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Approval Procedures

The policies set forth below comply with the NIH Guidelines. They apply to all recombinant DNA research conducted at Northwestern University, without regard to source of funding.

Registration Document

Principal investigators intending to use recombinant DNA molecules shall notify the Institutional Biosafety Committee (IBC) by contacting ORS for information and access to ISIS. The principal investigator shall prepare the registration document according to the nature of the research. A copy of the current NIH guidelines should be available for reference. All recombinant DNA research falls into one of six classes, described in the NIH guidelines as follows:

• section III-A Experiments that require Institutional Biosafety Committee approval, Recombinant DNA Advisory Committee (RAC) review, and NIH Director approval before initiation
• section III-B Experiments that require NIH/ORDA and Institutional Biosafety Committee approval before initiation
• section III-C Experiments that require Institutional Biosafety Committee approval, Institutional Review Board approval, and NIH/ORDA registration before initiation
• section III-D Experiments that require Institutional Biosafety Committee approval before initiation
• section III-E Experiments that require Institutional Biosafety Committee notice simultaneous with initiation
• section III-F Exempt experiments

If an experiment falls into section III-A, III-B, or III-C and one of the other sections as well, the rules pertaining to section III-A, III-B, or III-C shall be followed. If an experiment falls into section III-F alone, or into section III-F and into section III-D or III-E as well, the experiment is considered exempt from the NIH guidelines.

Status Report

Principal investigators are required to file an annual Status Report for all recombinant DNA research. In addition, principal investigators must file a new or amended registration document when there are changes in their research protocols that require reclassification.

Training

Principal investigators performing recombinant DNA experiments covered by Sections III-A through III-E under the NIH guidelines shall file Statement of Training and Experience forms with the IBC for all active researchers.

Changes in Approved Research

Principal investigators wishing to modify approved research regulated under the NIH guidelines are responsible for notifying the IBC. Modifications to research conducted under Sections III-A, III-B, III-C, and III-D must be approved prior to implementing new procedures. The IBC must be notified of modifications under Section III-E at the time they are implemented. Notification of modifications to exempt research conducted under Section III-F is not required; however, the annual Status Report will reflect the changes.

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Office for Research Safety
researchsafety@northwestern.edu

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