Financial Disclosure and Conflict of Interest

Conflicts of interest in research may occur when financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher. We strive to ensure a transparent research process by requiring a disclosure of financial interests.

Rush policies, Conflicts of Interest and Commitment (OP-0359) and External Relationships and Financial Conflicts of Interest in Research (CC-RC-0008), seek to maintain the balance among competing interests that have the appearance or ability to bias the design, conduct or reporting of the research.

Disclosure of financial interests

Disclosure of financial interest in research can be made through the Rush research portal. Investigators can make disclosures at any time, but they must be made within 30 days of a change in financial interest.

There are two ways to make a disclosure:

  1. In the annual conflict of interest survey administered by corporate and research compliance based on the fiscal year
  2. By completing a protocol specific disclosure form for institutional review board human subject research

In either instance, if you have actual or potential conflicts of interest, you remain responsible for updating your information on a timely basis should new information arise.

Disclosure of funded travel

Investigators, co-investigators and key research personnel who are supported by the U.S. Department of Health and Human Services Public Health Service (PHS) are required to disclose the occurrence of any reimbursed travel or sponsored travel related to their institutional responsibilities. This disclosure must be filed within 30 days of the travel.

The only reimbursed travel that is excluded from disclosure is that which is sponsored by a federal, state or local government agency or by a U.S. institution of higher education (an accredited college or university).

The disclosure must include the following:

  • Purpose of trip
  • Sponsor or organizer
  • Destination
  • Duration of the travel

Mandatory training requirements

All PHS-funded investigators must complete financial conflict of interest training prior to the expenditure of funds on any newly funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012.

You must complete training at least every four years. Current PHS awards are not subject to these new requirements until the noncompeting continuation award. However, we encourage investigators to take the training now to fulfill this mandatory requirement.

The definition of an investigator includes the principal investigator (PI) and any other person, regardless of title or position, that the PI identifies as independently responsible for the design, conduct or reporting of the research.

To be compliant with the federal requirements, researchers must complete mandatory training in one of these two ways:

  1. An online tutorial is available for researchers at Rush from the National Institutes of Health and PHS. Upon completion of the tutorial, each investigator will generate a certificate of completion. Send a copy of the certificate to Rita Tharpe, RN, BBA, MSHS, CCRC in the Office of Research Compliance.
  2. The Office of Research Compliance will provide training on a case by case basis. To set up an appointment, please contact Stephanie C. Guzik, MBA, BSN, RN.

If you received a a new or renewed award after August 24, 2012, you will not be able to participate in PHS-funded research until you have completed training.

Public disclosure of financial conflicts of interest

PHS regulations require that, prior to Rush’s expenditure of any funds under a PHS-funded research project, that Rush ensure the public can access certain information by submitting a written request for information concerning any significant financial interest disclosed to Rush that meets the following three criteria:

  1. The significant financial interest was disclosed and is still held by the senior/key personnel for the PHS-funded research project identified by Rush in the grant application, progress report or any other required report submitted to the NIH.
  2. Rush determines that the significant financial interest is related to the NIH-funded research.
  3. The institution determines that the significant financial interest is a financial conflict of interest.

If you would like to request information on a FCOI identified on or after 8/24/12  related to a senior/key investigator associated with a Public Health Service-funded award, then please email a request to stephanie_guzik@rush.edu and ensure to include the following information in the request:

  • Your email address
  • The PHS project title
  • The PHS award number
  • The senior/key investigator’s first and last name

Within five business days, ORC will provide a response that will include the following information:

  • Senior/key investigator’s name
  • Senior/key investigator’s title and role with respect to the research project
  • Name of the entity in which the significant financial interest is held
  • Nature of the significant financial interest
  • Approximate dollar value of the significant financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value