Review Process

IRB-SBS protocol review process is based on federal regulations 45 CFR 46 and UVA Human Research Protection Program Standard Operating Procedures. The purpose of the IRB-SBS review is to assist UVA researchers as they prepare a human subjects research protocol that is compliant with federal, state, and local regulations, UVA policy, and ethical standards.

 

 

Exempt Determination Protocols

The 2018 Federal Regulations (45 CFR 46) exemption categories define specific protocols that are exempt from the federal regulation requirements. Protocols that qualify for exemption from the federal regulations (also called the common rule) are still required to be submitted for IRB review. 

 

The following categories are most likely to be used in a social and behavioral sciences study:

  • Normal Education Practice

  • Surveys

  • Benign Behavioral Interventions

  • Educational Tests

  • Observations

  • Secondary Use of Existing Data

 

Expedited Approval Protocols

The federal regulations recognize that studies with a low level of risk do not require review by the full board for IRB approval but could be reviewed and approved by the IRB Chair or designee. This IRB process is called Expedited Approval. To qualify for expedited approval by the IRB, the study protocol must meet the definition of minimal risk (as 45 C.F.R. § 46.102(i)) and fit the criteria for the research categories as defined by the U.S. Department of Health and Human Services.

 

Full Board Approval Protocols

If a protocol doesn't meet the criteria for an exemption determination or the criteria for expedited approval, then protocol needs to be reviewed by the IRB Full Board for the study approval. 

 

The full board meets twice per month on the 2nd and 4th Wednesday of every month with the exception of December that only has one meeting.  When your study has completed the pre-review process and is ready for the full board to review it, your protocol will be assigned to the next available meeting with an open agenda. See Full Board Meeting for more information about the board meeting cycle.

 

Once the protocol is reviewed, you will receive a notice regarding the board's determination. See Board Determinations for more information about the various determinations and how to respond.

 

When a protocol is reviewed in a full board meeting for a modification, ongoing continuation review also happens in at that time. 

 

If the study is closed to enrollment and in the "data analysis only" phase at the continuation review, or if the protocol is modified and the modification significantly reduces the risk level, then the full board can determine that the study now qualifies as minimal risk.