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IRB-HSR > Getting Started > Protocol Submission Process

 

 

 

 

 

 


IRB-HSR Protocol Submission Process

1. Develop protocol idea. If you are a medical, nursing or BIMS student, or are employed by the Health System, you may obtain assistance with protocol development, statistical plans or data management from Public Health Sciences @ the Library-  https://www.bioconnector.virginia.edu/phs.

2. Obtain IRB Approval of Grant. 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.

3. Follow the instructions below. 
If you have never used Protocol Builder before, you will need to take the following steps to create an account and register:

  • If you plan to use Protocol Builder off grounds you will need a VPN from ITS. NOTE: this is different from a VPN you may have from the health system. To obtain a VPN from the academic side follow the instructions found at http://its.virginia.edu/network/vpn/. If you have difficulty with this you may contact IT personnel within your department or call the ITS helpdesk at 924-4357.
  • If you have not done so already, verify that your e-mail ID is registered with ITS (Information Technology Services) and/or with the Medical Center Computing Helpdesk.  Their phone numbers are listed below:
    • ITS Helpdesk:  924-4357
    • Medical Center Computing Helpdesk:  924-5334
  • After you have confirmed that your e-mail ID is registered, go to IRB Online at www.irb.virginia.edu 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

 

4. Full BOARD Pre-Review:

  • Protocol Cover Sheet,
  • IRB Protocol or IRB Application
  • Consent(s) and/or assents (including short forms)
  • Sponsor’s protocol (if applicable)
  • Investigator’s Brochure, package inserts, or device background literature (if applicable)
  • Manual of Operations (if applicable)
  • Outside committee approvals (Radiation Safety, PRC, IBC)
  • Proposed study specific research tools (questionnaires, surveys etc.)
  • The documents will be returned to the individual that submitted the initial documents for pre-review via EMAIL with tracked changes and comments within 7 working days.
  • After all changes have been made- resend the revised documents to the IRB administrative staffer that performed the pre-review. 
  • You will receive communication from the IRB staff member within 1-2 working days to confirm you have made all required changes and that the protocol is ready for submission. This step must be completed by Thursday at 5 pm PRIOR to the agenda deadline, in order for the protocol to be considered for the next full board agenda. 
  • The protocol documents will be assigned an IRB-HSR #. This number should be added to the documents (except the protocol coversheet).You will be asked to NOT MAKE ANY ADDITIONAL CHANGES TO THE DOCUMENTS UNTIL AFTER YOU HAVE HEARD BACK FROM THE FULL BOARD.  You will be provided instructions on submitting your hard copies to the IRB along with the next applicable deadline for submission.  This would include obtaining appropriate signatures and making copies.

 

5. EXPEDITED Pre-Review:

  • Protocol Cover Sheet,
  • IRB Protocol or IRB Application
  • Consent(s) and/or assents (including short forms)
  • Sponsor’s protocol (if applicable)
  • Package inserts, or device background literature (if applicable)
  • Manual of Operations (if applicable)
  • Outside committee approvals (Radiation Safety, PRC, IBC)
  • Proposed study specific research tools (questionnaires, surveys etc.)
  • The documents will be returned to the individual that submitted the initial documents for prereview via EMAIL with tracked changes and comments within 10 working days.
  • After all changes have been addressed, resend the revised documents to the IRB administrative staff that performed the prereview.  All revisions recommended by the IRB-HSR must be made prior to final submission to the IRB-HSR.
  • You will receive communication from the IRB staff member within 1-2 working days to confirm you have made all required changes and that the protocol is ready for hard copy submission.
  • The protocol documents will be assigned an IRB-HSR #. This number should be added to the documents (except the protocol coversheet).You will be asked to NOT MAKE ANY ADDITIONAL CHANGES TO THE DOCUMENTS. 

  • You will be provided instructions on submitting your hard copies to the IRB. This would include obtaining appropriate signatures and making copies.

Please note the Submission Deadlines

 

6. EXEMPT, CODED RESEARCH, or NON-ENGAGED Pre-Review:  

  • To submit a protocol for exempt, coded research, or non-engaged pre-review EMAIL the following documents to IRBHSR@virginia.edu
    • Protocol Cover Sheet
    • IRB Exempt, Coded Research or Non-Engaged Application
    • Sponsor’s protocol (if applicable)
    • Coded Research Data/Specimens Agreement (if applicable)
    • IRB Authorization Agreement (if applicable)
    • Waiver of HIPAA Authorization (if applicable)
    • Data Key Nondisclosure Agreement (if applicable)
    • Manual of Operations (if applicable)
    • Outside IRB approvals (if applicable)
    • Proposed study specific research tools (questionnaires, surveys etc.)
  • The completed pre-review will be returned to the individual that submitted the initial documents with comments within 10 working days.
  • After all changes have been addressed, resend the revised documents to the IRB administrative staff that performed the prereview. All revisions recommended by the IRB-HSR must be made prior to final submission to the IRB-HSR.
  • You will receive communication from the IRB staff member within 4-5 working days to confirm you have made all required changes and that the protocol is ready for hard copy submission.
  • The protocol documents will be assigned an IRB-HSR #. This number should be added to the documents (except the protocol coversheet).  You will be asked to NOT MAKE ANY ADDITIONAL CHANGES TO THE DOCUMENTS.
You will be provided instructions on submitting your hard copies to the IRB. This would include obtaining appropriate signatures.

 

7. 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" .)

8. 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.

9. Advertising for Subjects. Refer to Advertising for Subjects.

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

Revised on 01/10/14