Author: Deepika Bhatia, AVP, RCRA
Minimizing administrative burden in research while ensuring compliance with regulations is a critical challenge for research compliance teams. Here are a few strategies from the Emory Research Compliance & Regulatory Affairs (RCRA) team to achieve this balance:
Operationalizing streamlined processes, efficient communications to relevant stakeholders early and often, striving for an approach to balance enabling research while also adhering to research regulations and upholding research integrity.
Illustrated below are some proven examples from RCRA teams to support our researchers, administrators and partners in Schools and departments.
- COI/COC – disclosure requirements for research are only needed 1-3 times a year depending on the researcher’s role and/or if new financial interests are acquired/discovered as opposed to disclosure triggers at almost every stage of the lifecycle of the project, implementing eDisclose to facilitate online conflict of interest and commitment submissions
- Research Integrity – support and infrastructure in RCRA/ORIC team to assist faculty and school leadership on policy compliance, support during various stages of the lifecycle of research misconduct allegations, external ORI reporting and corrective action sustainability along with restoring respondent reputation as needed, developing RCR training that is easily accessible for researchers at Emory, that could be implemented by schools or individual labs as a complement NIH, NSF or NIFA awardee training requirements, partnering with schools on authorship disputes, diminishing the school burden by facilitating the faculty committee’s work.
- Export Control – liaisons across campus administrative offices to proactively screen restricted entities, apply for export licenses, implement and train on TCPs to firewall projects appropriately, Visitor’ review process implemented in collaboration with the HR admins across campus
- IACUC – operational infrastructure in place for protocol reviews, inspections, regulatory agency inspections, required routine reporting, onboarding touch point with PIs to assist and support compliance requirements pertaining to animal research. – onboarding process with PIs to support protocol maintenance from cradle to grave, drafting educational resources to address frequent asked questions, ongoing communications to provide updates on ever changing regulatory environment and enhance best practices on animal care and use
- Research Security – proactive screenings, implementing new NIH, OSTP regulatory requirements with faculty input, benchmarking with other AMCs, customized programmatic solutions tailored to be sustainable and successful at Emory.
Our team believes in collaborative connections to help us all comply!