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A message from Pamela Webb, sent on October 5, 2018.

Colleagues,

The University has made the decision to change the facilities and administration (also called "F&A" or indirect costs) rate for Business and Industry funded Clinical Trials from 26% total direct costs (TDC) to 30% TDC, effective January 2, 2019. The new rate reflects the first increase in 13 years and brings us in line with the rate being charged by many of our national peers.

The new 30% TDC rate is available for use now on an optional basis, but will become mandatory for trials whose full PRFs are signed and submitted to SPA on January 2nd, 2019 and beyond. The long lead time is purposely intended to allow for smooth completion of negotiations for trials already in process. If you have not yet budgeted your trial, we recommend going ahead and using the new rate now. The rate applies to both sponsor-initiated and PI-initiated human or animal trials where the primary sponsor is for-profit. Pre-clinical and basic or applied research agreements will continue to use the University's standard F&A rates (no change from present.) F&A rates may be found at: https://research.umn.edu/units/oca/fa-costs/current-fa-rates.

In general, ongoing active clinical trials will retain their current F&A rate until their existing statement of work is complete (even if that occurs well after 1/2/19); however, trials that propose new arms, new substudies, or additional scopes of work after 1/2/19 will be expected to charge the new rates to the new work. If you are uncertain which rate to use, please consult your SPA Business and Industry Grant Administrator (see list under "Quick Links" at https://research.umn.edu/units/spa# )

In accordance with University policy, for-profit sponsors are expected to pay both direct and indirect costs of the projects they fund, and F&A waivers or reductions are rare. Nonetheless, if you have a special circumstance that requires an F&A reduction after 1/2/19, you may submit a waiver request through the usual University procedure (https://policy.umn.edu/research/cost-proc03) . Reductions from 30% TDC to 26% TDC will be considered under the "regular" F&A waiver category. Waivers to rates lower than 26% TDC fit in the "strategic" category and are very rarely approved (as is the case today.)

Should you have any questions, please don't hesitate to contact me.

Pamela