DARRC/DEC Project Approval Request Form

DARRC/DEC Project Approval Request Form

If there are any questions please contact Katie.Dehne@SanfordHealth.org

Date of Request*

Requester Name*

Requester Email*

Project Title*

PI*

Has this project gone through Sanford's IRB?

Yes

IRB #*

What is the status of this project?*

Pre-IRB Review

External IRB

Sanford's not engaged

Sanford's IRB approved

External IRB involved *

IRB approved or Determination?*

Non-Human Subjects Research

Quality Improvement Project

Human Subjects Research

Where is the data being shared?*

Internal

External

Consent/HIPAA Authorization*

Do you intend to obtain patient consent/HIPAA authorization or do you plan to obtain a HIPAA waiver from the IRB or Privacy

Pre-IRB ONLY- HIPAA waiver requested

Patients consent and give HIPAA authorization

Patients Consent

HIPAA waiver is granted from Sanford IRB

HIPAA waiver is granted from Sanford Privacy

Non Human Subjects Research Determination

Other

If other, please explain*

Level of PHI*

https://internal.sanfordhealth.org/entities/research/Shared%20Documents/Data%20Access%20Governing%20Procedure%20and%20Policy.pdf#search=data%20exchange%20core

Aggregate Data- numbers only

De-Identified – All 18 HIPAA identifiers are removed

Limited Dataset -The only PHI present are full dates and/or City, State, or ZIP Codes

PHI- Patient identifiers are present

Does your project request any of the following*

For more information see the Data Access and Governing Policy https://internal.sanfordhealth.org/entities/research/Shared%20Documents/Data%20Access%20Governing%20Procedure%20and%20Policy.pdf#search=data%20exchange%20core

Insurance data

Financial Data

Geographical info smaller than a state

Employee data (employee satisfaction, staffing outcomes, etc)

Comparison data (within Sanford vs other institutions, Sanford vs Sanford, etc.)

Variables being released*

If attached, put see attached

Note: What is submitted is what is approved by DARRC. Any additional variables requested will need to be reviewed and proper updates to protocols, IRB applications, etc. will need to be updated.

Estimated Number of Records*

Use IRB approved value of records if applicable

Purpose of Data Sharing*

What is Sanford's involvement in the project?

Data Use Agreement (DUA) in place?*

Yes

In Progress

Documents

Please attach any protocols, IRB determination letter, and relevant information

File Upload

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