Author(s)
Frank G. Ondrey, MD, PhD
Affiliation(s)
Univ of Minnesota
Abstract:
Objectives: Over the past 10-15 years, surgery departments have had an inordinate decrease in National Institutes of Health funding relative to other academic departments. This makes it difficult to provide funds for necessary infrastructure in an era of increasing regulatory compliance and oversight to research activities. We performed a needs analysis to better understand appropriate staffing levels for department research functions. Methods: From 2009 to 2016, we kept a detailed analysis of the amount of full-time employee (FTE) effort for regulatory compliance, safety, physical space management, and orientation of investigators, fellows, residents, and students doing research for five principal investigators. Then, we queried a focus group of eight senior research administrators and directors at several medical schools to examine whether the effort we assigned appeared correct for their institution and for other comments. Results: We found that a 10% effort is necessary for safety oversight of the laboratories. We next found that consistently at least 20% effort is needed for regularly occurring tasks (personnel orientation, DEA and other requirements for animal studies, chemicals, etc.). We also discovered that there was a 20% variable effort for intermittent tasks (e.g., lab remodeling, lapsed safety training, etc.). The focus group commented that compared with our department, 0.5-2.0 FTE would be required for similar tasks at their institution for a similar sized entity (mean 1.25±0.87 standard error of the mean FTE; n=4). Conclusions: There was agreement that increasing regulatory demands require about 10% of an FTE/laboratory program for sufficient oversight of compliance. Various “recharge” mechanisms were suggested by a highly experienced focus group.