Updated Data and Specimen Analysis Protocol Template

Dear Research Community,

The IRB office has significantly revised HRP-1704, the protocol template for analysis of data and/or specimens, to make the template more user-friendly and collect more of the information that the IRB needs to process these types of studies efficiently.  HRP-1704 should be used if your only research procedure is analysis of data and/or specimens, the data/specimens are identifiable or include a coding system, and you are not planning to prospectively collect biospecimens for research purposes as part of your project.  (For example, medical record review; analyzing data or biospecimens that were collected in prior research studies; analyzing data available from student education records, government datasets, etc.)  New instructions have been added to the beginning of HRP-1704 providing more detail on when this is the appropriate template to use, and additional instructions have been added about HIPAA, FERPA, and mental health records.  

Please utilize the applicable version for any new projects.

The document can be found in the Templates, Forms, & SOPs tab.

Thank you,

The Northwestern University IRB Office