Process for Modifications

Learning Shot: Process for modifying IRB-approved protocols

IRB approval of the following types of modifications are NOT required for those studies reviewed under a coded, exempt or non engaged review. 

• Personnel changes
• Change in # of subjects to be enrolled
• Change of Status

There are several types of modifications that may be needed. Please see sections below for more specifics on:

• Personnel Changes
• Change in # of Subjects to be Enrolled ( e.g. sign a consent form)
• Change of Status ( e.g. changing from open to enrollment to closed to enrollment, follow-up only)
• Any Additional Modification
• For ALL Modifications with Content Changes
• Expedited
  
• Full Board
• 5 Year Updates
  • Expedited
  • Full Board
    
• Additional Considerations for Studies Reviewed by PRC
• Additional Considerations for Studies Reviewed by GCRC Advisory Committee

Personnel Changes

• Personnel other than the Principal Investigator : 
  • Verify new personnel have completed IRB-HSR Training in Human Subject Research Protection Training ( See link to CITI on IRB website at http://www.virginia.edu/vprgs/irb/hsr/citi.html
  • Complete Personnel Change form
  • Submit Personnel Change Form and a completed routing form to IRB-HSR by e-mail.  Email address for submission is on the Personnel Change Form.
  • The IRB staff will add/delete the personnel, stamp the form with a receipt acknowledged, and return a copy to you. 
  • At this point, the new personnel may begin work on the protocol ( e.g. have access to subjects or identifiable data)
  • File the document with your regulatory files.

• Change in Principal Investigator :
• Verify new Principal Investigator has current training in Human Subject Research Protection
• The following table indicates which documents need to be modified when the PI is changing:

• When applicable according to the table above, submit the following documents to the IRB
• One (1) tracked IRB -HSR protocol with the version date updated.
• One (1) tracked consent with the new PI information inserted in the appropriate places.
• One (1) IRB-HSR Personnel Change Form .

The documents will be reviewed and returned with comments via email to the investigator within 10 business days.  Once you have received confirmation that all necessary updates have been made to the protocol and/or consent, you will submit the following hard copies (as applicable according to the table):

• One (1) tracked IRB -HSR protocol signed and dated by the PI.
• One (1) tracked consent and two (2) clean copies.
• One (1) original Investigator Agreement signed by the new PI and the Department Chair.
• One (1) original IRB-HSR Personnel Change Form
• One (1) routing form.

Change in # of Subjects to be Enrolled (e.g. sign a consent form)

If requesting to increase or decrease the # of subjects to be enrolled in a protocol by, you MUST modify the IRB-HSR protocol and consent (if applicable)

• Submit the following documents to the IRB
  • One (1) tracked IRB-HSR protocol with the version date updated and revision to number of subjects at UVA and all sites (if applicable).
  • One (1) tracked consent with the number of subjects revised.
  • One (1) IRB-HSR Enrollment Change Form.  Email address for submission is on the Enrollment Change Form.
  
  The documents will be reviewed and returned with comments via email to the investigator within 10 business days.  Once you have received confirmation that all necessary updates have been made to the protocol and/or consent, you will submit the following hard copies (as applicable):
  • One (1) tracked IRB -HSR protocol signed and dated by the PI.
  • One (1) tracked consent and two (2) clean copies.
  • One (1) original IRB-HSR Enrollment Change Form .
  • One (1) routing form.

Change of Status ( e.g. changing from open to enrollment to closed to enrollment, follow-up only)

• Submit Change of Status Modification Form and a completed routing form to the IRB-HSR.
• Attach any supporting documentation from the sponsor
• If requesting to close the study permanently, (all participants have completed the required procedures and follow up phases of the study and analysis are completed to the point that participant's medical records or contact with study subjects will no longer be needed), complete the Study Closure Form.

Any Additional Modifications

For ALL Modifications with Content Changes

Exempt, Coded Research or Non- Engaged Applications
If you need to make a change to a application that was submitted as an Exempt. Coded Research or Non-Engaged submission, you must send an email to the IRB to irbhsr-mods@virginia.edu outlining the change you wish to make.  The IRB staff will review the modification and determine if the project still meets the criteria for Exempt, Coded or Non- Engaged review.  You will be notified by return email of the decision.  You may not implement the change until you have heard from the IRB.

All Other Protocols

Before obtaining signatures, please submit electronically the following documents  for PREREVIEW:

The email address for submission is on the Modification Request Form.

• IRB-HSR Protocol with tracked changes ( if applicable)
• IRB-HSR Consent with tracked changes (if applicable)
• If applicable, non-IRB  protocol (most current version)
• If applicable, Summary of Changes document
• Request for Modification Form / Request for Modification Form (GCRC)
• If Applicable Consent Addendum .  Please note:  a consent addendum must be created if the study is closed to enrollment .  As a general rule, the consent addendum should not be used if the protocol is open to enrollment.
• If applicable, any supporting documents.
• The documents will be reviewed and returned with  comments via email to the investigator within 10 business days. 
• The investigator should make the requested changes or write a response to any request made for which they do not agree and re-submit to the IRB-HSR by email. 
• IRB-HSR staff will re-review the protocol, verifying that all issues have been addressed . A protocol will not be put on the agenda until this step is completed.
• IRB-HSR staff will notify the researcher of the status of the protocol within 1-2 business days of receipt of the revised documents.
• The PI will be required to send the following FINAL hard copies to the IRB-HSR office:

If Expedited

• Current IRB-HSR Protocol signed and dated by the PI with tracked changes (if applicable).
• One (1) tracked copy  of each IRB-HSR Consent
• Two (2) clean copies of each IRB-HSR Consent
• If applicable, one (1) copy of the non- IRB protocol (most current version)
• Please note:  a consent addendum  must be created if the study is closed to enrollment .  As a general rule, the consent addendum should not be used if the study is open to enrollment.
• If applicable Summary of Changes document.
• One (1) copy of the Request for Modification Form / Request for Modification Form (GCRC).
• If applicable any supporting document
• Once all the documents have been reviewed administratively, the mod will be reviewed by the IRB -HSR Chair , vice chair or member designee.  After approval, the PI will be sent the approval form and any other applicable documents.

If Full Board

• Original IRB-HSR Protocol signed and dated by the PI with tracked changes and one copy (if applicable).
• One (1) tracked copy of each IRB-HSR Consent
• Two (2) clean copies of each IRB-HSR Consent
• If applicable, one (1) copy of the non- IRB protocol (most current version)
• Please note:  a consent addendum  must be created if the study is closed to enrollment .  As a general rule, the consent addendum should not be used if the study is open to enrollment.
• If applicable one(1) Summary of Changes document.
• One (1) copy of the Request for Modification Form / Request for Modification Form (GCRC )
• If applicable  one(1) copy of any supporting document

5 Year Updates

The investigator is required to re-write the protocol and consent in protocol builder and submit to the IRB.  The protocol will undergo a comprehensive review that will look at the many detailed aspects of the protocol and consent form (s), if applicable, and ensure that the core principles of research with human subjects are upheld; essentially the review will be identical to the review of a new study.  As with all new full board and expedited studies , a pre-review will be required.   If the initial review of the protocol required the review of the full board, the 5 year review will also require review by the full board.  See instructions below.

The IRB-HSR has taken several steps to assist the investigator in meeting this requirement.

In order to provide the study team time to complete the changes, the study team will receive an email approximately 6 months prior to the 5 year continuation.  The email will notify them of the need for the update to the current template if the protocol will remain Open to Enrollment or is Temporarily Closed to Enrollment at the time of continuation.

As a reminder the study team will receive another email notifying them of these requirements approximately 2 months prior to the 5 year continuation.

In order to complete the pre-review process prior to the IRB expiration date the following steps should be followed.

Expeditable Protocols

Re-write IRB protocol or IRB Applicatiion and consent via protocol builder http://www.irb.virginia.edu/

If you have not used Protocol Builder before and need help with updating your protocol and consent, please contact Margaret Ball.  You may contact her via email  mnw2h@virginia.EDU or by phone at (434) 243-0639.

If the study has oversight by the PRC/GCRC verify with them if their approval is needed prior to submission to IRB-HSR.

Before obtaining signatures, please electronically submit the following documents to mnw2h@virginia.edu for PREREVIEW:

• 5 Year Update Summary Form for Expedited Protocols
• IRB-HSR Protocol Cover Sheet
• IRB-HSR Protocol or IRB Application
• IRB-HSR Consent
• If applicable, non-IRB protocol (most current version) (e.g sponsor's protocol)
• Electronic versions of most currently approved IRB-HSR protocol and consent.

If you are making any additional modifications (besides updating to the current template), include a copy of the Request for Modification Form / Request for Modification Form (GCRC) .

If one is not included with the submission, the IRB-HSR will assume that no additional modifications are being made.

If you are adding or deleting study personnel, include a copy of the Personnel Change Form.

The documents will be reviewed and comments returned via email to the investigator within 10 business days. 

The investigator should make the requested changes or write a response to any request made for which they do not agree and re-submit to the IRB-HSR by email. 

IRB-HSR staff will re-review the protocol, verifying that all issues have been addressed. A protocol will not be approved until this step is completed.

IRB-HSR staff will notify the researcher of the status of the protocol within 1-2 business days of receipt of the revised documents.

In addition to sending the electronic version of the protocol and consent to irbhsrmrprereview@virginia.edu  the PI will be required to send the following FINAL CLEAN (no track changes) hard copies to the IRB-HSR office:

• Original of the IRB-HSR Protocol Cover Sheet
• Original IRB-HSR Protocol or IRB Application signed and dated by the PI
• Two (2) copies of the IRB-HSR Consent
• If applicable, One(1) Sponsor protocol (most current version)
• If applicable, One (1) copy of the Request for Modification Form / Request for Modification Form (GCRC).
• If applicable One (1) copy of the Personnel Change Form.

If these steps are not completed by the Continuation Deadline the IRB approval for this study will expire unless the PI changes the status of the study to closed to enrollment.  This means that no additional subjects may be recruited until the protocol and consent are updated to the current template and are approved by the IRB-HSR.

Full Board Protocols:

Re-write protocol/IRB Applications and consent via protocol builder http://www.irb.virginia.edu/

If you have not used Protocol Builder before and need help with updating your protocol and consent, please contact Margaret Ball.  You may contact her via email  mnw2h@virginia.EDU or by phone at (434) 243-0639.

If the study has oversight by the PRC/GCRC- verify with them if their approval is needed prior to submission to IRB-HSR. 

Before obtaining signatures, please submit electronically the following documents to irbhsrfbprereview@virginia.edu for PREREVIEW:

• IRB-HSR 5 Year Summary Form
• IRB-HSR 5 Year Summary Form
• IRB-HSR Protocol Cover Sheet
• IRB-HSR Protocol or IRB Application
• IRB-HSR Consent
• If applicable, non-IRB protocol (most current version) (e.g. sponsor's protocol)
• Electronic versions of most currently approved IRB-HSR protocol and consent.

If you are making any additional modifications (in addition to updating to the current template), include a copy of the Request for Modification Form / Request for Modification Form (GCRC) .

If one is not included with the submission, the IRB-HSR will assume that no additional modifications are being made.

If you are adding or deleting study personnel, include a copy of the Personnel Change Form .

The documents will be reviewed and comments returned via email to the investigator within 10 business days. 

The investigator should make the requested changes or write a response to any request made for which they do not agree and re-submit to the IRB-HSR by email. 

IRB-HSR staff will re-review the protocol, verifying that all issues have been addressed. A protocol will not be put on the agenda until this step is completed.

IRB-HSR staff will notify the researcher of the status of the protocol within 1-2 business days of receipt of the revised documents.

At that time the documents should be printed, IRB Protocol/IRB Application signed by PI and submitted to IRB-HSR. 

The PI will be required to send the following FINAL CLEAN (no track changes) hard copies to the IRB-HSR office:

Routing Form with Contact Information

One ORIGINAL packet that includes One (1) original Protocol Cover sheet with questions One (1) original IRB-HSR protocol or IRB Application, signed and dated by the PI  and includes IRB# in header One (1) original of the IRB-HSR consent including IRB# in header One (1) Proposed study-specific research participant tools  (e.g. diaries, questionnaires) One (1) Sponsor Protocol (if applicable) One (1) copy of PRC/GCRC approval notice (if applicable) If applicable, one (1) copy of the Request for Modification Form / Request for Modification Form (GCRC) . If applicable One (1) copy of the Personnel Change Form .

3 PACKETS (all items stapled) that include the following: IRB-HSR Protocol cover sheet with questions IRB-HSR Consent(s)  with IRB # in header IRB-HSR Protocol/IRB Application with IRB# in header  Sponsor Protocol (if applicable) Copy of the Request for Modification Form / Request for Modification Form (GCRC) .  IRB-HSR 5 Year Summary Form Once all the documents have been received and reviewed administratively, the IRB-HSR staff will post the protocol on the next full board agenda and the final electronic copies of the documents will be provided to IRB members for review at the next convened meeting.

If these steps are not completed by the Continuation Deadline the IRB approval for this study will expire unless the PI changes the status of the study to closed to enrollment.  This means that no additional subjects may be recruited until the protocol and consent are updated to the current template and are approved by the IRB-HSR.

Additional Considerations for Studies Reviewed by PRC  (Cancer Center Protocol Review Committee)

If the protocol you intend to modify has been approved by the Cancer Center Protocol Review Committee (PRC), please note that the modification you are planning must be approved by the PRC prior to this modification being submitted to the IRB-HSR.
Protocols which require PRC approval usually include those protocols that allow patients with a cancer diagnosis to enroll and are investigator initiated.  They do not usually see studies that are sponsored by a cooperative group or a commercial sponsor.

Additional Considerations for Studies Reviewed by GCRC Advisory Committee

If the protocol you intend to modify has been approved by the GCRC Advisory Committee, please note that the modification you are planning must be approved by the GCRC prior to this modification being submitted to the IRB-HSR.  

Revised 1-19-11