IBC Protocol Submission

Who may submit a Protocol for IBC Review?

Only full-time paid faculty members (instructor level and above) may submit protocols for review by Thomas Jefferson University’s IBC.

What research needs IBC approval?

Principal Investigators (P.I.s) who plan to carry out research that will involve any of the following materials must complete an IBC protocol:

• Recombinant and/or synthetic nucleic acids not exempt by the NIH Guidelines  (this includes transgenic plants and animals)
• Infectious Agents
• Human blood, body fluids, or unfixed tissue
  • Includes material that has been treated recombinantly, whether or not returned to the patient
  • Excludes material removed from the patient, treated mechanically or chemically, then returned to the patient
• Tissues, organs or cell cultures of human origin
  • Includes material that has been treated recombinantly, whether or not returned to the patient
  • Excludes material removed from the patient, treated mechanically or chemically, then returned to the patient
• Human Gene Transfer
• Old World primates – they may be carrying Herpesvirus simiae (Cercopithecine herpesvirus [CHV-1], B-virus)
• Sheep – they can carry Coxiella burnetii causing Q-fever.
• Select agents
• Toxins and  Hazardous Chemicals
• Nanotechnology

How to Submit IBC Protocol

Jefferson’s IBC protocols are submitted through Key Solutions, Inc. (KSI) eProtocol database. P.I.s can access the database through the link below by entering your Campus Key and Password.  If you receive a message “Unauthorized” access, reach out to the Biosafety Officer.  This means that your name is not in the software’s database, and you need to be added to the system.

KSI eProtocol (secure link)

Lay Description - Each protocol must contain a succinct but complete abstract of the study, written in lay terms (written in terms that an individual with an 8^th grade education can understand) with all acronyms defined. The typical generalized abstract for a grant submission is not acceptable.

Pre-Review and Return Notes - To assist P.I.s in ensuring the completeness of protocols, thereby reducing the need for returning incomplete submissions, each submitted protocol will be pre-reviewed by a member of the IBC.  Return Notes in the KSI database will be returned to the P.I. requesting changes to the protocol. A protocol will NOT be brought before the entire committee until it has been pre-reviewed and the requested updates have been completed. Consequently, please submit your protocol in a timely manner to allow for the pre-review and updates to be made PRIOR to the Submission Deadline.

Amending Approved IBC Protocols

IBC approval must be obtained if research changes the current safety or containment level of an approved protocol. These changes can be added to an approved IBC protocol by submitting an Amendment in the KSI database. Such changes that would require IBC approval include, but are not limited to the following.

• New pathogens, new vector systems
• In vitro work being changed to work in vivo
• In vivo work being changed to in vitro procedures
• Work with new cell lines which change the biosafety level or whose use causes a significant change to the protocol
• Changes in constructs or systems that result in significantly higher titers
• Enhanced replication or infectivity
• Expression of toxic products
• Partial viral genomes increased to more than two-thirds of whole genome
• New or altered procedures that pose increased risk of aerosol or other types of exposure
• Addition or deletion of personnel

If you are uncertain about whether a change in your research or protocol requires IBC approval, please contact either the Chair of the Committee or the Biosafety Officer.