Does my study need health sciences IRB determination or approval?
Most human subject research related to health sciences will require the review and approval of the IRB-HSR. It is critical that this approval (or the determination that it is not required) be established and documented prior to the start of any of the human subject research activities.
Please be aware that if your research does not require IRB approval, other federal, state and local laws such as HIPAA privacy law) may still apply. Please note that the recording of any HIPAA identifiers during the course of your research (including dates of clinical events) will likely mean your research requires some type of IRB approval or an IRB letter of exempt determination.
A help document from the IRB that defines EXEMPT criteria is available here.
When you are ready to begin the IRB-HSR submission process (for all types of research including IRB review types of exempt, expedited, and full-board), you will need to use the IRB-HSR Protocol Builder tool.
Please use the contact information provided to contact the IRB-HSR with questions.