The IRB Proposal Process
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?
II. How you intend to conduct the research?
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?
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.