IBC Registration Forms
- Registration of Recombinant DNA Experiments will only be accepted through the online Lab Safety Plan. Please submit online.
- Classification Summary Page for rDNA research
Filling out the Schedule G
- Forms are due to Environment Health & Safety (CB 1650) by the 15th of the month.
- The Schedule G is required when you are making rDNA. The top portion of the document is for administrative information including Principal Investigator name, PID number CB# etc.
- As a part of the Schedule G you are required to classify your research using the link to the Classification Summary Page for NIH Guidelines.
- A project title is required. You will need to identify the proteins being produced under #2.
- If you click “yes” under #3 you must fill out Section III Entitled “Gene Transfer Experiments”.
- Number 4 asks you to specify your containment level. Please remember if your recipient organism is human cells lines then you must classify your project as BSL2. If the vector you are using (i.e. lentiviral vector) is a BSL2 vector then you will classify your containment level as BSL2.
- If you are working at BSL3 then your containment level is going to be BSL3.
- Please do not forget to describe the experiment fully under #8.
- When using vectors under Section III please remember to attach a map of the vector.
- In order for your Schedule G to be considered for approval the entire form must be filled out.
- Use of Transgenic Animals or Plants will only be accepted through the online Lab Safety Plan. Please submit online.
- If you intend to create a transgenic animal or plant, you must complete Schedule G: Registration of Recombinant DNA Experiments
Filling out the Schedule H
The Schedule H is required to be filled out when you are acquiring transgenic mice from other researchers (including UNC) or outside companies such as Jackson labs. If your IACUC protocol lists transgenic mice you will be required to provide the IACUC with an approved Schedule H. The Institutional Biosafety Committee must approve the Schedule H and send it to the IACUC.
- The top portion of the document is for administrative information including Principal Investigator name, PID number CB# etc.
- A project title is required. Under #1 list where the animal was produced.
- It is important to fill out the entire form.
- Under containment level most Schedule H applications fall under BSL1 containment. If your animal is expressing human genes or is being transfected by replication competent vectors such as Adenovirus, Retroviruses or wild type Cowpox, then your animals would be classified as BSL2.
- Registration of Human Gene Transfer Experiments. Complete this form if you intend to transfer recombinant DNA, or DNA or RNA derived from rDNA, into human subjects
Submission of Registration Forms to IBC
The IBC meets the first Monday of each month (except holidays). Online registrations must be received by the 15th of the month prior to the meeting to be considered at that meeting. This is necessary to allow the appropriate review of your registration. If you have any questions, please email email@example.com or call Jessica Poole at 919-962-5726.
Experiments Involving Whole Animals
It is the policy of this University that the PI is responsible for complying with the NIH “Guidelines for Research involving Recombinant DNA Molecules,” regardless of the source of the funds supporting research.
Animal Experiments Requiring IBC Approval Prior to IACUC Approval
The following animal experiments require prior approval from the IBC. These experiments are to be described on the appropriate online registration form.
- Experiments involving whole plants or animals
- Creation of transgenic organisms. Schedule G form
- Transfer of viable recombinant DNA-modified microorganisms into animals. Schedule G form
- Transfer of rDNA or DNA or RNA molecules derived from rDNA into animals. Schedule G form
- Use of transgenic animals. Schedule H: Use of Transgenic Animals or Plants
Animal Experiments Requiring IBC Notice Prior to IACUC Approval
Some recombinant DNA work requires IBC review and approval, but prior approval is not required. These experiments are to be described in the appropriate online registration form. Examples include:
- Use of transgenic rodents for experiments that require biosafety level 1 (BSL1) containment. Schedule H: Use of Transgenic Animals or Plants.
To obtain more detailed information about how your particular experiments are classified under the Guidelines, email firstname.lastname@example.org or call Jessica Poole at 919-962-5726.