Human subjects research training
General guidelines for submitting a proposal
How to determine what category a submitted proposal is?
Classroom Based Student Research Projects
Submitting a category 1 proposal
Submitting a category 2 proposal
Submitting a category 3 proposal
Instructions for creating a consent form
Modifications and Amendments to protocols
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Institutional Review Board
Continuation of research after 12 months
The IRB is required to reevaluate research projects at intervals appropriate to the degree of risk, but not less than once a year. The approval letter from the IRB will indicate the approval period (maximum of 12 months) and the date for submitting a request for continuation.
One month prior to the expiration of your approval the IRB will send the investigator a courtesy reminder notice. However, it is the investigator’s responsibilities to complete the continuation form you will be sent, attach the appropriate information and return the package to the IRB Administrator. Please note that if for some reason you do not receive the reminder notice it is your responsibility to contact the IRB Administrator in advance of your project’s expiration date if you wish to continue the research. Only two continuations can be granted under federal guidelines (total of three years). After that you must have a full review.
Your continuation request must include: a) request for extension; b) number of participants involved to date; c) any modifications you many want to make; d) any adverse events or subject complaints from the previous year; d) a brief summary of findings to date; e) a summary of any recent literature, findings, or new information about any risks associated with the research; f) a copy of the current and any newly proposed informed consent forms.
If you have completed data collection and are just analyzing unidentifiable data, you do not need to seek continued IRB approval. However, you must be certain to maintain the data as specified in your application protocol.
Note that if your proposal required a category 3 review – a continuation will also require approval by a quorum of the IRB members.
