External Relationships and Conflicts of Interest in Research
Conflicts of interest in research may occur when interests compromise, or have the appearance of compromising, the professional judgment of a researcher. Maintaining objectivity in research and education is a fundamental academic value. We strive to ensure a transparent research process by requiring a disclosure of certain interests.
Rush policies Conflicts of Interest and Commitment (OP-0359) and External Relationships and Financial Conflicts of Interest in Research (CC-RC-0008) articulate our position on conflicts of interest. We 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 External Interests
Disclosure of external interests are made through the Rush Research Portal (RRP). There are two ways to make a disclosure:
- The Annual Conflict of Interest Survey is administered by the COI Office within Corporate Compliance.
- Opens July and ends in August
- Annual survey collects information from the previous Fiscal Year (FY)
- Disclose all professional external relationships
- All remuneration (e.g., dollars, equity, meals)
- Link is sent through Rush email (survey housed in the RRP)
- A Protocol Specific Disclosure is completed by individuals listed as Key Personnel/Study Staff when a Master Project is created in the RRP and located on the main page of the Master Project.
- Collects disclosures related to the project/protocol/grant (e.g., study)
- Disclose relationships that may be related to the proposed study
- Disclose remuneration related to the external relationship
- Created/opened at the start of the project and remains open for the life of the study
- If changes/updates to external relationship- Mandatory notification within 30 days
Definition of Key Personnel: Any individual who is listed as Key Personnel on a PHS/NIH funded study; or studies not PHS/NIH funded (e.g., FDA regulated research). Key Personnel are those who contribute to the project in a substantive measurable way, involved in the design, conduct or reporting of the research.
New Information: Investigators/key personnel/study staff can make disclosures at any time, but they must be made within 30 days of a change in the interest.
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
Federally Funded Research
Public Health Service (PHS) funded research requires training on Financial Conflict of Interest (FCOI). Mandatory training on FCOI is required for all Principal Investigators (PI’s) and key personnel prior to the expenditure of funds on any newly funded projects, including non-competing continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. The regulations require re-training on Conflict of Interest (COI) every four years .
A Rush specific tutorial has been created that covers Rush policy on Conflict of Interest (COI) and federal requirements on FCOI at 42 CFR Part 50 Subpart F, Promoting Objectivity in Research. This training is now offered through the new Rush Learning Hub, effective January 2021.
Click the link below to access the FCOI module within the Rush Learning Hub. Once accessed, click “Register” and then “Launch”. The video will be available for you to view.
Researchers may also filter by course name in the Course Library at learninghub.rush.edu
It is important to store your training completion date for future reference and to provide proof of completion to the Rush Sponsored Program Administration (SPA) Office and COI Office.
NIH FCOI Training and Resources
Non-Federally Funded Research
For non-federally researchers (e.g., FDA sponsored), Conflict of Interest training is offered within the Collaborative Institutional Education Initiative (CITI) at www.citiprogram.org for Biomedical Research and/or Behavioral Basic coursework. This is valid for three years.
Open Payments
Open Payments is a national disclosure program that promotes transparency by publishing the financial relationships between the medical industry and healthcare providers (physicians and hospitals) on a publicly accessible website developed by the Center for Medicare & Medicaid Services (CMS). Physicians should check data reported in the system on a routine basis to access accuracy of payments associated to them. Please see the Open Payments Schedule below to understand key dates. Open Payments link can be found here: https://openpaymentsdata.cms.gov
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.
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, the COI Office 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