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.
Principal investigators intending to use recombinant DNA molecules shall
notify the Institutional Biosafety Committee (IBC)
by contacting ORS for information and access to NSIS. 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
- 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.
The IBC meets on the third Tuesday of each month at 2PM via teleconference.
These meetings are open to members of the NU community.
Anyone wishing to attend an IBC meeting should contact
Iwona Spath at firstname.lastname@example.org.
Each registration must be submitted to ORS two weeks prior to the IBC meeting.
Prior to submission, a registration must be completed and all answers provided as requested.
Should there be a need to consult, Iwona Spath or Dr. Andrea Hall can be contacted for help
at 1-5581 (Evanston) or 3-8300 (Chicago).
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.
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.