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Standard Procedure for Submission of Studies to the Institutional Biosafety Committee (Revised
Effective immediately, the revised policy presented below is in effect.
The reasons for the change in policy are to reduce delays in approvals due to submission of incomplete information, to reduce the time required to approve submissions involving both recombinant DNA as well as pathogenic organisms, to eliminate the submission of paperwork by investigators when there are no significant changes to previously approved protocols, to provide lay members of the committee with an understandable abstract of the work, and to facilitate the committee's review process by establishing monthly submission deadlines. In order to accomplish this, the changes are as follows:
- To assist investigators to ensure the completeness of IBC form submissions and reduce the need to return incomplete forms, prior to submission to the IBC, each form(s) must be pre-reviewed for completeness by a member of the IBC. The investigator should contact a member of the IBC with the appropriate area of expertise chosen from the list of IBC members and request a pre-review of the study. A list of members is posted on the IBC web site.
- Each IBC submission must contain a succinct, but complete abstract of the study written in lay terms with all acronyms defined. The typical generalized abstract for a grant submission probably will not be acceptable.
- The IBC meets at 10 am on the 2 nd Friday of each moth that there are studies to review. One (1) electronic submission and one (1) signed "hard" copy are due to the IBC Administrative Assistant NO LATER than 5:00pm on the Friday before the meeting date. The mailing address, telephone number and email address are located on IBC web-site under the "Staff & Personnel" link. Submissions received after that date will be held over for the next meeting. The IBC does NOT perform expedited reviews. A copy of the meeting dates and their deadlines is posted on the IBC web-site.
- Note: Under some circumstances, submission of a new grant application or a change in research protocols may not require submission of completely new IBC protocol form(s). If you are an investigator that has already been issued an IBC Inspection Number (for example, 99-66-2), then your laboratory has been inspected by the Institutional Biosafety Officer and you have been approved by the IBC to conduct work of a specific nature using recombinant DNA and/or pathogens.
- If you subsequently submit a grant or begin a new line of research that consists of work that is similar to the work previously approved by the IBC (e.g. does NOT involve an increase in Biological Safety Level, new vectors or pathogens, or other significant changes), then you DO NOT need to submit new IBC protocol forms. However, a letter addressed to the chair of the IBC indicating the new cell line, new, but similar vector, etc... is required. The receipt of this letter will be acknowledged, and it will be added to your file.
- If your new research involves a new cloning or delivery vector or a new pathogenic agent that you have not used before, even if the new work falls under the same Biosafety Level that you are approved for, a letter requesting approval for the new work must be submitted to the IBC that describes the proposed amendments to the previously approved work. This letter must contain sufficient detail to permit a safety assessment by the IBC.
A formal approval letter will be issued for such an amendment.
- Finally, if your research involves a change in your Biosafety level (e.g. the use of lentiviral vectors vs. adenoviral vectors), then new IBC forms MUST be submitted.