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West Virginia University Office of Human Research Protections
WVU Research Office

Protocol Submissions

Submission and Management

WVU requires that the human subjects research protocols be submitted and managed through the WVU+kc system.

Access to the system is automatic, you do not need to request an account. If you cannot access the system, contact WVU ITS. Before submitting a protocol application, visit the Get Started page.

Relevant SOPs

WVU Protocol Submission Types

Only Minimal Risk

Protocol Type           
    		 Approval Term

Amendments
Renewals 		Expiration Action

Flex Single
5-Year Team    		 No Automatic Expiration
Resubmit as New
NHSR Single
5-Year Term		 No No Resubmission -
If risk is unchanged
Exempt Single
5-Year Term		 No Automatic Expiration
Resubmit as New
Expedited New Common Rule: 5 Years
Old Common Rule: 1 Year		 Yes Determined by WVU IRB
CIRB 10-Year Term To CIRB only Determined by CIRB


More than Minimal Risk

Protocol Type           Approval Term      Amendments
Renewals 		Expiration Action
Full Board
Clinical Trial		 1 Year
or less		 Yes Determined by WVU IRB
Full Board
Non-Clinical Trial		 1 Year
or less		 Yes Determined by WVU IRB



Protocol Type Definitions

Only Minimal Risk Protocols

  • WVU Flex 
    A WVU specific type of review that applies to research that is not federally funded.  Flex cannot be used for Clinical Trials and International Research. 
  • NHSR 
    A project that does not directly involve human participants nor does it involve their data in a manner where there is any identifiable risk to individuals.   Protocols active after five years, do not need to reapply is no changes are made that increase risk or change the protocol type.
  • Exempt 
    Research that unless otherwise required by law in which the only involvement of human subjects will be in one or more of the exempt categories in paragraph are exempt from the federal regulatory requirements, except that research activities must comply with the requirements specified in each exemption category and institutional requirements for managing research and data protection. 
  • Expedited 
    Federal regulations have established expedited IRB review procedures for certain kinds of research involving no more than minimal risk (OMR), and for minor changes in approved research. 

More Than Minimal Risk Protocols

  • Full Board  - Non Clinical Trial
    Research that involves more than minimal risk (MMR), or involves protected populations such as children, prisoners, or disabled individuals. Research that is not eligible for exempt or expedited review.
  • Full Board - Clinical Trial 
    Voluntary research studies conducted on human participants and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. Clinical trials are MMR.

Other Submission Types

Risk Categories

  • Only Minimal Risk (OMR) Also referred to as Minimal Risk. The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance
  • More Than Minimal Risk (MMR)  Also referred to as Greater than Minimal Risk - There is a probability of an event that is serious, prolonged and/or permanent occurring as a result of participation in the research or there is significant uncertainty about the nature or likelihood of adverse events.