Human Research Protections (HRP)Toolkit

The HRP Toolkit is a webpage (previously the IRB Forms page) that houses all critical-IRB related documentation in one place. We expect this format and the information within to provide a more streamlined approach to successfully conducting and administrating human subject research at UCI. Please take a minute to review this webpage.

You will note the same templates that you have been using in Kuali Research Protocols (e.g., consent forms).

You will also see new information.  As a few examples: User Guides & Manuals, Standard Operating Procedures (SOPs) and within the latter, Principal Investigator Worksheets.

ZOT IRB Researcher’s Guide

Within the HRP Toolkit and under the User Guides & Manuals Tab is the NEW ZOT IRB Researcher’s Guide.

This reference walks researchers through ZOT IRB basics like drafting and submitting a new study, responding to the IRB and submitting follow on submissions (continuing reviews, modifications and reportable new information).  There is lots of helpful information. We encourage you to review prior to the ZOT IRB launch.

The Investigator Manual

Also NEW is the HRP-103 Investigator Manual. The Investigator Manual provides an overview of expectations and practices to conduct human subject research at UCI.  This document serves as a quick reference guide for both new and experienced researchers by providing succinct, basic guidance with web links to our HRP webpages and new Standard Operating Procedures for further details.

Standard Operating Procedures (SOPs)

This section of the HRP Toolkit falls under the tab of the same name.  Here you will find SOPs for relevant human research protections topics.  These SOPs are divided by those worksheets that are resources for our human researcher community (the IRB, HRP staff, UCI researchers and partners) and those for our Principal Investigators (PI) to complete.

The PI Worksheets will be completed and uploaded as an attachment  to the ZOT IRB SmartForm, accompaning the specific applicable version of the Protocol Narrative, Master Protocol, Investigator Brochure, Consent Form, Assent Form, non-standardized Surveys and Questionnaires, etc.  The PI Worksheets will provide opportunity for PI (expert) input in assessing special topics of research that may require the IRB to make additional regulatory determinations.

The NEW HRP-101 The Human Research Protection Plan references the scope, purpose, mission and all programmatic components of human subject research at UCI.  This document, along with the Worksheets and Investigator Manual replace our prior HRP Policies and Procedures.  Refer to these HRP Toolkit materials upon launch of  ZOT IRB.

Protocol Narratives

Our templates for Protocol Narratives and Principal Investigator (PI) Worksheets have been finalized and are available in the HRP Toolkit. Please consider creating your templates NOW as part of preparing for a new submission in ZOT IRB on or after September 15, 2025.

As part of ZOT IRB, a protocol submission includes the electronic application, a Protocol Narrative (as applicable), Principal Investigator (PI) Worksheets (as applicable), and other research documents (e.g., recruitment materials, consent forms). PI Worksheets are to be completed based on special populations and considerations in human research that either require regulatory documentation and / or input from the PI to ensure human research protections.

Protocol Transcription

For current IRB approved protocols, a PDF was generated of the KRP protocol (KRP PDF) and was attached to the protocol in ZOT IRB. The information from the KRP PDF must be transcribed (i.e., cut and paste) into the Protocol Narrative and / or applicable PI Worksheets according to the table below.

 

Edit

	Greater than minimal risk protocols & FDA regulated protocols	Non-FDA regulated protocols, including exempt research that requires IRB review	Protocols closed to enrollment, in follow-up or data analysis only
Minor (non personnel) modification. Transcribe only the sections of the protocol that require changes.	YES*	YES*	YES*
Major modification. Transcribe the entire protocol.	YES	YES	YES
Renewal. Transcribe the entire protocol.	YES	YES+	NO

 

*While the goal is to try to minimize burden to our UCI Research Community, the IRB and HRP Staff reserve the right to use discretion as to when they believe a complete Protocol Narrative should be included in the submission for the purpose of facilitating the IRB review process.

⁺Should the transcription cause an administrative hardship on the study team, at their discretion the IRB and HRP Staff may issue a one-time exception to transcribe the protocol.

Continuous Improvement

Feel free to share your feedback as you use ZOT IRB and the HRP Toolkit. We anticipate continuous improvement and we need input and feedback from our UCI Researchers, the IRB and our HRP.  Email feedback to the IRB at IRB@UCI.edu or reach out to Beverley Alberola or Jessica Sheldon directly.

A BIG Thank You!

We appreciate our UCI Research Community, our IRB Chairs, IRB Members, Human Research Protections (HRP) and Office of Research Colleagues for their patience and support during this important and complex transition.  We look forward to working together to make ZOT IRB a success at UCI for (many) years to come!!