All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. The purpose of the information below is to assist WCM faculty, staff, and students who are planning to conduct studies that involve human subjects. If you have a question that is not addressed here please reach out to us at irb@med.cornell.edu so we can help!
Your relationship with the IRB does not end once you receive IRB approval for your study! You must maintain approval status by submitting post-approval applications and reports.
Most studies require modifications to keep the investigative team current, to incorporate changes to the protocol, study instruments, or consent form(s). Amendments to approved studies represent the single largest volume of IRB submissions. No changes may be made to the approved research plan without first submitting a request to the IRB and obtaining the IRB's approval, unless there is need to eliminate an immediate hazard facing the subject as outlined in 45 CFR 46.103(b)(4).
The WCM IRB requires investigators to report certain events or circumstances that occur during the conduct of a study, including situations where participants experience unanticipated or anticipated problems during the course of the research study. There are specific reporting timelines; familiarizing yourself with the requirements will help in avoiding non-compliance.
At the time of approval, the WCM IRB will determine if and when the approval will expire. it is the investigator's responsibility to either apply for a new approval period (i.e. submit a continuing review application) or submit a study closure before the IRB approval expiration date.
The typical progression of a submission through the IRB application process begins when the Investigator submits an Initial Application in the WRG-HS system. That then sets off a number of processes that must be complete before IRB analyst review.
We provide a detailed description of the IRB review process for your reference.
The following may delay the release of an IRB approval letter and documents:
Study team members should also check the Study Activation Status Page (SASP) for their study to ensure all applicable approvals are obtained PRIOR to starting human research activities. The SASP page is your "one-stop" location for all required approvals.
