Institutional Guidance: Not Human Subjects Research (NHSR) and Other Projects That Do Not Require IRB Review

Overview

NHSR Categories

• NHSR submissions are considered research under the federal DHHS definition of research. 
• All research SOPs and institutional policies apply including Data Protection, including Conflict of Interest. 
• Do not submit an IRB protocol. This is not required and will no longer be accepted.
• You will or should have received a PDF in email that contains the "Letter of Determination" language for NHSR that may be needed for publication.

Publicly Available Data

• Additional institutional requirements:
• Store the data using an approved research data storage plan (select from Data Protection Form).
• Ensure an up-to-date COI disclosure has been submitted in WRAP. 

Decedent Data Collection

• Ensure that the research is only using decedent data. If NOT, this is human subjects research. 
• STOP and modify the Data Protection and Determination form and resubmit.
• Additional institutional requirements: 
• Complete the  HIPAA Decedent Form (if using WVU Health System EMR data).
• Store the data using an approved research data storage plan (selected from Data Protection Form).
• If transferring data out of the University a Data Agreement may be required.
• Ensure an up-to-date COI disclosure has been submitted in WRAP. 

Secondary Analysis of Data

• To qualify for NHSR, WVU Health System medical records CANNOT be directly accessed , the data must be de-identified and provided by WVCTSI to qualify for NHSR.
• If the medical/dental record will be directly access, this is human subjects research. 
• STOP and modify the Data Protection and Determination form and resubmit.
• For all data sources, the research team must never have access to identifier or be able to re-link data to identifiable data. 
• Additional institutional requirements:
• Store the data using one the approved storage plans (selected from Data Protection Form)
• If transferring data out of the University a Data Agreement may be required. 
• Ensure an up-to-date COI disclosure has been submitted in WRAP. 

Other Activities & Projects - IRB Review Not Required

• The data supporting activities sponsored by the Health System must be stored at the Health System according to the Health System IT policy. 
• Access to WVU resources such as Qualtrics, REDCap, and Zoom may not be available for these activities.  
• Data supporting University sponsored activities must be managed and stored according to University IT policy. 
• WVU Research Office and WVU IRB policies and process do not apply to these activities. Project teams must adhere to applicable professional ethics codes and the institutional policies outlined below. 
• EMR ACCESS:  Access to the WVU Health System medical records should be obtained from the WVU Health System for both Health System and University Sponsored Activities in these categories (Contact Health Information Management for more information).
• DATA STORAGE for WVU HEALTH SYSTEM PROJECTS:  Store the data at the Health System according to Health System policies (contact Health System IT for more information).
• DATA STORAGE for WVU - UNIVERSITY PROJECTS:   Store the data at the University according to general University data storage policies (contact your local or central IT support for more information).
• DATA TRANSFER:  If transferring data out of the University a Data Agreement may be required.
• Do not submit an IRB protocol. This is not required and will no longer be accepted. Use the PDF as the WVU "Letter of Determination" needed for publication. 
• Institutional policies for data security, access, and data agreements apply; however, the WVU Research Office has no oversight responsibility for the projects in these categories.
  

Case Studies (5 or fewer records)

• Additional Institutional Requirements:
• Complete a Case Authorization Form and include it in the patient EMR.
• If a Case Authorizations form is not possible, contact the WVU Medicine Office of Health Information Management and/or complete HIPAA Waiver of Authorization Request (reviewed on case-by-case basis).
• Contact your Department Head and/or WVU Medicine Office of Health Information Management if using WVU Health System EMR information. 
• Contact WVU or WVU Medicine General Counsel for Data Agreement information according to the entity sponsoring the activity.

Quality Improvement/Quality Assurance; Evidence-Based Practice; or Program Evaluation 

• Additional institutional requirements:
• Contact your department IT for appropriate and compliant storage. 
• Contact your Department Head and/or WVU Medicine Office of Health Information Management if using WVU Health System EMR information.
• Contact WVU or WVU Medicine General Counsel for Data Agreement information according to the entity sponsoring the activity.  
• Obtain appropriate/applicable permissions to conduct the project
  

Classroom/Educational Activities

Oral Histories

Scholarly and Journalistic/Documentary Activities

Public Health Surveillance

• Per 45 CFR 46:  Activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• Additional institutional requirements:
• Contact your department IT for appropriate and compliant storage.
• Contact your Department Head and/or WVU Medicine Office of Health Information Management if using WVU Health System EMR information. 
  
• Contact WVU or WVU Medicine General Counsel for Data Agreement information according to the entity sponsoring the activity.  

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