Inside Implementation: Conflict of Interest Module

Since implementation began last August, the ERA Project’s main focus has been on the Animal Care and Use module — which went live May 22. But since we’re implementing the Research Enterprise Data (RED) system in phases, there are many moving parts and we’ve been working on multiple modules simultaneously. And because RED is an enterprise-level system, we’re always thinking of how the decisions made for one module may affect others.

Over the past couple of months, our focus has steadily shifted more toward working on both the Sponsored Programs module and Conflict of Interest (COI) module. And we’ve made some significant progress on the latter.

The COI module will replace both the existing online systems used for disclosing 1) conflicts of interest and 2) notices of intent (NOI) to engage in external professional activities for pay (EPAP).

All faculty (including adjunct faculty and emeritus faculty who are participating in a sponsored project); postdoctoral scholars; EHRA professionals paid from any source; graduate assistants paid from sponsored-research funds; SHRA employees paid from sponsored-research funds;  and research personnel engaged in the design, conduct, or reporting of a sponsored research project (e.g., part-time and temporary employees) must complete a conflict of interest disclosure. And any faculty member or EHRA professional planning to engage in EPAP must complete a notice of intent. There is a $0 threshold for reporting EPAP, so all EPAPs must be reported.

The COI module is currently set to go live during fall 2019.

For more information about university policies on conflicts of interest and notices of intent, check out any number of the resources provided on this SPARCS webpage.

The successful implementation of the COI module will undoubtedly be an exciting accomplishment for our university. It will be another huge step toward accomplishing one of the ERA Project’s primary goals — to increase the efficacy of research compliance activities.

“Eventually, the COI module — as well as the future Sponsored Programs modules — will share a single, common database of sponsors and entities engaging faculty and staff in outside activities,” says Richard Best, director of research compliance. “This will greatly enhance the identification and management of potential conflicts of interest.”

Lakshmi Ramanathan, functional lead for all compliance modules, and technical lead Natalie Boone began their work on the COI module while they were still having to mainly focus on the Animal Care and Use module’s implementation. Always proactive, one of the first steps Ramanathan took, back in February, was facilitating virtual meetings with representatives from fellow InfoEd institutions Yale University and Weill Cornell Medical School. During the meetings, she and the key stakeholders on the COI compliance team, Jill Dale and Tracy Harden, got an early, firsthand look at the capabilities of InfoEd’s software. Yale and Weill Cornell even shared copies of their e-forms with our team, so Dale and Harden were able to work on the form content with a solid understanding of the system’s functionality.

For us to determine exactly what we want our system to do, we must first figure out exactly what the software is capable of.

“It was very helpful for us to gain an in-depth understanding of the software’s capabilities at such an early stage,” Ramanathan says. “This way, Jill, Tracy and I have been able to hit the ground running in terms of figuring out exactly what we want our module to do.”

Ramanathan says she’s currently working with groups like the Provost’s Office to get a head start on their reporting needs (e.g., system-generated email reminders and other notifications).

In May, InfoEd sent a representative down to Raleigh for an on-site visit, marking an important milestone for both the COI module and the Proposal Tracking (PT) and Award (AT) Tracking submodules of the Sponsored Programs module. Between the progress made during the May visit and the valuable insights gained during InfoEd’s annual User Group Meeting, we’ve got InfoEd well on its way to completing the first iteration, or prototype, of the COI module.

However, to be clear, at this early stage, there is still plenty of room in the schedule for feedback and revisions. And keep in mind that the entire RED system is highly configurable, which was one of the main reasons we chose InfoEd as our vendor. So expect to see regular enhancements and updates throughout the RED system’s lifetime.

What’s Next

Over the next few weeks, Best will be meeting with the Research Operations Council and other stakeholder groups to determine additional requirements for the COI module. InfoEd will be back on campus later this month to ensure the prototype they’ve built is what we asked for and is ready for us to begin reviewing and testing.

We’re currently aiming to begin user-acceptance testing around mid-August, in order to allow plenty of time to document feedback from end users and make sure all major changes are incorporated before we go live.

Meanwhile, work will also continue on the Sponsored Programs module. We soon plan to properly introduce you to a few more people who’ve been working hard behind the scenes to ensure implementation runs smoothly.

So keep an eye on this blog and your email inbox, for that and more information about the ERA Project.