5 Simple Steps to a RuleAbiding Science Fair Project

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5 Simple Steps to a Rule-Abiding Science Fair
Project

• Step 1 Have your student complete a Research
  Plan
• (Question, References, Hypothesis, Supplies
  Needed, Detailed Procedure)
• Step 2 Review the Research Plan (Assess Risk
  Safety for All)
• Human Subjects
• Non-Human Vertebrate Animals
• Potentially Hazardous Biological Agents
  (bacteria, fungi, human or vertebrate animal
  tissue, recombinant DNA)
• Controlled Substances
• Hazardous Substances or Devices
• Step 3 Obtain the appropriate approval and
  signatures
• (science teacher, school administrator, doctor
  or biomedical scientist)
• Step 4 Review rules with student
• Step 5 Your student is now ready to begin
  experimentation

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Human Subjects

• When students conduct research with human
  subjects, the rights and welfare of those
  participating must be protected. There are
  federal regulations protecting human subjects
  that require the prior review by an Institutional
  Review Board (IRB) and, in most cases informed
  consent of research subjects or their parents.
• An IRB consists of 3 individuals, a science
  teacher, school administrator and one of the
  following psychologist, psychiatrist, medical
  doctor, physician s assistant or licensed
  social worker.

• Human subjects research includes projects
  involving
• Subjects participating in physical activities
  (e.g., physical exertion, ingestion of any
  substance, any medical procedure).
• Psychological and opinion studies (e.g., survey,
  questionnaire, test of any kind)
• Behavioral observations
• Studies in which the researcher is the subject of
  research.

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Rules for Human Subject Projects

• Students must obtain approval from an IRB prior
  to experimentation.
• If the IRB determines that there is more than
  minimal psychological or physical risk to the
  human subjects, the student must receive written
  consent from each subject and written parental
  consent for subjects under age 18.
• If IRB determines that there is unacceptable
  risk, the student must revise the project.
• Students may observe collect data for analysis
  of medical procedures under the direct
  supervision of a qualified professional.

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Rules for Human Subject Projects

• Students are prohibited from administering
  medications and performing medical procedures on
  human subjects.
• Students may not publish or display any
  information that identifies the subject directly
  without written consent.
• The use of the Internet to obtain data is
  permitted.

High Risk Groups Include pregnant women,
children, prisoners, mentally disabled
individuals, or economically or educationally
disadvantaged persons or individuals with
diseases such as cancer, asthma, diabetes,
cardiac disorders, psychiatric disorders etc.
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Vertebrate Animals

• The rules for vertebrate animal research were
  developed to help pre-college student researchers
  adhere to the federal regulations that govern
  professional scientists and to, therefore,
  protect the welfare of both animal and the
  student. When students conduct research with
  animal subjects, the health and wellbeing of the
  animal must be protected.

Vertebrate Animals live, non-human vertebrate
mammalian embryos, fetuses, bird and reptile eggs
within 3 days (72 hours) of hatching, and all
other non-human vertebrates at hatching or birth.
A Scientific Review Committee (SRC) consisting of
two science teachers and a biomedical scientist
(e.g., veterinarian) must review and approve the
project prior to experimentation.
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Vertebrate Animals
Alternatives must be explored and discussed in
the research plan

• Replace vertebrate animals with invertebrates,
  lower life forms, tissue/cell cultures, or
  computer simulations.
• Reduce the number of animals without compromising
  statistical validity
• Refine the protocol to lessen pain or distress
• to the animals

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Rules for Vertebrate Animal Projects
These types of projects are PROHIBITED

• Projects that cause more than momentary pain or
  suffering or are designed to kill vertebrate
  animals
• All induced toxicity studies (alcohol, acid rain,
  insecticide, herbicide, heavy metals)
• Behavioral experiments involving operant
  conditioning with aversive stimuli (mother/infant
  separation or induced helplessness)
• Predator/prey experiments
• Projects with 30 death rate or 15 weight loss

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Rules for Vertebrate Animal Projects

• Animals must be treated kindly and cared for
  properly. Animals must be housed in a clean,
  ventilated comfortable environment compatible
  with the species used. Pens, cages and or tanks
  must be cleaned frequently.
• Care must be provided at all times including
  weekends, holidays and vacation periods!
• Animals must be given clean (uncontaminated)
  water food.
• Animals may not be captured from or released into
  the wild without approval of authorized wildlife
  officials.
• Behavioral, observational, supplemental
  nutritional, non-invasive studies on pets may be
  conducted at home, school or farm.

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Potentially Hazardous Biological Agents
Potentially Hazardous Biological Agents include

• Microorganisms
• (including bacteria, viruses, viroids, prions,
  rickettsia, fungi, and parasites)
• Recombinant DNA (rDNA) technologies
• Human or animal fresh tissues, blood, or body
  fluids.

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Potentially Hazardous Biological Agents

• The student and adults involved conduct a Risk
  Assessment
• Risk assessment defines the potential level of
  harm, injury or disease to plants, animals, and
  humans that may occur when working with
  biological agents.
• The end result of a risk assessment is the
  assignment of a Final Biosafety Level this must
  be confirmed by the SRC

• All experimentation with potentially hazardous
  biological agents, including Biosafety Level 1
  (BSL-1) is prohibited at home,
• Biosafety Level 2 (BSL-2) projects must be
  conducted in a laboratory rated BSL-2 or above,
  be approved by the IBC, and the student must
  receive training on microbiological procedures
• Biosafety Levels 3 4 are prohibited

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Controlled Substances

• Controlled substances, including DEA classed
  substances, prescription drugs, consumable ethyl
  alcohol, and tobacco, must be acquired and used
  according to existing local, state, and federal
  laws.

• Research involving controlled substances must be
  approved by two science teachers, a school
  administrator or biomedical scientist before
  experimentation
• Student researchers must adhere to all local,
  state, U.S. Federal and country regulations
  governing controlled substances.

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Rules for Controlled Substances

• Production of consumable ethyl alcohol is
  federally regulated and students must contact the
  Bureau of Alcohol, Tobacco and Firearms for
  regulations.
• Only under the direct supervision of a Qualified
  Scientist may students use federally-controlled
  medications, including prescriptions and
  experimental substances in their research.
  Student research with consumable alcohol, tobacco
  or explosive materials may only be performed
  under the direct supervision of a Designated
  Supervisor
• Students under 21 are prohibited by federal and
  most state laws from purchasing and handling
  explosive materials, including smokeless powder
  or black powder for science projects

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Hazardous Substances or Devices
Students are allowed to conduct research
involving hazardous substances or devices as long
as students adhere to federal and state
regulations and guidelines which are designed to
protect the safety of researchers.
Students do not require prior approval to work
with hazardous substances or devices but they do
require proper supervision by a Designated
Supervisor. The Designated Supervisor must be
directly responsible for overseeing student
experimentation.
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Rules for Hazardous Substances Devices

• Students must follow proper safety procedures for
  each chemical or device used in research. Extra
  precautions should be taken with flammable,
  explosive, toxic, or carcinogenic chemicals,
• For all research requiring a Federal and/or State
  Permit, the student will be expected to have the
  permit prior to experimentation.
• Students must adhere to safety standards when
  using radiation radioactive substances