Disclosing

Completing a Disclosure

Disclosure of outside professional activities and financial interests that relate to your role(s) and responsibilities at OUHSC is required by OUHSC's Policy on Conflict of Interest.

General instructions for completing or updating a disclosure:

  1.  Download the appropriate COI forms for completion
  2. Complete forms
  3. Either
    1. Upload to your ticket in Soonertrack, or
    2. Email your completed form(s) to ORA

Tips for what to disclose or not disclose include:

  • Is the activity related to what you do at OUHSC?  If so, it should be disclosed. If not, it likely does not need to be disclosed.
  • Mutual funds or holdings in a retirement account do not need to be disclosed.
  • The disclosure asks about outside activities and financial interests that relate to your role at OUHSC, not just self-identified conflicts of interest. While self-identified conflicts should definitely be disclosed, responding honestly and completely is an important best practice that allows OUHSC to demonstrate that OUHSC work is free from even the perception that decisions were biased by personal gain.

Want a few examples? See the What to Disclose? page for more information and examples of what should and should not be disclosed.

When is disclosure required?

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 OUHSC's COI requirements, which includes federal and industry sponsors as well as other sponsors with specific COI requirements or terms and conditions
  • 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).

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