Feinberg School of Medicine and any researchers primarily affiliated with Northwestern Memorial Hospital (NMH), Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie), and the Shirley Ryan Ability Lab (SRALab))
Disclosure is required prior to initiating a project, within 30 days of receiving a new significant financial interest, and at least annually, even if acknowledging no change.
What must be disclosed?
Any Significant Financial Interests (SFI) of an Investigator (and those of the Investigator’s spouse and dependent children) related to the individual's Northwestern institutional responsibilities.
Signifcant Financial Interests fall into categories:
- Payment or compensation totaling more than $5,000* in the previous 12 months
- Ownership (e.g., stock) of a publicly-traded entity valued at more than $5,000
- Any ownership or investment interest in a non-publicly traded entity, even if worth nothing
- Royalties from IP rights totaling more than $5,000* in the previous 12 months that did not go through Northwestern's tech transfer office, INVO
- Sponsored or reimbursed travel of more than $5,000* in the previous 12 months
* Investigators whose primary appointment is in the Feinberg School of Medicine (FSM) are subject to a $0 disclosure threshold for compensation, intellectual property interests, and sponsored/reimbursed travel. Please read each disclosure question carefully.
When is disclosure required?
Prior to submitting a research proposal or prior to engaging in research, as applicable:
|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|
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|
- One-Page Guide on Research COI Process for Investigators and Administrators
- eDisclosure Compliance Page guidance for research administrators
- Research Sponsors Subject to Northwestern's Research Conflict of Interest (COI) Disclosure Requirements
- Identifying and Assessing COI Terms & Conditions - a guide for research administrators
- Example of Unusual COI Requirements in Sponsor Proposal Solicitations, FAAs, and BAA
- Conflict Management Plan Recommended Disclosure Language - A guide for Investigators under COI management as to the nature, frequency, and mechanism of specific disclosure requirements contained in COI management plans
External Agency Resources
- NIH Financial Conflict of Interest Website
- NIH FAQs: Promoting Objectivity in Research Where PHS funding is Sought
There are no training events scheduled at this time. To request an in-person training, please contact email@example.com.
There is a COI session included in the quarterly ORI Research Administration Training Seminar.