Conflict of Interest Systems for Multi-Purpose Usage
David Propen, Allison Shah
When implementing conflict of interest (COI) systems, institutions often want their system to be able to accommodate multiple purposes. These purposes may include, but are not limited to:
- Annual certifications of disclosures and financial interests
- Certifying financial interests for specific purposes at various times, e.g.
- Funding proposals
- IRB submissions, or at time of award
- Board of directors or trustee-related questions
- Prior Approval Requests
- Conflict of commitment and others
These different purposes are often managed by multiple owners or stakeholders such as research offices, compliance committees, legal departments, academic units and affiliates.
For multiple-purpose COI systems to be successful, the different purposes and stakeholders must be addressed thoughtfully and related considerations planned in advance of implementation. Several options and approaches to system implementation can be employed depending on institutional drivers.
This white paper explores these key options and considerations, providing recommendations as to best practices for multi-purpose COI systems based on experience across a variety of higher education institutions.
Options for Multi-Purpose Implementation Approach
When implementing COI systems for multiple purposes, offices or organizations, there are a number of options that can be employed. The two options presented below have been proven successful and provide for a greater likelihood of strong, positive outcomes. Other options, such as implementing a system without alignment, introduce more risk and are less advisable:
- Implement One system: Aligning key elements completely and other elements as much as possible, to manage long-term costs
- Implement Multiple/Separate Systems for Different Purposes, uses or organizations: More achievable when discloser populations don't align and/or requirements cannot be reconciled (for regulatory cultural or other reasons)
1. Implementing One System
Aligning Processes Completely
Aligning processes completely implies that all (or most) of the considerations for alignment listed below have been discussed amongst the multiple purposes, offices or organizations.It also implies that agreement, compromise or alignment has been reached regarding the approach and design to achieve multiple purposes.
We recognize that establishing consensus can be challenging, but a strong alignment and analysis effort can allow a wide range of purposes, offices or organizations to operate harmoniously within a single system.
Aligning Key Elements of the System
Successful implementation of a single COI system for multiple purposes can be achieved without total alignment if key system elements and definitions are aligned. This model can accommodate some differences in areas such as routing, access, reporting or notifications, but the extent of differences will impact system complexity and maintenance.
The most important elements for alignment are definitions for disclosure reporting, such that a complete set of disclosed interests can be shared across purposes, offices, or organizations, and sharing the majority of the workflow.
This option has its merits, specifically in enabling the institution to remain within a single system; however, risks associated with this approach can include:
- Greater design and development effort
- Long-term support
- Potential for insoluble differences
- Increased timeline and budget
Indeed, establishing the details of alignment, across the multiple purposes or offices, during the course of an implementation — even if the high-level elements are previously agreed upon — can require additional coordination, time and effort that must be accounted for.
2. Implementing Separate Systems
In some cases, alignment of multiple purposes is neither possible nor desired by either one or more offices or organizations which are interested in an automated COI solution.
Implementing One System Without Alignment
When institutions force alignment where there is no agreement, or when different purpose- groups compromise where key elements cannot or should not be compromised, a lack of user adoption and potentially noncompliance can result. For example, in cases where alignment is not established across definitions, disclosure data entry, and reporting and/or business process/workflow, noncompliance risks such as dislcosers not completing their certifications in a timely manner are increased. Similarly, nonalignment amongst these items can introduce audit risks as well. Finally, increased risk of investigator burden, e.g. risks of seemingly duplicative data entry by disclosers can accompany misalignment associated with definitions or disclosure data entry and reporting. In these cases, implementing two separate systems would be advisable.
In cases where alignment was not established between multiple purpose-groups or organizations, this has also led to budget overruns, project delays and, subsequently, recognition of mistaken approach. Implementing a second system to accommodate such differences should be viewed as a valid approach and considered for any multi-purpose implementation where considerations for alignment begin to point to significant differences or complexity.
Considerations for Alignment: How much is "Enough"?
When determining which of these approaches best suits an institution and the multiple stakeholders who will utilize a system, it is important to consider a number of areas where alignment is critical and necessary to successfully “live” in a single system. These include:
- Definitions of financial interests
- Disclosure data entry and reporting
- Business process/workflow
Table 1 below, includes a number of questions to help an institution determine whether the degree of alignment between the multiple offices/purpose areas is sufficient to “live” in a single system.
Table 1. Areas Critical To Align
|ID||Area||Primary Question||Follow-Up Questions||Summary|
|1||Definitions of Financial Interest||
Is there alignment across disclosure definitions and timelines?
If offices or organizations are not willing or able to share a common set of disclosures, alignment within a single system will be difficult to achieve and less beneficial to disclosers.
The time periods of disclosure data collection, specifically, should be aligned to avoid introducing undue complexity into the system.
Disclosure Data Entry and Reporting
Are forms for the disclosure agreed upon?
Collecting different data on the disclosure forms by purpose, office or organization introduces significant complexity into the system, is not recommended and is a good indicator of misalignment.
Is workflow, for the most part, aligned?
Overall workflow must be well aligned in order for multiple purposes, offices or organizations to "live" successfully in a single system.
While there are exceptions to this rule- e.g. some institutions have department review; and an institutional review board (IRB) office may have different review processes than a pre-award office - if customization are required, there are still certain elements that should remain unchanged. These include, but are not limited to: administrative determinations/ central office toutings and approvals that dictate large portions of the workflow as well as the project statuses which are utilized in the product. If an office/purpose area is necessitating a new custom project type or state not required by the others, this is a good indicator of misalignment. differences in where the management plan should be "housed" within the data model is also a good indicator of misalignment.
There are some variations across multiple stakeholders that can logically be accommodated within a single system. To the degree that such variations require customization, long-term support costs, associated with the complexity variations carry with them, should be considered. Areas where variances can be accommodated, include:
- Certification data entry and reporting (or other data entry not specific to the disclosure/financial interest)
- Notifications and communications strategies
- Security and visibility
- System access
Table 2 below includes a number of questions to help an institution determine the degree of customization that may be required to support nonalignment between multiple purposes, offices or organizations; and to facilitate discussion around what level of complexity these customizations may add to future upgrades and long-term cost of ownership.
Table 2. Areas That Can Vary
|ID||Area||Primary Question||Follow-Up Questions||Summary|
Certification Data entry and Reporting
Are there significant differences in the certification forms by purpose, office or organization?
1. Can these differences be captured by hiding/showing questions in the context of existing forms?
The certification forms can often be customized to accommodate multiple purposes, offices or organizations utilizing multiple types of certification and thus alignment is less critical.
However, if the answer to this follow-on question is no, then it is likely that new custom views and branching will be required. While this is not an obstacle to multiple purposes, offices or organizations "living" in a single system it will increase the complexity of the system and impact the ease of future upgrades.
Notifications and Communications Strategies
What differences exist in the notifications and communication strategies by purpose, office or organization?
Notifications are very customizable, can vary by purposes, offices or organizations with often minor configurations to existing activities or scheduled background operations, and thus are less critical to align.
However, as more customizations accumulate, the complexity of the system and ease of future upgrades will be affected.
Security and Visibility
Is there alignment on security, user roles and who can see what within the system?
Differences in security across purposes, offices or organizations can be accommodated and thus alignment is less critical.
However, security often requires some level of change to the product that will require repeated changes as part of future upgrades.
Is there alignment on a single point of access to the system?
Both approaches to proxies and authentication types can vary across purposes, offices or organizations; however, it is important to note that it is critical for there to be alignment on a single point of access, or a single URL/"Login Page".
From this point users can choose their office/purpose area/login method, and be directed to the appropriate authentication method. Having multiple login method, and be directed to the appropriate authentication method. Having multiple login URLs for different purposes, offices or organizations in a single system is not recommended.
Looking to the Future: Upgrades
When making determinations around accommodating or reconciling differences between different purposes, offices or organizations, an institution should understand how each setting, extension and customization is made to support nonalignment, ultimately impacts the upgrade-ability of your system and its long-term cost of ownership. Some questions for consideration around this topic include:
- Do the customizations required to align your purposes, offices or organizations take your institution/system significantly off the upgrade path?
- Is the business requirement necessitating a customization something that applies to other clients and are there immediate or long-term plans to build this enhancement into the Huron product?
- If the requirement does not apply to other clients and/or this is not on the Huron product roadmap, should this business requirement be re-examined on simplified?
Single or Multiple Systems?
As these areas for alignment are considered, eventually a determination must be made as to whether these multiple purposes, offices or organizations are currently aligned or if they can reach sufficient alignment. Some additional considerations that should be accounted for include: discloser population and culture.
- Discloser Populations: If the intersection of discloser populations is large, the benefits of using a single aligned system will be greater. Conversely, if there are differences between the requirements that subsequently require alignment, will these differences be easy, moderately difficult or difficult to manage across the populations?
- Culture: Organizations must also ask whether their culture will allow them to reach alignment. Do constituents have the drive to align on key system elements and do the resources and bandwidth exist to dedicate to this effort? Regardless of the level of alignment, if the intent is to align, the next-level question is: Can the organization design a single system that reasonably accommodates the differences and can the organization afford the long-term cost of supporting them? Alternatively, if the differences cannot be supported in one system, how does the institution approach the need for multiple systems?
Huron recognizes that clients often desire a single system to cover all of their multi-purpose requirements around COI. However, this entails often difficult alignment efforts on everything from definitions and data collected to reporting and workflow. Huron recommends that clients, when considering multiple purposes, offices or organizations within the context of a COI system, attempt to align processes, or, failing that strongly consider separate systems. Either approach can be successful but the effort to create alignment can be significant.
A thorough review and strong understanding of the COI product’s current capabilities and future roadmap will help clients level-set on what settings and extensions the product can currently accommodate “out-of-the-box” as opposed to what will require client-specific customizations.