NHSR and Not Research Go-Live Support

Next Steps and Guidance:
NHSR and Not Research Projects

Overview

On November 14, the process for projects that do not meet the federal definition of research and projects that are considered research but Not Human Subjects Research (NHSR) will change.

The process for FLEX submissions remains unchanged.

The WVU Research Office recognizes the need to streamline processes and save time and so we have removed the need to submit an IRB protocol to obtain an Letter of Determination for publication purposes for projects that do not require an IRB review.

What Changed

The Letter of Determination, for research projects and activities that do not meet the US Department of Health & Human Services definition of research and Not Human Subjects Research (NHSR) will be obtained by using the Human Research Data Protection & Determination application.

• Is the federal definition of research met?
• Category of Project that is not considered research
• Next Steps

NHSR submissions will be required to complete the Data Protection Form after confirming the NHSR type to receive the Letter of Determination as these projects are considered research and are under the oversight of research policies and procedures.

• Summary of Categories (PDF)