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
- Review of Records/Data/Images option should be selected if records/data/images will be accessed or used for any reasons other than the identification and recruitment of potential subjects.
- Do NOT select Review of Records/Data/Images if records will be reviewed to identify and recruit potential subjects. If records will be used to identify potential subjects, this should be addressed in the Subject Identification and Recruitment section.
|Health Sciences IRB Applications
- Review of Records/Data/Images option should typically NOT be selected for applications submitted to the HS-IRB. Please contact the HS-IRBs office for guidance if the examples below do not cover how records/data/images will be reviewed for your study.
- Do NOT select Review of Records/Data/Images if records/data/images will be reviewed for any of the following reasons:
- Identifying and recruiting potential subjects. If records will be used to identify potential subjects, this should be addressed in the Subject Identification and Recruitment section.
- Confirming adverse event information
- Collecting lab results (whether standard of care or research) or other subject information from medical records as part of their participation in a clinical trial.