IBC Policy on Renewals, Suspensions, and Terminations of Protocols

Adopted (10/25/2018)

DEFINITIONS


CLOSED:  his designation is used when a project is completed or when the investigator requests closure of a protocol. This indicates the research covered under a previously approved protocol will no longer be pursued, data collection is finished, the essential work is completed, or the laboratory will be closed.

SUSPENDED: This designation is used when a temporary hold is placed on activities (all or a subset) associated with an approved protocol.  Protocols may be suspended due to failure of the investigator to renew a protocol in advance of the expiration date or any noncompliance that does not result in immediate termination of the protocol.  Upon suspension of a protocol, the Chair of the Institutional Biosafety Committee (IBC) will send a notification letter and email to the Department Head and principal investigator (PI), defining the activities associated with the protocol that shall be SUSPENDED until IBC approval is obtained.  The suspension period is to be determined by the IBC, but will not be extended beyond 60 days.  Suspended protocols that are not resolved to the satisfaction of the IBC will be TERMINATED.

TERMINATED:  This designation is used when the protocol has been actively terminated by the IBC.  A previously approved protocol will be terminated due to noncompliance with University or federal government policy resulting in serious or unexpected risks to an individual, the public, or the environment from recombinant or biohazardous materials.  Termination is defined as a permanent withdrawal of protocol approval, and explicitly mandates all related activity must cease immediately.  The Vice Chancellor for Research, Research Dean, Department Head, appropriate University committees, the Office of Sponsored Programs Administration, the National Institutes of Health and other approval agencies (if applicable) may be notified, in addition to the PI, of protocols terminated by the IBC.  Continued use of materials or procedures that pose a risk to an individual, the public, or the environment will result in reporting to the Office of Research for further disciplinary action.

CONTINUATION:  In rare cases, a request for continuation may be submitted by a PI who has extenuating circumstances for missing a protocol submission deadline.  Continuation requests will be reviewed by the IBC Chair and Biological Safety Officer and shared with the IBC at the next scheduled meeting.  Continuation requests must be submitted within 72 hours of protocol expiration and will not be granted for a period of greater than 60 days.  If a protocol is not received by the end of the continuation period, it will be TERMINATED.


SUBMISSION OF RENEWALS


The PI is responsible for submitting, in a timely manner, a renewal protocol for activities that will continue beyond the currently approved term. Protocol renewals must be received, reviewed, and approved by the IBC before expiration of the current protocol. The IBC will send a reminder notice requesting submission of a renewal by email to the PI four months before the protocol expires.  If necessary, a second notice will be sent two months prior to protocol expiration and a SUSPENSION notice will be sent on the date of expiration.  Investigators who fail to submit a renewal protocol form with sufficient time to allow IBC approval will have their protocol SUSPENDED on the date of expiration, pending completion of IBC review and approval. It is recommended that protocol renewals are submitted for review at least 3 months prior to the date of the meeting during the month of protocol expiration.  Good faith requests for temporary CONTINUATION will be considered by the IBC Chair and Biological Safety Officer (BSO).