IRB Application: What to Prepare and Submit

Submitting an IRB application is one of the most critical steps in launching a clinical study. Whether you’re preparing your first submission or streamlining an existing process, knowing exactly what to include can prevent costly delays and keep your research on track. 

Whether you are a sponsor or site, this guide walks you through the required documents, key IRB forms, and best practices for a complete, compliant submission. 

What Does an IRB Application Include? 

An IRB application is a formal submission requesting ethical review and approval to conduct research involving human subjects. When preparing an IRB application, both sponsors and research sites play distinct roles and provide different materials to ensure a thorough ethical review. Understanding these differences from the outset will streamline your submissions, reduce the likelihood of delays, and support compliance across all trial locations. 

Sponsor Requirements 

• IRB Application Form – Some institutions use this form to capture your study’s purpose, design, participant population, and risk-benefit analysis. This form provides demographic and other information not contained in the protocol and consent form. WCG’s IRB submission form only captures information not included in the protocol, consent form, and Investigator’s Brochure (IB). 

• Model Consent Form – A master template that sites adapt to meet their institutional policies and local regulations. 

• Study Protocol – A detailed description of your research methodology, objectives, and procedures. 

• Investigator Brochure (IB) and Study Manuals – Key scientific and operational documents supporting the trial. 

• Recruitment Materials – Any advertisements, scripts, or outreach content used to identify and contact potential participants. 

• Funding and Regulatory Documentation – Sponsor information, contracts, and relevant financial disclosures to support documentation of compliance. 

• Site Management Plan – Outlines expectations for site performance, training, and communications. 

• Supporting Documents – Surveys, questionnaires, data collection instruments, and any other study-related materials. 

Site Requirements 

• Site-Specific Application Form – Details about the site, including the Principal Investigator (PI), research team qualifications, local recruitment strategies, and targeted patient population. 

• Adapted Consent Form – The site modifies the sponsor’s model consent form to reflect local contact information, institutional requirements, and state or regional regulations. 

• Investigator Credentials and Training Records – Current CVs, license documentation, and proof of mandatory research ethics training for all key personnel. 

• Locally Approved Recruitment Materials – Any IRB-mandated changes or site-branded materials reflecting unique contact information or language preferences. 

• Institutional Approvals or Ancillary Reviews – Documentation showing compliance with unique site requirements, such as pharmacy, radiation safety, or ancillary department sign-offs. 

• Site Budget and Contract Documents – If required by the reviewing IRB, the site may need to include agreement documents or attestations of sponsor funding. 

Each component plays a distinct role in demonstrating that your research meets ethical standards and regulatory requirements. 

How to Submit an IRB Application: Step-by-Step 

Step 1: Gather Your Required Documents 

Before logging into your submission portal, compile all required materials. Review the checklist above to confirm you have everything in order. 

Step 2: Complete the IRB Application Form 

The IRB application form (also referred to as the IRB submission form) is the foundation of your review package that is required by some IRBs; however, this component is not required by WCG IRB. For sponsors, include research objectives, inclusion criteria, safety mitigation strategies, anticipated benefits, and privacy measures. For sites, adapt the master application materials provided by the sponsor to reflect your site’s operations, staff, patient population, and compliance needs.  

Step 3: Prepare the IRB Consent Form 

The IRB consent form must communicate study information in plain, accessible language. It should include various aspects such as the nature and purpose of the study, known risks and potential benefits, participants’ rights, and much more. Sites should ensure consent forms are updated for local policy, institutional requirements, or state-specific content. You can review the full list of required elements by reviewing 45 CFR 46.116 and 21 CFR 50.25. 

Step 4: Review Submission Requirements 

Different IRBs may have specific formatting, word count, or supplemental documentation requirements. Both sponsors and sites should review the submission guidelines for your review board before finalizing your package to avoid common errors that delay approval. 

Step 5: Submit and Track Your Application 

Once your package is complete, submit it through the designated portal or system, such as WCG’s eReview Manager. Keep a record of your submission date and confirmation number. Most IRBs will communicate their review timeline and any requests for additional information through the same platform. 

Frequently Asked Questions 

What forms do I need to submit to an IRB? 

The core forms required for most IRB submissions include the IRB application form, the IRB consent form, and any supplemental forms required by your specific institution or reviewing board. Some studies may also require additional forms for vulnerable populations, multi-site research, or amendments to previously approved protocols. 

What is the difference between an IRB application form and an IRB submission form? 

These terms are often used interchangeably. Both refer to the primary document you complete when initiating a new study for ethical review.  

How long does IRB review take? 

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. 

Can I submit an IRB application before my study protocol is finalized? 

No. A complete study protocol is a required component of your IRB application. Submitting an incomplete package will delay review. It’s best to finalize your protocol before beginning the application process. 

What happens if my IRB application is not approved? 

If your application requires revisions, the IRB will issue a letter outlining specific concerns or requests for additional information. You’ll then have the opportunity to respond and resubmit. Working with a knowledgeable review partner from the start helps reduce the likelihood of revisions. 

Submit with Confidence 

A thorough, well-organized IRB application is the foundation of a successful study launch. WCG has supported the ethical review process for nearly 60 years, helping sponsors, institutions, and research teams navigate submissions with accuracy and efficiency. Our average full-board IRB review determinations arrive 20 percent ahead of targeted turnaround time, so your study can move forward without unnecessary delays. Fill in your information below for a free ethical review consultation or for answers to your IRB review questions.