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IRB Studies

All studies submitted to the IRB that involve human participants are subject to the Conflict of Interest in Research policy, which requires:

  1. All Investigators must complete COI training and complete a disclosure in eDisclosure prior to initiating a study. (Note: COI training is different than CITI training, or GCP training)
  2. Each Investigator's outside interests must be reviewed with respect to the study. A determination must be made for all Investigators prior to initiating the study of whether there is no conflict or a potential conflict that should be managed. We have developed guidelines for when and what kinds of management may be required for common investigator relationships.

Sections below provide information on how to check the status of the COI review of project, what some of the regulations are related to conflict of interest and research involving human participants, and resources for Investigators to understand what kind of relationships create the appearance of conflicts and what management strategies can be implemented in those situations.

We have a pdf as a quick reference guide to study team members to understand COI review of IRB studies.

COI Review of IRB studies

How will I know that COI review of a study is complete?

COI review for a study is complete when:

  • The COI tab in eIRB+ has project information for your study – project ID, title and list of Investigators (PI and Co-I's), and
  • The COI Determination for everyone listed is either "No Conflict" or "Conflict Managed"

Interpreting the COI tab in eIRB+

The COI tab in eIRB+ displays some information about the PI and Co-Investigators on a study from eDisclosure. Specifically, it displays:

  • COI Training Date - This is the last time the person completed COI training. Training must be updated every four years.
  • Last Submitted Disclosure - This is the date of their last disclosure, which must be within the last 365 days.
  • COI Determination - This is the status of the review of the person. COI review is not complete until the determination is either "No Conflict" or "Conflict Managed" for each Investigator on the study.
Below is additional information on how to interpret information on the COI tab in eIRB+ and what actions may be required.

The COI tab in eIRB+…

Action?

Is totally blank
  • If it is a new study, it will probably be imported the next time we do an import – we import twice a week.
  • If urgent, or it is not a new study, email NUCOI.

COI tab has title & correct people, but someone is still "Under Review"

There are multiple reasons why someone might be Under Review:

  1. They have not completed their disclosure or their disclosure is out of date. Disclosures must be updated at least annually.
  2. They have not completed COI training (which is different than CITI training). Training is required every four years.
  3. That person is still under review with respect to this project

COI tab has title & correct people, but someone is still "Under Review" and their disclosure date is blank

This person is likely still Under Review because they have never completed a disclosure in the eDisclosure system.

NUCOI may have already asked them to disclose, but we would encourage individuals on the study team to also reach out. Instructions for completing a disclosure (which incorporates COI training) can be found on the disclosing page.

Has a title, but no people
  • If project ID is an STU#, we are likely in the middle of the import process.
  • If project ID is an SP#, we need to associate people to it – email NUCOI.

Has title & people, but people are wrong / some people are missing

Email NUCOI to let us know personnel list is incorrect.

Has a funding source associated with it (an SP#) but it is incorrect

Email NUCOI to let us know that the protocol was associated with an incorrect grant/contract.

Has a title & people, but the project is listed as (Inactive)
  • If the project ID is the STU# and it is (Inactive), email NUCOI to let us know that this study is active.
  • If the project ID is an SP# and it is (Inactive), it may be that the grant/contract has ended but the study is still open. Email NUCOI if you have questions about it.

Investigator Resources

Guidelines for consulting / other outside activities that may impact research

Northwestern has developed guidelines for Investigators involved in research with human participants. These guidelines provide thresholds for when common management strategies would be used (e.g., when is disclosure in the consent form required? Under what conditions could someone no longer be PI of a study?).

Note: The guidelines require log in to view.

Template disclosure language for use in consent forms

If an Investigator has a relationship with a study sponsor or interest in a product being tested in a given study, disclosure in the consent form is often requested.

The IRB has developed and provided example disclosure language that is suitable for use in consent forms.

We have also developed example disclosure language as guidance for how to disclose a relationship in publications, presentations, or to a study team.

Regulations

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