IRB Application Checklist: How to Prepare Your Submission Packet

Key takeaways

• You’ll need IRB review if your project meets the definition of “research” (as defined by DHHS and FDA) and includes any interaction or intervention with human subjects or access to identifiable private information.
• Always review your organization’s protocol submission policies and confirm you have the neccessary attachments before submitting your application.
• IRB protocols typically require a list of personnel involved, a synopsis of the project, the participant population, how human participants will be engaged in the research, and how you will minimize risks to the participants, including their data. 
• Compliance Management solutions like Cayuse IRB can help ensure you application contains all necessary information and attachments.

Institutional Review Board (IRB) approval is more than just a regulatory requirement; it is a commitment to participant safety. Obtaining IRB approval can feel like an overwhelming task to many researchers, especially faculty or students who are going through the process for the very first time. 

What is required for submission?
Who needs to sign-off on my packet?
When can I expect approval?
What do I need to remember to do after that? 

When I was a research administrator, my preliminary review process was often the lengthiest part of the review workflow. Researchers commonly omitted important details within their application, forgot attachments, did not complete the required training, and even used outdated forms! These drawn out steps only served to delay the approval process and create frustration within the research community. My job as a research administrator was to help facilitate research activities at my institution, and a more researcher-friendly process would have gone a long way in smoothing out these large kinks. 

In this post, I will walk you through the key items you need to complete before submitting the IRB, so you can prevent avoidable delays and keep your project on track.

Does your project need IRB review?

This should be the first question individuals ask when thinking about conducting research that involves human subjects. If your project meets the definition of “research” (as defined by DHHS and FDA) and includes any interaction or intervention with human subjects or access to identifiable private information, then the answer is yes, you need an IRB review. 

IRB approval is required to protect the rights, safety, and welfare of human subjects. Reviews fall into three main categories based on the risk to the participants: Exempt, Expedited, and Full Board. Depending on the type of research you wish to conduct, the IRB will categorize your submission accordingly. Each type of review may have different expectations around time to approval that are specific to your organization. 

Some sponsors may even require IRB review even if the study does not meet the criteria mentioned above. In this case, the IRB may issue a Non-Human Subjects Research determination, so it is important to check with your institutional administrator on requirements. 

You need to submit – now what?

Once you have determined that IRB review is required, it is important to follow your organizational policies on protocol submission. The submission typically includes an application or protocol form and attachments such as consent forms, data collection instruments, recruitment materials, and any other documents the IRB may need to assess the project. 

Depending on the scope of the research project, you may also need to provide proof of approvals from other stakeholders, departments, or committees, such as feasibility reviews, faculty advisor sign-offs, or biosafety approval to name a few. Utilizing an electronic IRB system like Cayuse can help streamline this process of assembling the correct packet and acquiring the necessary approvals through the use of smart forms and automated routing. 

The application foundation

The application, otherwise known as the protocol form, includes a series of questions that are specific to the overall research project you are proposing. This may generally include:

• a list of personnel involved
• a synopsis of the project
• participant population
• how human participants will be engaged in the research,
• how you will minimize risks to the participants, including their data. 

Each type of research project may necessitate different types of questions in the application form to allow researchers to elaborate on applicable areas. For example, a physician conducting a clinical trial would need to respond to significantly different questions from a student collecting survey data. 

When using an electronic IRB solution like Cayuse, your organization can configure the application form to expand and contract in response to previous responses, exposing or hiding questions that do or do not need to be addressed. This saves time for the researcher because they know exactly which questions are required and do not have to respond to irrelevant ones.

All personnel involved in human subjects research will be required to complete training as issued by organizational policy. An electronic IRB solution like Cayuse can integrate with training databases, such as CITI training, to automatically pull completion data into the submission. Organizations without an electronic system may require proof of training via certifications uploaded to the submission, manually. 

The project synopsis will define the objectives, hypothesis, purpose, and specific aims of the research. The IRB will analyze: Does the potential knowledge gained justify the involvement of human participants? This may require a lay description in order to allow non-scientific members of the committee to understand the overall goals of the research.

The IRB will need to understand the type of human participant that will be included in your research project. This includes your inclusion and exclusion criteria, sample size and target demographic, and the inclusion of vulnerable populations, such as children, prisoners, pregnant women, or economically/ educationally disadvantaged individuals. 

It’s important to note that there are additional safeguards required by federal regulations when vulnerable populations are studied, and IRBs need ways of tracking which studies include specific populations. This is where study flags or codes built into an electronic system like Cayuse become helpful to easily identify and report on this data captured within the application.

Documentation for participant interaction 

At this point in the submission process, the IRB will need to understand how you plan to engage human participants in your research. This involves the recruitment process and obtaining consent or a request to waive consent. 

The exact recruitment materials should be included in your submission, including flyers, advertisements, scripts, or other mechanisms to be used. These recruitment materials should identify the researcher, state the purpose of the study in layman’s terms, explain the eligibility criteria and research activities to take place, provide contact information for the study team, and include a statement that participation is voluntary. The FDA has mandated that recruitment language must avoid misleading or undue influence. This includes coercive payment emphasis, therapeutic misconception or not clarify that the intervention is experimental, and promise of “free” medical care. 

Data collection instruments must also be included. These can include survey questions, interview guides, or other mechanisms to capture participant responses. The IRB will want to understand what instrument will be used and how often. 

It is the IRB’s responsibility to ensure that participants receive clear, complete information about your research so they can make a voluntary, uncoerced choice to join a study. For this reason, the IRB must also understand how subjects will consent to participate in the research. Your IRB office may have consent templates that you can use to provide the details required by regulatory agencies, sponsors, and the organization, but in short, it is imperative that these documents include the purpose and duration of the study, a description of procedures, potential risks/benefits, and the voluntary nature of participation. 

Understanding that you are likely recruiting non-scientists, the consent form must be written in a way that is understandable to a lay audience. If you will not obtain consent from human subjects, then the application form should include rationale for requesting a waiver. A smart form in an electronic IRB solution like Cayuse will provide branching logic, helping you to understand what is required for your project. 

Upon approval of the study, your IRB will likely “stamp” some or all of your documents, indicating an approval and expiration date. Electronic IRB solutions like Cayuse can help facilitate this process, allowing researchers to easily download stamped and approved documents and view previous “voided” versions that are out-of-date, ensuring only the recent versions are used. 

Additional certifications and approvals

Depending on the scope of the research and organizational policy, your IRB may require other stakeholders, offices, or committees to approve the submission. For example, a student researcher may need sign-off from their faculty advisor who will help oversee the study. 

Sponsored human subjects research will also require a conflict of interest (COI) disclosure to be completed for each person listed on the protocol. For more information on what a conflict of disclosure is, you can check out our blog post: What is a Conflict of Interest Disclosure and Why is it Important.

If the IRB protocol also utilizes biohazards or radiation, then Biosafety or Radiation committee approvals may be required. Some organizations require feasibility or scientific review of the protocol to ensure the organization has the necessary resources to support the study and also to ensure it is scientifically sound. 

While you should check with your IRB administrator on any additional certifications or approvals that may be required for your study, some electronic IRB systems like Cayuse can help facilitate this process without manual routing touch-points, ensuring the correct stakeholders are automatically brought into the review where needed and additional forms, like COI disclosures, are automatically disseminated and assigned to all study team members. 

Ready to go!

Congratulations on compiling your IRB packet! Do a final check to make sure protocol details are correct and consistent across forms and attachments, then submit to the IRB. 

Your IRB administrator will likely conduct a preliminary review of the submission and contact you with any questions or additional requirements. They may also assign a review method (full board, expedited, exempt) depending on the study, and time to approval can vary based on the review method. 

Once your study is approved, it is imperative that you follow the protocol, use approved and stamped documents, report issues to the IRB, and track your protocol expiration to ensure you remain compliant with your approval. 

In conclusion

A thorough IRB submission not only speeds up time to approval, but it also protects human subject participants and ensures research is ethical and sound. Cayuse IRB can support researchers at your organization to compile complete submissions through configurable smart forms, training and COI integrations, automated routing, document management, expiration tracking, and more. These tools can help create a more researcher-friendly process and eliminate bottlenecks and frustration for applicants.