NHSR Institutional Requirements

Not Human Subjects Research (NHSR)

Researchers conducting NHSR projects cannot access or use identifiable human data unless the data is decedent data or from a publicly available source.

If you WILL directly access the medical record, your project IS considered human subjects research; it is NOT NHSR.

• Summary of Categories and Requirements (PDF)

NHSR Categories

There are three NHSR categories:

1. Publicly Available Data
2. Deceased Person Data Collection
3. Secondary Analysis of Data

NHSR submissions are considered research under the federal definition. All research SOPs and institutional policies apply, including Data Protection.  Note that an IRB protocol is not required for NHSR submissions.

Publicly Available Data

• Store the data using an approved LOW-RISK research data storage plan (select from Data Protection Form)

Deceased Person Data Collection

• Ensure that the research is only using deceased person data, if NOT, this is human subjects research. STOP and modify the Data Protection form and resubmit.
• Complete the HIPAA Decedent Form (if using WVU Health System EMR data).
• Store the data using an approved LOW-RISK research data storage plan (select from Data Protection Form).
• If transferring data out of the University a Data Agreement may be required (via the Data Protection process).

Secondary Analysis of Data

• NHSR means that WVU Health System medical records CANNOT be directly accessed, the data must be de-identified and provided by WV CTSI to qualify for NHSR.
• If the medical/dental record will be directly accessed, this is human subjects research. STOP and modify the Data Protection form and resubmit.
• Store the data using one the approved LOW-RISK storage plans (Data Protection).
• If transferring data out of the University a Data Agreement may be required (via the Data Protection process).