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Table 2. Framework for research project categorization and DHS resource support


DHS consumables and supplies

DHS staff time and effort, including administrative, IT back-end system access and clinical staff

Fixed cost DHS resources, e.g., space, IT front end systems, utilities, etc.

Access to Patients for study recruitment (study performed at another institution)

Category 1:

Research performed at DHS sites and well-aligned with DHS business needs and strategic priorities. It is anticipated that the results of the research will have a significant direct impact on clinical operations for a significant number of DHS patients. Direct DHS resources can be used to fully support projects in this category; however, researchers should make every effort to obtain extramural funding.




DHS supports fully or partially




DHS supports fully or partially




DHS supports fully or partially




DHS supports fully or partially


Category 2:

Research performed at DHS sites and well-aligned with DHS business needs and strategic priorities. The research results are expected to affect care of the population served by DHS. Some external funding support is required to accomplish the research objectives




DHS supports partially or none




DHS supports partially or none




DHS supports partially or none

DHS supports partially or none for group recruitment.

Individual patient referral to an appropriate study is always allowed


Category 3:

Research performed at DHS sites with potential benefit to DHS patients in the future. DHS will allow access to resources, but the study must cover the cost of these resources.



DHS supports

Study must fully fund at least marginal cost



DHS supports Study must fully fund at
least marginal cost




DHS supports

Study must fully fund at least marginal cost

DHS allows access, but study must cover cost of any negative operational impact of recruitment

Individual patient referral to an appropriate study is always allowed

Category 4:

Research intended to support the development of new drugs, medical devices, or procedures that, although having the potential of improving the care of patients in the future, does not address a key component of DHS's service priorities or needs that disproportionally affect DHS's patient population.

These projects have potential positive impact for the DHS population (e.g. drug discovery)




Full compensation of at least marginal cost





Full compensation of at least marginal cost





Full compensation of at least marginal cost

DHS allows access, but study must cover cost of any negative operational impact of recruitment

Individual patient referral to an appropriate study is always allowed

Category 5:

Research that has no benefit to DHS or its partners and should not be conducted on a DHS campus


No


No


No


No


(a) Services and supplies includes clinical services and supplies. This excludes outpatient pharmaceuticals (340b). Subject to the facility CEO’s approval, drugs may be issued from the inpatient pharmacy inventory at average wholesale prices.- Pg. 5 – revised February 2018

(b) DHS staff time and effort includes administrative and clinical staff. DHS staff time will be based upon actual hourly salary, plus variable employee benefits. Space and related space support (utilities) is subject to availability and approval by the facility’s Chief
Executive Officer. Space and related space support will be billed based upon County CEO Real Estate’s fair market value rental rate per square foot and facility’s utilities cost per square foot, absent other research master space lease agreement provisions.

(c) For purposes of determining variable costs, the following rate structure is applicable. Rates billed will be based upon date of service.

• Inpatient services: Medi-Cal daily per diem rate.

• Outpatient services: Medicare fee schedule + 20%.

• Ancillary services: Medicare fee schedule +20%.

• Information Technology services: Hours multiplied by programmer’s actual hourly rate, plus variable employee benefits.



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