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.<\/p>\n
Research proposal involving any of the agents listed below needs to be reviewed by the IBC before initiation.<\/p>\n
PLEASE NOTE:<\/strong> Additional biohazardous material may be reviewed at the discretion of the IBC or as regulations and guidance changes.<\/p>\n IBC applications (i.e. \u201cIBC protocol\u201d) are submitted online through the Research Information Management System (RIMS)<\/a>. Step-by-step instructions on IBC protocol submission are available in the RIMS training tab and on the IBC website<\/a>.<\/span><\/p>\n 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 SciSure (formerly SciShield).<\/a> Details of this requirement is available in the IBC Training page.<\/a><\/p>\n 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<\/a>.<\/p>\n For approval of new protocols and all 3-year renewals, there will a mandatory EHS site inspection of PI\u2019s 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<\/a>.<\/p>\n 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.<\/p>\n Expirations:<\/em><\/strong> 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. <\/strong> If no renewal application has been received, the IBC office may be required to administratively close the protocol by the IBC within 30 days following the final expiration notice.<\/strong><\/em><\/p>\n Failure to renew an IBC protocol or to work on a protocol without a current\/valid approval is considered serious non-compliance with federal regulations and the BU <\/span>IBC Noncompliance policy.<\/a><\/p>\n Closures<\/strong><\/em>:<\/strong> 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.<\/strong><\/a><\/p>\n <\/p>\n Principal Investigators (PIs) must complete a RIMS PI Account Registration<\/a> 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. The BU IBC requires that all BU PIs be members of the faculty. Projects from BU post-docs or other non-faculty members require a faculty PI sponsor.<\/p>\n PIs seeking IBC approval for the first time also need to submit a NIH biosketch with their application. Please see this example biosketch<\/a> for reference. Step-by-step instructions on IBC protocol submission is available in the RIMS training tab.<\/span><\/p>\n 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<\/a>. 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.<\/div>\n<\/div>\n\n <\/p>\n 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 longer pursued, must be removed. The renewals will receive do novo review by the IBC.<\/p>\n PI and all listed members must remain current with all of the biosafety training requirements, and medical clearances.<\/p>\n 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.<\/div>\n<\/div>\n\n <\/p>\nIBC Requirements for the Submission and Approval<\/h2>\n
Online Submission<\/h3>\n
Biosafety Training Requirements<\/h3>\n
Medical Clearance Requirements<\/h3>\n
BUA Site Assessment by Environmental Health and Safety Office<\/h3>\n
Principal Investigator Leave of Absence<\/h3>\n
Expiration and Closure of an IBC Protocol<\/h3>\n
IBC Protocol Submission Types<\/h2>\n
New Applications<\/h3>
Renewals<\/h3>
Amendments<\/h3>