Required Approvals

Research performed at Parkland requires approval by the Parkland Office of Research Administration. Following are the necessary approvals to initiate and conduct your study at Parkland.

In this section:

• Institutional Review Board (IRB) Approval
• Parkland Site Approval by Office of Research Administration
• Parkland Research Credentialing & Systems Access

Institutional Review Board (IRB) Approval

All research involving human subjects must have an Institutional Review Board (IRB) approval from a recognized IRB. The  Research Project Checklist and  Quality Improvement (QI) Project Checklist may assist you in determining whether your study meets the definition of Human Subject Research or is more appropriately designated as Quality Improvement (QI). Additional resources are accessible via the Office of Human Research Protections (OHRP) website.

The IRB’s primary concerns in the review of research are that:

• risks are minimized for participants and are reasonable when compared to benefits to the individual and/or to society; 
• participant selection is equitable so that the benefits and burdens of research are equitably shared;
• privacy and confidentiality are protected; and
• participants are adequately informed of what their participation will entail so that they can make an informed decision about whether to participate.

Parkland Health & Hospital System relies upon an external Institutional Review Board (IRB). Parkland’s Federalwide Assurance (FWA) as approved by the Office of Human Research Protections identifies the respective external IRBs linked to this assurance. The number is FWA00001387 and is filed with the legal name Dallas County Hospital District (d/b/a Parkland Health & Hospital System). 

The FWA covers the hospital, outpatient clinics, primary care clinics and the Dallas County Jail. The assurance lists the five external IRBs that Parkland primarily relies upon: UT Southwestern IRBs #1, #2, #3 and #4; National Cancer Institute IRB #1.

A full list of IRBs upon which Parkland relies may be accessed via the Office of Human Research Protections (OHRP) online database for the status of IRBs and FWAs. 

For more information regarding the IRB application and submission process, click here or email Research@phhs.org.

Parkland Site Approval by Office of Research Administration

All research conducted at Parkland must have Parkland Office of Research Administration Approval as demonstrated by a signed letter by the Parkland Vice President of Research Administration. This is to ensure compliance with The Joint Commission, OHRP, and other regulatory requirements. 

Additionally, if you are applying for a grant or require assistance with any type of research contractual matter, including subcontracts, letters of support, or letters of indemnification, contact the Director of Research Grants & Contracts. Additional information may be accessed via the Research Grant Lifecycle section.  

Parkland Research Credentialing &Systems Access

Parkland has developed an Annual Non-Physician Research Credentialing Process for non-Parkland personnel, primarily emanating from UT Southwestern Medical Center. 

The Parkland Research Credentialing process must be completed if performing any of the following research activities at Parkland: 

• Interacting with Parkland patients (recruitment, consenting, medication administration, phlebotomy, etc.)
• Collecting or reviewing Parkland patient medical records (paper & electronic) or specimens
• Requesting Parkland EPIC access

Principal Investigators must have Medical Staff Privileges at Parkland or obtain a faculty sponsor on staff at Parkland. 

For questions regarding non-physician research credentialing email Research.Credentialing@phhs.org.