First, what is the IRB? The Institutional Review Board (IRB) is a committee that reviews and monitors all research involving human subjects. Their job is to protect human rights and welfare in research. When performing research involving children, pregnant women, or prisoners, the IRB has procedures that must be completed. So before beginning an IRB proposal, it is a good idea to meet with your Institutions’ IRB personnel, discuss your research idea with them and ask their opinion on how you should proceed as not only are they great advisors, but every institution does things slightly differently. The IRB office is also one who will determine the type of IRB approval needed. But for any research study, there are specific things that all IRB proposals should include.
When you are writing an IRB proposal, the most important thing to keep in mind is that you are talking to an audience who typically has no background knowledge of your research topic! The IRB is made of a board of individuals from many walks of life so you MUST assume that they know absolutely nothing about your topic. This means that your proposal should be written as if you were talking to someone random on the street or imagine giving a Ted Talk to a diverse audience. You must be explicitly clear at all times.
Before I go into the sections typically needed for an IRB proposal, check out the graphic below where I list my top 8 tips of things to keep in mind while writing an IRB proposal!
IRB Proposals Typically Include These Sections:
1. Specific Aims of Study: Clearly describe your aims or goals for your study. You are also introducing your Research Question. Make sure to specify what do you hope to achieve with this project and write these research aims in a way anyone could understand.
2. Background and Significance: In this section, you must give an introduction to your research topic. Why is it important, etc. At the end of this section, introduce your project and make sure to answer this question: What is the purpose of this proposal? This is where you are again stating your Research Question! You also should discuss what is new about your research project. Make sure to describe why your project is new, innovative, and never been done before. By showing what is different and new about your study, you are proving that you are conducting a research study, an aspect that the IRB needs to see.
3. Methodology: Participants: Give a precise number of how many participants will be involved in your study or at least a range. Make sure to answer where and how you will recruit participants. You should also discuss your plan to obtain informed consent here. Depending on your study, you may need to create a participant consent form to turn in with the proposal. Luckily, the IRB has a template for this so make sure to reach out to your IRB office to ask their advice on your consent process and gain a consent template. Next, make sure to walk through every detail of your methodology including what data you will be collecting. You also need to discuss how data will be obtained. If you will be collecting identifiable information (such as a name, birthdate, etc.), describe how you will protect individual information. Some studies give their participants study identification numbers and blind personal information. Lastly, include how you plan to analyze the data (what statistical tests are being used).
4. Data Safety: It is important to be very detailed in this section. Make sure to discuss how you will protect individual identities and who will have access to any private identifiable information.
5. Risks/Benefits: This is where you will describe any risks participants may experience. You can state potential benefits as well. Potential is the key word here! There is never a guarantee of a benefit, so it can only be described as a possibility.
6. References
7. At the end of the proposal, attach all pre/posttests or surveys, or other questionnaires you will have participants fill out.
