• Submit a New Project Application
• Submit a Response to a letter from the IRB
• Amend an existing project
• Submit information for Continuing Review
  
• Submit a "Resubmission" of an existing, approved project after 4 IRB reviews completed
  

Submit a New Project Application

The New Project Submission (and 4-year resubmission of an existing project) includes the following steps: 

1. Download a Word templatefor describing your Research Plan.  This is the document that contains contains headings for each of the areas on which the IRB must base its judgement of safety and ethics.
2. Download the Instructions for filling out the Research Plan template.
3. Fill in the template document using the Instructions, the same way you would if producing a paper submission and save it on your computer. The difference between the e-IRB and paper-based review process is that you will upload this Word document to this website rather than printing multiple copies of it.
4. Create your consent document(s) in Word or WordPerfect format. You can use the HRPP's Informed Consent Assistant for help with this.  Save the informed consent(s) and adolescent or child assents, if needed, one consent document per file, on your computer. You will have the opportunity to upload each consent or assent separately.
5. Once your research plan document and consents are ready and saved on your workstation, fill out the Biomedical Application Face Pages.  These face pages are in Adobe Acrobat format and can be submitted online via your web browser, or submitted on paper. (Please note that a facepage signed by the Principal Investigator, Department Chair --and for VA projects the VA Service Chief-- is required as a paper submission even if you submit the facepage data online. Please also note that one of the idiosyncrasies of Acrobat is that the free Acrobat Reader cannot save the Acrobat form with its data on your local computer. If you wish to save the facepages for future editing and re-use, you will need to full version of Acrobat (available from the UCSD bookstore at the academic price of about $50).
6. After completing the Face pages you can either submit the project online via the e-IRB website (preferred), or on paper by making 2 copies and mailing them to the HRPP office, mailcode 0052. 

1. Download the SBS Cover Letter and Instructions
2. Download the SBS Application Form  (Please note the form can be filled out using Acrobat reader but cannot currently be submitted online; please print it for submission).
3. Submit 2 copies of the application to the HRPP office at mailcode 0052.  You can also deliver items in person to the HRPP offices; see a map of our location to do this.

Submit a Response to a Letter from the IRB

Responses can be submitted online as a series of protocol-associated documents at the e-IRB website (preferred), or by mail to mailcode 0052.  You can also deliver items in person to the HRPP offices; see a map of our location to do this.

Amend an Existing Project

1. See the Fact Sheet on Making Amendments and Changes to an existing protocol.
2. Amendments can be submitted on paper or submitted online via our e-IRB services.  (Please do not submit amendments as a New Project submission.)
3. Please note that a four year renewal is a New Project Application, not an amendment of an existing project.  See the instructions at the top of this page for a New Project Submission.

Submit information for Continuing Review

1. Federal Regulation required that projects undergo Continuing Review at intervals not greater than 365 days. Courtesy reminders regarding upcoming expiration dates may be sent electronically at intervals set by users of the HRPP system. The default reminders are sent 75, 60 and 45 days before a project expires, but these intervals, and the entire reminder service, can be set to a user's preference using our e-IRB services. However, this courtesy notification should not substitute for the researcher's own internal tracking of expiration dates. Ultimately, it is the PI's responsibility to submit documentation within the due dates provided.
   
2. If a project is within 76 days of its expiration, the My Protocols at a Glance function will include a menu option to begin the Continuing Review submission process. You may also access these documents at any time via the Forms page.
   
3. A Continuing Review submission has three or more components:
• Continuing Review Face Pages, which are created via a web form accessible from My Protocols at a Glance.  The printed copy of the Face Pages must be signed by the PI and submitted to HRPP at mailcode 0052, along with the information listed below.
  
• A Narrative Summary of Progress made since the most recent IRB review. This is a Word document that can be downloaded and saved on your workstation.
  
• A copy of the IRB-approved blank consent form currently in use by the project. (Note: although HRPP has a copy of this on file, federal regs require that you send us the current consent so that the IRB can determine that you are using the correct version.) Do not send a consent that has been signed by a study participant.
• Associated study documentation, including any study monitor reports or FDA audit reports since the most recent IRB review. 
  
4. The items listed in #3 should be mailed to HRPP at mailcode 0052 not less than 45 days before expiration of the current IRB approval.
   

Submit a 4 year project "Resubmission" application for an existing approved project

Therefore, DO NOT submit the revised project application as a set of documents associated with an existing application.  Rather, on the face pages, please list the number of the protocol being renewed in the appropriate place on the form and submit the application as a New Project submission.  The steps for doing this are listed at the top of this page.

We encourage you to use the e-IRB online submission process whenever possible, as it saves both you and the IRB paper and time.