Key Takeaways

• A conflict of interest (COI) disclosure refers to the formal declaration of any potential conflicts of interest by a researcher submitted to an independent committee or board for review
• Financial conflicts and personal conflicts make up the two major categories of COI
• COI disclosures must be submitted prior to proposal submission, within 30–90 days of a new potential conflict arising, and at least once every 12 months
• Dedicated software like Cayuse COI helps institutions more easily collect, track, and manage COI

In the field of research, conflicts of interest are defined as situations in which personal or financial considerations have the potential to affect or compromise professional bias or objectivity. Failure to disclose such conflicts can result in significant consequences for investigators, teams, and entire research organizations, ranging from funding revocation and lawsuits to lasting damage to an institution’s reputation. 

With such high stakes involved, research administrators must ensure that timely and accurate COI disclosures are included in their organization’s research workflows. In this blog, we’ll take a look at COI disclosure requirements, different types of conflicts of interest, and best practices for managing conflicts and COI disclosures to reduce institutional risk. 

What is a conflict of interest (COI) disclosure?

A conflict of interest disclosure refers to the formal declaration of any potential conflicts of interest by a researcher submitted to an independent committee or board for review. The review board is then responsible for determining whether action is needed to address active or potential conflicts of interest.

Not all conflicts of interest are severe enough to require action, and some researchers may not even be aware that a situation involves COI. However, investigators and faculty should always list any potential conflicts in their disclosures to help their review boards determine the full scope of any conflicts.

What are the major types of conflicts of interest?

Conflicts of interest in research broadly fall under two main types, financial conflicts and personal conflicts. Individual organizations may 

Financial Conflicts

Financial conflicts of interest arise when a researcher has a financial interest in the outcome of their research. Financial conflicts can take many forms, but most often include one of the following factors:

• Equity or stock ownership in companies that would benefit from the results of an individual’s research
• Income—including salary, dividends, consulting fees, and other financial compensation—received on behalf an outside entity
• Intellectual property rights and interests 
• Travel, accommodation, and registration fees covered by an outside organization

Personal Conflicts

Personal conflicts of interest refer to any non-financial conflicts that may impact a researcher or faculty member’s impartiality in regards to a specific project or their research in general. Personal conflicts can be more broadly defined—often at the discretion of one’s institution—but usually cover:

• Relationships with others who may have a financial or personal stake in the results of an individual’s research, such as a spouse who works at a pharmaceutical company
• Non-financial connections to organizations or institutions that may have an interest in the results of an individual’s research, such as unpaid membership on the board of an environmental nonprofit

When am I required to disclose a conflict of interest?

Disclosure submission frequency will usually vary depending on an instituion’s specific policies and guidelines. However, researchers and faculty will always need to submit a COI disclosure for the following events:

• Prior to proposal submission
• Within 30–90 days of a new potential conflict arising
• At least once every 12 months, regardless of current research (or the lack thereof)

COI disclosure vs. COI management: what’s the difference?

Researchers and faculty are responsible for disclosing all potential conflicts of interest to their isntitution’s appropriate review board or committee. 

Once a disclosure has been submitted, the corresponding board or committee’s members are responsible for determining a management plan to address any significant conflicts. Management plans can range from monitoring and further investigation to withdrawal of a researcher from a particular project to avoid an overt, damaging conflict. In the event of noncompliance, a research department’s leadership is usually responsible for any disciplinary action.

Research administrators also play a crucial role in assisting COI management. They are often the faculty members responsible for confirming that relevant participants have submitted timely disclosures, assigning COI training and other support services to ensure adherence to relgulatory changes, and breaking down administrative barriers to support a consistent culture of compliance.

Best practices for managing COI disclosures

As mentioned above, research administrators are the main team members responsible for establishing and promoting best practices for effective COI disclosures. While the specifics regarding COI disclosure requirements and workflows will vary from institution to institution, ideal COI compliance always stems from five key management features: transparency, proactivity, documentation, training, and frictionless workflows.

Transparency

When it comes to COI disclosures, investigators and faculty should always be aware of what is required of them, and when. Additionally, reviewers should always have a clear view of where individuals have potential conflicts of interest, and whether conflict of interest disclosures are missing for a proposal.

Cayuse COI supports transparency for all stakeholders with real-time dashboards for checking disclosure statuses and holistic visibility into institutional and personal COI relationships. 

Proactivity

Make sure researchers have a clear understanding of COI disclosure deadlines, and that they have the resources they need to complete their disclosures for timely submissions. Flagging the need for COI disclosures early in the proposal lifecycle ensures that researchers know that this important step is required before their proposal can continue.

Reminders and automated notifications in Cayuse COI ensure timely disclosure submissions, reviews, and approvals. Additionally, standardized digital workflows and an easy-to-use disclosure process significantly reduce the time and effort needed to submit disclosures sooner, rather than waiting until the last minute.

Documentation

Disclosures should be consistently documented, updated, and stored for easy access in case they need to be referenced in the future. While many organizations are moving away from paper documentation, digital documents still need to maintain a consistent format and should be stored in a secure, centralized repository. 

With integrations between Cayuse Sponsored Projects, COI, IRB, IACUC, and IBC, the Cayuse Platform supports consistent documentation across the research lifecycle. Cayuse COI’s in-app documentation also allows users to amend disclosures mid-cycle without re-entry of pre-disclosed conflicts.

Training

Institutional guidelines, federal regulations, and other COI requirements can change over time. Research administrators need to keep track of any updates that will impact disclosure processes and provide training to ensure researchers and other affected faculty members understand what is required of them when submitting their COI disclosures.

Consolidating COI management on a platform like Cayuse can help keep track of upcoming and overdue trainings, while transparent management plan tracking also encourages accountability in the event of significant conflicts arising.

Frictionless workflows

Administrators, researchers, and reviewers can easily spend too much time completing, updating, reviewing, and approving COI disclosures when an organization relies on manual processes like email handoffs and data entry across disparate documents. COI disclosure workflows should eliminate friction wherever possible to facilitate easier disclosure submissions and faster reviews.

Disclosure management software like Cayuse COI automates forms and handoffs to reduce administrative workloads as much as 60%, saving valuable time and effort for all faculty members involved in the process.