Compliance with IRB requirements

An understanding of the purpose and process for compliance with IRB requirements is an educational goal of the emphasis Program. Therefore:

• All students enrolled in the Emphasis Program must complete the CITI Program in the Fall of VMS1 and maintain certification for the duration of the Emphasis program.
• All students will review their projects with their mentors to determine whether an application to the IRB is required.
• Even if the project is classified as an educational assignment , an application must be made to the IRB for an exemption.

Process
  1. All projects involving human subjects will be reviewed by the area head to decide if IRB approval
      is needed.
  2. The student is responsible for initiating an application to the IRB.
  3. The Office of the IRB will notify the Director of the Emphasis Program when an IRB application is
      initiated.
  4. Completion of the IRB application process once initiated is compulsory. If it’s determined during
      the process that IRB approval is not in fact required, the student must submit a formal withdraw
      letter to close the file.
  5. For those projects requiring IRB approval, work cannot start without IRB approval and sign off by
      the area head.
  6. The Director of the Emphasis Program will be notified by the IRB when an IRB decision is made.
  - Emphasis Planning Committee May 29 2007