Colorado Science and Engineering Fair Presentation

Roles & Responsibilities of
Adult Sponsor
May be a:
 Teacher
 Parent
 University Professor
 Working Scientist
They must have a solid
background in science and should
have close contact with the
student during the course of the
The Adult Sponsor is responsible for working with the student to evaluate any
possible risks involved in order to ensure the health and safety of the student
conducting the research and the humans or animals involved in the study.
Qualified Scientist
 Should possess an earned
doctoral/professional degree in the
biological or medical sciences as it
relates to the student’s area of
 Must be thoroughly familiar with
the regulations that govern the
student’s area of research.
 May be the Adult Sponsor.
 May be located in a different city or
state as long as the student works
locally with a Designated
Supervisor who has been trained in
the techniques the student will use.
Designated Supervisor
 Is directly responsible for
overseeing student experimentation.
 Does not need an advanced degree,
but should be thoroughly familiar
with the student’s project.
 Must be trained in the student’s area
of research.
 May be the Adult Sponsor.
If a student is experimenting with live vertebrate animals and they are in a
situation where their behavior or habitat is influenced by humans, the
Designated Supervisor must be knowledgeable about the humane care and
handling of the animals.
Institutional Review Board
Must consist of a minimum of three
 An educator
 A school administrator
 Someone who is knowledgeable
and capable of evaluating the
physical and/or psychological
risk involved in a given study
The Parent, Adult Sponsor,
Designated Supervisor CANNOT
be a member of the IRB
reviewing a students’ project. For
this reason, it is recommended
that an IRB enlist additional
members to avoid conflicts of
 Charged with evaluating the potential
physical and/or psychological risk of
research involving human subjects.
 Federal regulations encourage local
community involvement, therefore, an
IRB should be established at the school
level to evaluate human research
projects involving its students.
However, a district IRB may be used.
 If the research is being conducted at a
federal institution (such as university,
medical center, correctional facility)
then that institution’s IRB must review
and approve all proposed research.
 If an SRC, reviewing projects prior to
competition, judges that the IRB’s risk
assessment was inappropriate, the SRC
may override the IRB’s decision and the
project may fail to qualify for
Scientific Review Committee
Must consist of a minimum of three
 A biomedical scientist (Ph.D.,
M.D., D.V.M., D.D.S., D.O.)
 An educator
 One other member
If animal research is involved, at least
one member must be familiar with
proper animal care procedures.
The Parent, Adult Sponsor,
Designated Supervisor CANNOT
be a member of the SRC
reviewing a students’ project. For
this reason, it is recommended
that an SRC enlist additional
members to avoid conflicts of
Charged with reviewing projects BEFORE
experimentation for the following:
 Evidence of literature search
 Evidence of proper supervision
 Use of accepted and appropriate research
 Completed forms, signatures and dates
showing maximum of one year duration of
research and appropriate preapproval dates
 Evidence of search for alternatives to animal
 Humane treatment of animals
 Compliance with rules and laws governing
human and animal research
 Compliance with rules and laws governing
human, animal research and those involving
potentially hazardous biological agents
 Documentation of substantial expansion for
continuation projects
 Compliance with the ISEF ethics statement
Forms, Rules & Guidelines
Requirements for ALL Projects
All projects must have the following forms
and should be completed in this order:
Student Checklist (1A) completed in
conjunction with the Research Plan.
Research Plan MUST be TYPED and
should be completed in conjunction with the
Student Checklist (1A).
Checklist for Adult Sponsor (1) should be
done once the Student Checklist and
Research Plan are near completion.
Approval Form (1B) should be completed
once the Student Checklist, the Research
Plan and the Checklist for Adult Sponsors are
all complete.
An Abstract must be completed once the
project is completed and all analysis and
conclusions are done.
A Regulated Research
Institutional/Industrial Setting Form (1C) is
completed AFTER experimentation is
completed at a research institution or
industrial setting.
Requirements for Human Subject Projects
The Research Plan for a project that uses Human Subjects
must include the following:
Subjects - Describe who will participate in the study and
identify any vulnerable populations.
Recruitment – Where will the subjects be found and how
will they be invited to participate?
Methods - What will participants be asked to do (survey,
questionnaire, tests) and what is the frequency and length
of time involved for each subject?
Risks - What are the risks or potential discomforts (physical,
psychological, time involved, social, legal, etc) to
participants and how will the risks be minimized?
Benefits - List any benefits to society or to individual
Protection of Privacy - Will any identifiable information
(e.g. names, phone numbers, birth dates, email addresses)
be collected? Will data be confidential or anonymous? If
anonymous, describe how the data will be collected
anonymously. If not anonymous, what procedures are in
place for safeguarding confidentiality (where will the data
be stored; who will have access to the data; and what will
be done with the data at the end of the study)?
Informed Consent Process - Describe how participants will
be informed about the purpose of the study; what they
will be asked to do; that their participation is voluntary;
and they have the right to stop at any time.
Informed Consent for Humans Subjects Projects
Students should feel free to either use the form as it is provided by ISEF, or copy all of the
following information into a new document:
Purpose of the project: This is where the Student Researcher should explain as simply as possible,
why they are doing the project.
If you participate, you will be asked to: Include EVERYTHING the subject will be asked to do in
the study. If there are different tasks for different sets of subjects, then different consent forms
must be used for each set of tasks.
Time required for participation: Give a good estimate for how much time the subject should
expect to spend participating in the study.
Risks: Remember, there is no such thing as NO RISK. If no risks are anticipated, then use the
phrase “NO KNOWN RISKS.” Always keep in mind that there are emotional as well as physical
risks involved in some studies. This is also where a description of how risks will be minimized
should be explained.
Benefits: Give any benefits to the individual participant as well as the benefit to society in general.
If there are no benefits, it is perfectly all right to state that there are no benefits for participating in
the study except to satisfy the curiosity of the student researcher.
How confidentiality will be maintained: The best procedures are those where absolutely no
identifying information is collected along with the data. Another technique is to have a numbered
linked list where the data from the participant is given a number and the number is separately
identified by name. This would allow the researcher to destroy the numbered list of names as soon
as the need for the link is done. It is also best that the Adult Sponsor or Designated Supervisor be
in charge keeping the data.
Requirements for Vertebrate Animal Projects
The research plan for a project that uses
Vertebrate Animals must include the following:
 A discussion of potential alternatives to the
use of vertebrate animals and detailed
justification as to why vertebrate animals
must be used.
 An explanation of the potential impact or
contribution this research may have.
 Detailed procedures to be used, including
methods used to minimize potential
discomfort, distress, pain and injury to the
animals during the course of experimentation
and detailed chemical concentrations and
drug dosages if applicable.
 Detailed number of animals being used, the
species, strain, sex, age, etc. including
justification for the number of animals
planned for the research.
 Housing and oversight of daily care.
 Disposition of the animals at the termination
of the study.
Research Projects at Non-Regulated Sites
Vertebrate Animal studies may only be conducted at a non-regulated research site (home, school, farm, ranch, field,
etc.) ONLY if BOTH of the following applies:
 The research involves agricultural, behavioral, observational, or supplemental nutritional studies on animals AND
 The research involves only non-invasive and non-intrusive methods that do not negatively affect an animal’s health
or well-being.
All other studies using vertebrate animals must be conducted at a regulated research institution.
A researcher must STOP experimentation if there is unexpected weight loss or death in the experimental subjects. The
experiment can only be resumed if the cause of illness or death is not related to the experimental procedures and if
appropriate steps are taken to eliminate the causal factors. If death is the result of the experimental procedure, the study
must be terminated, and the study will not qualify for competition.
The SRC must decide what type of supervision the project requires:
A Designated Supervisor is required for all Vertebrate Animal studies and are responsible for the quality of care
and handling of the animals in the project.
A Veterinarian is not required for all Vertebrate Animal studies, but is recommended for experiments that involve
supplemental nutrition and/or activities that would not be ordinarily encountered in the animal's daily life.
A Qualified Scientist is not required for all Vertebrate Animal studies, but may be suggested by the SRC.
Form 5A must be filled out by the researcher for each different type of animal being used and include the number of
animals being used in the study, the housing and husbandry to be provided, and what will happen to the animals after
Research Projects at Regulated Institutes
Form 5B must be filled out by the Qualified Scientist or the Principal Investigator at the
regulated research institution. A copy of the regulated research institution IACUC
approval letter must be attached to this form. The Qualified Scientist must describe the
USDA Pain Category that the research falls under. The local SRC must also review the
project to certify that the research complies with ISEF rules. This review should
happen before experimentation begins.
Proper euthanasia at the end of experimentation for tissue removal and/or pathological
analysis is permitted. Only the Qualified Scientist or an institutional representative may
perform the euthanasia.
The following types of studies on vertebrate animals are prohibited:
 All induced toxicity studies, such as those using alcohol, acid rain, insecticide,
herbicide, heavy metal, etc.;
 Behavioral experiments involving operant conditioning with adverse stimuli,
mother/infant separation or induced helplessness;
 Studies of pain; and
 Predator/prey experiments.
Requirements for Potentially Hazardous Biological
Agent Projects
Experimentation with potentially hazardous biological
agents is prohibited in a home environment!!!
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
 Experiment involves only procedures in which the
Petri dish remains sealed throughout the
 The sealed Petri dish is disposed of in the
appropriate manner by the Designated Supervisor.
If a culture is opened for identification, sub-culturing
or isolation, it must be treated as a BSL-2 study and
involve BSL-2 laboratory procedures and equipment.
A high school lab is not typically considered a BSL-2
Any study involving agents belonging to the BSL-3 or
BSL-4 groups ARE NOT ALLOWED AT ALL!! BSL3 contains agents that usually cause serious disease or
that can result in serious economic consequences.
BSL-4 contains agents that usually produce disease
that is often untreatable.
Requirements for Tissue Projects
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 collections (the source
and/or catalog number must be identified);
Fresh or frozen meat, meat by-products, pasteurized milk or eggs obtained from food
stores, restaurants, or packing houses;
Teeth that have been sterilized to kill any blood borne pathogen that may be present;
Fossilized tissue or archeological specimens; and
Prepared fixed tissue slides.
There are additional rules that apply to projects that involve tissues and body fluids,
including blood and blood products. These types of project must ALSO complete a
Human and Vertebrate Animal Tissue Form 6B.
Additional Considerations for Potentially
Hazardous Biological Agent Projects
 Established human and/or non-human primate cell lines and tissue 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, then it does not need to be considered a Vertebrate Animal project 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 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 and be handled in
accordance with standards and guidelines set forth in the OSHA, 29CFR, Subpart Z.
 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 stem cells must be conducted at a regulated research institute
and reviewed and approved by the Embryonic Stem Cell Research Oversight Committee.
Requirements for Projects Using
Hazardous Chemicals, Activities
or Devices
 The Risk Assessment Form 3 is a good form to have all students complete, even if it isn't
necessarily required as the questions really get them to think about safety.
 It is important that the Designated Supervisor include ALL hazardous chemicals, activities
and/or devices that will be used in the project under #1 and answer the remaining questions
for each one. Be very specific and provide as much detail as possible to avoid future questions
when the SRC reviews it for competition.
 Use the Research Plan as a guide as to what to include and make sure to include items that are
used to build parts of the project as well.
 If firearms and/or bows and arrows are used, it is important that you include a copy of the
student's and supervisor's Colorado Hunter Safety Card.
 Just as a scientist needs to be qualified in the area of research that a student is working in, a
Designated Supervisor may need to explain their qualifications. For example, if a student
were using power tools, it would be appropriate to have someone who is a carpenter by trade
supervising the student, even though the parent or teacher may know how to use the tools.
Being MOM or DAD is not necessarily qualification enough to supervise a project using
hazardous chemicals or devices.
 If the student isn't going to be directly using a tool or device, but merely assisting, please
indicate this under the description of safety precautions and procedures (#3).
 Sources of Safety Information (#5) should be done in the same manner as a reference cited list
is done.