Guide :: Submission :: Getting Started
Getting Started
First, you need to determine if you should submit a protocol to our office. Our office 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 our office before completing and submitting a protocol form.
Next, determine where you are at in your study development. Some studies need grant funding and in order to qualify for a grant, a researcher needs a level of IRB approval called a Grant Approval. The Board can give a preliminary approval called a Grant Approval, helping researchers apply for grants. If you need a Grant Approval, go to the Grant Approval section.
Next: Grant Approval >>
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 construct 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.
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Guide :: Submission :: Getting Started |
