If you have significant changes in procedures and/or organisms

advertisement
UC Davis BUA Amendment
Principal Investigator and Laboratory Information
This amendment involves:
Date received:
BSL/RG:
ABSO Reviewer:
NIH Guidelines:
Amendment, BUA#
Recombinant DNA
App. C:
Exempt under NIH Guidelines section: IIIF:
If you have significant changes
in procedures and/or organisms,
please either submit a major
change amendment or a new
BUA application. Please note that
BUAs expire three years from the
original approval date.
Infectious Agents
(Human, animal, or plant)
Bloodborne pathogens,
human & nonhuman primate
materials
First review:
Second review:
Action:
Third review:
Action:
Third review:
Amendment
Approval date:
Action:
BUA Expiration
date:
Principal investigator:
Department:
Phone:
Shared space owner
IBC review dates
Action:
Title:
Fax:
Building:
E-mail address:
Room:
Title:
Co-investigator
A “Shared space owner” is the director, manager, or owner of research space or special equipment not assigned to the Principal Investigator. A “co-investigator” is a UC Davis faculty or
Academic Federation member with a significant collaborative role in the research. Use additional sheets if necessary.
Department:
Phone:
Building:
Fax:
Room:
E-mail address:
Check here if you have listed additional shared space owners or co-investigators on a separate sheet
Lab contact
Department:
Phone:
Title:
Fax:
Building:
E-mail address:
Room:
General conditions for Biological Use Authorization Amendment approval
The principal investigator agrees to the following (please check boxes on the left):
Ensure that personnel listed in this application have received or will receive appropriate documented training in safe laboratory practices and
procedures for this protocol before any work begins on this amendment and at least annually thereafter
Follow the health surveillance practices as approved for this amendment and inform those working on the protocol about appropriate emergency
assistance information for their location(s).
Inform EH&S (530 752 1493) and the occupational medicine physician (530 752 6051) of any research-related accident or illness as soon as
possible after its occurrence.
Comply with UC Davis biosafety procedures specified in the BUA Appendix A and the UC Davis Biosafety Manual, with UC Davis and UC
systemwide biosafety policy and procedure, with the NIH Guidelines for Research Involving Recombinant DNA Molecules, and with all other
applicable laws and regulations.
Submit in writing (by BUA Amendment) a request for pre-approval from the Institutional Biological Committee (530 752 1493) for any
significant deviations from the biohazard containment or personnel protection provisions of the approved BUA and amendments, or any
modifications to the study or additions or deletions of personnel, facilities, recombinant or infectious agents, or procedures.
By signing below, I certify that I have reviewed the above conditions and agree that all project personnel will abide by those requirements and adhere
to all UC Davis policies and procedures governing the use of recombinant DNA and infectious agents.
Principal investigator signature:
Date:
Shared space or co-investigator (if applicable):
Date:
IBC chair:
Biological Safety Office (Final Approval for Conditional Amendments):
Date:
Last revised July 10, 2013
Date:
1
Project title.
1. Changes in project location?
Add
Delete
Building Name and Room Number
Yes
No
Yes
No
Intended Use for Room (purpose)
2. Changes in personnel?
Appropriate Training Taken and Documented
Add
Delete
Last Name
First Name, MI
UCD ID
Biosafety
BSC*
BBP & MW**
* BSC=Biological Safety Cabinet training (mandatory for users of Biological Safety Cabinets)
** BBP and MW=Bloodborne Pathogens and Medical Waste. These are given initially with the Biosafety class offered by EH&S. Annual refreshers should provide training for the BBP and
MW in tandem.
3. Changes in the agents, hosts, or laboratory procedures?
Add
Delete
Agents, hosts, or laboratory procedures
Yes
No
Risk Group/Biosafety Level
1
1
1
2
2
2
3
3
3
3A. Animal care protocol # (If applicable.)
3B.Applicable section(s) of the NIH Guidelines.
3C. If there are changes noted above (1 or 3), please describe below. (The box will expand as needed.) For guidance on required
information, visit http://safetyservices.ucdavis.edu/programs-and-services/biosafety/Forms%20and%20Plans/bua/amend-guide.
Last revised July 10, 2013
2
Download