INTEL INTERNATIONAL SCIENCE AND ENGINEERING FAIR 2012 Rules and Guidelines

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<ul><li> Slide 1 </li> <li> INTEL INTERNATIONAL SCIENCE AND ENGINEERING FAIR 2012 Rules and Guidelines </li> <li> Slide 2 </li> <li> Adult roles and responsibilities Adult Sponsor Adult Sponsor Qualified Scientist Qualified Scientist Designated Supervisor Designated Supervisor Institutional Review Board (IRB) Institutional Review Board (IRB) Scientific Review Committee (SRC) Scientific Review Committee (SRC) </li> <li> Slide 3 </li> <li> Adult sponsor Oversees project to make sure that student Oversees project to make sure that student is informed of ISEF Rules and Guidelines is informed of ISEF Rules and Guidelines is aware of risks associated with project is aware of risks associated with project is aware of forms required for project is aware of forms required for project will receive proper supervision during experimentation will receive proper supervision during experimentation if required, submits project to IRB or SRC if required, submits project to IRB or SRC Teacher usually serves as Adult Sponsor Teacher usually serves as Adult Sponsor </li> <li> Slide 4 </li> <li> Required for some projects Required for some projects Doctoral/professional degree related to student research Doctoral/professional degree related to student researchor Masters degree with SRC approval Completes Form 2 QS Form Completes Form 2 QS Form Qualified Scientist </li> <li> Slide 5 </li> <li> Designated Supervisor Animal Care Supervisor for vertebrate animal projects Animal Care Supervisor for vertebrate animal projects Supervises projects involving hazardous chemicals, activities or devices Supervises projects involving hazardous chemicals, activities or devices Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student </li> <li> Slide 6 </li> <li> Slide 7 </li> <li> IRB (Institutional Review Board) Reviews human participants studies Reviews human participants studies Membership must include: Membership must include: an educator an educator a school administrator a school administrator someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor </li> <li> Slide 8 </li> <li> SRC (Scientific Review Committee ) Reviews some projects before experimentation Reviews some projects before experimentation Reviews all projects just prior to competition Reviews all projects just prior to competition Membership must include: Membership must include: a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) an educator an educator one other member one other member </li> <li> Slide 9 </li> <li> Combined IRB/SRC a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) a school administrator a school administrator an educator an educator someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor </li> <li> Slide 10 </li> <li> Forms required for all projects </li> <li> Slide 11 </li> <li> Slide 12 </li> <li> Slide 13 </li> <li> A Research Plan is required for all projects. It must incorporate all of the relevant topics listed in the Research Plan Instructions. </li> <li> Slide 14 </li> <li> Slide 15 </li> <li> Slide 16 </li> <li> Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C </li> <li> Slide 17 </li> <li> Slide 18 </li> <li> Project based on prior research in the same field of study Project based on prior research in the same field of study Longitudinal studies are permitted Longitudinal studies are permitted Multi-year study Multi-year study Studies time-based change Studies time-based change Require form 7 Require form 7 Continuation studies </li> <li> Slide 19 </li> <li> Slide 20 </li> <li> HUMAN PARTICIPANTS </li> <li> Slide 21 </li> <li> What are human participants studies? Human participants studies involve living individuals where there is Intervention or interaction with participants Intervention or interaction with participantsand/or Collection of identifiable private information Collection of identifiable private information </li> <li> Slide 22 </li> <li> Exempt studies do not require IRB review nor human participants forms Product testing of a student invention, program, concept, etc. Product testing of a student invention, program, concept, etc. No health hazards No health hazards No personal data collected No personal data collected Feedback directly related to product Feedback directly related to product Studies using pre-existing, publicly available human data Studies using pre-existing, publicly available human data </li> <li> Slide 23 </li> <li> Additional exempt studies Behavioral observations in unrestricted public settings Behavioral observations in unrestricted public settings No interaction No interaction No manipulation of environment No manipulation of environment No recording of any personal identifiers No recording of any personal identifiers Studies using certified de-identified/ anonymous data Studies using certified de-identified/ anonymous data </li> <li> Slide 24 </li> <li> Human participants research The IRB must review and approve the research plan before experimentation begins The IRB must review and approve the research plan before experimentation begins Research participants 18 years of age or older must give informed consent Research participants 18 years of age or older must give informed consent Research participants under 18 must give assent and their parents may be required to give permission Research participants under 18 must give assent and their parents may be required to give permission </li> <li> Slide 25 </li> <li> Human participants research, contd The IRB evaluates the project and determines The IRB evaluates the project and determines Risk level Risk level Requirement for Qualified Scientist Requirement for Qualified Scientist Requirement for written informed consent/assent/parental permission Requirement for written informed consent/assent/parental permission </li> <li> Slide 26 </li> <li> Risk evaluation No more than minimal risk No more than minimal risk Anticipated harm and discomfort not greater than encountered in daily life More than minimal risk More than minimal risk Anticipated harm or discomfort is greater than encountered in daily life More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB </li> <li> Slide 27 </li> <li> Types of Risk Physical risks Physical risks Exercise Exercise Ingestion, tasting, smelling, application of substances Ingestion, tasting, smelling, application of substances Exposure to potentially hazardous material Exposure to potentially hazardous material Psychological risks Psychological risks Invasion of privacy Invasion of privacy Participant is a member of an at-risk group Participant is a member of an at-risk group </li> <li> Slide 28 </li> <li> IRB decisions are documented on Form 4 </li> <li> Slide 29 </li> <li> Slide 30 </li> <li> If IRB determines that written informed consent/assent or parental permission is required, documentation is obtained on an informed consent document </li> <li> Slide 31 </li> <li> Slide 32 </li> <li> VERTEBRATE ANIMALS </li> <li> Slide 33 </li> <li> What is a vertebrate animal? Live, nonhuman vertebrate mammalian embryos or fetuses Live, nonhuman vertebrate mammalian embryos or fetuses Bird and reptile eggs within 3 days of hatching Bird and reptile eggs within 3 days of hatching All other nonhuman vertebrates (including fish) at hatching or birth All other nonhuman vertebrates (including fish) at hatching or birth Zebrafish embryos 7 days (168 hours) post fertilization Zebrafish embryos 7 days (168 hours) post fertilization </li> <li> Slide 34 </li> <li> Prohibited studies Induced toxicity studies involving known toxic substances that could impair health or destroy life Induced toxicity studies involving known toxic substances that could impair health or destroy life Behavioral experiments with Behavioral experiments with Conditioning using aversive stimuli Conditioning using aversive stimuli Mother/infant separation Mother/infant separation Induced/learned helplessness Induced/learned helplessness Studies of pain Studies of pain Predator/vertebrate prey experiments Predator/vertebrate prey experiments </li> <li> Slide 35 </li> <li> Additional restrictions Projects that cause more than momentary or slight pain or distress or which are designed to kill vertebrate animals are not permitted. Projects that cause more than momentary or slight pain or distress or which are designed to kill vertebrate animals are not permitted. A weight loss or growth retardation greater than 15% of any experimental or control animal is not permitted A weight loss or growth retardation greater than 15% of any experimental or control animal is not permitted A death rate of 30% or greater in any group or subgroup is not permitted A death rate of 30% or greater in any group or subgroup is not permitted </li> <li> Slide 36 </li> <li> Behavioral observations of animals are exempt from SRC review if There is no interaction with the animals There is no interaction with the animalsand There is no manipulation of the environment There is no manipulation of the environmentand All federal or state fish, game and wildlife regulations are followed All federal or state fish, game and wildlife regulations are followed </li> <li> Slide 37 </li> <li> Research sites School/Home/Field School/Home/Field Regulated Research Institution ( must have an IACUC review and approval process) Regulated Research Institution ( must have an IACUC review and approval process) Universities Government research agencies Private research laboratories </li> <li> Slide 38 </li> <li> Requirements for studies at school/home/field Agricultural, behavioral, observational or supplemental nutritional studies Agricultural, behavioral, observational or supplemental nutritional studiesand Non-invasive and non-intrusive with no negative effect on animals health or well-being Non-invasive and non-intrusive with no negative effect on animals health or well-beingand Require SRC pre-review and approval Require SRC pre-review and approval </li> <li> Slide 39 </li> <li> Additional requirements for studies at school/home/field SRC determines level of supervision appropriate for the study: SRC determines level of supervision appropriate for the study: Designated supervisor Designated supervisor Veterinarian Veterinarian Qualified scientist Qualified scientist Form 5A required Form 5A required </li> <li> Slide 40 </li> <li> Slide 41 </li> <li> Requirements for studies at regulated research institutions Must be approved by IACUC (Institutional Animal Care and Use Committee) Must be approved by IACUC (Institutional Animal Care and Use Committee) Local SRC should review project before experimentation Local SRC should review project before experimentation Experimentation must follow ISEF guidelines Experimentation must follow ISEF guidelines QS completes Form 5B which includes documentation of IACUC approval QS completes Form 5B which includes documentation of IACUC approval </li> <li> Slide 42 </li> <li> Slide 43 </li> <li> POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS </li> <li> Slide 44 </li> <li> Potentially hazardous biological agents include Microorganisms (including bacteria, viruses, fungi, etc.) Microorganisms (including bacteria, viruses, fungi, etc.) Recombinant DNA Recombinant DNA Human or animal fresh/frozen tissues, blood or body fluids Human or animal fresh/frozen tissues, blood or body fluids </li> <li> Slide 45 </li> <li> All studies involving potentially hazardous biological agents Studies must have prior approval by SRC/IACUC/IBC Studies must have prior approval by SRC/IACUC/IBC Most studies are prohibited in a home environment Most studies are prohibited in a home environment Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated Research Institution under documented IBC review and approval Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated Research Institution under documented IBC review and approval </li> <li> Slide 46 </li> <li> Risk assessment Required of all PHBA projects Required of all PHBA projects Defines potential level of harm, injury or disease to plants, animals or humans Defines potential level of harm, injury or disease to plants, animals or humans Involves Involves Assignment of biological agent to risk group Assignment of biological agent to risk group Determination of level of biological containment Determination of level of biological containment Assessment of expertise of adult(s) Assessment of expertise of adult(s) Assignment of final biosafety level Assignment of final biosafety level </li> <li> Slide 47 </li> <li> Risk assessment, contd BSL 1 studies can usually be conducted in a high school or college teaching laboratory. BSL 1 studies can usually be conducted in a high school or college teaching laboratory. BSL 2 studies are usually conducted in a regulated research institution BSL 2 studies are usually conducted in a regulated research institution BSL 3 and BSL 4 studies are prohibited for ISEF projects BSL 3 and BSL 4 studies are prohibited for ISEF projects Form 6A (Potentially Hazardous Biological Agents form) required for most projects involving microorganisms, and for all projects involving rDNA and fresh human and vertebrate animal tissues Form 6A (Potentially Hazardous Biological Agents form) required for most projects involving microorganisms, and for all projects involving rDNA and fresh human and vertebrate animal tissues </li> <li> Slide 48 </li> <li> Slide 49 </li> <li> Studies exempt from prior SRC review and no additional PHBA forms required Studies using bakers and brewers...</li></ul>