1.

Develop protocol idea. If this protocol will be funded by an external grant, follow the Grant Submission Summary to submit the grant for IRB-HSR approval.  The IRB-HSR cannot approve the protocol before approving the grant.  They can be submitted to the IRB-HSR at the same time.

2.

Obtain IRB Approval of Grant if the protocol will be funded by an external grant.    See Grant Application Submission Summary for additional information.  The IRB-HSR cannot approve the protocol before approving the grant.  They may be submitted to the IRB-HSR at the same time.

3.

Use Protocol Builder. Go to www.irb.virginia.edu , log in, click on Protocol Builder, and follow the instructions. 
If you have never used Protocol Builder before, you will need to take the following steps to create an account and register:

• If you have not done so already, verify that your e-mail ID is registered with ITC (Information, Technology and Communications) and/or with the Medical Center Computing Helpdesk.  Their phone numbers are listed below:
• ITC Helpdesk:  924-3731
• Medical Center Computing Helpdesk:  924-5334
• After you have confirmed that your e-mail ID is registered, go to IRB Online and click on "Request Account."  Complete the required information and hit the "Submit" button at the bottom.
• IRB-HSR staff will review the account request and either grant or deny an account.  You will be notified of this by e-mail.
• After you have received an account, click on "First Time Users- Register Here."
• Enter your UVA ID and click on "Register Account."
• Within a few minutes an automatic e-mail will be sent to you providing you with a temporary password.
• Once you have this password you may log in.  Your Login is your UVA ID and the password is the temporary password sent to you in the e-mail.
• Once you have logged in, you may change your password to something easier for you to remember by clicking on "Change Password" at the top of the page.
• Then click on the Protocol Builder and follow the instructions.

PLEASE NOTE: The IRB-HSR will NOT accept a protocol for review unless the protocol and consent form(s) are written in using Protocol Builder. For your assistance the IRB-HSR offers a one-on-one assistance with Protocol Builder at no charge.  Please contact Margaret Ball at mnw2h@virginia.edu or 243-0639 or Karen Mimms at kcm6t@virginia.edu or 243-9847

Mandatory Pre-Review for Protocols Needing Expedited or Full Board Review

4. Expedited Pre-Review
To submit an expedited protocol for pre-review, EMAIL the Protocol Cover Sheet, Protocol and Consent(s) along with Sponsor's protocol (if applicable) to IRBHSRmrPreReview@virginia.edu

• The documents will be returned by EMAIL with tracked changes and comments within 10 working days
• All changes recommended by the IRB-HSR must be made prior to final submission to the IRB-HSR.
• Once ALL changes have been made, you will be instructed to submit the following documents in hard copy:
• One original protocol signed and dated by the PI.
• One original investigator agreement signed and dated by the PI and Department Chair.
• Two (2) clean copies of the consent (if applicable)
• Sponsor protocol (if applicable)

5. Full Board Pre-Review
The IRB-HSR requires mandatory pre-review of a protocol to be submitted for full board review. 

• The IRB-HSR requires mandatory pre-review of a protocol to be submitted for full board committee review. 
• To submit a protocol for pre-review EMAIL the following documents to IRBHSRfbPreReview@virginia.edu.
• One (1) IRB-HSR Protocol Cover Sheet,
• One (1) IRB-HSR Protocol
• One (1) IRB-HSR Consent(s) /Assents (if applicable)
• Non-English Speaking short forms (if applicable)
• One (1) Sponsor's protocol (if applicable)
• One (1) Screening Log (if applicable)
• One (1) Investigators Brochure (if applicable)
• The documents will be returned by EMAIL with tracked changes and comments within 5 working days.
• The investigator should make the requested changes or write a response to any request made for which they do not agree.
• Resend them to IRBHSRfbPreReview@virginia.edu.
• You will receive communication within 1-2 working days to confirm you have made all required changes and that the protocol is ready for submission.  The researcher will be given the IRB # for the protocol at this time.  This number should be added to the documents.  DO NOT MAKE ANY ADDITIONAL CHANGES TO THE DOCUMENTS AFTER THIS POINT UNTIL AFTER YOU HAVE HEARD BACK FROM THE FULL BOARD.   This step must be completed by Thursday 5 pm prior to the Submission Deadline in order for the protocol to be put on the next agenda.
• Once you have received approval from the IRB, follow the instructions on Protocol Builder to submit the protocol to the full board for review. This would include obtaining appropriate signatures and making copies. Protocols must be submitted according to the deadline dates (see link below).
  
  Please note the Submission Deadlines

6.

Review Outcomes . For full board review submissions, following the meeting you will receive a letter from the IRB-HSR explaining any changes which need to be made prior to final approval.  (See  "Possible Outcomes of IRB-HSR Review" .)

7.

Enrollment of Subjects Following Approval. If the protocol is approved pending minor modifications, you will receive an approval form noting items to be changed prior to the protocol being open for enrollment.  After those changes have been done and submitted and approved by the IRB-HSR, you will receive an approval of the modifications along with the stamped approved consent forms.  At that time you may begin to advertise and enroll subjects.  Note that you are approved to enroll a specific number of subjects.  If you wish to enroll more subjects than approved, you MUST obtain approval from the IRB-HSR prior to enrolling additional subjects beyond that approved.
If approval of the protocol is withheld pending major modifications, you will receive a letter noting the revisions that are required.

8.

Advertising for Subjects. Refer to Advertising for Subjects.

9.

Notice of Privacy Practices. Refer to the Notice of Privacy Practices  web page for more information.