West Texas A&M University
Institutional Biosafety CommitteeAmendment
Use this form to make a change to institutional biosafety protocol. Return completed form to Killgore Research Center-IBC, WTAMU Box 60217, Canyon, TX 79016, fax 806-651-2733, phone 806-651-2270, e-mail AR-EHS@ wtamu.edu. Only typed forms will be accepted. For assistance please see theIBC website.
Principal Investigator: Protocol number:______
Phone: Box: .
E-mail: ______
Protocol title:
Which type(s) of changes in protocol are being proposed? Check all that apply.
Change in personnel ___
Change in procedures___
Change in agent(s)/organism(s)___
Change in rooms___
Change in funding source___
(Please attach copies of the grant proposal being added to the approved IBC Permit)
Change in protocol title ___
Change in Biological Safety Level (BSL)___
(Note: If the level is changing from BSL1 to BSL 2, Part II and Part IV of the application will be needed. Additionally, you may be asked to submit a new application.)
Other (Describe):______
* Please note that upon review of the proposed changes, the IBC may request that additional information be submitted. If additional revised parts of the registration document are required, you will be asked to submit this information within thirty (30) days of the request.
Describe all proposed change(s) in detail, in terms understandable to a non-scientist, please provide a detailed description of the proposed changes to the existing protocol. This description should provide the goal(s), methodology, and use of biohazardous or recombinant material. Please review the original protocol and confirm that all principal investigator assurances apply to proposed change(s). (Attach additional sheets if necessary.)
Justify the need for these proposed changes. (Attach additional sheets if necessary.)
Are you adding any agents? No Yes If yes, complete the Agent/Vector/Host characteristics Table A located on page 3.
Signature of Principal Investigator Date
------IBC Chair’s Action:
___ The changes proposed are not significant and do not require IBC review. The changes may be implemented and this form is included in the record for this protocol for information only.
___ The changes proposed are considered significant and do require IBC review. This form and the original protocol review form along with any attachments and comments are forwarded to the IBC committee. A copy of this form is sent to each IBC member to permit an opportunity to request additional information or convened IBC review. In all other respects, the IBC review of changes is the same as review of an original protocol.
IBC Chair Signature Date Approved
1
Table A: Agent/Vector/Host characteristics
In the table below, list each agent that will be used. Note the ID of the agent for later use in your application. If the agent is recombinant, pick “Yes” in the appropriate cell and enter insert information into Table B. Please note that if a vector is used to generate a recombinant host, both the vector and host need to be entered into Table A. If the agent is to be used with animals or plants give the species, otherwise enter “No”.
ID / Genus, species / Strain / RG(pick) / BSL
(pick) / ABSL
(pick) / Recombinant
(pick) / List all
locations IDs where agent
will be
used/stored / Use in
Animals/Plants
(Give species)
- / Example – E. coli / K-12 / RG-1 / BSL-1 / N/A / Yes / Bldg., Room # / No
A-1
A-2
A-3
A-4
A-5
A-6
A-7
A-8
A-9
USA CDC/NIHClassification of Infective Microorganisms byRisk Group (RG):
Risk Group 1 (no or low individual and community risk). A microorganism that is unlikely to cause human disease or animal disease
Risk Group 2 (moderate individual risk, low community risk). A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventative measures are available and the risk of spread of infection is limited.
Risk Group 3 (high individual risk, low community risk). A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.
Risk Group 4 (high individual and community risk). A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.
CDC/NIH Guidelines forBio Safety Levels:
Biosafety Level 1 (BSL 1): well characterized agents not consistently known to cause disease in healthy adult humans of minimal potential hazard to laboratory personnel and the environment
Biosafety Level 2 (BSL 2): agents of moderate potential hazard to personnel and the environment
Biosafety Level 3 (BSL 3): indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route (applicable to clinical, diagnostic, teaching, research or production facilities)
Biosafety Level 4 (BSL 4): dangerous and exotic agents which pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease
Animal BioSafety Levels (ABSL):
Animal Biosafety Level 1is suitable for work involving well characterized agents that are not known to cause disease in immunocompetent adult humans, and present minimal potential hazard to personnel and the environment.
Animal Biosafety Level 2 builds upon the practices, procedures, containment equipment, and facility requirements of ABSL-1. ABSL-2 is suitable for work involving laboratory animals infected with agents associated with human disease and pose moderate hazards to personnel and the environment.
Animal Biosafety Level 3 involves practices suitable for work with laboratory animals infected with indigenous or exotic agents, agents that present a potential for aerosol transmission and agents causing serious or potentially lethal disease. ABSL-3 builds upon the standard practices, procedures, containment equipment, and facility requirements of ABSL-2.
Animal Biosafety Level 4is required for work with animals infected with dangerous and exotic agents that pose a high individual risk of life-threatening disease, aerosol transmission, or related agent with unknown risk of transmission.
Recombinant DNA (rDNA) is a form of artificial DNA that is created by combining two or more sequences that would not normally occur together. In terms of genetic modification, it is created through the introduction of relevant DNA into an existing organismal DNA, such as the plasmids of bacteria, to code for or alter different traits for a specific purpose, such as antibiotic resistance.
Table B: Insertcharacteristics
Inthetablebelow,enterinformationabouteachvectororhostDNAinserts. EntertheappropriateHostIDfromTable1to
indicate which hostwillcontainthe insert.
ID / Host ID(Table A) / Source of Insert
(e.g. human, mouse, bacteria) / Insert Source
Rick Group
(RG1, RG2, RG 3, RG4) / Insert Name
(e.g. insulin) / Insert Characteristic or Function
(e.g. hormone)
Exp. / A-1, A-2 / Human / RG 1 / Insulin / hormone
I-1
I-2
I-3
I-4
I-5
I-6
I-7
I-8
I-9
1