Selecting the Review of Records/Data/Images Option on the Special Procedures Page
What is the purpose of the Review of Records/Data/Images section?
The Review of Records/Data/Images section of the initial review application asks study teams to provide information about the access and use of records/data/images for certain research purposes (e.g., retrospective chart review).
When does the Review of Records/Data/Images section display?
The Review of Records/Data/Images section displays only if the study team selects this option the list of Special Considerations and Procedures in the initial review application.
When should the Review of Records/Data/Images option be selected on the Special Considerations and Procedures page?
When to select the Review of Records/Data/Images option largely depends on the IRB that will be reviewing the application. The reason for this is that the Minimal Risk (MR) IRB and Health Sciences (HS) IRB review different types of studies and the need for specific information about review of records/data/images frequently depends on the type of study. Please see the table below for specific guidance on when to select this option.
|Minimal Risk IRB Applications||
|Health Sciences IRB Applications||