Conflicts of Interest in Research
Conflicts of Interest in Research
A Conflict of Interest (COI) is when an Outside Interest is related to an investigator’s institutional responsibilities and could or may appear to affect the design directly and significantly, conduct, or reporting of research.
Outside financial interests should be reported per the research sponsors regulation. Outside financial interests are any financial interests and other personal interests or relationships with an external entity that are related to an investigator’s institutional responsibilities. These financial interests include but are not limited to income, travel, equity, intellectual property rights. Positions constitute an outside financial interest whether paid or unpaid. Financial interests and positions of immediate family members are included in outside financial interests.
When investigators share their financial interests per the research sponsors regulation, this assists in promoting transparency and accountability, financial disclosures also protect the researcher’s interests by 1) meeting the requirements set by sponsors and the University, 2) having the RCOI committee, an objective third party, review the financial interests and the research, and 3) demonstrating a commitment to scientific integrity.
Research Conflicts of Interest Committee (RCOIC)
The RCOI committee is composed of faculty from the campus and serves as an advisory body to the Senior Vice President of Research and Biotechnology (SVPRB). Since investigators at WU are subject to WU policies, as well as State and Federal Regulations, the RCOI Committee makes recommendations based on these policies and regulations to the SVPRB regarding the management, reduction, or elimination of conflicts of interest among WU investigators. This process helps the RCOI Committee achieve its primary goal of promoting research objectivity by maintaining and upholding standards that ensure the design, conduct, reporting, and purpose of WU research are free from bias.
RCOIC Committee Chair:
Jennifer Baker, CHRC, CCEP
jbaker@westernu.edu
909-469-5606
RCOI Resources
How to Disclose:
All investigators must submit their financial disclosures to ORRA. The COI disclosure form can be downloaded from the IRBNet forms and templates library. Disclosures will be made available to the Office for Sponsored Research and Contract Management.
When to Disclose:
A. Covered Individual must disclose any interest that they and/or their Family Members, as defined in section IV of the Conflicts of Interest in Research and Disclosure policy, using the WesternU-approved disclosure form, must be made:
i. Not later than the 30th day of initial employment for any interests
that represent a COI in relation to a new Covered Individual’s
appointment.
ii. At least annually.
iii. Not later than the 30th day after acquiring a new interest that
requires disclosure due to creating a COI.
B. Covered Individuals who are planning to participate in a Public Health Service
(PHS)-funded research project must disclose not later than the time of
application for PHS-funded research if the financial interest if has not been
previously disclosed and presents a COI related to the proposed research.
On behalf of the SVPRB, ORRA staff are the initial reviewers of disclosure forms submitted to IRBNet COI. If the staff find that an investigator’s financial interest relates to their research, they then route the disclosure forms to the RCOI Committee. The RCOI Committee reviews the financial interest alongside the investigator’s research at a convened meeting. If the RCOI Committee determines that the financial interest constitutes a conflict of interest—meaning it could directly and significantly influence the design, conduct, reporting, or purpose of the research—the committee then recommends an appropriate management and monitoring plan for approval by the SVPRB.
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All Research personnel (faculty, staff, students, and collaborators) must complete the Conflict of Interest training using the CITI platform. If you need assistance, please contact ORRA.
Training completion records will be made available to the Office for Sponsored Research and Contract Management for verification of investigator compliance with the mandatory training requirement.
Public Requests for COI Information. Upon request, the institution will provide the following information to the public for each identified COI involving a Covered
Individual who plays a significant role in the scientific development or execution of a research project. This includes individuals serving as project directors or
principal investigators:
• the Covered Individual’s name.
• the Covered Individual’s title and role with respect to the research.
• the name of the entity in which the significant interest is held.
• the nature of the significant interest that constitutes a COI.
• the approximate value of the FCOI, expressed in ranges. If the dollar value
cannot be determined by reference to public prices or other reasonable
measures of fair market value, a statement to that effect will be provided.
FCOI Public Disclosure Page
FAQs
While COI and COC may both relate with an Investigator’s financial interest and their institutional responsibilities, this campus has separate offices, policies, and procedures for dealing with each.
Research-Related Conflicts of Interest: Situations where an investigator’s outside financial interests (e.g., salaries; consulting income; receipt of income from intellectual property rights; equity interests; ownership of equity in publicly or privately held businesses; honoraria; gifts; loans; or travel payments) or paid or unpaid obligations (e.g., director, officer, partner, consultant or manager of an entity) bias or have the potential to bias a research project. This also applies to the immediate family members of that investigator. For more information, Investigators should contact COI.
Whether professional or non-professional, compensated or uncompensated, an outside activity that interferes with successful performance of a faculty member’s University obligations represents a conflict of commitment.
Some examples of how to manage, eliminate, or reduce potential research related conflicts of interest:
- Public disclosure of significant financial interests.
- Training on research-related conflicts of interest for all personnel involved in the research.
- Monitoring of research by independent reviewers.
- Double-blind study and/or randomized study
- Modification of the research plan to ensure objectivity.
- Have non-conflicted investigators collect data and perform data analyses.
- Remove oneself as the Principal Investigator.
- Disqualification from participation in all or a portion of the research.
- Divestiture of significant financial interests.
- Severance of relationships that create actual or potential conflicts.
Depending on the nature of the disclosure the review may take four to six weeks to be reviewed by the ORRA and RCOI Committee. ORRA staff will contact you if additional review is required.
If you have any concerns regarding COI issues, we strongly encourage you to contact ORRA immediately. There are significant risks involved for not reporting:
- Compromise of scientific integrity (objectivity of the research);
- Misuse of University facilities;
- Improper direction of student’s or University employee’s work;
- Unbalanced allocation of faculty member’s time and effort;
- Failure to recognize the University’s right to intellectual property and related financial interests;
- Improper channeling of research funds;
- Inappropriate delay or restriction on publications;
- Appearance of impropriety