网曝门 Biosafety
Institutional Biosafety Committee (IBC) is one of the 网曝门's compliance committees
established in accordance with federal requirements. IBC is charged with the oversight
of recombinant DNA, pathogens, toxins, toxicants and carcinogens,听and to ensure that
网曝门 complies with all federal and state regulations.
Accordingly, all 网曝门 research and instructional activities involving biohazardous
materials will be reviewed and approved by IBC prior to the use of any such reagent.
Department Biosafety Form captures the biosafety information for the upcoming semester and is submitted by
the Department head for the entire instructional-related activities.
Biosafety Research Form is the protocol form to be used by Principal Investigators (PI) for research activities.
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Biosafety information and instructions
1. Any 网曝门 faculty member that plans to conduct research involving biological materials
or plans to implement laboratory teaching modules involving biological materials should
be trained in biosafety and may be required to complete an IBC protocol submission
form.
2. Research and teaching activities that may require IBC review include experiments
involving 1) recombinant DNA that is propagated in a host or vector organism; 2) infectious
microorganisms and viruses; 3) biological toxins; and 4) human or mammalian derived
tissue, including cell lines and blood or body fluids.
3. A faculty member performing research utilizing any of these agents should review
the IBC Protocol Submission Form to determine if IBC approval is required.
4. Department Heads may be required to submit protocol forms for any teaching laboratories
that utilize biological materials. Department Heads and course instructors should
review the IBC Protocol Submission Form to determine if IBC approval is required.
Department Heads will submit a 鈥淒epartment Biosafety Form鈥� if IBC approval is required.
5. All protocols must be approved by the IBC before initiating the research or teaching
activity.
6. All laboratories must be designated at an appropriate biosafety level (BSL) level,
as defined in the biosafety training course. BSL designations must be clearly indicated
by signage placed on the outside of the laboratory door(s).
7. Departmental safety officers should ensure that labs are properly designated and
labeled and that activities are being performed in compliance with the designated
BSL and with the 网曝门 Safety Manual and the laboratory Chemical Hygiene plan.
8. Applicants who will require IBC review are encouraged to read the following documents
in addition to receiving specific biosafety training. These resources provide information
on biosafety policies and procedures. Applicants may be required to reference specific
sections of these documents as part of the protocol review.
- Biosafety
a. American Biological Safety Association
http://www.absa.org/
- Recombinant DNA
a. 鈥淣IH Guidelines for Research Involving Recombinant DNA鈥�
https://osp.od.nih.gov/wp-content/uploads/2014/01/NIH_Guidelines_and_Synthetic_Nucleic_Acids_Slides.pdf
b. "Biosafety Considerations for Research with Lentiviral Vectors
https://osp.od.nih.gov/wp-content/uploads/Lenti_Containment_Guidance.pdf
- Microorganisms and biological toxins
a.听听 鈥淏iosafety in Microbiological and Biomedical Laboratories鈥澨�
http://www.cdc.gov/od/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf
b.听听 鈥淣ational Select Agent Registry鈥�
www.selectagents.gov
c. 鈥淢aterial Safety Data Sheets
http://www.phac-aspc.gc.ca/msds-ftss/index-eng.php
- Human and mammalian tissue, including blood, body fluids
a.鈥� Exposure Control Plan for Blood-Borne Pathogens
http://www.ulm.edu/safety/manual_bpp.html
b. Working with Human and other Primate Tissue鈥�
http://www.cdc.gov/OD/ohs/biosfty/bmbl4/b4ah.htm
- General Laboratory Safety
a. 鈥溚孛� Safety Manual鈥�
http://www.ulm.edu/safety/safety_manual.html
Responsibilities of the IBC
The 网曝门 IBC reviews and approves research or teaching activities that involve biological
materials that have the potential to cause harm to humans, other animals, or the environment.
These include:
- Acquisition, storage, use, disposal, and propagation of recombinant DNA, including
transgenic animals or plants;
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Acquisition, storage, use, disposal, and propagation of microorganisms (bacteria, viruses, parasites or fungi) that are potentially infectious to humans, other animals, or plants (Risk Groups
2-4);
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Acquisition, storage, use, and disposal of biological toxins;
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Acquisition, storage, use, and disposal of human and other mammalian tissue containing
or potentially containing blood-borne pathogens, including cell lines and blood/other
body fluids
The activities of the IBC intersect with other campus research review committees including
the Institutional Animal Care and Utilization Committee (IACUC) and the 网曝门 Internal
Review Board that approves research on human subjects. The 网曝门 IBC will review animal
and human research incorporating the activities described above and the biosafety
procedures associated with these activities. However, applicants performing animal
or human research are required to receive approval from IACUC and the IRB prior to
submitting protocols for IBC approval. It is also assumed that applicants will follow
all general safety policies of the 网曝门 Environmental Health and Safety office.
The 网曝门 IBC will verify that all personnel involved with these activities will adhere
to the appropriate federal, state, and local regulations and are trained in the proper
and safe use of any hazardous or potentially hazardous agents. The 网曝门 IBC will also
ensure that hazardous or potentially hazardous agents have been identified, and that
these hazards will be controlled and monitored.
Under no circumstances should any of these agents be purchased, produced, stored,
used or disposed of for any university activity without approval of the 网曝门 IBC.
Review Process
The 网曝门 IBC will receive applications for protocol approval throughout the academic
year. Decisions of the committee will be communicated to the principal investigator
within one week of the committee decision. If an application is incomplete or if the committee has
questions, the applicant will have one week to respond from the date of notice. If a response is not received within this time
period, the initial application is administratively closed and the applicant must
resubmit the entire application.
The applicant is notified in writing, via campus mail, when a project is approved
by the 网曝门 IBC. If there are any special conditions under which approval is given,
those conditions will accompany the approval. No project can be initiated until this
written approval is received by the applicant.
When an application is denied, the reasons for the denial will be provided to the
applicant. An applicant may modify their project and re-submit a new application for
consideration by the 网曝门 IBC.
The 网曝门 IBC will grant protocol approval for the duration of the project as determined
by the applicant. If no time period for the project is indicated, then a default approval
period of one year will be granted. Approval to conduct the project is to be terminated at that
time unless the committee receives a request for continuance.
Modification of an approved project is prohibited without prior committee approval
of these modifications. Request for continuance or protocol modification must be received
by the IBC before initiation of the modified protocol.
Applications and other information can be obtained from the 网曝门 Office of Sponsored
Programs and Research. Applications can be sent by e-mail to the Chair of the IBC
(Dr. Srinivas Garlapati, garlapati@ulm.edu). A copy of the application should also
be forwarded to the Office of Sponsored Programs and Research (ospr@ulm.edu).
The IBC will conduct on-campus meetings as needed. Meeting times will be posted on
the web site of the 网曝门 Office of Sponsored Programs and Research. 网曝门 IBC meetings
are open to the public and applicants are invited to attend. Minutes of 网曝门 IBC meetings
will also be posted on the OSPR web site.
For further information, contact:
Dr. Srinivas Garlapati
College of Pharmacy
E-mail:garlapati@ulm.edu
Phone: 342-3304
Office: CNSB 323
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