The IRB Approval Process: Steps, Requirements, and Timelines

Key Takeaways

• IRB approval is required for research involving human subjects
• IRB approval ensures research involving human subjects ensures the safety and security of its participants
• IRB reviews usually take between one and eight days, but can be longer due to application errors or IRB limitations
• IRB management software like Cayuse IRB can help researchers receive faster approvals and document the review process

IRB approvals are one of many necessary steps in the research administration process to ensure research is conducted safely and ethically. While the review and approval process can lead to delays when not planned for or managed correctly, failure to secure an IRB approval for research involving human subjects often means the loss of funding and inability to complete a project. 

It’s essential that researchers understand the IRB approval process, are able to appropriately prepare applications, and are supported by consistent, efficient, and well-documented IRB workflows. In this blog, we’ll take a look at the basics of the IRB approval process, including its purpose, requirements, steps, and usual timelines.

What is IRB review?

IRB review is a process required by FDA regulations for all research involving human subjects. The review involves submitting information to an Institutional Review Board (IRB), an administrative body of at least five members of varying backgrounds tasked with ensuring research protects the rights and welfare of human research subjects. 

When a project undergoes IRB review, the board examines its research protocols and related materials, such as informed consent documents and safeguard brochures, to confirm whether the study contains adequate protection measures for its human subjects. The review process always starts before a study begins, and also involves periodic check-ins while the study is in progress. After a review, the IRB will either approve the study, indicating that it can continue, or disapprove it, indicating that revisions are required before the study can proceed.

When is an IRB review required?

IRB review and approval is required for any research involving human subjects that meets any of the criteria outlined below:

• Directly or indirectly receives federal funding
• Occurs in a university or hospital setting
• Tests therapies that will require FDA approval
• Receives private funding, but is intended as a first step to future research that would require IRB review for any of the above reasons

According to 45 CFR 46.102 (d) and (f), “Human Subjects” are defined as living individuals about whom an investigator (whether professional or student) conducts research that either a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 

What are the types of IRB review?

There are three main categories of IRB review a qualifying study may require: exempt review, expedited review, and full review.

Exempt Review

A study involving human subjects may qualify for an IRB review exemption if the proposed research involves no greater than minimal risk to participants. This includes, but is not limited to, research that:

• Is conducted in established educational settings involving standard educational practices that are unlikely to negatively impact students’ opportunity to learn or the responsibilities of the educators, such as research on pedagogies and research comparing instructional techniques
• Only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior, as long as the subjects can be anonymized, their privacy can be protected without anonymization, or disclosure of their participation would not put them at risk
• Is conducted or supported by a Federal department or agency and designed to examine service programs or a public benefit

It is important to remember that only the IRB can determine which review category a study will fall under, and that all studies involving human subjects must be submitted to an IRB for review, even if the investigators believe that their study qualifies for exemptions. Failure to submit a study for IRB review can present serious compliance risks and jeopardize the study itself, the researchers involved, and their institution.

Expedited Review

Studies may qualify for expedited IRB review if they involve no more than minimal risk to human subjects and do not involve vulnerable populations but also do not meet any of the criteria required for exemption. 

Full Review

All studies that do not meet the criteria for exempt or expedited review will need to undergo a full IRB review. This includes studies that might cause physical harm or psychological stress, studies that collect information about highly sensitive topics or illegal activity, and studies involving human subjects from vulnerable populations — such as children under the age of 18, prisoners, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons.

What do researchers need before submitting an IRB application?

Before submitting an IRB application for a study, the researchers must determine the type of review required, where they will submit their study for review, and what materials they need to send for review.

First, the researchers should determine whether their study qualifies for an IRB review using guidelines like those covered earlier in this blog. To summarize, most studies involving human subjects will need IRB approval unless they qualify for exemption. Even then, the study should still be submitted for IRB review to confirm whether or not exemption is indeed appropriate.

Second, the researchers should identify the appropriate IRB for their submission. This will largely depend on whether the study is conducted by a sponsor or a site. Sponsors and clinical research organizations (CROs) establishing multi-site clinical trials will need to submit to a central IRB — a single IRB that all sites involved in the study will refer to — to ensure consistency and a faster review process. Conversely, research conducted by a team at a single site may prefer to submit to their local or institutional IRB, as they will likely be familiar with the IRBs requirements and workflows. Single-site studies can still submit to central IRBs for any reason, such as discrepancies between IRB resources and a study’s requirements.

Once the researchers have determined that their study qualifies for IRB review and selected the appropriate IRB, they will need to complete an IRB application and gather any information required for the submission. Typically, an IRB application will require:

• The study protocol
• Informed consent forms
• Investigator brochures or device descriptions
• Recruitment materials
• Data collection instruments
• HIPAA authorization forms
• Investigator qualifications and training documents

Because incomplete submissions can delay IRB reviews, researchers should always double check that their applications contain all necessary materials. Many institutions and IRBs today rely on IRB software and digital submission portals to confirm that an application is ready to submit, with the added benefit of providing an audit-ready documentation record throughout a study’s lifecycle.

How long does an IRB review take?

The IRB review process length will vary depending on a project’s complexity, the submission’s readiness for review, and the institutions and IRB’s workflows and resources. Expedited reviews can be completed in as little as one to three days, while full reviews often take between five and eight days. However, this timeline can expand from days to weeks if an application requires resubmission to clarify reviewer questions or include missing information. While a busy IRB can also cause delays, it’s a general best practice to eliminate delays on your end by ensuring an application is correctly submitted the first time.

What happens after an IRB review?

Once an IRB review is complete, the researchers will be informed that their study is either approved to proceed or disapproved, requiring updates and resubmission. Disapprovals will always contain a rationale, and may also allow for an opportunity to appeal the decision.

After a study is approved to move forward, the researchers are still responsible for maintaining IRB compliance. This requires submitting annual continuing review reports, reporting any adverse events or protocol deviations, and submitting protocol amendments for changes to the study design or consent documents. A long study may also require re-approval if its IRB approval expires while the study is still ongoing. Once a study ends, the researchers should also notify the IRB of its completion.

Conclusion

IRB approval is essential for research involving human subjects, but the single biggest factor that impacts the length of the IRB review is submission error. Even when a project is approved, poor record keeping and a failure to keep the IRB up-to-date with study changes can result in noncompliance, funding revocation, and the study’s early termination.

For these reasons, research institutions should ensure their teams have a dependable IRB management system to automate administrative workflows, guide submissions and build audit-ready project histories to confirm ongoing compliance. Cayuse IRB is designed to give teams the tools they need to reduce IRB turnaround times by 30–50%, improve compliance accuracy, and provide transparent visibility for researchers and reviewers alike.