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Table 1. Guiding Principles of the DHS Research Oversight Board





Support meaningful, proportionate, and impactful healthcare research that aims to achieve the DHS mission


Streamline and facilitate research approvals


Enhance accuracy, availability, and management of data for research


Set-out a framework to guide oversight and the decision making process


Promote institutional capacity and external collaboration for research

  1. That is, support effectiveness research, which directly impacts the DHS patient population
  2. That is, support efficiencies that align project review, approval, and oversight processes
  1. Streamline the IRB process with other regulatory and DHS oversight approvals
  2. Harmonize IRB and compliance processes across the network of Los Angeles County institutions

1. Subsume the rules for access and use of research data under the DHS Business Intelligence governance model

  1. A guidance for resource and research planning (refer to Table 2)
  2. Discussions the framework will generate are understood to be complex and the Research Oversight Board is empowered to establish precedence
  1. Facilitate changes to DHS operational practices from within the office of the Chief Medical Officer and from the Research Oversight Board
  2. Facilitate a meaningful and effective mentorship model for opportunity creation
  3. Facilitate partnerships with regional and national networks

ard

PI initiates Institutional Review Board process



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 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 allowedTable 2. Framework for research project categorization and DHS resource supportDHS 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 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

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