All investigators planning to work on recombinant and synthetic nucleic acid molecules or with any biohazardous materials must submit their research proposal to the IBC for review. The work may only be initiated after receiving approval from the IBC. Any subsequent changes to the proposal must be pre-approved by the IBC in the form of an amendment. All existing approvals are required to be re-reviewed de-novo at every 3-year anniversary of the original approval.
Research that Requires IBC Approval
Research proposal involving any of the agents listed below needs to be reviewed by the IBC before initiation.
Recombinant or synthetic nucleic acid molecules
Hazardous biological agents (such as human or non-human primate [NHP] cell lines, virus, bacteria, fungi, parasite, prion, rickettsia, and others)
Other potentially infectious materials (human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organ and cells)
Biological toxins including select agent toxins
Inactivated Biological Samples derived from BSL-3 or BSL-4 agents
Attenuated pathogens derived from BSL-3 or BSL-4 agents
Human gene transfer
Transgenic animals or plants
Sheep and any tissues derived from them (these tissues can transmit Coxiella urnetiid, the causative agent of Q-fever)
Field studies with wild animals or other creatures and/or their tissues (that could be inherently infected or would be experimentally infected with BSL-2 or higher agents)
PLEASE NOTE: Additional biohazardous material may be reviewed at the discretion of the IBC or as regulations and guidance changes.
IBC Requirements for the Submission and Approval
Online Submission
IBC applications (i.e. “IBC protocol” or “Biological Use Authorizations”) are submitted online through the Research Information Management System (RIMS). Step-by-step instructions on IBC protocol submission is available in the RIMS training tab.
Biosafety Training Requirements
Based on the nature of the proposed work, PI and the listed members of the protocol will need to complete various biosafety training modules in Scishield. Details of this requirement is available in the IBC Training page.
Medical Clearance Requirements
Most research with biohazardous materials may also require that PI and listed members secure medical clearance from the Research Occupational Health Program (ROHP). This may require providing medical information (to ROHP only) and vaccination records. Details available in the ROHP website.
BUA Site Assessment by Environmental Health and Safety Office
For the approval of new protocols and all 3-year renewals there will a mandatory EHS site inspection of PI’s lab from to check that lab is equipped properly, all engineering controls are in place, and to ensure that all the proposed work can be done safely. Details available on the EHS website.
Principal Investigator Leave of Absence
If a principal investigator takes a leave of absence (i.e., sabbatical, medical, or family-related leave), the IBC office staff should be contacted to ensure that a member of the research lab is assigned to maintain the protocol during that period of absence.
Types of IBC Protocol that may be Submitted for Review
New Applications
A new application is required when a PI is seeking IBC approval for the first time for their work on recombinant or synthetic nucleic acids and/or biohazardous materials. Complete all IBC applications online in the Research Information Management System (RIMS). A new application may also be required when a PI embarks on a new project that has different biosafety risk factors and/or procedurally different than their existing IBC approvals.
Principal Investigators (PIs) must complete a RIMS PI Account Registration in order to access the IBC application. The PI can designate others to assist in completing the application, however, only the PI can submit the application. IBC requires that all PIs be members of the BU/BMC faculty. Projects from postdoctoral scholars or other non-faculty members will require a faculty PI sponsor.
PIs seeking IBC approval for the first time also need to submit a NIH biosketch with their application. Please see this example biosketch for reference. Step-by-step instructions on IBC protocol submission is available in the RIMS training tab.
All applications must be received by the protocol submission deadline to allow time for review by the committee members and a Biological Use Authorization Site Assessment by EHS. Upcoming deadlines can be found under Meeting Dates & Deadlines. Each application will be assigned to a primary reviewer and a secondary reviewer. Reviewer comments will be discussed at a convened IBC meeting towards making a decision on approval of the protocol.
Renewals
Renewal applications are required for all IBC approval before the 3-year anniversary of their original approval and at every 3-years thereafter. Aprart from 3-year renewals, Annual renewals may also be required for BSL3 and BSL4 protocols. An email notice through the RIMS system will notify the PI when a renewal is due.
To complete the renewal, PIs should consolidate all proposed or previously approved changes of the protocol compared to the initial or last 3-year renewals. The Research Project Description must reflect current laboratory practices, current list of personnel and current list of hazardous biological agents. Major changes in the protocol since its last approval also need to be summarized. New studies on organisms, a new host-vector-donor system, or any other modifications that may affect the containment level, must be specifically stated. Activities that are completed or are no loger pursued, must be removed. The renewals will receive do novo review by the IBC.
PI and all listed members must remain current with all of the biosafety training requirements, and medical clearances.
The IBC Office will notify you when your Renewal has been processed and approved. IBC approval is required before any changes in the work may commence.
Amendments
Amendments must be submitted to the IBC for the approval of changes within an approved project. All changes should be described in detail, and these must be reviewed and approved by the IBC according to the table below. IBC approval is required before any changes in the work may commence.
All Amendments must be done on the existing application inRIMS and confirm the submission to send it to the IBC Office for amendment evaluation.
The IBC Office will notify you when your Amendment has been processed and approved. IBC approval is required before any changes in the work can commence.
Amendment
Review Type
Considerations
Title Additions
Expedited
Approvals may be applied to several different granting agencies, but all grant titles must be registered with the IBCInstitutional Biosafety Committee
The IBC is an instituti...
Lab Space additions
Expedited
IBC approval applies only to work performed in registered lab space
Non-PI personnel change
Expedited
Individuals must complete the “Initial Laboratory Safety Training” and “ROHP clearance” requirements
Technical Changes
Full Committee
If changes are extensive, the IBC may require that a completely new application be submitted by the PI. For change in PI, proposed new PI’s curriculum vitae must be attached