Modifications

All modifications to research must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects.

We are transitioning to a new electronic application form for all post-approval applications. The Post-Approval Submission (PAS) Form is now live in IRBNet and can be used to submit Continuing Review Progress Reports, Amendments/Modifications, and Reports of New Information.

Changes to research must be submitted as a modification. Each modification submission must include the PAS form and supporting documents. When modifying previously reviewed documents that were uploaded into IRBNet you must submit a marked version (tracked changes) and a clean version (changes accepted) of each document, and they must be “stacked” on any previously submitted versions. This allows the IRB to identify all proposed changes to research. You DO NOT need to submit a marked version when making changes to the Initial Review Application because the document is edited online. A modification submission may also include new study documents, changes to the IRBNet Project Overview page, and/or edits to the IRBNet Initial Review Application or Project Information Worksheet. Please review the instructions provided below for detailed information.

In This Section

Create New Package/Adding New Documents
Editing the Initial Review Application
Updating Existing Documents with Revised Documents Stacking
Editing the Project Information Worksheet
Responding to a Letter of Action
Change of Principal Investigator (PI) or Co-PI
Change of Faculty Advisor
Edit the IRBNet Project Overview and online document
Modifications at the time of Continuing Review
Planned Protocol Deviations
Administrative Modifications

Create New Package/Adding New Documents

UC Davis Demonstration Video: How do I submit a Modification /Amendment for review?

Enter your user name and password at irbnet.org.
Click the project title to open the protocol.
From the left hand menu click “Create New Package.”
From the left-hand menu click “Designer”
Click “Start a Wizard”
Click “UC Davis – Post-Approval Submission Form”
Click “Next” to move through the form.
Create and save marked versions (tracked changes) and clean versions (changes accepted) of updated study documents.
Upload other study documents as needed. To upload documents click “Designer” from the left hand menu. There are two ways to upload documents:
- Click “Attach New Document.” Locate the document(s) needed and hold the “Ctrl” button on the keyboard while selecting all document(s). When finished, click “Open,” OR
- Drag and drop files to the bottom right corner of the screen.
Once documents are uploaded use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu for each document.
To stack new a version of a document on previously reviewed versions, drag and drop the new version of the document onto the version from previous packages.
To edit the Initial Review Application click the pencil icon at the far right. Using the “Jump To” feature, go to the information screen that requires updating and enter the changes. Click “Next” until all information has been completed. Click “Save and Exit.”
Edit other project information, as appropriate
Collect necessary signatures
Submit the package

Editing the Initial Review Application

UC Davis Demonstration Video: How do I edit the Initial Review Application?

Historically the IRB has required researchers to provide “tracked changes” and “clean” copies of the protocol/description of study when submitting amendments/modifications to their protocols. It is not possible to submit tracked changes versions of the Initial Review Application because it is an online document. Instead, the document will be updated online, as described below. To ensure the IRB is able to locate and review all edits to this document the IRB requires that all changes be detailed within the Post Approval Submission Form by providing the following information; location of the change within the Initial Review Application (e.g. Research Location Information, HIPAA, Consent, etc.…), information removed, and information added.

Making edits to the Initial Review Application

Enter your user name and password at irbnet.org
Click the project title to open the protocol
From the left hand menu, click “Designer”
Locate the Initial Review Application and click the pencil icon at the far right
Using the “Jump To” feature, go to the information screen that requires updating
Update as appropriate and click “Next”
When finished updating click “Save and Exit”
The Initial Review Application is now updated

Note: IRBNet does keep historical record of all previously approved versions of the Initial Review Application.

Updating Existing Documents with Revised Documents Stacking

UC Davis Demonstration Video: How do I stack or what is stacking of documents?

“Stacking” is uploading a new version of a document that has already been reviewed by the IRB, thus creating multiple versions of the same document in IRBNet. To stack a document the study must have already gone through one review cycle. Prior to submitting updated documents to the IRB you must create a subsequent package by clicking “Create New Package” in the left hand menu. Once the package has been created click the Designer to access existing documents. When uploading a new version of an existing document follow the steps below:

Enter your user name and password at irbnet.org
Click the project title to open the protocol
From the left hand menu, click “Designer”
There are two sections in the Designer: “New and Revised Documents in this Package” and “Documents from Previous Packages.” Locate the document you wish to update in the “Documents from Previous Packages” section and click the pencil icon next to the document
Click “Choose File”
Locate the file you wish to upload and click “Open”
Click “Update”
If appropriate, update the Description field
The new version of the document is now “stacked” on top of the previous version of the document and has moved to the “New and Revised Documents in this Package” section. Click the stack of papers icon to view a list of all versions of the document.
Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

Editing the Project Information Worksheet

The Project Information Worksheet is a data collection tool that was used by IRB Administration for studies started prior to the implementation of the online Initial Review Application in September 2015. All studies will have either a Project Information Worksheet OR an Initial Review Application. They should not have both. If you are making edits to an existing study, you may be asked to update the Project Information Worksheet.

Enter your user name and password at irbnet.org
Click the project title to open the protocol
From the left hand menu, click “Designer”
Click the pencil icon next to the Project Information Worksheet
Using the “Jump To” feature, go to the information screen that requires updating
Update as appropriate
Click “Save and Exit”
The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon to view a list of all versions of the Project Information Worksheet.

If you have used the online Initial Review Application for your submission, you do not need to create a Project Information Worksheet.

Responding to a Letter of Action

UC Davis Demonstration Video: How do I submit a response to a Letter of Action?

Enter your user name and password at irbnet.org.
Click the study title to open the protocol.
Click “Create New Package.”
To upload documents click “Designer” from the left hand menu. There are two ways to upload documents:
- Click “Attach New Document.” Locate the document(s) needed and hold the “Ctrl” button on the keyboard while selecting all document(s). When finished, click “Open,” OR
- Drag and drop files to the bottom right corner of the screen.
Once documents are uploaded use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu for each document.
To stack new a version of a document on previously reviewed versions, drag and drop the new version of the document onto the version from previous packages.
Edit other project information, as appropriate.
Collect necessary signatures.
Submit the package.

Change of Principal Investigator (PI) or Co-PI

Every project needs a principal investigator who accepts the responsibilities of leadership, ethical engagement in research, and research integrity. A change of principal investigator can be necessary because of a change of employment, retirement, reallocation of professional duties, or other reasons. The new PI or Co-PI must be eligible to serve under HRP-103 (Investigator Manual) and have current certifications. A modification must be submitted to change a PI or Co-PI, and the submission must be reviewed and approved by the IRB prior to implementation.

The submission requirements for changing a Principal Investigator include:

Updated Principal Investigator on IRBNet Project Overview.
New PI must have “Full” access to the project in IRBNet.
Post-Approval Submission Form documenting change in PI.
Marked (tracked changes) versions of study documents updating the PI information, where applicable.
Clean (changes accepted) version of study documents updating the PI information, where applicable.
Updated Initial Review Application with new PI information. If your study does not have an Initial Review Application, update the HRP-215 Research Personnel List for the study, instead.
Department Chair’s electronic signature using the IRBNet “Sign this Package” feature. If your study does not have an Initial Review Application, please updated the HRP-226 Administrative Approvals form instead.
Current PI’s electronic signature using the IRBNet “Sign this Package” feature. If the current PI is unable to provide signature because he or she has left the institution, please state this in the Post-Approval Submission Form.
New PI’s electronic signature using the IRBNet “Sign this Package” feature.

Note: If you are changing the PI, and the only change to the consent form is updating the PI’s name in the Header area on page one of the consent form, it is unnecessary to re-consent any subjects. However, if the PI change will also result in an update to the contact information on the consent form, you may either re-consent currently enrolled subjects or provide the currently enrolled subjects with the new information and document the communication in the study files.

The submission requirements for changing a Co-Principal Investigator include:

New Co-PI must have completed CITI training requirements
New Co-PI must have “Full” access to the project in IRBNet.
Post-Approval Submission Form documenting change in Co-PI.
Marked (tracked changes) versions of study documents updating the Co-PI information, where applicable.
Clean (changes accepted) version of study documents updating the Co-PI information, where applicable.
Updated Initial Review Application with new Co-PI information. If your study does not have an Initial Review Application, update the HRP-215 Research Personnel List for the study instead.
Current PI’s electronic signature using the IRBNet “Sign this Package” feature.

Note: Updates to research personnel, unless it is a change of PI or Co-PI, are not required to be submitted to the IRB as a Modification. Please keep records of your personnel changes and submit at Continuing Review or Study Closure. The PI or Co-PI is responsible for ensuring that all research personnel have completed the required training. Click here to view who must be listed as research personnel and complete the required training.

Change of Faculty Advisor

The submission requirements for changing a Faculty Advisor include:

New Faculty Advisor must have completed CITI training requirements
New Faculty Advisor must have “Full” access to the project in IRBNet.
Post-Approval Submission Form documenting change in Faculty Advisor.
Marked (tracked changes) versions of study documents updating the Faculty Advisor information, where applicable.
Clean (changes accepted) version of study documents updating the Faculty Advisor information, where applicable.
Updated Initial Review Application with new Faculty Advisor listed as Additional Personnel. If your study does not have an Initial Review Application, update the HRP-215 Research Personnel List for the study instead.
New Faculty Advisor’s signature using the IRBNet “Sign this Package” feature.
Current PI’s electronic signature using the IRBNet “Sign this Package” feature.

Edit the IRBNet Project Overview and online document

The IRBNet Project Overview page displays essential study details such as the study title, the name of the principal investigator, and the study sponsor. These details must be accurate. If changes are made after initial study approval, the Project Overview page must be updated within IRBNet and submitted as a modification to the project. Making changes to the Project Overview page will also require an update to your study’s online document. The steps to update both the Project Overview and the online document are described below.

Follow the steps to create a new package
From the left hand menu click “Project Overview“
Click the yellow word “Edit”
You can now update the following fields:
- Project Title
- Local Principal Investigator First Name, Last Name, Degree(s)
- Sponsor
Update and click “Save” – You have now updated the Project Overview page.
Your project should have one of the two documents listed below. Complete the steps as appropriate for your study.
- Project Information Worksheet – click the pencil icon. The document will open. Click “Save and Exit.” The form will automatically update the information that has been entered in the IRBNet fields.
- Initial Review Application – click the pencil icon to open the online document.
  - If updating the project title click “Save and Exit.” The document will update automatically.
  - If updating the principal investigator use the “Jump To” feature to select “Principal Investigator Information.” Update the PI’s information and click “Next.” Ensure that other application details, such as Conflict of Interest, are accurate and click “Save and Exit.”
  - If updating the sponsor use the “Jump To” feature to select “Funding Information.” Update the information and click “Next.” Continue updating the information and clicking “Next” until you have updated all sponsor information. Once finished click “Save and Exit.”
Follow the steps complete the submission and submit the amendment/modification

Modifications at the time of Continuing Review

The IRB requests that researchers do NOT combine modification and continuing review submissions, unless the modification is required as part of the continuing review. Examples of modifications required by the IRB as part of continuing review include updates to the following:

Research personnel lists or personnel listed in the Initial Review Application
Sponsor information
Enrollment numbers
Conflict of Interest disclosures
Addition of 21st Century Cures Act language to the informed consent form

These IRB-required modifications should be included in the continuing review submission, as they are required to secure approval. Additional modifications beyond what was described in this section should be submitted as a separate modification submission. This is to ensure timely review and approval of both the modification and the continuing review.

Planned Protocol Deviations

This section describes the process for obtaining review and approval of a “planned deviation.”

A “planned deviation” occurs when an investigator prospectively and intentionally plans to deviate from the protocol requirements. Examples include: Enrollment of a subject who does not meet eligibility criteria, conducting a procedure out of the window, or allowing a prohibited concomitant medication. Most planned deviations are one-time requests for a single participant.

For clinical investigations, the PI must obtain IRB approval before purposefully deviating from the protocol unless the deviation is to prevent an imminent harm to subjects (See 21 CFR 312.66). Sponsor approval of planned deviations is also necessary.

How do I submit a planned deviation request?

Complete the Post-Approval Submission Form. Then create a New Package in IRBNet and upload the documents.

What information must be included with the planned deviation submission?

Documented approval from the study sponsor, medical monitor and other oversight entities as applicable
A description of the deviation including:
- Page and section of the protocol where the applicable procedure is described
- Proposed date of the deviation
- Rationale for the deviation
- Clarification as to whether the request is for a single participant
- Any plans for communicating the planned deviation to the subject
A statement indicating whether the deviation will result in increased risk to the participant and a description of the risks
Description of the benefit to the participant that might result from the planned deviation
Description of the impact of the planned deviation on data integrity

If the deviation needs to occur within the next 10 days, send an IRBNet project mail requesting a rush review along with a rationale for the rush and the proposed date of the deviation.

Example: Page 16, Section 5.3 of the protocol requires subjects to be randomized within 21 days of screening. Due to a recent hospitalization with pneumonia, patient XYZ will be at least 29 days from window before she can be randomized. The sponsor has approved enrollment of this subject up to 35 days from screening if her chest x-ray is unchanged from baseline and her CBC is within normal limits. We plan to randomize and dose this patient on Wednesday, 01/03/2017, which will be 32 days from screening. The risks will not be increased with this plan because the study medication is not expected to affect this participant’s immune or respiratory system. The subject can clearly benefit from staying in this study because there are no other alternatives available to treat her renal insufficiency. This deviation is not expected to have any effect on data integrity. We would appreciate a rush review of this submission so that approval is received before 01/03/2017.

Other issues to consider when submitting a request for a planned deviation:

Whether the participant should be provided with a revised consent form or an addendum to the consent that includes a description of the deviation
Whether the protocol should be permanently modified

How does the IRB review planned deviation requests?

Rush requests for planned deviations are assigned for immediate processing.

For all planned deviation requests that are not time-sensitive, IRB review and screening of the submission will follow IRB Administration’s normal procedures. Upon receipt of a planned deviation request, the submission will be assigned to the appropriate IRB administrator for screening and an assessment of the level of IRB review required.

What will the IRB consider when reviewing planned deviations?

The time sensitivity of the request
The level of risk involved in both the study itself and the planned alteration.
Whether approval of the planned deviation is in the best interest of the subject
Whether the planned deviation request holds out the prospect of direct benefit to the subject
Whether the risk/benefit ratio specifically related to the planned deviation request is favorable

Administrative Modifications

Administrative modifications are changes to research which are considered so minor that they can be made without prior IRB review. There are separate standards for research which has been previously approved by the IRB and research which has been previously determined to be exempt due to varying regulatory requirements in the two classes of studies.

Changes to Previously Approved Research

Research which has been previously approved by the IRB generally requires that no changes be made prior to IRB review and approval with the notable exception of a change which needs to be made to eliminate an apparent immediate hazard to a subject. However, researchers may encounter modifications in the course of performing the research which do not have an effect on the criteria for approval and do not affect the subjects or integrity of the data in any way. These modifications are considered administrative modifications and do not need to be submitted to the IRB prior to implementation. If they are submitted to the IRB, they will be administratively acknowledged.

The below list is not exhaustive so please reach out to us at [email protected] if you have a situation which you do not think needs to be submitted prior to implementation. One of our team members will be happy to evaluate the specific circumstances and let you know whether a submission is required.

This list may be updated as new circumstances are brought to the attention of the IRB.

Correction of typographical, formatting, or grammar errors in approved documents when such correction does not alter the meaning of the documents.
Changes to revise phone numbers, physical addresses, or email addresses associated with a study.

- Note: Current subjects receiving study related interactions or interventions must be provided the updated information as soon as is feasible but in no case later than their next study related interaction or intervention.

Changes in the name or contact information of a study monitor in a multi-site industry sponsored study.
Changes in shipping couriers to be used in the course of a study (e.g. FedEx vs. UPS).
Changes to allow remote monitoring of studies by the Sponsor (or designee) so long as the methods have been previously approved and vetted by IT (e.g. PhysicianConnect).
Revising an approved advertisement so long as it remains within the requirements of the IRB as laid out in HRP-315.
Study team/personnel changes (except a change in PI, Co-PI, or Faculty Advisor).

Changes to Exempt Research

Unlike research that has been approved by the IRB, studies that have previously been determined to be Exempt can be changed without further IRB review so long as the changes will not alter the IRB’s Exempt determination. To reduce administrative burden, the IRB has compiled the below list of modifications to Exempt studies that do not need to be submitted prior to being implemented.