Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Please include the following information on your new IRB application. If you are filing an amendment to an existing IRB application, please use this as a guide for the information you need to include.

Section 2

Expand
titleQuestion 2.1

Ensure that all study personnel that will access the data are listed. If they will access identifying patient data (names, dates, MRNs, etc.), select ‘Yes’ under ‘Access Identifiable Data’

Section 9

Expand
titleQuestion 9.1

If your study involves secondary analysis (ex. retrospective chart review), select the secondary analysis option that applies to your research. Checking one of these boxes triggers the activation of section 13, also needed for your application.

Info

Studies conducting retrospective review of medical records typically select the second checkbox: “Secondary Analysis. Thus study involves use of data/specimens that have been or will be collected/generated for non-research purposes (e.g., medical records, student records).”

Section 13

Expand
titleQuestion 13.1

If you would like to include patients known to be deceased in the dataset, please select ‘Yes’. Otherwise, we will automatically exclude any patient known to be deceased from your dataset.

Note that patients are typically only marked as known to be deceased in the medical record if they pass away while admitted to the hospital.

Expand
titleQuestion 13.2.1

Select ‘Yes’

Section 24

Expand
titleQuestion 24.1 (for studies recruiting subjects only)

If you will be using the dataset to contact patients for study recruitment, select ‘Clinical Data Warehouse’:

Section 35

Expand
titleQuestion 35.1

Select ‘Yes'

...

Expand
titleQuestions 35.3 to 35.6

Please select ‘Yes’ as applicable if your dataset will include HIV data, mental health data, or substance abuse treatment data. Make sure to select ‘Yes’ if your study’s selection criteria has any of this data.

Section 36

Expand
titleQuestion 36.1
  • If you will be using the dataset to contact and recruit subjects for your study, select ‘Partial Waiver of HIPAA Authorization for screening, recruiting, and identifying participants’

  • Otherwise, select ‘None of the Above’

Section 42

Expand
titleQuestion 42.1

Select ‘Keck Medicine of USC’

...

Expand
titleQuestion 42.3.1 (for studies recruiting subjects only)

Describe how you will contact patients (for example, sending emails to potential subjects)

Section 45

Expand
titleQuestion 45.1

Select “USC HSC - Health Sciences Associated Locations”

image-20240628-222551.png

Section 45a

Expand
titleQuestion 45a.1

Select “Keck Hospital of USC Facilities” and “Keck School of Medicine of USC”

image-20240628-222743.png

...