Protocol Submissions | Office of Human Research Protections

Submission and Management

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

Protocol Type	Approval Term	Amendments Renewals	Expiration Action
Flex	Single 5-Year Team	No	Automatic Expiration Resubmit as New No longer available; effective November 9th, 2025.
Exempt	Single 5-Year Term	No	Automatic Expiration Resubmit as New
Expedited	New Common Rule: 5 Years FDA regulated: 1 Year	Yes	Determined by WVU IRB
CIRB	10-Year Term	Some	Determined by CIRB

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

WVU Flex
A WVU specific type of review that applies to research that is not federally funded. No longer available, effective November 9th, 2025. Previously approved FLEX studies may continue and do not need to be resubmitted as Exempt or Expedited studies at this time.
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 are exempt from some federal regulatory requirements. The research activities must comply with the requirements specified in each exemption category and institutional requirements for managing research.
Expedited
Federal regulations have established expedited IRB review procedures for certain kinds of research involving no more than minimal risk (OMR) that fit into one or more designated categories, and for minor changes in approved research.

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.

External IRBs (CIRB, sIRB, IAA)
A registration submission for registering protocols when WVU is not the IRB of Record.

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.