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.

The Initial Review Application Update takes effect June 1, 2021.

Review the Researcher’s Guide to the Initial Review Application Update for details.

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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.

Document Requirements

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. The IRB will also accept a sponsor or investigator’s protocol. Do not submit more than one research protocol.

Additional Requirements

Depending on the study design and research procedures, the following additional documents may be required. The Form Complete page of the Initial Review Application will provide a list of required documents based on project details.

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

Required Signatures

All signatures must be completed using IRBNet’s Sign this Package feature. System instructions and demonstration videos are available on the IRBNet Guidance page.

  • For all projects, the Principal Investigator.
  • For all Departments, except the School of Nursing, the Department Chair.
  • For the School of Nursing, the Dean.
  • For principal investigators who are clinical nurses not associated with the School of Nursing, the Director for the Center for Nursing Science and Chief Nursing and Patient Care Services Officer.
  • For principal investigators who are students, medical residents, or visiting scholars, a Faculty Advisor.

In signing a package, the PI attests to the following:

    1. I will personally conduct or oversee this research.
    2. I will adhere to the reporting requirements as stated in the UCD Human Research Program Investigator Manual (HRP-103, Appendix A).
    3. I will ensure that all personnel assigned to this study are qualified to perform the protocol procedures assigned to them.
    4. I will ensure personnel complete all required training related to human subjects protections and the research protocol prior to engaging in research activities.
    5. I will ensure personnel disclose any financial interests, as required by UCD Human Research Program Standard Operating Procedure: Financial Conflicts of Interest (HRP-055).
    6. If this study requires a consent process, the consent process will comply with any applicable portions of UCD Human Research Program Standard Operating Procedures: Informed Consent Process for Research (HRP-090).
    7. If this study requires documentation of consent, documentation of consent will comply with any applicable portions of UCD Human Research Program Standard Operating Procedure: Written Documentation of Consent (HRP-091).
    8. If relying on an external IRB, the PI will comply with the requirements outlined in the UC Davis Human Research Program Standard Operating Procedure: IRB Reliance when UC Davis relies on an External IRB (HRP-058) as well as all IRB and protocol requirements of the reviewing IRB.

In signing a package, the administrative signatory attests to the following:

    1. The PI is qualified by education, training and experience to personally conduct and/or supervise the research described in the protocol.
    2. The PI has completed all applicable institutional credentialing processes to conduct this research.
    3. The PI has sufficient resources to carry out this research as proposed.
    4. The protocol is scientifically valid and employs research procedures which are consistent with sound research design, in accordance with UC Davis Human Research Program Worksheet: Scientific or Scholarly Review (HRP-320).
    5. The PI will conduct this protocol in accordance with requirements in the UC Davis Human Research Program Investigator Manual (HRP-103) listed in the section “What are my obligations after IRB approval?

 

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 an Initial Review Application.  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 examples of the documents required at initial review:

Generic Protocol Review:

  • Initial Review Application
  • HRP-503 Protocol Template or a sponsor protocol (If your study has a sponsor protocol, you do not need to complete HRP-503 Protocol Template)
  • HRP-502 Consent Form
  • Data Collection Tools
  • Recruitment Materials
  • Subject Facing Documents
  • Principal Investigator Signature
  • Department Chair Signature
  • Faculty Advisor Signature * if applicable

Survey/Interviews/Focus Group Review:

Secondary Analysis – Record/Data/Specimen Review:

UCD Health Medical Record Review:

Clinical Trial Protocol Review: