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*

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

Study Concept

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?

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 (central vs local)
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, number of sites, and organizational setting.

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/commerical 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. Identify organizational starting point

3. For multisite studies

4. Confirm site-level requirements

IRB Resources

Beginner's Guide to IRB

CTTI's Single IRB Project Resources

How to Submit for IRB Review

Protocol and Researcher's Relationship with Institutional Review Board

FDA Guidance on IRB Interactions

IRB Written Procedures

Sponsor Investigator IRB Inter-relationship

IRB Toolkit

Interactive IRB Toolkit

SMART IRB