Conflict of Interest in Research
Conflict of interest in research may occur when interests compromise, or have the appearance of compromising, the professional judgment of a researcher. Maintaining objectivity in all areas of scholarly activity (e.g., clinical and preclinical) is a fundamental academic value. We strive to ensure a transparent research process by requiring a disclosure of external interests to promote research integrity.
RUSH policies Conflict of Interest and Commitment (OP-0359) and External Relationships and Financial Conflict 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 research.
The Conflicts of Individual and Institutional Interest (COIIIR) Committee determines the necessary action in order to eliminate, reduce and/or manage an individual’s interest.
Disclosure of External Interests and Innovation
Disclosures of external interests and innovative interests are made through the RUSH Research Portal (RRP). There are two ways to make a disclosure:
- Annually at the end of the fiscal year by completing the Annual COI Survey
- Protocol Specific (Transactional) COI (PSCOI) disclosure related to research
Information and detailed instructions on how to complete your Annual COI Survey can be found here.
Information and detailed instructions on how to complete your Protocol Specific COI disclosure can be found here.
Who is required to complete a Protocol Specific Disclosure?
- Any individual who is listed as Key Personnel on a federally (e.g., NIH) funded study.
- Study staff listed as Key Personnel on studies that are not NIH funded (e.g., FDA regulated research).
Definition of Key Personnel: Any individual who is listed as Key Personnel on a NIH funded study; or studies not 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.
Please note whether you are listed as Key Personnel or Study Staff, if you contribute to this research in a substantive measurable way, you are required to complete a PSCOI disclosure if you have a financial interest directly related to a research study.
When are you required to complete a Protocol Specific COI (PSCOI) Disclosure?
- IRB: at the creation of a Master Project within the RUSH Research Portal
- NIH: at the creation of a grant application and/or contract; per federal regulations, prior to receiving funding
- Non-Human: at the creation of the Master Project within the RUSH Research Portal
Investigators/key personnel/study staff can make disclosures at any time, but they must be made within 30 days of acquiring a new interest or a change in the interest.
Disclosure of Funded Travel for Researchers
Investigators, co-investigators and key research personnel who are supported by the U.S. Department of Health and Human Services Public Health Service (PHS) grants 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). All funded foreign travel must be disclosed regardless of the sponsor.
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. The Learning Hub module cited below will take about 15 minutes to complete.
Click the link 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. FCOI-Promoting Objectivity
Researchers may also filter by course name in the Course Library at learninghub.rush.edu
For detailed registration instructions, please click here.
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
Procurement Related to Federal Awards
The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (the “Uniform Guidance”), is a set of regulations that consolidates federal guidelines impacting the management of Federal Awards.
Effective July 1, 2018 RUSH complied with the Procurement Standards set forth in sections 200.317 – 200.326 of the Uniform Guidance. This guidance focuses on increased competition and transparency in the procurement process for goods and services procured from Federal Award sources. Toward our goal of compliance, the current RUSH Procurement policy was amended to incorporate the Uniform Guidance requirements. The policy requires that all procurement transactions be conducted in a manner providing full and open competition.
Procurement COI Assessment
A Conflict of Interest would arise when the RUSH employee, officer, faculty or agent, and/or any member of his or her immediate family, his or her partner, has a financial or other interest in or a tangible personal benefit from a firm considered for a contract that involves federal awards.
RUSH officers, faculty, employees, and agents may neither solicit nor accept gratuities, favors, or anything of monetary value from contractors or parties to subcontracts for federal awards.
No employee, officer, faculty or agent may participate in the selection, award, or administration of a contract supported by a Federal award if he or she has a real or apparent conflict of interest.
If a COI has been assessed, the conflicted individual must assign a non-conflicted administrator to facilitate the selection, award, or administration of a contract supported by a Federal award.
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.
More education and training information can be found here.
Public Disclosure of Financial Conflict 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, please click here.