IRB : Study Concept

Trial Design Stage

Published Date: April 29, 2025

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Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources*

Interested in learning more or contributing to a resource?

*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.

Study Concept

For the purposes of this roadmap, “IRB” refers to Institutional Review Boards in the United States and Ethics Committees (ECs), including Independent Ethics Committees (IECs), in global research settings.

Training and Preparedness for IRB Engagement

Individuals interacting with Institutional Review Boards or Ethics Committees (IRB/IEC) are expected to have appropriate training in Good Clinical Practice (GCP), human subjects protection, and applicable regulatory requirements.

Additional training may include study-specific protocol training and institution- or sponsor-defined requirements related to ethical review, informed consent, and compliance. While specific training requirements vary by institution and region, IRBs/IECs generally expect that personnel are adequately prepared to support ethical review and conduct of the study.

Why involve IRBs now?

At the study concept stage, IRBs do not typically conduct formal reviews. However, early planning for IRB expectations helps ensure that the protocol will meet ethical and regulatory standards once submitted.

Early preparation reduces delays later in the process by aligning study design with requirements for risk assessment, informed consent, and participant protections.

Helpful actions at this stage:

Identify which IRB(s) will oversee the study (local institutional vs. independent/commercial/other external)
Review IRB templates, guidance, and submission requirements
Consider ethical risks early (e.g., vulnerable populations, privacy, consent)
Ensure team members understand human subjects research requirements and training expectations
Begin developing a clear scientific rationale and unmet need

IRB review type planning:
Use this stage to anticipate the likely level of IRB review required.

Exempt Review

Expedited Review

Full Board Review

How to locate an IRB

The appropriate IRB depends on study design, funder preference or requirements, number of sites, and organizational setting.

Single IRB of record (sIRB)

Required for most federally funded or supported U.S. non-exempt multisite studies
One IRB oversees all sites
Reduces duplication and improves consistency
A range of entities may serve as the sIRB (e.g., another institution’s IRB, a federal IRB, an independent/commercial IRB). For multisite studies subject to the NIH Single IRB Policy or the Revised Common Rule there is a requirement to rely on an sIRB to conduct the ethical review on behalf of all U.S. research sites for the entire study.
For multinational studies, a single IRB may oversee U.S. sites, while Ethics Committee(s) conduct local ethical review in accordance with regional regulations.

1. Determine IRB model

Local (Institutional) IRB

Used for single-site studies at institutions (e.g., hospitals, universities)
Contact the institution’s IRB office, typically located within its research administration or compliance department. If your organization does not have an IRB, your research administrator or compliance office can advise on the IRB(s) typically used to oversee research and/or policies for choosing an external IRB.

Single IRB (sIRB) / Central IRB

Required for most U.S. multisite studies under federal policy
One IRB oversees all sites
Reduces duplication and improves consistency
A range of entities may serve as a central IRB (e.g., another institution’s IRB, a federal IRB, an independent/commercial IRB). For multisite studies subject to the NIH Single IRB Policy or the Revised Common Rule there is a requirement to rely on a sIRB to conduct the ethical review on behalf of all U.S. research sites for the entire study.
For multinational studies, a single IRB may oversee U.S. sites, while Ethics Committees conduct local ethical review in accordance with regional regulations.

Commercial / Independent IRB

Common for industry-sponsored trials
Used by sponsors, CROs, and organizations without internal IRBs
Organizations without their own IRB, or a sponsor/coordinating center/lead site of a multi-center study, can contract with a commercial/independent IRB. Commercial or independent IRBs are often utilized for efficiency, combination with other research services, specialized expertise, or as the IRB that was required by the sponsor.

2. For multisite studies

3. Confirm site-level requirements

“Single institutional review board” or “sIRB” refers to one designated IRB relied on by all U.S. sites in a multicenter clinical trial. The terms “central IRB,” “single IRB,” and “reviewing IRB” are synonyms in CTTI materials.

Questions To Ask

What training is required to conduct human subjects research (e.g., CITI or NIH training)?
What are typical IRB review timelines and key milestones?
Are pre-submission meetings or consultations available with the IRB?

IRB Resources

Regulatory Authority & Formal Guidance

These documents define the legal requirements and interrelationships between sponsors, investigators, and the IRB.

- FDA: IRB Frequently Asked Questions: The official FDA interpretive guide regarding IRB operations, record-keeping, and regulatory compliance.
- FDA: Sponsor-Investigator-IRB Interrelationship: Clarifies the specific roles and communication obligations between these three key stakeholders under the FDA framework.
- HHS/OHRP: Guidance for Institutions and IRBs: Primary policy resource for institutions and IRBs managing human subject research protections.
- Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance (PMC8251897): An evidence-based analysis of the barriers to effective sIRB implementation.

IRB Frameworks

Essential for modernizing trial oversight, specifically for multi-site and decentralized studies.

- CTTI: Single IRB Project: CTTI’s evidence-based recommendations for successfully implementing a Single IRB (sIRB) model to streamline study startup.
- SMART IRB for Study Teams: The industry-standard platform for harmonizing IRB reliance and managing the logistics of multi-site review.
- Strategies for Central IRB Success (PMC7876614): Academic evaluation of how centralized IRB oversight improves (or complicates) multi-center clinical research efficiency.

Operational Toolkits & HRPP Resources

Practical tools for managing submissions, HRPP compliance, and educational outreach.

- Advarra: Beginner’s Guide to IRBs: A foundational operational overview for team members new to the human subject protection review process.
- MRCT Center: IRB and HRPP Toolkit: A highly specialized toolkit for ensuring diversity and operational excellence within HRPP and IRB workflows.
- Rutgers: Interactive IRB Tools: Practical, interactive templates for study teams to use during the application and modification submission phases.