Office of Research New Projects - Office of Research

New Projects

All new projects must be reviewed by the IRB prior to the conduct of any research involving human subjects. On this page, you will find directions for submitting a new project to the IRB.

 

Directions for Submitting a New Project to the IRB

Getting Started

Read the UC Davis Investigator Manual

The Investigator Manual outlines the roles and responsibilities for those engaged in human subjects research at UC Davis. All Principal Investigators must read the Investigator Manual before starting their research.

Download the Investigator Manual

Complete CITI training

All investigators and staff engaged in human subjects research at UC Davis must complete CITI training. CITI training is valid for 3 years and must be renewed prior to expiration.

The specific CITI training courses required for your research depend on the type of research you are conducting. The Required Education Page has a link to the CITI training website and will inform you of the courses to be completed based on your research.

  • COMMON MISTAKE: Do NOT complete any of the CITI Responsible Conduct of Research (RCR) modules. These trainings do not fulfill the human subjects research training requirements for UC Davis.

Go to the IRB Required Education Page

Create an IRBNet account

All applications to the UC Davis IRB  must be submitted using our electronic submission system, IRBNet. To use IRBNet, you must first register as a new user. Visit our IRBNet Information page for more information.

Go to IRBNet

 

Completing a New Project on IRBNet

Create a New Project package on IRBNet

Follow along with this IRBNet Demonstration video to learn how to create a New Project.

Complete the Initial Review Application Form for your New Project package

The Initial Review Application (IRA) is an online data entry form. You must log into IRBNet to access and complete the IRA.

  • IRB TIP: The final page of the IRA is the Form Complete page. Under Additional Documentation, you will see a complete list of the documents that should be included in your submission to the IRB based on your answers in the IRA.
  • COMMON MISTAKE: To make edits to the Initial Review Application, go to the Designer page and click the pencil icon to open the electronic data entry view of the form. Do not download the PDF and change the document.

Go to the IRA Guide

Develop the research protocol and consent documents

Research Protocol

Each project must have one research protocol. If there is a sponsor protocol or outside researcher protocol, it can be used as the research protocol. If there is no existing research protocol, use one of our HRP-503 Protocol Templates for your project. Complete the required fields and upload the protocol in IRBNet.

Consent Document(s)

If your project involves any interaction with research subjects, consent for participation in research will be required. Select the appropriate HRP-502 template for your project.

  • IRB TIP: If the sponsor or coordinating site provided a consent document, transfer the sponsor’s language into the appropriate HRP-502 template. HRP-502 templates contain required UC Davis language.
  • IRB TIP: If children are the primary subjects in research, add a sentence to the consent document indicating the word “you” refers to the child, not the parent.

Go to the IRB Forms Page

Upload documents to IRBNet

Depending on the study design and research procedures, the following additional documents may be required:

  • Research protocol
  • Informed consent document/consent script/information sheet
  • Anything intended to be seen or heard by participants
    • Recruitment materials (flyers, brochures, advertisements)
    • Surveys/interview/focus group questions
    • Data collection instruments (assessments)
  • Investigator’s Brochure or Package Insert (for a clinical trial of an investigational product)
  • Ancillary review documentation
  • IRB Fee Form
  • IRB TIP: File names will be printed in IRB approval letters. To obtain a list of documents reviewed and manage version control, use version dates in file names when they are uploaded into IRBNet.
  • COMMON MISTAKE: Do NOT submit the following: CITI training completion certificates, HIPAA authorizations, grants, conflicts of interest paperwork, abstracts, HRP-507 Short Forms, any HRP-300s Worksheets, or any HRP-400s Checklists.

How to Categorize Documents on IRBNet

 

Sharing Your Project and Obtaining Required Signatures

Share the project with signatories and other research personnel on IRBNet

Principal Investigators, Co-principal Investigators, and Faculty Advisors are required to have Full access to projects in IRBNet. Research coordinators, administrators, and anyone responsible for correspondence with the IRB may also benefit from having access to the study in IRBNet. Anyone with Full access to a project can share it with another user.

Follow along with this IRBNet Demonstration video to learn how to share a project.

Obtain required electronic signatures on IRBNet

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.
Signatory Role

Principal Investigator

Department Chair

Dean of School of Nursing

Faculty Advisor

IRBNet Signatory Title

Principal Investigator

Department Head

Other Signatory

Advisor

Follow along with this IRBNet Demonstration video to learn how to sign a project on IRBNet.

  • COMMON MISTAKE: Designee signatures are NOT accepted. For New Projects the Co-Principal Investigator’s signature is not accepted in lieu of the Principal Investigator’s signature.

Submit the project

Once all requirements are complete, submit the application to the IRB for review. IRB Administration will screen the application for completeness and route it for review.

  • COMMON MISTAKE: Don’t forget to click submit! Applications are not automatically routed for review when signatures are completed. The researcher must click the “Submit this Package” button in IRBNet to submit the application for review.

 

 

What Comes Next?

While you are waiting for your new project to be reviewed by the IRB, this is a good time to familiarize yourself with the IRB review process and learn about the type of determinations the IRB might make about your project.

Familiarize yourself with the review process Learn about IRB letters and determinations

 

Example Submissions

The required documents to be reviewed during a New Project submission to the IRB depend on the nature of the research. 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:

UC Davis Health Medical Record Review

UC Davis Health Medical Record Review Cheat Sheet

Secondary Analysis of Records, Data, or Specimens

Surveys, Interviews, or Focus Groups

Survey Study Cheat Sheet

Clinical Trial

Generic Protocol

 

 

Additional Resources