As assistant VP for research administration, Brenda Seiton's main responsibility is to help Emory researchers understand and manage financial relationships that could be a conflict of interest (COI).
Compliance sounds straightforward enough: don't let financial interests or personal considerations bias your scientific or clinical judgment, objectivity, or trustworthiness. However, documenting and demonstrating compliance for the public, the government, and funding agencies can be difficult. COI reporting became even more complex with announcement of tighter NIH regulations. Fortunately, changes set in place in the four years since Emory created Seiton's office have put the university ahead of the curve.
The first of those changes was revision of existing Emory research policies, then more than a decade old. The second was implementation of a new COI electronic reporting system (eCOI), developed by Emory staff led by Seiton and Marc Overcash in information technology. eCOI helps track which relationships need to be reported as well as when and where to report them (for example, financial interests with health-related companies, consulting fees, or ownership or investment in a device or drug being studied). Significant changes were recently made to eCOI to meet the new NIH regulations.
The system is designed to make all required reporting easier, more intuitive, and more fail-safe, making it virtually impossible, for example, to report data in three places and forget the fourth. The system links reports required for review by government agencies and by various Emory administrators, including those in Emory Healthcare and in dean's and department chair offices, both of which have to approve outside consulting activities and other types of financial ties that could present COI issues for researchers.
Much of Seiton's time currently is spent strategizing how to implement policies and procedures that both comply with the new regulations and conserve investigators' time and energy. When she or a staff member receives information about a possible conflict, they work with the researcher and the COI Review Committee. This committee, led by Tris Parslow (chair of pathology) and Bob Taylor (cardiology), is made up of faculty (from the college and schools of public health and medicine) and a community member. This group helps Seiton and the researcher develop a management plan in which the researcher may be required to reduce his or her financial interests or eliminate a relationship entirely.
Seiton, a lawyer by training, first joined Emory in 1997, working in a new position in the medical school in which she spent the majority of her time on COI issues. New federal COI guidelines had just been implemented the previous year.
As research continued to grow across the university, leaders decided to bolster the review process across the board at Emory, and in 2008, Seiton was tapped to head a new university office, reporting to David Wynes, VP for research administration. Jeff Steltzer, another attorney, moved with Seiton from the medical school's COI program, before he left for a similar position at Georgia Tech (he and Seiton still work closely). Karly Taylor, who previously worked on COI at Partners Healthcare, joined the group as a senior COI specialist in 2009. Joi Mindingall, an attorney who previously managed the COI office at Vanderbilt, came on board as a senior COI specialist in 2011. Seiton's other staff member is Carrie Przybilla, COI specialist.