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:

Appendix C Form 1

Appendix C Form 1 is for the initial application. This will need to be completed and any pertinent documents should accompany it when submitted. Pertinent documents include the protocol, Investigators Brochure, Informed Consent Form, survey document, etc. The principal investigator and/or study coordinator will need to attend the initial meeting and present the study to the IRB.

Federal Regulations/Centra IRB Policy and Procedures require at least annual renewal/update by the expiration date. Renewal/update/closure forms will be sent to you prior to the scheduled review.

Appendix D Form 2A 2B

Appendix D Form 2A 2B is for an annual renewal, update or closure of the study. The principal investigator and/or study coordinator may be required to attend the meeting; however, usually a phone number to contact the PI or SC for any questions is sufficient.

Appendix E Form 3

Appendix E Form 3 is for any modification to the study.

Appendix F Form 4

Appendix E Form 3 is for any modification to the study.

Appendix G Form 5

Appendix G Form 5 is a Waiver of Authorization is for need access to and use only the minimum amount of Protected Health Information (PHI) necessary to review eligibility criteria and contact potential subjects complete this form.

Appendix H Form 6

Appendix H Form 6 is a Exempt Research Form. The ERF is to determine if your research requires submission of a full/initial application to Centra IRB. Appendix A checklist to the form is important. The IRB Exempt committee will review this application.

Appendix I Form 7

Appendix I Form 7 is a HIPAA Authorization. Each participant will need to sign this form if your study will use Protected Health Information (PHI).

Additional forms

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:

The application that was made to the IRB providing review
The study protocol
The informed consent
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.)
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:

Annual total and local enrollment (number of subjects enrolled)
Local SAEs reportable to the IRB of record
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.