by Bryan Hamilton

So, you've done your research, and you've found a gap in the literature that needs to be addressed. Even more impressive, you have designed a study that can fill this gap. Before you conduct your study you'll need Institutional Review Board (IRB) clearance. For many students, the IRB application presents a particular challenge because it is written for a different target audience than the rest of the dissertation.

The IRB application can be broken down into a few key components, and by focusing on meeting these requirements you can simplify the process.

The purpose of the IRB proposal is to answer four key questions:

  • Why your research is important
  • How you intend to conduct the research
  • Who will take part in your study
  • How you will manage experimental data once you have collected it.

Adequately addressing these components will give your IRB confidence in your ability to proceed with the study in a safe and ethical manner.

I. Why is your research important?

Your IRB will want a simple explanation of the purpose of your study. It is important to provide a brief description of the state of the field, identify the gap in the literature, and explain how your study will help fix this issue. You should also identify why your research is important to the wider population. Since your IRB committee members may be from an entirely different field than you, the most important thing to remember is to be concise and accessible. Your description of the study's purpose should be straightforward and should be written in layman's terms to ensure that your readers understand why they should approve your study.

II. How you intend to conduct the research?

This aspect of your proposal should begin by informing the review committee of the basic details of the study, including the setting and the personnel who will be conducting research activities. Specifically, you should provide a complete list of individuals who will be assisting with data collection or interacting with participants. Additionally, it is important to note all locations where data collection will take place, particularly if this will occur off of your campus. This section must also cover the specific experimental protocol that all participants will take part in during the study, which many consider the most important part of this section; therefore, handle this part with great care. A proper protocol should describe all details of the participant's experience, from the moment they are recruited to when they walk out the door. This will include a description of all study activities and questionnaires or surveys (which should also be attached to your IRB application) that the participant will complete, as well as the methods you will use for obtaining consent and debriefing the participants. In short, it is vital that you provide a clear description of this process, as the details of the study protocol can often be a sticking point in the IRB review process.

III. Who will take part in your study?

One of the primary goals of the IRB is to ensure the safety of research participants, so providing details on how you plan to recruit and treat these individuals is a critical part of any IRB application. To fulfill this requirement, you will need to identify the population of interest for the given study. It is important to note what factors will lead to individuals' inclusion in, or exclusion from, the study and how you will screen potential participants to ensure that they are eligible to take part in research activities. You will also need to specify whether individuals from at-risk populations will be allowed to participate. At-risk populations include individuals who may not be able to make informed decisions for themselves (e.g., individuals younger than 18 years of age or those with mental handicaps) or those populations that may be taken advantage of due to their circumstances (e.g., prisoners or economically disadvantaged individuals).

After identifying who will take part in the study, you need to provide information regarding how participants' rights will be upheld. One of the key components of this is the inclusion of an informed consent form that you must provide to participants prior to their inclusion in the study. This document should inform participants that they have no obligation to take part in the study, and that they can withdraw at any time without penalty. Finally, you will need to include information regarding the risks and benefits of participation in your study. This will include any physical, emotional, or social risks that the participant may encounter, no matter how unlikely. Additionally, you should note what measures you have taken to prevent any negative outcomes for your participants. You also need to disclose any benefits or payment the participant may receive to ensure that this value is not perceived as coercive.

IV. How you will manage experimental data once you have collected it?

Your IRB knows that the goal of any experiment is to acquire data; they simply need the details concerning data management and participant confidentiality. In discussing your plans for data management, note specifically how you will store any study materials. Most often, the data will be stored digitally on a computer, but you should also specify security measures that will be put in place to protect the data. For example, if you plan on using a password-protected computer, which you will store in a locked office, this is the place to note that. It is also important to state how long you intend to keep any study materials. Many institutions have set guidelines for how long data should be kept after the conclusion of the study, so make sure to check with your school to find what they recommend. This component of the IRB application should also contain details of how you will protect your participant's confidentiality. In doing so, you will need to specify whether data will be anonymous, de-identified, or if it will contain identifying markers, and how you will ensure participant confidentiality in light of this information.

By addressing these four aspects of your IRB application, you should be well prepared to address any concerns that might arise during the IRB review of your study.