Managing an FIU IBC Approved Project

The following guidelines are provided to assist investigators with managing their FIU IBC approved protocols. All investigators are required to adhere to the Investigator Responsibilities outlined below.

Investigator Responsibilities

The principal investigator (PI) is responsible for full compliance with the NIH Guidelines in the conduct of recombinant or synthetic nucleic acid molecule research. The PI is responsible for obtaining approval on all recombinant or synthetic nucleic acid molecules activities prior to initiating and for ensuring proper laboratory techniques and practices are followed. In addition, it is the responsibility of the PI to ensure proper training for all laboratory staff, and to update /amend their IBC protocols prior to initiating any changes in their approved protocol PI responsibilities are fully specified in Section IV-B-7of the NIH Guidelines.

All institutions that receive NIH funding for research involving recombinant or synthetic nucleic acid molecules must follow the NIH guidelines. Failure to adhere to these guidelines can result in suspension or termination of NIH funding, or to a requirement for NIH approval of any or all recombinant or synthetic nucleic acid projects at the institution. The IBC is therefore responsible for establishing and implementing policies that provide for the safe conduct of recombinant and Synthetic Nucleic Acid research and to ensure compliance with NIH guidelines. IBC responsibilities are fully specified in Section IV-B-2-b of the NIH Guidelines.

The Summary of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules provides additional guidance.

Submitting Annual Renewals

Renewal submissions are submitted via the ‘IBC Renewal Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Renewal Protocol’ to access the IBC Renewal Form in the TOPAZ system.

Investigators are responsible for ensuring that their protocols are renewed prior to their expiration dates. Investigators are not permitted to conduct research with recombinant / synthetic nucleic acid once the IBC approval has expired.

IBC approval of recombinant or synthetic nucleic acid molecules is effective for three years. PIs must complete an IBC Annual Renewal application each year to continue work for up to three years after the initial approval. After three years, a new application must be submitted and reviewed by the committee.

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Submitting Amendments

Any additions or changes in the procedures involving recombinant or synthetic nucleic acid must be submitted to the IBC for review and approval. Amendments are submitted via the IBC Amendment Form or IBC Exemption Amendment Form within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on Create Amendment Protocol to access the IBC Amendment Form in the TOPAZ system.

Alternatively, investigators can request amendments as part of their annual renewal (via the ‘IBC Renewal Form’) if the proposed changes are not needed until that renewal time frame. The renewal form will ask if there are any changes being requested and the investigator can then incorporate the proposed changes directly into the renewal form.

The IBC must approve the additions or changes PRIOR to them being implemented in the study.

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Reporting Adverse Events or Problems

The PI is responsible for reporting serious unanticipated events within 24 hours, and non-serious events within 5 days of the occurrence. All key personnel need to be familiarized with AE procedures and aware of the appropriate contact persons in case of an event.

Adverse Events are submitted via the ‘IBC Event Report Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IBC Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project). For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IBC Office to see if your pending submission is almost ready for approval. If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IBC Coordinator via email. The IBC Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Reporting Adverse Events
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Reporting Protocol Deviations

The PI is responsible for reporting all instances that involve a deviation from the IBC approved protocol. A protocol deviation occurs when there is a variance in a research study between what is described in the protocol (reviewed and approved by the IBC) and the actual activities performed by the research team.

Protocol Deviations are submitted via the ‘IBC Event Report Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IBC Event Report Form in the TOPAZ system.

Note: The TOPAZ system only allows for one application form submission per project at a time (e.g., you cannot simultaneously submit an Amendment, Renewal, or Event Report for the same project).  For those rare cases where you already have a pending submission in the TOPAZ system and are unable to report your Adverse Event or Problem, it is advised to first contact the IBC Office to see if your pending submission is almost ready for approval.  If the pending submission will not be approved in time, then you will need to proceed with submitting a Microsoft Word version of the Event Form (only used in this circumstance) to the IBC Coordinator via email.  The IBC Office will later import the contents of the form into the TOPAZ system on your behalf.

Information about Reporting Protocol Deviations
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Submitting Project Completions

The PI is required to submit a completion report when the study is completed and all activity related to this project has ceased.

Studies completed prior to the end of the approval term need to submit their completion reports via the ‘IBC Completion Form’ within the online TOPAZ Electronic Protocol Submission System. Investigators need to first click on ‘Create Interim Review Protocol’ to access the IBC Completion Form in the TOPAZ system.

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