Institutional Review Board (IRB)

This document outlines the different types of ancillary reviews that may be required for human subjects research at Saint Louis University or in collaboration with SSM Health. 

It includes:

• A breakdown of the ancillary reviews specific to SLU and SSM Health
• When each review must occur (e.g., before submission, before IRB approval, or in parallel)
• Who initiates them and how to assign them correctly in ARCH-IRB
• Which types of studies require specific reviews
• Contact information for each review entity

The matrix is designed to help study teams avoid delays by clarifying expectations and responsibilities related to operational, legal, technical, safety, and compliance reviews that affect IRB processing.

The HRP-309 – Ancillary Review Matrix is now available in the ARCH-IRB Library under “General.”

The Saint Louis University IRB has implemented an updated fee schedule, effective July 15, 2025. This is the first revision of our IRB fees since 2015. The revised schedule reflects significant changes in research oversight infrastructure, increasing regulatory requirements, and rising administrative and system-related costs over the past decade. When setting the new fees, we carefully reviewed the fee structures at peer institutions and aligned our rates with current market standards to ensure fairness and sustainability. 

Key Points:

• Currently, the revised fees apply only to externally funded research, including industry-sponsored and foundation-supported studies. Federal agency-funded research is exempt.
• The new rates will apply only to new studies submitted on or after July 15, 2025.
• Studies with fully executed contracts or those in the final stages of negotiation using the prior fee structure will be honored under the existing terms.
• Fee waivers may be considered in limited circumstances upon request.

A full breakdown of the new fee schedule is available in the ARCH-IRB Library under “General.”

Saint Louis University, as a recipient of federal, industry, or foundational research awards, assumes and maintains a fiduciary responsibility to adhere to applicable laws, guidelines, and terms associated with a sponsored award. Research is a shared responsibility at Saint Louis University. Principal investigators play a significant role in our research ecosystem. PIs serve as an extension of the University and share the responsibility to ensure adherence with all applicable University and external sponsor requirements, terms, and conditions. As such, SLU is committed to ensuring that all individuals engaged in research activities understand their roles and responsibilities as principal investigators.

Access Principal Investigator Policy

HRP Consulting Group has provided sample IRB guidelines for investigators with research at risk for stop or pause work orders in the hope that this will be helpful as institutions develop their own instructions and guidelines. As of March 19, 2025, this guidance has been updated to include reference to SACHRP recommendations, data management and sharing and other responsibilities, ClinicalTrials.gov reminder, and other minor changes.

Access the Sample IRB Guidance

As of March 3, 2025, ARCH-IRB, our new electronic submission system, is live.

ARCH-IRB is designed to streamline the submission, review, and approval process for human research studies, enhancing efficiency, communication, and transparency.

How to access ARCH-IRB:

• Direct link: arch-irb.slu.edu
• MySLU Access: You can also find ARCH-IRB under the "My Apps" tab in MySLU

Key Features of ARCH-IRB

• Standardized policies, SOPs and templates based on best practices
• Improved tracking and communication tools
• Increased efficiency in IRB review and approval timelines
• Real-time transparency, allowing researchers to track submission progress

HRPP Toolkit

The HRPP Toolkit, a revised set of policies, SOPs, and templates to guide researchers through the IRB submission process, has been added to the ARCH-IRB Library.

Training and Support

To support the transition, we have prepared training materials, user guides, and support resources, available on the HRPP SharePoint Site and the ARCH-IRB Library. In addition, we will be hosting live training sessions and open hours to walk you through the system and answer any questions. Please visit the HRPP SharePoint Site for additional information.

Stay Updated

We are actively updating the HRPP SharePoint Site with important news and information about the ARCH-IRB implementation. 

Human subjects research is an integral component of the knowledge development and mobilization goals of Saint Louis University. Within this framework, SLU maintains a diverse portfolio of human subjects' research activities in both clinical and nonclinical settings. The purpose of this policy is to describe the requirements and responsibilities of SLU in the application, review, and approval of research compliance education requirements to engage in human-subjects research at Saint Louis University.

Access the SLU Research Compliance Education Program Policy

A group of research nurses and study coordinators developed a process map of the current clinical trial submission process at SLU.

Access the SLU Clinical Trial Process Map

Navigating the SLU research enterprise can be tricky, especially if you are new or you have worked at another research institution. This site attempts to make navigating this process easier and prepare research staff for the necessary levels of oversight needed to conduct human subjects research at SLU.

The site content defines the components that make up the SLU research machine, and describes important steps, considerations, and tips for navigating the SLU research enterprise.

Please note: This site is internal, so you must log in to your SLU Google account to access it. You can do this by logging into MySLU or (when prompted after clicking the link) using your MySLU username (called a SLU NetID) followed by @slu.edu and your MySLU password.

Visit the New to SLU Research Site

Open Requests for Comments

This is only the beta version of the New to SLU Research Site. We seek your comments and feedback to help improve the site moving forward. Please submit comments or feedback here.

Please take a moment to visit the ARCH-IRB SharePoint site. This is your central hub for all related to the ARCH-IRB implementation including submission resources, training materials, helpful FAQs, and important announcements. We encourage all researchers and study team members to bookmark the page and check it regularly for updates.

• IRB Meeting Dates/Deadlines (PDF)

The time to process an application depends on the complexity of the research study and the quality and completeness of the application submitted. Other variables include whether the application can be approved by the IRB Chair or Designee (exempt/expedited review) or by the full board.
*Please note: Estimated review times may vary during times of high volume.

Depending on the type of review, you should anticipate the following response times:

New Protocols

• Exempt Review: Notification in two to three weeks
• Expedited Review: Notification in four to six weeks
• Full Board Review: Notification within two weeks of IRB meeting date

Modifications

• Exempt/Expedited Review: Notification in one to two weeks
• Full Board Review: Notification within a week of IRB meeting date

Forms/Reports

• Continuing Review Forms: Notification within 30 days of expiry date
• Report Forms: Varies
• SAE Reports: Varies
• Final Report Forms: Notification within a week

For questions about the status of the review, please contact the IRB Office at 314-977-7744, irb@slu.edu, or visit the IRB staff page for department-specific contact information.

For your convenience, view a compilation of IRB forms and guidelines.

The Research Investigator Project Planning Checklist can help you navigate the different offices responsible for ensuring research safety and compliance regulations are met at SLU.