IRB/URR

So, you’ve done your research, and you’ve found a gap in the literature that needs to be addressed.  Even more impressively, you have designed a study that can fill this gap.  So what do you do now?  The obvious answer is to actually conduct your study, but before that can happen you have to overcome the roadblock of attaining Institutional Review Board (IRB) clearance.  Unfortunately, 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.  However, just as with the other chapters you will write as you work through this process, the IRB application can be broken down into a few key components, and by focusing on meeting these requirements you can greatly simplify the process.  To put it simply, the purpose of the IRB proposal is to answer four key questions of why your research is important, how you intend to conduct the research, who will take part in your study, and how you will manage experimental data once you have collected it.  Adequately addressing these four key components will give your IRB confidence in your ability to proceed with the study in a safe and ethical manner.

Get a Jump Start on Your IRB/URR



To begin, your IRB will want a simple explanation of the purpose of your study.  While completing the Introduction and Literature Review chapters of your dissertation certainly positions you as an expert in your field, your IRB committee has quite possibly never heard of your topic.  As such, it is important to provide a brief description of the state of the field, as well as to identify where the gap in the literature exists and how your study will help fix this issue.  Perhaps more importantly, 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 purpose should be straightforward and should be written in layman’s terms to ensure that your readers can readily understand why they should approve your study.

Once you have explained why your research is important, it’s time to move onto detailing how you plan to perform your study.  This aspect of your proposal should cover all of the specifics around what you will do to prepare for, and actually conduct, your study.  As such, this portion of the 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 any 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.  Importantly, 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.

Next, you will need to include information about 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.  In doing so, 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 will need to provide information regarding how participant rights will be upheld.  One of the key components of this is the inclusion of an informed consent form which 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.  Furthermore, you will also need to disclose any benefits or payment the participant may receive to ensure that this value is not so high that it can be seen as coercive.  By discussing all of these aspects of who will participate in your study, you allow the IRB committee to feel certain that you have taken all of the necessary steps to ensure the safety of your research participants.

Following these components, you will need to prove to your IRB that you have adequately thought through the aspects around what you will do with your data once you’ve collected it.  Essentially, your IRB knows that the goal of any experiment is to acquire data; they simply need the details around how you will handle data management and participant confidentiality.  In discussing your plans for data management, you should note specifically how you will store any study materials.  This often entails noting that 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 participants’ 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.  However, we understand that gaining IRB approval is a complex and difficult process, and that you may still have questions.  If you are unsure of any aspect of the IRB application, Statistics Solutions is happy to help you along the way, and we would love to hear from you. Feel free to fill out the contact request form and one of our dissertation specialists will be in touch for a Free 30-minute consultation.  We love nothing more than using our decades of experience to help dissertation students get the results we know they are capable of!