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四色AV Biosafety

Institutional Biosafety Committee (IBC) is one of the 四色AV'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 四色AV complies with all federal and state regulations.

Accordingly, all 四色AV 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 四色AV 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 四色AV 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.

  1. Biosafety
    a. American Biological Safety Association


  2. Recombinant DNA
    a. 鈥淣IH Guidelines for Research Involving Recombinant DNA鈥�


    b. "Biosafety Considerations for Research with Lentiviral Vectors



  3. Microorganisms and biological toxins
    a.听听 鈥淏iosafety in Microbiological and Biomedical Laboratories鈥澨�


    b.听听 鈥淣ational Select Agent Registry鈥�


    c. 鈥淢aterial Safety Data Sheets


  1. 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�
  2. General Laboratory Safety
    a. 鈥溗纳獳V Safety Manual鈥�
    http://www.ulm.edu/safety/safety_manual.html

Responsibilities of the IBC

The 四色AV 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:

  1. Acquisition, storage, use, disposal, and propagation of recombinant DNA, including transgenic animals or plants;
  2. 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);
  3. Acquisition, storage, use, and disposal of biological toxins;
  4. 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 四色AV Internal Review Board that approves research on human subjects. The 四色AV 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 四色AV Environmental Health and Safety office.

The 四色AV 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 四色AV 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 四色AV IBC.

Review Process

The 四色AV 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 四色AV 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 四色AV IBC.

The 四色AV 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 四色AV 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 四色AV Office of Sponsored Programs and Research. 四色AV IBC meetings are open to the public and applicants are invited to attend. Minutes of 四色AV 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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