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

Study Concept

Questions To Ask

What training is necessary to conduct human research?
How long does the IRB review process typically take, and what are the key milestones?
Are pre-submission meetings scheduled?

Why involve IRBs now?

At this stage, the Institutional Review Board (IRB) does not typically review materials formally. However, sponsors and study teams should begin preparing for IRB expectations early to ensure the protocol will meet ethical and regulatory standards once it is drafted.

Helpful actions at this stage:

Identify which IRB(s) will oversee the study (central IRB vs. local IRBs).
Review publicly available IRB guidance, templates, and standard expectations.
Consider ethical issues early, including anticipated risk level, use of vulnerable groups, data privacy, and consent requirements.
Ensure team members understand ethical foundations of human subjects research (e.g., NIH training), even though formal certification may be required later for investigators at study sites.
Begin drafting a strong scientific rationale supported by evidence and a clear unmet need.

IRB review type planning:
This is a good time to determine whether your study is likely to require exempt, expedited, or full board review based on anticipated risk.

Exempt Review

Criteria

Applies to research involving no more than minimal risk.
Must fall into specific regulatory exemption categories (e.g., certain educational tests, surveys, benign behavioral interventions, use of de‑identified data).
Clinical trials are rarely exempt, except in very narrow circumstances (e.g., some low‑risk behavioral interventions with adults).

Process

The IRB (or designated reviewer) determines whether the study qualifies for exemption—researchers cannot self‑declare.
An exempt study still requires IRB submission, documentation, and determination.

Recommended Engagement

Confirm early whether the project might fit an exemption category.
Use IRB templates to ensure the submission includes required exemption‑justification language.
For multisite studies, confirm whether the single IRB policy applies, even for exempt determinations.

Expedited Review

Criteria

Research that involves no more than minimal risk.
Must fall into one of nine expedited categories (e.g., noninvasive specimen collection, limited data collection procedures, minimal‑risk blood draws).
Many minimal‑risk clinical studies (e.g., surveys + routine clinical data collection) qualify.

Process

Reviewed by one or more designated reviewers (not the full board).
Faster turnaround but still requires full documentation, including consent materials unless waived.

Recommended Engagement

Provide clear justification for the applicable expedited category.
Engage early with your IRB if unsure whether your procedures exceed minimal risk.
Ensure your consent process matches the level of risk—this helps avoid reviewer hold‑ups.
For multisite trials, confirm whether you will use a single independent IRB (very common for industry‑sponsored expedited studies).

Full Board Review

Criteria

Required for research that:

Involves more than minimal risk (e.g., investigational drugs/devices, invasive procedures).
Involves vulnerable populations (children, prisoners, individuals with impaired consent capacity).
Examines sensitive topics that may pose psychological or social risk.

Does not fit any exempt or expedited category.

Process

Reviewed during a convened meeting of the full IRB committee.
Requires quorum and a formal vote.
Can result in approval, modifications required, deferral, or disapproval.

Recommended Engagement

Meet with your IRB office early if your study involves complex or higher‑risk procedures.
Build time into your schedule—full board reviews typically take longer due to meeting cycles.
Provide detailed risk‑mitigation strategies and a clearly written consent document.
For multisite clinical trials, plan early for single‑IRB reliance agreements (common for high‑risk trials).

How to locate an IRB

Finding the right Institutional Review Board (IRB) is essential to ensure ethical oversight and regulatory compliance. The correct IRB depends on where the study is conducted, how many sites are involved, and your organization’s role.

Determine whether you need a Local, Central, or Commercial/Independent IRB

Local (Institutional) IRB

Central or Single IRB (sIRB)

For multisite studies, federal regulations—the NIH Single IRB Policy and the Revised Common Rule—require that all U.S. research sites rely on one IRB (the “single IRB” or sIRB) to conduct the ethical review for the entire study.

The goal is to:

Reduce duplicate IRB submissions
Create one consistent set of approved study documents
Speed up study activation
Improve oversight for multisite trials

How it works:

The sponsor or lead site selects the sIRB (institutional, commercial, or central IRB).
All sites sign reliance agreements so they can rely on the same IRB.
The coordinating center submits one complete IRB application to the sIRB.
The sIRB reviews and approves the protocol and consent documents.
Each site completes its own local institutional requirements (training, ancillary reviews).
Sites are added to the sIRB via amendments and receive the same approved documents.
All future amendments, safety reviews, and continuing reviews go through the sIRB only

Commercial/Independent IRBs

Identify where your study team is based. Your organizational type determines your starting point.

Academic / Hospital sites

Industry sponsors (pharma/biotech/CRO)

Nonprofits, community clinics, startups, or independent researchers

If the study includes multiple sites

Determine which IRB will serve as the IRB of record. For multisite studies

Workflow for determining the IRB of Record (sIRB)

Confirm sIRB requirement (NIH policy + Revised Common Rule).
Choose the sIRB (commercial IRB, lead‑site IRB, or network IRB).
Verify that all sites can rely on the selected IRB.
Execute reliance agreements for all participating sites.
Submit the full protocol package to the sIRB.
Local IRBs perform administrative/local context reviews as needed.
Add each site to the sIRB via site‑specific submissions.
All amendments, safety reporting, and continuing reviews go through the sIRB only.