We receive funding from multiple industry sponsors and several branches of HHS, including the Centers for Medicare & Medicaid Services (CMS), NIH, and the Centers for Disease Control and Prevention (CDC).
We also encourage our staff to seek meaningful opportunities within their field, such as participating in patient advisory groups or presenting research to new stakeholders. We pride ourselves on the high level of collaboration across our research teams because we understand the need for peer review and the benefit of skilled researchers learning, sharing, and training with one another.
The strength of our research hinges on this collaborative nature, but also comes with an additional obligation to be open about our COI policies and management plans.
The new FCOI regulations provided an opportunity for our organization to revisit our existing practices and strengthen our efforts to effectively manage any conflict.
Our COI policies go above the HHS requirement that only investigators and key personnel disclose any significant financial interests, sponsored or reimbursed travel expenses, or payments from external organizations above $5,000.
We ask everyone involved with our research to abide by these guidelines and be aware of perceived and actual COIs. Additionally, all employees must complete an annual COI training session and submit a statement identifying any COI.
All honoraria, payments, and significant financial interests related to an individual’s obligations to Arbor Research must be disclosed to our internal compliance group, regardless of amount. Our goal in addressing COI in this manner is not to increase the burden on our collaborators, but rather to promote awareness and encourage open discussions on potential conflicts and the ramifications they may have on our research.
It is our responsibility as a contributor to the scientific community, to promote the highest standards of research conduct. Doing this is best for our organization, our sponsors, the research community, and ultimately, the patients and stakeholders affected by our research.
Strategic discussions about our funding have always included potential COIs, but the new federal regulations have sparked a larger effort to involve our entire staff and update practices to fit our funding models. We encourage other research organizations to take advantage of these new requirements as an opportunity to formalize COI practices and to promote organizational awareness of this vitally important issue.
Bruce Robinson, MD, MS, FACP, is the vice president of Clinical Research at Arbor Research Collaborative for Health and serves as the organization’s compliance officer. He obtained training in nephrology and an MS in clinical epidemiology at the University of Pennsylvania. Dr. Robinson is the principal investigator of the Dialysis Outcomes and Practice Patterns Study (DOPPS) programs. He is also the co-investigator on the CDC-funded National Kidney Disease Surveillance (NKIDDS) Initiative, and previously served as the co-director for several Centers for Medicare & Medicaid Services-funded projects at Arbor Research.
Francesca Tentori, MD, is a research scientist at Arbor Research Collaborative for Health and completed her nephrology fellowship at the University of Milan. Dr. Tentori’s research interests include outcomes research in chronic diseases and delivery of high quality care in hemodialysis. She is part of the Arbor Research team responsible for defining research priorities in the Dialysis Outcomes and Practice Patterns Study (DOPPS).
Sharon Steig, BA, is the operations coordinator at Arbor Research Collaborative for Health. Ms. Steig oversees the organization’s compliance policies and procedures, including those related to conflict of interest and human subjects