All research involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by Carleton is in compliance with federal regulations. Any project performed by Carleton faculty, students, and staff must formally be registered with the Institutional Biosafety Committee (IBC) in advance of the research activities. Before completing a new registration, familiarize yourself with the NIH Guidelines.
New Registrations
Section III of the guidelines specifies different levels of oversight for proposed experiments with different levels of risk.
The highest risk categories:
- Experiments that require IBC approval, RAC Review, and NIH Director approval before initiation (III-A);
- Experiments that require NIH OSP and IBC Approval Before Initiation (III-B); and
- Experiments that require IBC and IRB approvals and RAC review (if appropriate) before research participant enrollment (III-C);
Are not appropriate for performing at Carleton’s facilities with Carleton’s personnel and will not be considered by Carleton’s IBC for registration and approval.
All research involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by Carleton will be in one of the following three categories:
- Experiments that require IBC approval before initiation (III-D);
- Experiments that require IBC notice simultaneous with initiation (III-E); or
- Exempt Experiments (III-F).
Exempt Experiments (Section III-F)
If you believe that your experiment is exempt, you should complete an exempt application and await confirmation of your experiment’s exempt status from the chair of the IBC. The chair may ask for additional clarifying information from you before granting this status. Exempt experiments must be re-registered with the IBC every three years.
Non-Exempt Experiments (Sections III-D or III-E)
If your experiment is not exempt, complete the “Registration of Recombinant DNA Research” document and submit — as a Word document, with attachments if necessary, and using an electronic signature — to Eric Egge, IBC Chair. Make sure to save a backup copy of all documents for your records.
Be prepared to attend the IBC meeting in which your proposal is discussed, in order to address questions. (The chair will notify you of the meeting date, time, and location.) If approved, Non-Exempt experiments must be re-registered with the IBC every three years.
Conditional approval
The IBC can issue conditional approval; in these cases, the chair of the IBC will verify that the conditions have been met before the proposal will be fully approved and any work requiring prior approval of the IBC may commence. Some examples of possible conditions are:
- Completion of training of all students involved;
- The inclusion of additional clarifying information in the proposal.
Amendment of existing approved proposals
Over the three-year period of an approved proposal, the personnel performing the work are likely to change. In addition, new vectors within the same family may be necessary for the project. The IBC must be notified of these changes and the training of the personnel must be verified. These modifications must be submitted annually to the IBC using the rDNA Registration Amendment Form.