IRB-HSR Study Review Submission Types

Not all studies receive the same type of IRB review.  The IRB reviews studies differently based on the level of risk and the specific conditions around the need for the study.  For example, a Humanitarian Use Device study is reviewed under different criteria, in accordance with the federal regulations, as opposed to a simple chart review study.  To speed up the review of your study, please clarify the type of study you are submitting at initial review.  We have created the IRB-HSR Submission Types Chart to provide background information.

Federal Regulations require prospective IRB review and approval if any of the following criteria exist:

  • When research with human subjects is conducted by an employee, student or agent, or under the direction of an employee or agent of University of Virginia, or its affiliated institutions, in connection with his or her institutional responsibilities, or
  • When the conduct or recruitment of the research involves institutional resources (property), facilities or funding, including extramural funds administered by University of Virginia , or
  • When the research involves the use of University of Virginia's nonpublic information to identify or contact human research subjects or prospective subjects.

 

Initial Study Submissions

Determination of Exemption
Expedited Review
Full Board Review
EMERGENCY USE

 

Expanded Access Submissions

Expanded Access for Unapproved Drugs and Biologics
Expanded Access to Unapproved Medical Devices

 

Reliance Agreement and Single IRB Submissions

Reliance on the IRB-HSR to serve as the Single IRB (sIRB) of record
Reliance on a Non-UVA IRB to serve as the Single IRB (sIRB) of Record

 

Study Submissions for Continuing IRB Approval

Continuing Review Process
Data and Safety Monitoring Plans and Data Safety Monitoring Boards

 

Study Amendments & Modification Submissions

Modifications to Approved Research - Background
Modifications to Approved Research Process

 

"When things go wrong" Submissions

Serious Adverse Events
Reporting an Unexpected Adverse Event
Protocol Deviations, Non-compliance and Protocol Exceptions

 

Special Situations:

Submission of a Protocol to a Second IRB after Disapproval from another IRB

If an investigator submits a protocol to a University of Virginia IRB or to another IRB outside the University and the reviewing IRB disapproves the study, and it is subsequently sent to another IRB for review, that IRB must be informed by the PI of the original disapproval.

When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution. If the study is submitted to a second IRB, a copy of this written statement should be included with the study documentation so that it can make an informed decision about the study. Federal regulations require an IRB to "... review ... all research activities...." The FDA regulations do not prohibit submission of a study to another IRB following disapproval. However, all pertinent information about the study should be provided to the second IRB.

Grant Proposal Submissions

Research regulated by pre-2018 Common Rule

Where a protocol has funding from a grant and the proposal involves the use of human subjects in research, a copy of the grant proposal must be forwarded to the IRB along with all other documentation. No work may be initiated on a grant, or protocols funded by that grant prior to receipt of approval from the IRB. 

Research regulated by 2018 Common Rule

The IRB-HSR is only required to review the Grant proposal in rare situations such as if the Grant will be funded by a federal agency besides the FDA that does not follow the Common Rule (e.g. Department of Justice). 

Investigators Transferring Protocols from Outside Institution

Research regulated by pre-2018 Common Rule
Investigators who transfer research to University of Virginia from their previous institution are required to submit the protocols/grants to the IRB for review and approval in order to continue the study. See the information listed above. Please feel free to contact the IRB for further information. See IRB Contacts.

Research regulated by 2018 Common Rule
Investigators who transfer research to University of Virginia from their previous institution are required to submit the protocols to the IRB for review and approval in order to continue the study or obtain an IRB Reliance Agreement.

If the study is funded by a federal agency that has not signed onto the Common Rule, the investigator must also submit the Grant Proposal to the IRB-HSR. Please feel free to contact the IRB's for further information. See IRB Contacts.

Submissions Required After Initial Study Approval

For information on submissions required after initial protocol approval see: Maintaining a Protocol After Initial Approval