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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.
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. 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.
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.
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.
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