How to Get IRB Approval: A Step-by-Step Guide

Navigating the IRB approval process doesn’t have to slow your research down. Whether you’re submitting your first IRB application or managing a multi-site study, understanding each stage of the process helps you protect your timeline, stay compliant, and get your trial off the ground faster. 

What Is IRB Approval? 

An Institutional Review Board (IRB) is an independent committee that reviews research involving human subjects to ensure it meets ethical, regulatory, and scientific standards. IRB approval is required for federally funded or FDA regulated research and must be completed before any human subject research can begin. Without it, the study cannot proceed. 

The IRB approval process evaluates your study protocol, informed consent documents, and participant safeguards to verify that risks are minimized and that the rights and welfare of participants are protected. 

How to Get IRB Approval: Six Steps 

Step 1: Determine Whether Your Study Requires IRB Review 

Not every research activity requires full IRB oversight. You should first confirm whether your study involves human subjects as defined by federal regulations. Research that involves identifiable private information or direct interaction with individuals typically requires a level of review. If you’re unsure, consult your institution’s IRB office or a qualified IRB provider before proceeding. 

Step 2: Identify the Appropriate IRB 

Determining which IRB has jurisdiction over your study is important and can vary depending on whether you are a sponsor or a site. 

For sponsors or clinical research organizations (CROs) overseeing multi-site clinical trials, selecting a central IRB is essential for maintaining operational efficiency and regulatory consistency. A central IRB, such as WCG IRB, not only reduces redundancy and streamlines submission requirements but also provides unified oversight across all participating sites. This centralized approach supports standardized communication, helps manage IRB queries for multiple sites, and ensures that regulatory documentation meets the requirements for each location. By leveraging a central IRB, CROs can accelerate study activation timelines, minimize administrative burden, and maintain high levels of data integrity and participant protection throughout the duration of the trial. 

For sites, partnering with your local IRB may offer direct familiarity with site policies and local context. WCG IRB serves as a local IRB for many institutions. However, selecting a central IRB can streamline oversight across multiple sites or studies, reducing redundant submissions and ensuring regulatory requirements are consistently met. By working with a central IRB, sites benefit from a unified review process, reliable timelines, and reduced administrative workload, which helps staff focus on recruiting participants and executing the protocol. This approach supports both workflow efficiency and a high standard of participant protection. 

Step 3: Prepare Your IRB Application and Supporting Documents 

A complete IRB application typically includes: 

• The study protocol 

• Informed consent forms (ICFs) 

• Investigator brochure or device description 

• Recruitment materials (advertisements, scripts, flyers, etc.) 

• Data collection instruments 

• HIPAA authorization forms, where applicable 

• Investigator qualifications and training documentation 

Incomplete submissions are one of the most common causes of IRB review delays. Be sure to review the application materials carefully before you submit. 

Step 4: Submit Your Application Through the IRB’s Portal 

Most IRBs use an electronic submission platform. At WCG, this process is managed through eReview Manager, supporting streamlined workflows, real-time reporting, and predictable turnaround times. Submit all required documents in the formats specified by your IRB and confirm receipt of your submission. 

Step 5: Respond to IRB Queries and Contingencies 

Before the formal IRB review, the board may issue queries or contingencies, requesting clarifications or modifications to your protocol or consent documents. Respond thoroughly and promptly as incomplete or vague responses can add weeks to your timeline. Assign a point of contact within your study team to manage IRB correspondence efficiently. 

Step 6: Receive Your IRB Determination 

Once all contingencies identified by staff are resolved, the IRB performs its formal IRB review and issues its determination. Common outcomes include: 

• Approval: The study may proceed as submitted. 

• Disapproval: The study cannot proceed in its current form. The IRB will provide a rationale and may allow an opportunity to appeal or resubmit. 

If the IRB determination is Approved with modifications or Disapproved, the IRB will provide the reasons for the decision. To obtain an Approval, you will need to respond to the IRB’s questions. 

Fulfill Ongoing Reporting and Continuing Review Requirements 

IRB approval is not a one-time event. Once your study is underway, you are responsible for: 

• Submitting annual continuing review reports before your approval expires. 

• Reporting unanticipated problems, serious adverse events, and protocol deviations promptly. 

• Submitting protocol amendments for any changes to the study design or consent documents. 

• Notifying the IRB upon study completion or early termination. 

Staying current with ongoing obligations protects your study and your participants. 

Frequently Asked Questions 

How long does the IRB approval process take? 

IRB timelines vary by institution, review type, and IRB workload, with some IRB partners taking up to a few weeks for turnaround. WCG’s turnaround times can be as short as a few days to about a week depending on the type of review. Full board review is typically five to eight days, and expedited review is approximately one to three days. 

What is the difference between a local IRB and a central IRB? 

A local IRB operates within a single institution and reviews studies conducted at that site. A central IRB, such as WCG IRB, provides oversight across multiple sites under a single review, which reduces redundancy, lowers administrative burden for sites, and accelerates study start-up for multi-site trials. WCG IRB acts as a local IRB for many institutions. 

Can I submit amendments after my study receives IRB approval? 

Yes. Any changes to your approved protocol, consent documents, or study procedures must be submitted to the IRB as a protocol amendment before implementation, unless the change is necessary to eliminate an immediate hazard to participants. 

What happens if my IRB approval expires? 

If your continuing review is not submitted and approved before your current approval expires, you must stop enrolling new participants immediately. Conducting research under expired approval is a regulatory violation that can jeopardize your study and your organization’s compliance standing. WCG does not let study approvals lapse. If your continuing review is not submitted before it is due, WCG will approve the research for another review period and suspend enrollment.   

Move Through the IRB Process with Confidence 

WCG IRB has reviewed over 70,000 protocols since 1998 – underscoring our track record of experience and breadth of review expertise. Our IRB expertise, purpose-built technology, and dedicated support teams are designed to keep your study moving without compromising ethical rigor or regulatory compliance. Fill in your information below for a free ethical review consultation or for answers to your IRB review questions.