PROCESS & INFRASTRUCTURE

Borrego Health is committed to ensuring a high quality of research activity that prioritizes patient-centered, community-engaged, and culturally sensitive research.

 

Borrego Health’s Research Department will approve and oversee all human subjects research (HSR) activity to ensure the research provides protection for its participants as per the federal regulations at 45 CFR part 46 (the Common Rule) and any applicable State of California regulations. Borrego Health has an active Federal-wide Assurance with the Office for Human Research Protections.

 

PLEASE NOTE: While Borrego Health does not have its own Institutional Review Board (IRB), the Research Department requires IRB approval and if applicable, continuing review, for all human subjects research activity.

 

External researchers interested in partnering with Borrego Health should email research@borregohealth.org with their contact information, abstract/specific aims (if available), and a link to the funding opportunity (if applicable).

 

PLEASE NOTE: If you are a Borrego Health employee or contractor (including our residents who must complete a research or QI project to fulfill residency requirements), you must fill out an application for any research project you are interested in that would utilize Borrego Health resources, including data, facilities and/or involve Borrego Health patients or patient charts. Please log in with your Borrego Health email account and find the Application for Borrego Health Employee - Initiated Research Project on our Team Site. The Research Department must review and approve all research projects before they can start.

 

What To Expect When Partnering In Research With Borrego Health

 

Pre-award Process:

 

The initial pitch must be made to the Research Department.

The Research Department will make its initial assessment based on criteria, including, but not limited to:

  • Approval from Department(s) likely to be impacted by the research

  • Resources the project brings to Borrego Health (e.g. financial & workforce contribution)

  • Alignment with clinical priorities (e.g. topic & timing)

  • Feasibility of the project

  • Adequate protections for HSR participants and their protected health information (PHI)

 

The Research Department is responsible for:

  • Approval from the corporate Chief Operating Officer (COO)

  • Presentation to and approval from the Clinical Development Committee [convenes 1x/month]

  • Facilitating approvals and signatures from Chief Financial Officer (CFO) [allow for 1 week]

  • Facilitating approvals and signatures from Chief Executive Officer (CEO) [allow for 1 week]

 

Post-award Process:

 

The Research Department is responsible for oversight of all research activities. This includes maintenance of compliance files, such as IRB approval letters, informed consent, valid HSR training certificates, documentation of Borrego Health's reliance on the partnering institution's institutional review board (IRB) and more.

BCHF is a Federally Qualified Health Center and a Federal Tort Claims Act Deemed organization. The Federal Government is the primary insurer.
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