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The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
Before completing the IRB application form, you must know: The identity of all of the investigators who will be working on the project; Who will be recruited to participate and how they will be recruited; Where the research will be conducted; What data will be collected and what will happen to that data; How
This is an IRB-approved retrospective study, all patient information was deidentified and patient consent was not required. Our study was approved by X Institution Review Board (approval no. XYZ123) on Month DD, YYYY.
The IRB recommends writing in a narrative form, explaining the specifics of what the participant will experience if they take part in the study, from beginning to end. If the Research Protocol is written in too technical of a manner (i.e., its not clear what you are doing), it may unnecessarily go to the Convened IRB.
Use lay language The IRB application should be written in a way that all can understand. The IRB recommends writing in a narrative form, explaining the specifics of what the participant will experience if they take part in the study, from beginning to end.
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The IRB approval letter lists the consent document(s) and other study documents that were approved with the submission. Please note, it does not list the study application.
The research proposal describes the protocol you will follow and can include: the research hypothesis, study background, design and methodology, data analysis, study procedures, details about the subject population, inclusion/exclusion criteria, recruitment, informed consent process, benefits, risks, privacy and
IRB Review of Survey / Interview Research Research that solely involves interpersonal interactions with participants such as surveys, interviews, and focus groups most often qualifies for review under exempt or expedited categories. Less commonly, some research of this type may require convened board review.

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