When a protocol is pre-reviewed, the investigator will receive correspondence detailing requests for revisions, clarification, or additional information. When the modifications are made and submitted to the IRB, they are reviewed by administrative staff.

The investigator has 90 days to respond to the revisions requested.  If the investigator does not respond in 90 days, the application is withdrawn and returned to the investigator. If the investigator wishes to conduct a study that has been withdrawn, the investigator must submit  a new application, incorporating comments from the prior IRB review.

• Approved: no revisions needed
• Approved with Conditions: minor revisions that can be verified by the PR
• Deferred: revisions needed that need to be reviewed by the full board at another convened meeting
• Not Approved: protocol cannot be approved even with revisions
• Suspend: previously approved protocol is reviewed due to an unexpected adverse event or protocol violation and board requires a temporary cessation of research activities
• Terminate: previously approved protocol is reviewed due to an unexpected adverse event or protocol violation and board requires a final cessation of research activities

Please note that “Not Approved” and “Terminate” are end points for the protocol. The protocols cannot be copied or resubmitted. See the next sections regarding resubmission for "approved with conditions" or "deferred" protocols. 

The Board strives to make recommendations that will ultimately protect participants, but they do not want to compromise the research process either. The protocol process is not always perfect; although the Board is very diligent in trying to understand the study, sometimes details get lost in translation. 

If you are concerned about a recommendation made by the Board, first, talk to your pre-reviewer. Your pre-reviewer may be able to help you better understand what the Board is asking and help you determine if the Board’s request has any flexibility. 

Second, if the recommendation for your protocol still needs to be altered, devise alternative solutions to present to the Board. Generally the Board’s underlying concern behind their recommendation is the most important part to satisfy. For example, if the Board recommended that you make a change in your data collection process because they felt like the proposed process would compromise the participant’s confidentiality, but you find that the recommendation actually doesn’t protect participants or makes it impossible for you to collect the data, you should re-evaluate your data collection process and propose a solution that will improve your ability to protect participant confidentiality while maintaining your data collection. In most cases, the Board will be willing to consider alternative solutions if the underlying goal is met. 

However, if you refuse to consider the concerns of the Board or decide that their recommendations are inconvenient, the Board will be less willing to work with you. Please know that the Board is bound by the federal regulations which determine how the Board makes its decisions; the Board cannot approve measures which violate the regulations that they follow.

If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person and/or in writing. 

Investigators may appeal an IRB decision. A principal investigator may appeal the decision by writing a letter to the IRB requesting reconsideration.  At the discretion of the chair, the investigator may make such an appeal in person and/or in writing to the IRB. 

An appeal of a disapproved research project must be reviewed at a full board meeting. 
In the case of a decision by the IRB to disapprove, suspend, or terminate a project, the decision may not be reversed by the Vice President for Research or any other officer or agency of the University of Virginia, state government or federal government. 

The IRB retains the final authority for approval of proposed research with human subjects. 

The IRB has the authority to suspend or terminate approval of human subject's research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, related and serious harm to subjects. Any suspension or termination of approval includes a statement of the reasons for the IRB's action and is reported promptly to the investigator, the investigator's department chair, and to Office of Sponsored Programs/ Office of Grants and Contracts. The IRB may require remedial action or education as deemed necessary for the investigator or any other key personnel. Federal regulatory agencies are notified as required by federal regulation. Suspension is the temporary closing of a human research project or discontinuing an investigator's privilege to conduct human subject research. The suspension may be partial in that certain activities may continue while others may stop or it may be complete in that no activity related to the research may proceed. The IRB will make this determination.

Termination is the ending of all activities related to a human research project or an investigator's privilege of conducting human subject research at the University of Virginia except for the continuation of follow-up activities necessary to protect subject safety.