Office of Research New Projects - Office of Research

New Projects

All new projects must be reviewed by the IRB before any research involving human subjects  has been conducted. If your research does not require IRB oversight, but you wish to have an official IRB determination, you must submit an application for not human subjects research determination. Review Does My Project Need Review by the IRB? for help determining if IRB review is required.

 

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First Time Submitter Guidance

If you are new to the process of IRB review or new to UC Davis, you will need to complete a few steps before submitting to the IRB. Below is a list of things to review and complete before submitting to the IRB for the first time:

  1. Read the Investigator Manual.
  2. Complete required training courses.
  3. Create an IRBNet account.
  4. Access IRBNet training resources in our Training Library.
  5. Review the Initial Review Application Guide.
  6. Learn about the IRB Review Process.
  7. Learn about possible IRB Determinations.

 

Submission Requirements

The UC Davis IRB uses an electronic project management system called IRBNet. All applications to the IRB must be submitted using IRBNet. While all research projects are unique, every new project must have the following minimum elements:

  • Initial Review Application: Electronic document wizard found in IRBNet. The Research Personnel List is captured in the Initial Review Application. Review the Initial Review Application Guide for detailed instructions.
  • Research Protocol: Templates are available for download. We will also accept a sponsor or investigator’s protocol. Do not submit more than one research protocol.
  • HRP-226  Administrative Approvals and required signatures: Review our guidance on electronic signatures
  • Electronic signature of Principal Investigator: Must use IRBNet “Sign this Package” feature. Designee signatures are not accepted.

Additional elements that are required, when applicable:

  • All Subject Facing Documents
  • Recruitment Materials (flyers, brochures, advertisements)
  • Screening scripts
  • Consent Form(s) (templates available)
  • Surveys/Interviews/Focus Group Questions
  • Investigator’s Brochure (for a clinical trial of an investigational product)
  • Disclosure of any Related Financial Interests
  • Sponsor Fee Form

 

Step-by-Step Instructions to Submit a New Project

If this is your first time submitting to the IRB, review our First Time Submitter Guidance before starting your application.

You can build a new project in IRBNet over time. IRB Administration will not see the project until you select “Submit”. This allows you to store documents electronically while developing your project. Once all study details and documents are completed, submit for review.

  1. Enter your username and password at irbnet.org
  2. Click “Create New Project
  3. Complete required Project Information, click “Continue
  4. From the left-hand menu click “Designer”
  5. Click “Start a Wizard
  6. Click “UC Davis – Initial Review Application
  7. Use the IRBNet Document Wizard to create a new application or clone an existing application. * Refer to the Initial Review Application Guide  for assistance.
  8. Upload additional study documents to the Designer page. There are two ways to upload documents:
    • Click “Attach New Document” and hold the  “Ctrl” button on the keyboard while selecting the documents. When finished click “Open.
      • NOTE: The IRB Determination Letter will contain a list of items reviewed. The list is auto-populated with the file names of all files in the submission. The file name you use will appear on the IRB Determination Letter and the IRB will not be able to alter this information.
    • Drag and drop files to the bottom right corner of the screen.
      • If your study has a sponsor protocol,  do not complete HRP 503 Protocol Template. Simply upload the sponsor protocol and other study documents into the Designer.
      • If your study does not have a sponsor protocol, please complete and upload ONE HRP 503 Protocol Template. There are three versions of this template available. Select the one that is best suited to your project. Do not submit more than one  HRP 503 Protocol Template. These templates can be found in the Library section of IRBNet.
      • Studies submitted using the online Initial Review Application do not require a Coverage Analysis; Qualifying Clinical Trials Form.
  9. Once documents are uploaded use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu.
  10. Collect necessary signatures
  11. Submit your New Project for review


 

Example Submissions

The required documents to be reviewed during an initial review application depend on the research and the research procedures themselves.

To begin, all New Projects will require the following: an Initial Review Application and an HRP-226 Administrative Approval.  Upon completion of the Initial Review Application, you will be presented with a list of required documents that need to be uploaded and submitted for review.

The following are sample initial submissions:

Generic Protocol Review:

Survey/Interviews/Focus Group Review:

Retrospective Record/Data/Specimen Review: (Record/Data/Specimen  existing at time of IRB submission)

Prospective Record/Data/Specimen Review: (Record/Data/Specimen not existing at time of IRB submission)

Clinical Trial Protocol Review:

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