|
Please note that the BUA application submission deadline is one month before the IBC meeting. For research involving recombinant DNA in human subjects, review may take two months. See the application deadline table below for specific dates.
A complete and accurate Biological Use Authorization (BUA) Application
or Request for Change to Biological Use Authorization must be received
by the application deadline to be reviewed at the Institutional Biosafety Committee (IBC) meeting
.
If your study involves biohazards, your work must be reviewed and approved by the Institutional Biosafety Committee (IBC)
and/or Environmental Health and Safety (EH&S) Research and Occupational Safety (ROS). It is the National Institutes of Health (NIH)
mandate that our institution establish an IBC for the review and approval of all research involving recombinant DNA.
Institutional Biosafety Committee review and approval for research involving all biohazards is required by the UW Administrative Policy 12.3.
The purpose of the biosafety review is to ensure that biohazardous materials are handled safely from start to finish.
EH&S ROS will review both your laboratory operation procedures and Principal Investigator and staff training that is related to work
with biohazards including all recombinant DNA.
Submitting the BUA Application will register your research with the IBC
and EH&S ROS and initiate the Biological Use Authorization
process. The IBC's working definition of a biohazardous agent includes the following:
- Pathogenic agents (bacteria, rickettsia, fungi, viruses, protozoa, parasites, prions, and select agents)
- Recombinant DNA molecules, organisms, vectors (e.g., plasmids, viral vectors), and viruses containing recombinant DNA molecules
- Human and non-human primate blood, tissue, body fluid, and cell culture (primary or continuous)
- Plants, animals or derived waste which contain or may contain pathogenic hazards (including xenotransplantation tissue)
One specific addition to the BUA Application addresses the NIH OBA directive that
the Principal Investigator must self identify the section of
The NIH Guidelines for Research Involving Recombinant DNA Molecules
that applies to their research. There are several different levels of oversight required for research with recombinant DNA
depending on the agents and procedures in a specific research project. Thus, it is critical that the Principal Investigator makes the initial assessment of the NIH
oversight required for approval. Much of the research with recombinant DNA that occurs at the University of Washington, such as use of viral vectors, falls under Section III-D.
Projects that fall under this section of the guidelines may not begin until the Principal Investigator obtains approval from the Institutional Biosafety Committee (IBC).
The table below summarizes the section and experiments covered under the NIH guidelines.
| Experiments Covered by the NIH Guidelines for Recombinant DNA |
| Section | Experiments Covered | Examples of Experiments Covered |
| Section III-A |
Experiments that Require Institutional Biosafety Committee Approval (IBC), RAC Review, and NIH Director Approval Before Initiation |
Deliberate transfer of drug resistance to a microorganism that is not known to acquire it naturally and is the primary treatment drug |
| Section III-B | Experiments that Require NIH/OBA and IBC Approval Before Initiation |
Cloning of toxin molecules with LD50 less than 100ng/kg |
| Section III-C |
Experiments that Require IBC and Institutional Review Board Approvals (IRB) and RAC Review Before Research Participant Enrollment |
Human gene transfer |
| Section III-D |
Experiments that Require IBC Approval Before Initiation |
Use in pathogenic microorganisms, animals, plants, viral vectors for gene transfer, gene transfer in Risk Group 2 microorganisms |
| Section III-E |
Experiments that Require IBC Notice Simultaneous with Initiation |
Recombinant DNA in Risk Group 1 microorganisms OR experiments involving whole plants at BSL1-P |
| Section III-F |
Exempt Experiments |
Recombinant DNA that is not in organisms or viruses, DNA/RNA that falls under the Exempt Experiments Under Section III-F |
When EH&S Research and Occupational Safety (ROS) receives your completed Biological Use Authorization Application, the (PDF) review process will begin.
- The IBC Chair and EH&S Biosafety Officer will screen the BUA Application for completeness and accuracy. It is critical that the BUA Application is entirely complete for IBC members to review your
research. If you do not fully complete the BUA Application describing your research, it will be returned to you to re-submit. This could potentially delay IBC
review and approval until the following month when the full committee meets again.
- The IBC primary reviewer and/or EH&S Biosafety Officer will be assigned to review and assess your research.
- The EH&S Biosafety Officer will work with you to obtain approval. A Biosafety Officer will inspect your laboratory
to confirm to the IBC that your laboratory and practices are in compliance with the biocontainment requirements for your research.
Deficiencies must be corrected prior to Biological Use Authorization.
- All IBC members will have the opportunity to review your BUA Application.
- Projects with recombinant DNA are reviewed at the monthly convened IBC meeting per the NIH Guidelines.
- Once your research has been approved, you will receive a notification of Biological Use Authorization from the IBC. This must be reviewed with your staff and available to staff in the lab.
- Biological Use Authorization Application: Submit this application to initiate the BUA process for new projects and renewals.
- Request for Change to BUA: Submit this application to request changes to your current BUA. Changes can include adding a new biohazardous agent, changing a location, or adding a new gene delivery method.
- Appendix A: Hazardous Material Information for Animal Husbandry Staff
Electronic submissions of the BUA Application are preferred. If the Principal Investigator does not have an electronic signature, then the signature page can be submitted separately via campus mail.
| Attention: |
EH&S Research and Occupational Safety |
| E-mail: |
ehsbio@uw.edu |
| UW Campus Box: |
357165 |
| Fax: |
206.221.3068 |
IBC monthly meetings take place on the third Wednesday of each month. Meetings are open to the public and take place from 10:00 AM to 12:00 PM in Magnuson Health Sciences Building, Room T-269.
Effective February 2012, a complete and accurate BUA Application or Request for Change to the BUA must be received by 5:00 PM twenty eight days prior to the meeting
to be considered at that month's meeting. See meeting schedule and submission deadlines below.
For research involving recombinant DNA in human subjects, allow eight weeks for completion of the IBC review which begins once all documents of the clinical investigator's application packet are submitted.
| IBC Meeting Dates | BUA Application Submission Deadlines |
| January 18, 2012 |
January 3, 2012 |
| February 15, 2012 |
January 18, 2012 |
| March 21, 2012 |
February 22, 2012 |
| April 18, 2012 |
March 21, 2012 |
| May 16, 2012 |
April 18, 2012 |
| June 20, 2012 |
May 23, 2012 |
| July 18, 2012 |
June 20, 2012 |
| August 15, 2012 |
July 18, 2012 |
| September 19, 2012 |
August 22, 2012 |
| October 17, 2012 |
September 19, 2012 |
| November 21, 2012 |
October 24, 2012 |
| December 19, 2012 |
November 21, 2012 |
When projects with biological agents are approved, they will receive an expiration date. Approvals will generally be given for a three year period or concurrent with Institutional Animal Care and Use Committee (IACUC) protocol expiration.
Any research performed on a project with biological agents after the expiration date will be out of compliance with the NIH Guidelines for Recombinant DNA. This is a reportable incident to the NIH Office of Biotechnology Activities, which oversees the NIH Guidelines for Recombinant DNA.
To renew your approval you must re-submit a BUA Application in sufficient time to obtain IBC approval before your expiration date. You will receive email notification, approximately two months prior, of your impending expiration to remind you of your need to resubmit if you plan to continue your research.
Principal Investigators may request changes to their current approval (e.g., new agent, location, or animal procedure). In certain situations, the EH&S ROS will be able to make the change administratively.
In others, review and approval from the IBC will be required. To request a change submit a
Request for Change to BUA to ehsbio@uw.edu . An EH&S Biosafety Officer will work with you to update your approval.
Contact an EH&S Biosafety Officer at EH&S Research and Occupational Safety:
206.221.7770
ehsbio@uw.edu
|
