IBC Approval and Submissions

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”) are submitted  online through the Research Information Management System (RIMS). Step-by-step instructions on IBC protocol submission are available in the RIMS training tab and on the IBC website.

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. Further information is available on the ROHP website.

BUA Site Assessment by Environmental Health and Safety Office

For 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.

Expiration and Closure of an IBC Protocol

Expirations: You will receive four (4) notices from the RIMS system to renew your IBC application before it expires (90, 75, 60, and 45 days ahead of expiration). If you do not submit a renewal application before the expiration date, you will receive a final expiration notice on the day it expires.  Following the expiration of a protocol, no work can continue on that project until a renewal application is submitted and approved by the IBC.  If no renewal application has been received, the project will be administratively closed by the IBC within 14 days following the final expiration notice.

Closures: Submission of an IBC closure form is required if the research has been completed or the PI has left or plans to leave BU. The closure form contains important information confirmation appropriate disposal of all biohazardous materials, or their transfer to another approved IBC protocol or PI, and appropriate decontamination of the laboratory space, per EHS recommendations. Closure forms are available here.

Any work on an expired protocol is considered noncompliance as per the IBC Noncompliance policy.

IBC Protocol Submission Types