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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.

Changes to research must be submitted as a modification. Each modification submission must include FORM: MODIFICATION (HRP-213) 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.

Step-by-Step Instructions to Submit a Modification:

Create New Package/Adding New Documents

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

  1. Download, complete, and save FORM: MODIFICATION (HRP-213)
  2. Download, complete, and save FORM: REPORTABLE NEW INFORMATION HRP-214 (if applicable)
  3. Create and save marked versions (tracked changes) and clean versions (changes accepted) of updated study documents.
  4. Enter your user name and password at irbnet.org.
  5. Click the project title to open the protocol.
  6. From the left hand menu click “Create New Package.
  7. 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.
  8. 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.
  9. To stack new a version of a document on previously reviewed versions, drag and drop the new verson of the document onto the version from previous packages.
  10. 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.”
  11. Edit other project information, as appropriate
  12. Collect necessary signatures
  13. 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 FORM: MODIFICATION (HRP-213) 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

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. Locate the Initial Review Application and click the pencil icon at the far right
  5. Using the “Jump To” feature, go to the information screen that requires updating
  6. Update as appropriate and click “Next”
  7. When finished updating click “Save and Exit
  8. 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:

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. 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
  5. Click “Choose File
  6. Locate the file you wish to upload and click “Open
  7. Click “Update
  8. If appropriate, update the Description field
  9. 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.
  10. 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 (For Projects Existing Prior to September 2015)

The Project Information Worksheet is a data collection tool that was used by IRB Administration for studies started prior to the development of the online Initial Review Application. 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.

  1. Enter your user name and password at irbnet.org
  2. Click the project title to open the protocol
  3. From the left hand menu, click “Designer”
  4. Click the pencil icon next to the Project Information Worksheet
  5. Using the “Jump To” feature, go to the information screen that requires updating
  6. Update as appropriate
  7. Click “Save and Exit
  8. 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.

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Signatures

UC Davis Demonstration Video: How do I get electronic signatures?

IRB Administration is accepting either physical or electronic signature on all forms except the new online Initial Review Application, which must be signed electronically by the PI. When submitting a new study, HRP 226 Administrative Approvals MUST be electronically by the faculty advisor, however, Department Chairs and Deans may sign either physically or electronically.

If providing physical signature print, sign, and scan the form. Then upload the signed copy to the Designer.

If providing electronic signature, follow the directions below. Please check with your PI and other signatories prior to routing for electronic signature and provide them the guidance document “Adding Your Electronic Signature,“ if necessary.

  • When uploading any form that requires signature write “electronic signature” in the space where a signature would have been collected.
  • If necessary, share the protocol with each signatory at the appropriate level of access
  • IRB Administration suggests the use of the “Send Project Mail” feature to request signatures. In each email, change the subject line to read “Please review and sign
  • Collect signatures in the following order:
    1. Principal Investigator

Adding your Electronic Signature

  1. Enter your Username and Password at irbnet.org
  2. Enter the IRBNet project number in the search field and click on the study title to open the project
  3. Review the necessary study details and documents
  4. From the left hand menu click “Sign this Package”
  5. Use the dropdown list to select the appropriate role and click “SignNote: if you have previously signed this package, the system will ask you if you wish to sign it again. If you need to re-sign the package for any reason, click “OK”
  6. Enter your user name and password to validate your identify and click “Continue”
  7. Your electronic signature has been applied to the contents of this package. IRBNet will send a notification to all users who have full access to this project.

NOTE: You must click “Submit this Package” and complete the subsequent screens to complete the submission process. If responding to an IRB request in an unlocked package, you must click “Designer” and “Mark Revisions Complete” to alert the IRB that the submission is ready for review.

Responding to a Letter of Action

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

  1. Enter your user name and password at irbnet.org.
  2. Click the study title to open the protocol.
  3. Click “Create New Package.
  4. 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.
  5. 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.
  6. To stack new a version of a document on previously reviewed versions, drag and drop the new verson of the document onto the version from previous packages.
  7. Edit other project information, as appropriate.
  8. Collect necessary signatures.
  9. 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. An amendment/modification submission is required to change a PI or Co-PI, and the submission must be reviewed and approved by the IRB prior to implementation.

Amendment/modification submission to the IRB must include:

  • Form HRP-213 Modification Form signed by the PI or Co-PI relinquishing his or her role. If the current PI or Co-PI is unavailable because s/he has left the University, the Department Chair may sign.
  • Marked (tracked changes) versions of study documents updating the PI or Co-PI information, where applicable
  • Clean (changes accepted) version of study documents updating the PI or Co-PI information, where applicable
  • HRP 226 Administrative Approvals documenting review and approval of the new PI or Co-PI’s qualifications.
  • Updated IRBNet Project Overview and online document.
  • New PI or Co-PI must have “Full” access to the project in IRBNet.
  • New PI or Co-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.

 

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.

  1. 5 Sandals Rainbow Expresso Small Sierra 5 Flirty Women's Sandals Braidy 6 5 Follow the steps to create a new package
  2. From the left hand menu click “Sandals Rainbow Braidy 5 Women's 5 Expresso 6 Sandals 5 Small Sierra Flirty Project Overview
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  4. You can now update the following fields:
    • Project Title
    • Local Principal Investigator First Name, Last Name, Degree(s)
    • Sponsor
  5. Update and click “Save” –  You have now updated the Project Overview page.
  6. 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 acurate 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.”
  7. Follow the steps complete the submission and submit the amendment/modification

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If your study is nearing the administrative due date for  continuing review, consider combining your modification and continuing review into a single submission package. The IRB will not review a continuing review/progress report if there is a pending amendment/modification submission, therefore the submission of an amendment/modification close to the administrative due date may delay your ability to submit a continuing review/progress report.

If you have submitted a continuing review/progress report and discover that modifications need to be submitted to the IRB, contact the IRB to discuss the best course of action. Do not create and submit a new package until you have been directed to by an IRB Administration staff member unless there is an immediate threat to the rights or welfare of research subjects.

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