IRB Application: Templates, Help Guides, and Supplemental Forms

📑IRB Application and Help Guides

An IRB Application must be completed for every IRB study. The IRB Application templates are Microsoft Word documents that contain most of the information the IRB needs to review. Many questions have been carried forward from iRIS and will feel familiar.

Fill out the IRB Application template that corresponds to the type of research you are conducting. 

Which application do I need?

Note: For full functionality, please use Microsoft Word to edit the IRB Application. VA SharePoint (for VA staff access). 

Study TypeIRB ApplicationHelp Guide or Website Guidance
Full Committee or Expedited Review Studies Involving Participant ContactHRP-503 503 Help Guide
Studies Involving No Participant ContactHRP-503a  503a Help Guide
Exempt Research Categories 1, 2, and 3HRP-503b 503b Help Guide
Not Human Research DeterminationsHRP-503c  Website guidance
Humanitarian Use Device (HUD) – Treatment Only ProtocolsHRP-503dWebsite guidance
Studies Relying on an External IRBHRP-503e 503e Help Guide
💡 Not sure which IRB Application to use? (Application Comparison Table)

This guidance is included in each Help Guide.

IRB Application When to Use This Document
HRP-503 - Full Committee and Expedited Studies Involving Participant Contact

The study: 

  • involves participant contact (either in person or via phone, email, online tool, another electronic method, postal mail, etc.), and
  • requires either full committee or expedited review, and 
  • does not fit in any of the categories listed below
HRP 503a - Studies Involving No Participant Contact

The study does NOT involve any participant contact - for example, use this template for studies limited to record review and/or biospecimen analysis. 

Participant contact refers to any interaction between the study team and participants, including obtaining consent. This applies to all the methods of contact, such as (but not limited to): in-person interactions, phone calls, emails, postal mails, online surveys or other online tools, other electronic methods

Do NOT use this version of the IRB application if anyone on the study team at UCSF or UCSF-affiliated site will have contact with participants.

HRP 503b - Exempt Research Categories 1, 2, and 3

The study includes research activities that are minimal risk and limited to one or more of the following categories: 

  • Category 1: Normal educational practices in established education settings;
  • Category 2: Educational tests, surveys, interviews, or observation of public behavior; and/or
  • Category 3: Benign behavioral interventions

Review the IRB guidance on exempt certifications for examples. 

HRP-503c - Not Human Participant Research

The project does not qualify as human research, and you require an official “Not Human Research” determination letter from the IRB. The letter may be used as proof of a formal IRB determination for publishers, funders, and other entities.

Review these resources to help determine if your project is not human research:

Note: The UCSF IRB allows researchers to self-certify that a project does not qualify as human research, so the submission of HRP-503c to the IRB may not be required.

HRP 503d - Humanitarian Use Device (HUD)The protocol is for the treatment use of an Humanitarian Use Device (HUD).
HRP 503e – Relying on an External IRB

The study includes a request to rely on an external IRB.

This applies to any type of research EXCEPT the following:

  • Exempt Category 4 Research: UCSF does not allow external IRB reviews for Exempt Category 4 research.
  • Not Human Research or Human Research, Not Engaged: If you are conducting research that does not involve human participants (see guidance and decision tree), or UCSF is not engaged in the conduct of human research. Instead, complete HRP-503c or self-certify that a project does not qualify as human research.
  • International Sites: UCSF does not enter into reliances with international sites.
Expanded Access/Compassionate Use Follow these instructions if this is an expanded access/compassionate use protocol and submit via email, not Research Gateway IRB.

📤How and When to Submit

Additional training materials and system user guides are available on the Research Gateway IRB Training, System User Guides, and Guidance Sheets page.

A. New Study

These instructions also apply to:

  • Studies approved in iRIS but not migrated to Research Gateway IRB, such as exempt studies.
  • New studies submitted in Research Gateway IRB which were never approved in iRIS.

📅 When to Submit

Attach a completed IRB Application when submitting your new study.  

📤 How to Submit

  • Attach this document in the PROTOCOL question in the Basic Study Information section of the IRB Study SmartForm.
  • The IRB application is the only document that should be uploaded to the PROTOCOL section. 
  • Review the New Study Submission user guide for step-by-step instructions.
RegAPP1

B. Study that was approved in iRIS and migrated to Research Gateway IRB

📅 When to Submit

Attach a completed IRB Application the first time you submit a Modification in Research Gateway IRB (excluding modifications to change Key Study Personnel only).

📤 How to Submit

  • Go to the Modification Details page of the Modification Form.
  • Attach this document in the PROTOCOL question in the Basic Study Information section of the IRB Study SmartForm.
  • Review the First Modification for Migrated Study user guide for more information.
RegAPP1

Partially transcribed IRB Applications for some currently approved studies

  • What is available? 
    • To reduce the amount of information that study teams need to re-enter during the transition, the ReGI project team provided some studies with a partially completed, draft IRB Application. Where possible, these templates are pre-populated with information from the study’s most recently approved iRIS IRB Application. Study teams are responsible for reviewing and updating the information before submission. Review the user guides for migrated studies for detailed instructions.
  • Which migrated studies have a draft IRB Application?
    • Most full committee or expedited studies involving participant contact have a draft IRB Application.
  • Which migrated studies do NOT have a draft IRB Application? 
    • Studies that do not involve participant contact (such as chart review studies), exempt research, studies relying on an external IRB, and certain other study types do not have a draft IRB Application. Please note this is not an exhaustive list.
  • Where can I find my draft IRB Application? 
    • You can find it in the Documents tab on the study’s workspace. It will be labeled as “DRAFT - IRB Application HRP-503” and include the study number.
  • What should I do if I do not have a draft IRB Application for my study?
    • No action is needed unless you are submitting a Modification to the IRB for your migrated study  At that time, you will need to:
      • Create an IRB Application using one of the IRB Application templates provided here. 
      • Transfer information from your iRIS study record into the new IRB Application. Each template has a corresponding help guide that identifies the equivalent questions in iRIS.
      • See the 1st Modification for a Migrated Study user guide for detailed instructions. 
      • For Exempt research: You do not need to resubmit your study in ReGI unless you are making significant changes to the research. You can make minor changes without submitting anything to the IRB. 
  • What training is available for migrated studies?

📑Other Supplemental Forms

The following forms are not required for every study and only need to be uploaded in Research Gateway IRB when requested.

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