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Use
of Human Subjects in Projects
These rules apply to all projects involving human
subjects in any of the following:
- physical activity
- blood testing
- tasting or sampling of food or drink
- surveys of opinions or behaviors
Research
Advisors
- In order to protect the health, safety and legal
rights of human subjects, the student conducting the
project must have a Research Advisor approve his/her
plans to any
work with human subjects. The Advisor will meet with
the student and a responsible adult who will supervise
student work. Qualifications for Research Advisors
vary with the type of project as follows:
- If the project involves:
- a physical activity IN ANY WAY BEYOND THE SCOPE OF
ANY SUBJECT'S EVERYDAY LIFE (running endurance trials,
sitting in hot tubs, test performance after reduced sleep,
etc.)
- work with human blood
- the ingestion of a food, drink or any other substance IN
ANY WAY BEYOND THE SCOPE OF ANY SUBJECT'S EVERYDAY LIFE...
... the Research Advisor must be a medical
doctor (M.D.)
-
- If the project involves:
- the ingestion of food, drink or any other substance COMPLETELY
WITHIN the scope of any subject's everyday life
- a physical activity COMPLETELY WITHIN the
scope of the subject's everyday life (i.e. Does color affect
taste? Do different ages have different food preferences? Measuring
changes in height before and after sleep, etc.)
- the collection of information through a questionnaire or
survey ...
... the Research Advisor must be the School Science
Fair Coordinator or the School Site Administrator.
-
- At the initial meeting, students must provide the
Research Advisor with all of the following:
- a written description of procedures they
plan
- a copy of the Humboldt County Science Fair
regulations pertaining to human subjects
- a copy of the Humboldt County Science Fair
Research Approval Certificate
- the form to be sent to parents for their
approval of their child's participation in
the project
- The Advisor will complete Part I of the Research
Approval Certificate. A copy of
this Certificate must be submitted with the County
Science Fair Project Entry Form.
- Research Advisors must assure that each individual
human subject will not be exposed to any risk of possible
injury either physical, psychological, or social as
a consequence of participation in a science fair project.
Parent Permission
- Prior
written permission approving any activity or
tasting by a student "subject" must
be obtained from the parent or guardian. These
permission forms
must be kept on file and a copy must be included
in the student's logbook.
- California Education Code 60650 requires that parents
review and approve any surveys their
children are asked to complete. The intent of this Section
is based on the protection of family privacy and personal
beliefs, nonetheless all surveys including those, for
example, with questions about television viewing habits,
birth weights, etc. must still comply with this requirement
for parental pre-approval. Written approval by
the parent or guardian must be on file for each student
subject. Simple notification of the questionnaire
to be administered is not sufficient.
Surveys
- See parent permission requirements in the Parent Permission
section.
Additional
Restrictions
No bio-medical deprivation studies involving
human subjects will be allowed.
Any human blood samples in the project
must follow safety procedures for the handling of bloodborn
pathogens as stated in the California Occupational
Safety and Health Standards, Section 5193. Copies of
these guidelines are available from the Humboldt County
Science Fair Coordinator. Written documentation that
blood samples are free of HIV and Hepatitis B, must
be presented with the project entry form. Testing may
be done at the Humboldt County Health Department or
other medical laboratory.
The exhibition of human parts is
prohibited except for teeth, hair, and nails. Slides
or other samples of human tissue obtained from a scientific
supply company may be displayed provided proof of source
is attached to the project or in the logbook.
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