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IRB-HSR > Getting Started > PI Responsibility > Types of Submissions to the IRB

 

 

 

 

 

 

Types of Submissions to the IRB

Investigators are required to obtain a 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.

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 Application for Non-industry Sponsored Research

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. For details on how to submit a grant application please refer to the following websites:

Instruments

The IRB is required to review all research instruments including standardized instruments such as surveys, questionnaires, inventories and assessments to be used in the proposed research. Please include the instruments, if available, with your initial application. Investigators may submit draft versions of investigator initiated study instruments for the IRB to review. The IRB is required to review any modifications to research instruments. Please submit a modification to the IRB when requesting changes to previously approved instruments. If draft instruments are submitted, the instruments cannot be used until they are approved by the IRB.

Investigators Transferring Protocols/Grants From Outside Institution

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's for further information. See IRB Contacts.

Submissions Required After Initial Protocol Approval

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