First, you need to determine if you should submit a protocol to our office. Our board reviews research studies that involve human subjects. Research is defined by the federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." A study needs to be systematic in that it has a defined plan for conducting the study; contributing to generalizable knowledge is generally interpreted as information that will be published or disseminated for public use, though this is not the only criteria used to determine if a research project contributes to generalizable knowledge. A human subject is defined as "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or (individually) identifiable private information." If you are unsure whether you study meets the requirements for review, please contact your IRB representative before completing and submitting a protocol form.
If you are ready to go forward with your study and you need IRB approval to do so, then you are ready to submit a new protocol. A protocol describes to the Board the basic design of the study, what the participants will do in your study (including any risks/ benefits to them) and how the data will be collected, analyzed, and stored. Use the links listed below to find out more information on putting together a protocol, submitting your materials, and how the IRB review process works.
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Putting together a new protocol can be a complicated task. If you have not organized your materials and ideas before this point, you will certainly need to now. However, understanding what you need to submit, how your documents will be processed through our office, and how the review process works can help you to better understand the IRB review and its purpose. Hopefully your submission process will be a chance to refine some of your research ideas and repair any issues that may be problematic when you work with human subjects. Take a moment to go through our submission information, especially if this is your first time submitting. If you have further questions, please do not hesitate to contact your IRB representative. We hate to hear of a researcher who was frustrated with an aspect of the submission but did not contact our office for support; one of the purposes of our office is to assist researchers with their protocols.
The materials that you will submit depend on the type of study you are doing. For example, an archival study may only need a protocol form but an in-depth education study may include assent and consent forms for children and parents as well as instruments and surveys. A good rule of thumb is that if you mention it in your protocol, most likely the Board will want to see it. Each submission has a core group of tasks that everyone needs to do. This includes submitting: