Download Request for Sensitive Study Status Worksheet

Request to Emory IRB for Determination of Sensitive Status
IRB File #
PI:
Date:
Instructions: Investigators should complete this form and upload it in the eIRB smartform (Data and
Safety Monitoring section, 6.0) to request “sensitive study” status for a clinical study.
Sensitive studies are subject to the following processes:

The Office of Clinical Research (OCR) will NOT link the signed consent/HIPAA documents in the
EeMR

OCR will link the Sensitive Study version of the Key Points Summary to the EeMr. This version
has key safety information but not the study title.
Please answer all of the following questions:
1. What is the stigmatizing condition or factor? (Note: Illicit drug use, behaviors placing a subject
at high risk of HIV or hepatitis infection, HIV serostatus, hepatitis infection, schizophrenia, and
bipolar disorder are presumed to be stigmatizing.)
2. How is this condition or factor noted in the study (e.g. study title)?
3. Will identifiable information about the subject be recorded that could be linked to the specific
condition or factor? If so, what information and how will it be linked?
4. What other measures are in place to protect the privacy of the subject and the confidentiality
of their information?
IRB Form: 07022011