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Protocol Types

Use the following protocol types for submissions in WVu+kc:

Only Minimal Risk (OMR) Protocol Types:

  • NHSR 
    A project that does not directly involve human participants or involve risk that data will be able to identify individuals. Approved for a single, 5-year term. Protocols active after five years, do not need to reapply if there is no change in risk or protocol type. Amendments and renewals are not required. 
  • Flex
    A WVU specific type of review that applies to research that is not federally funded and research that is only minimal risk (OMR). Flex cannot be used for Clinical Trials and International Research. Approved for single, 5-year term and then automatically expires. Protocols active after five years will automatically expire and must be resubmitted as new protocols. Amendments and renewals are not required.
  • Exempt 
    Research that unless required by law only involves human subjects in one or more of the exempt categories. Exempt research is exempt from federal regulatory requirements, although research activities must comply with the requirements specified in each exemption category and the WVU institutional requirements for managing research and data protection.  Protocols active after five years will automatically expire and must be resubmitted as new protocols. Amendments and renewals are not required.
  • Expedited 
    Federal regulations have established expedited IRB review procedures for research involving only minimal risk (OMR), and for minor changes in approved research. 

More Than Minimal Risk Protocol Types:

  • Full Board 
    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:

  • CIRB
    A registration submission for registering protocols when WVU is not the IRB of Record

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 of routine physical. 
  • 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.