Annual Renewal and Approval Period
HSIRB approval is usually given for a one (1) year period and must be obtained on a yearly basis. Approval may be given for a lesser period of time (less than one year) based on the relative perceived high level of risk to the subject population, previously reported issues with the drug, biologic or device, previous issues with the PI, nature and location of the study, or the vulnerability of the study subject population.
Notification of annual renewal will be sent two (2) months before the anniversary date of the approved protocol. Only one notice will be sent. Research cannot continue or subjects enrolled into the study beyond the expiration date. Federal regulations make no provisions for any grace period for extending IRB approval. If the approval period has expired and the required documentation for continuing review has not been received, the HSIRB Office will notify the Principal Investigator of lapsed approval for new subject enrollment. If the required documentation is not received the project will be administratively closed and appropriate University Administration and the study sponsor will be notified.
The Annual Renewal Notice for Continuing Review is available on line and can be returned to the HSIRB office as an e-mail attachment. Be sure to fill in the entire form if submitted as an email attachment. Renewal Application For Continuing Review (Rev 11/14/2007)
For continuing renewals send the electronic copy of the 2 page renewal application, HS1A form, clean informed consent, and any revisions (with cover memo indicating the proposed changes). The original signed HS1A form should be sent by mail and received by our office before approval can be given.
All files of the PI containing human subject documentation, i.e. consent forms, must be kept a minimum of 3 years upon completion of the project in the repository as stated on the HS-1A form. For annual renewal of continuing projects the following information must be submitted for HSIRB review depending on the status of the project:
- Project continuing, unchanged - actively enrolling participants
- HS-1A form
- current, clean, unstamped consent form
- protocol summary information
- Project continuing, requesting changes - actively enrolling participants
- HS-1A form
- revised protocol and support documents
- revised consent form
- cover memo indicating the proposed changes and where they occur in the protocol and/or consent form
- protocol summary information
- Project continuing, unchanged - enrollment closed, participants on study
- HS-1A form
- protocol summary information
- Project continuing, unchanged - enrollment closed, no participants on study, data analysis only
- HS-1A form
- protocol summary information
- Project completed
- protocol summary information
- Project denied funding/Project was not conducted
