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.
