NEWS ITEM
July 30, 2010
Increase in HSD fee for industry-initiated clinical trials
The Human Subjects Division (HSD) is raising its fee for industry-sponsored clinical trials from $1000 to $1500, effective with all contracts finalized on or after September 1, 2010.
Background
Since about 2003, industry-sponsored clinical trials at the UW have been charged a $1000 fee by HSD to help cover HSD’s costs for fulfilling mandatory regulatory and administrative responsibilities that HSD retains regardless of where the IRB review occurs. Industry sponsors are accustomed to paying such fees at academic institutions because the indirect cost rates applied to industry clinical trials are lower than federally-negotiated rates and therefore many costs become direct line items in the budget.
Rationale for Increase
· The fee has remained constant for 7 years, though the costs of fulfilling these responsibilities have increased. For example, two years ago HSD needed to hire a fulltime compliance analyst to work exclusively on industry trial issues. Other HSD staff members also spend significant effort on these activities.
· New and additional compliance activities for clinical trials have recently become HSD’s responsibility. These are responsibilities that must be regularly addressed throughout the life of each clinical trial.
· Service and improvements. By enhancing HSD’s cost recovery, we will be better able to maintain an acceptable level of service for researchers and sponsors. HSD has been an active participant in recent process improvement efforts focused on clinical trial startup processes at the UW. This fee increase will also help ensure that we can continue to identify and implement improvements.
Implementation
We believe that it is easier and more cost-effective for all parties involved to charge a higher one-time fee of $1500 at the beginning of the clinical trial, rather than to charge a fee annually during the life of a clinical trial. This will be implemented for all industry clinical trial contracts finalized on or after September 1, 2010.
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