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Institutional Review Board (IRB)

Our approach

The IRB meets monthly (usually the 3rd Tuesday of each month). The deadline for applications are due to the IRB secretary 14 days prior to the next meeting. (Example: Meeting is scheduled for Tuesday, February 19; all applications are due by Tuesday, February 5, 5:00 pm.) If the submission does not make this deadline the application will be placed on the next scheduled meeting (Example: Tuesday, March 19.)

The Centra Policy and Procedure Manual is revised annually. There are numerous documents: one is with the IRB manual and the rest of the documents are the Appendices.

IRB Executive Committee

Chair of IRB

Dean G. Gianakos, MD

Vice Chair of IRB

Amanda Keith, PharmD, BCPS

Secretary of IRB

Beth Burgess

Interacting with forms:

  • Download the Word document to be able to edit for your use
  • Email completed forms to the IRB secretary
  • Electronic signature are acceptable
  • All applications include a Conflict of Interest Disclosure Form

See below for the Waiver of Jurisdiction.

The following forms are necessary for approval from the Centra IRB:

Waiver of Jurisdiction

Local investigators may request a waiver of jurisdiction to another IRB. The investigator seeking a waiver should send a letter, or email, to the IRB secretary and should include the following documents:

  1. The application that was made to the IRB providing review
  2. The study protocol
  3. The informed consent
  4. A description of the IRB providing review (A link to a website is sufficient if it provides enough information for the Centra IRB to evaluate.)
  5. An authorization agreement that delineates the responsibilities of each party 

If the investigator provides the documentation referenced above, a Centra IRB application does not need to be submitted.
You will be asked to present your study to the full IRB committee.
Investigators who participate in waived investigations are required to report the following information for each study to the IRB annually:

  1. Annual total and local enrollment (number of subjects enrolled)
  2. Local SAEs reportable to the IRB of record
  3. Local protocol deviations and/or violations reportable to the IRB of record

 The Centra IRB may approve the use of another IRB in cases where an academic institution allows a local investigator to enroll Centra patients, but will not otherwise provide a reliance agreement to the Centra IRB. This is not a “waived” study per se, and the IRB at the institution has no responsibility to the Centra IRB.

However, the local investigator continues to be responsible for reporting to the Centra IRB and the Centra IRB will have the authority to discontinue local enrollment. The local investigator will be required to report the same information as other investigators who report on waived studies.