SAMPLE
COMPLETED FORM 6A's
See
a sample
Form 6A for a project where the SRC has determined the risk
level of the study is BSL-1.
See
a sample
Form 6A for a project where the SRC has determined the risk
level of the study is BSL-2.
See
a sample
Form 6A for a project where the research was done at a regulated
research institution.
SAMPLE
COMPLETED FORM 6B's
See
a sample Form
6B for a project that that is using human and/or vertebrate
animal tissue.
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Tips
for Forms & Projects:
Projects
incorporating microorganisms (including bacteria, viruses, viroids,
prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA)
technologies or human/animal fresh tissues, blood or bodily fluids
may involve working with potentially hazardous biological agents.
All of these types of projects must complete a Potentially
Hazardous Biological Agents Form 6A.
When
dealing with potentially hazardous biological agents, it is the
responsibility of the student and all of the adults involved in
a research project to conduct a risk assessment. Risk assessment
defines the potential level of harm, injury or disease to plants,
animals or humans that may occur when working with biological
agents.
Experimentation
with potentially hazardous biological agents is prohibited
in a home environment. This means absolutely NO CULTURING may be done at home, but COLLECTION may be done there.
Research
with unknown microorganisms can be treated as a Biosafety Level-1
(BSL-1) study under the following conditions:
- Organism
is cultured in a plastic Petri dish and sealed.
- Experiment
involves only procedures in which the Petri dish remains sealed
throughout the experiment.
- The sealed
Petri dish is disposed of via autoclaving or disinfection by the Designated Supervisor.
If a culture
is opened for identification, sub-culturing or isolation, it must
be treated as a Biosafety Level-2 (BSL-2) study and involve BSL-2
laboratory procedures and equipment.
Not all schools are equiped with the proper safety equipment and procedures to do even BSL-1 studies. To see what is required to for each safety level, view the Intel ISEF Rules and Guidelines for BSL-1 self-certification and BSL-2 self-certification for details. A high school laboratory is
not typically considered a BSL-2 lab. The CSEF or Intel ISEF SRC may request a completed self-certification checksheet in order to verify the biosafety level of the laboratory.
The following
types of studies are exempt from prior SRC review, are not considered
Potentially Hazardous Biological Agent studies and do not require
additional forms:
- Studies
involving baker's yeast and brewer's yeast, except when used
with rDNA studies.
- Studies
involving Lactobacillus, Bacillus thurgensis, nitrogen-fixing,
oil-eating bacteria and algae-eating bacteria introduced
into their natural environment. (Not exempt if cultured in a petri
dish environment.)
- Studies
of mold growth on food items IF the experiment is terminated at
the first evidence of mold.
The following
types of studies are exempt from prior SRC review, are not considered
Potentially Hazardous Biological Agent studies, but do require a
Risk
Assessment Form 3:
- Studies
involving protists, archae and similar microorganisms.
- Research
using manure for composting, fuel production or other non-culturing experiments.
- Commercially-available
color change coliform water test kits which will remain sealed
and will be properly disposed.
- Studies involving decomposition of vertebrate organisms (such as forensic projects).
There are additional
rules that apply to projects that involve tissues and body fluids,
including blood and blood products. These types of projects must
ALSO complete a Human
and Vertebrate Animal Tissue Form 6B.
- Established human and/or non-human primate cell lines and tissure culture collections must be treated according to the source's BSL information and catalog numbers included in the research plan.
- If tissue
is obtained from an animal that was sacrificed for a purpose other
than the student's project, it can be considered a tissue study and Form 5B does not need to be completed.
Documentation of the Institutional Animal Care and Use Committee
(IACUC) approval for the original animal study from which the
tissue was obtain is required however.
- If the animal
was euthanized solely for the student's project, the study must
be considered a Vertebrate Animal project and is subject to the vertebrate animal rules for studies conducted at a regulated research institution and a Form 5B must also be completed.
- All studies
involving human or wild animal blood or blood products must be
considered a BSL-2 study and involve BSL-2 laboratory procedures
and equipment under the supervision of a Qualified Scientist.
- All studies
involving domestic animals may be considered a BSL-1 study.
- Human breast
milk of unknown origin, unless certified free of HIV and Hepatitis
C and domestic unpasteurized animal milk must be considered BSL-2
agents.
- Studies
of human body fluids, where the sample can be identified with
a specific person, must ALSO be considered a Human Subjects project
and have IRB review and informed consent. Students may use their
own body fluid without review and consent.
- Studies involving embryonic human stem cells must be conducted at a regulated research institute and reviewed and approved by the Embryonic Stem Cell Research Oversight Committee.
The following
types of tissue do not need to be treated as potentially hazardous
biological agents:
- Plant tissue;
- Plant and non-primate established cell lines and tissue culture collection where the source and/or catalog number of the cultures have been identified in the research plan;
- Fresh or frozen meat, meat by-products, pasteurized milk or eggs obtained from food stores, restuarants, or packing houses;
- Hair;
- Teeth that
have been sterilized to kill any blood borne pathogen that may
be present;
- Fossilized
tissue or archeological specimens; and
- Prepared
fixed tissue.
Any study
involving agents belong to the BSL-3 or BSL-4 groups ARE NOT ALLOWED
AT ALL!!! BSL-3 contains agents that usually cause serious
disease or that can result in serious economic consequences (i.e.:
West Nile virus, equine encephalitis virus, Riskettsia riskettsii,
SARS coronavirus, etc.). BSL-4 contains agents that usually produce
disease that is often untreatable (i.e.: hemorrhagic fevers, Ebola
virus, etc.).
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