HIPAA, Researchers and the IRB Alan Homans, IRB Chair and Nancy Stalnaker, IRB Administrator.
Science Fair Independent Dependent Variable Rules and Regulations Abstract SRC Biological Hazards...
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Transcript of Science Fair Independent Dependent Variable Rules and Regulations Abstract SRC Biological Hazards...
ScienceScience Fair FairIndependentIndependent
DependentDependent
VariableVariableRules and Rules and
RegulationsRegulations
Abstra
ctA
bstra
ct
SRCSRC Bio
log
ical
Bio
log
ical
Haza
rds
Haza
rds
IRB
IRB
SponsorSponsorD
istrictD
istrict Regio
nal
Regio
nal
Sta
teS
tate
SafetySafety PH
BA
PH
BA
Risk AssessmentRisk Assessment
Human SubjectsHuman SubjectsB
SL1
BS
L1
BSL2BSL2
BSL3BSL3
Form
sFo
rms
Research PlanResearch Plan
INTERNATIONAL INTERNATIONAL SCIENCE SCIENCE
AND AND ENGINEERING ENGINEERING
FAIRFAIR
Rules and GuidelinesRules and Guidelines
SRC SRC Scientific Review CommitteeScientific Review Committee
Reviews some projects before Reviews some projects before experimentationexperimentation
Reviews all projects just prior to Reviews all projects just prior to competitioncompetition
Membership must include:Membership must include: a biomedical scientist (Ph.D., M.D., a biomedical scientist (Ph.D., M.D.,
D.V.M., D.D.S., D.O.)D.V.M., D.D.S., D.O.) an educatoran educator one other memberone other member
IRB IRB Institutional Review BoardInstitutional Review Board Reviews human subject studiesReviews human subject studies Membership must include:Membership must include:
an educatoran educator a school administratora school administrator someone knowledgeable about someone knowledgeable about
evaluating physical and/or evaluating physical and/or psychological risk: MD, PA, RN, psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed psychiatrist, psychologist, licensed social worker or licensed clinical social worker or licensed clinical professional counselorprofessional counselor
Forms Forms REQUIRED REQUIRED
for for ALL ALL
projectsprojects
Forms Required for All Forms Required for All ProjectsProjects
1 1 Checklist for Adult SponsorChecklist for Adult Sponsor
1A1A Student ChecklistStudent Checklist
1A 1A Research PlanResearch Plan
77 AbstractAbstract
1B1B Approval FormApproval Form
To be completed by Adult
Sponsor in collaboration with the student
researcher.
This form is required of
ALL projects; to
be completed by student researcher.
Part of Form 1A
A guideline explaining
components of Research Plan which
must be attached to
1A
Abstract to be completed
after experimentatio
n; one page, 250 words.
To be completed by student and parent.
If necessary, SRC and IRB are
completed here.
Adult Adult Roles and RRoles and Responsibilitiesesponsibilities
Adult SponsorAdult Sponsor Qualified ScientistQualified Scientist Designated SupervisorDesignated Supervisor Institutional Review Board (IRB)Institutional Review Board (IRB) Scientific Review Committee Scientific Review Committee
(SRC)(SRC)
Adult Adult SponsorSponsor Oversees projectOversees project
Completes Form 1 – Checklist Completes Form 1 – Checklist for Adult Sponsorfor Adult Sponsor
Parents DO NOT sign this formParents DO NOT sign this form
Required for Required for somesome projects projects QS must have a Doctoral QS must have a Doctoral
professional degree related to professional degree related to student researchstudent research
Master’s degree with SRC Master’s degree with SRC approvalapproval
Completes Form 2 – QS FormCompletes Form 2 – QS Form
Qualified ScientistQualified Scientist
Designated SupervisorDesignated Supervisor
Animal Care Supervisor for Animal Care Supervisor for vertebrate animal projectsvertebrate animal projects
Supervises projects involving Supervises projects involving hazardous chemicals, activities or hazardous chemicals, activities or devicesdevices
Supervises projects requiring a Supervises projects requiring a Qualified Scientist when the Qualified Scientist when the Qualified Scientist cannot directly Qualified Scientist cannot directly supervise the studentsupervise the student
When applicable,
the DS signs the
Risk Assessment
Form 3
Studies conducted at Studies conducted at a research institution, a research institution, industrial setting or industrial setting or any work site other any work site other
than home, school or than home, school or field require Form 1Cfield require Form 1C
Project based on prior research in Project based on prior research in the same field of studythe same field of study
Longitudinal studies are Longitudinal studies are permittedpermitted Multi-year studyMulti-year study Studies time-based changeStudies time-based change
Require form 7Require form 7
Continuation ProjectsContinuation Projects
HUMAN SUBJECTSHUMAN SUBJECTS
What are human subjects What are human subjects studies?studies?
Human Subjects studies involve Human Subjects studies involve living individuals where there is:living individuals where there is:
Intervention or interaction with Intervention or interaction with subjectssubjects
and/orand/or Collection of identifiable private Collection of identifiable private
informationinformation
ExemptExempt Studies Studiesdo not require IRB review nor do not require IRB review nor
human subjects formshuman subjects forms Product testing of a student Product testing of a student
invention, program, concept, etc.invention, program, concept, etc. No health hazardsNo health hazards No personal data collectedNo personal data collected Feedback directly related to Feedback directly related to
productproduct Studies using pre-existing, publicly Studies using pre-existing, publicly
available human dataavailable human data
Additional Exempt StudiesAdditional Exempt Studies
Behavioral observations in Behavioral observations in unrestricted public settingsunrestricted public settings No interactionNo interaction No manipulation of environmentNo manipulation of environment No recording of any personal No recording of any personal
identifiersidentifiers Studies using certified de-Studies using certified de-
identified/ anonymous dataidentified/ anonymous data
Human Human Subjects Subjects ResearchResearch
The IRB must review and approve The IRB must review and approve the research plan the research plan before before experimentation beginsexperimentation begins
Research subjects 18 years of Research subjects 18 years of age or older must give informed age or older must give informed consentconsent
Research subjects under 18 must Research subjects under 18 must give assent and their parents give assent and their parents may be required to give may be required to give permissionpermission
Human Human Subjects ResearchSubjects Research
The IRB evaluates the project and The IRB evaluates the project and determinesdetermines Risk levelRisk level Requirement for Qualified ScientistRequirement for Qualified Scientist Requirement for written informed Requirement for written informed
consent/assent/parental permissionconsent/assent/parental permission
Risk EvaluationRisk Evaluation
No more than minimal riskNo more than minimal riskAnticipated harm and discomfort notAnticipated harm and discomfort notgreater than encountered in daily lifegreater than encountered in daily life
More than minimal riskMore than minimal riskAnticipated harm or discomfort isAnticipated harm or discomfort isgreater than encountered in daily lifegreater than encountered in daily life
More than minimal risk studies should More than minimal risk studies should require require writtenwritten consent/assent and consent/assent and parental permission. Final parental permission. Final determination for this requirement determination for this requirement made by the IRBmade by the IRB
Types of RiskTypes of Risk
Physical risksPhysical risks ExerciseExercise Ingestion, tasting, smelling, application of Ingestion, tasting, smelling, application of
substancessubstances Exposure to potentially hazardous materialExposure to potentially hazardous material
Psychological risksPsychological risks Invasion of privacyInvasion of privacy Subject member of an at-risk Subject member of an at-risk
groupgroup
IRB can waive requirement IRB can waive requirement of written informed consent of written informed consent
ifif study is of minimal risk study is of minimal risk
andand data collection is anonymousdata collection is anonymous
andand one of the followingone of the following
Study of normal educational practicesStudy of normal educational practices Behavioral study with no manipulationBehavioral study with no manipulation Surveys of perception, cognition, game theorySurveys of perception, cognition, game theory Physical activity with no more than minimal risk Physical activity with no more than minimal risk
(routine physical activities, tasting of commonly (routine physical activities, tasting of commonly available food or drink, etc.)available food or drink, etc.)
IRB decisions are documented on IRB decisions are documented on Human Subjects Form 4Human Subjects Form 4
Must be completed prior to Must be completed prior to experimentation.experimentation.
Written informed consent is obtained from the research
subject on a form like the sample provided
Each research subject is required to sign the Informed Consent Form
All Forms must be present at all fairs.
VERTEBRATE ANIMALSVERTEBRATE ANIMALS
What is a vertebrate What is a vertebrate animal?animal?
Live, nonhuman vertebrate Live, nonhuman vertebrate mammalian embryos or fetusesmammalian embryos or fetuses
Bird and reptile eggs within 3 Bird and reptile eggs within 3 days of hatchingdays of hatching
All other nonhuman vertebrates All other nonhuman vertebrates (including fish) at hatching or (including fish) at hatching or birthbirth
Prohibited studiesProhibited studies Induced toxicity studies involving a Induced toxicity studies involving a
poison or toxin that could impair poison or toxin that could impair health or destroy lifehealth or destroy life
Behavioral experiments withBehavioral experiments with Operant conditioning with aversive stimuliOperant conditioning with aversive stimuli Mother/infant separationMother/infant separation Induced/learned helplessnessInduced/learned helplessness
Studies of painStudies of pain Predator/vertebrate prey Predator/vertebrate prey
experimentsexperiments
Additional restrictionsAdditional restrictions
A weight loss or growth A weight loss or growth retardation greater than 15% is retardation greater than 15% is not permittednot permitted
A death rate of 30% or greater in A death rate of 30% or greater in any group or subgroup is not any group or subgroup is not permittedpermitted
Behavioral observations of Behavioral observations of animals are exempt from SRC animals are exempt from SRC
review ifreview if There is no interaction with the There is no interaction with the
animals animals andand
There is no manipulation of the There is no manipulation of the environmentenvironment
andand All federal or state fish, game and All federal or state fish, game and
wildlife regulations are followedwildlife regulations are followed
Research SitesResearch Sites
Examples of Examples of non-regulated non-regulated sitessites HomeHome SchoolSchool Farm, ranchFarm, ranch Zoological parksZoological parks Field Field
Examples of Examples of regulated sitesregulated sites ((mustmust have an IACUC have an IACUC review and approval review and approval process)process) UniversitiesUniversities Government Government
research research agenciesagencies
Private research Private research laboratorieslaboratories
Requirements for studies at Requirements for studies at non-regulated sites non-regulated sites
Agricultural, behavioral, observational or Agricultural, behavioral, observational or supplemental nutritional studiessupplemental nutritional studies
andand
Non-invasive and non-intrusive with no Non-invasive and non-intrusive with no negative effect on animal’s health or well-negative effect on animal’s health or well-beingbeing
andand
Require SRC pre-review and approvalRequire SRC pre-review and approval
Additional requirements for Additional requirements for non-regulated sitesnon-regulated sites
SRC determines level of SRC determines level of supervision appropriate for the supervision appropriate for the study:study: Designated supervisorDesignated supervisor VeterinarianVeterinarian Qualified scientistQualified scientist
Form 5A requiredForm 5A required
Requirements for studies at Requirements for studies at regulated sitesregulated sites
Must be approved by IACUC Must be approved by IACUC (Institutional Animal Care and Use (Institutional Animal Care and Use Committee)Committee)
Local SRC should review project before Local SRC should review project before experimentationexperimentation
Experimentation must follow ISEF Experimentation must follow ISEF guidelines and adhere to restrictions guidelines and adhere to restrictions regarding painregarding pain
QS completes Form 5B which includes QS completes Form 5B which includes documentation of IACUC approvaldocumentation of IACUC approval
POTENTIALLY HAZARDOUS POTENTIALLY HAZARDOUS BIOLOGICAL AGENTSBIOLOGICAL AGENTS
Potentially hazardous Potentially hazardous biological agents includebiological agents include Microorganisms (including Microorganisms (including
bacteria, viruses, fungi, etc.)bacteria, viruses, fungi, etc.) Recombinant DNARecombinant DNA Human or animal fresh/frozen Human or animal fresh/frozen
tissues, blood or body fluidstissues, blood or body fluids
All studies involving All studies involving potentially hazardous potentially hazardous
biological agentsbiological agents Must have prior approval by Must have prior approval by
SRC/IACUCSRC/IACUC Most studies are prohibited in a Most studies are prohibited in a
home environmenthome environment Studies intended to genetically Studies intended to genetically
engineer bacteria with multiple engineer bacteria with multiple antibiotic resistance are antibiotic resistance are prohibitedprohibited
Risk assessmentRisk assessment Required of all PHBA projects Required of all PHBA projects Defines potential level of harm, Defines potential level of harm,
injury or disease to plants, injury or disease to plants, animals or humansanimals or humans
InvolvesInvolves Assignment of biological agent to Assignment of biological agent to
risk grouprisk group Determination of level of biological Determination of level of biological
containmentcontainment Assessment of expertise of adult(s)Assessment of expertise of adult(s) Assignment of final biosafety levelAssignment of final biosafety level
Risk assessment, cont’dRisk assessment, cont’d
BSL 1 studies can usually be conducted BSL 1 studies can usually be conducted in a high school or college teaching in a high school or college teaching laboratory.laboratory.
BSL 2 studies are usually conducted in a BSL 2 studies are usually conducted in a regulated research institutionregulated research institution
BSL 3 and BSL 4 studies are prohibited BSL 3 and BSL 4 studies are prohibited for ISEF projectsfor ISEF projects
Form 6A (Potentially Hazardous Form 6A (Potentially Hazardous Biological Agents form) required for most Biological Agents form) required for most projects involving microorganisms, and projects involving microorganisms, and for all projects involving rDNA and fresh for all projects involving rDNA and fresh human and vertebrate animal tissueshuman and vertebrate animal tissues
Studies exempt from prior Studies exempt from prior SRC review and no SRC review and no
additional PHBA forms additional PHBA forms requiredrequired
Studies using baker’s and brewer’s Studies using baker’s and brewer’s yeast (except rDNA studies)yeast (except rDNA studies)
Studies using Lactobacillus, B. Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and oil-eating bacteria, slime mold and algae-eating bacteria in natural algae-eating bacteria in natural environment. No exempt if cultured environment. No exempt if cultured in a petri dish environment.in a petri dish environment.
Studies exempt from prior Studies exempt from prior SRC review that require SRC review that require
Form 3Form 3 Studies involving protists, archae Studies involving protists, archae
and similar microorganismsand similar microorganisms Research using manure for Research using manure for
composting, fuel production, or composting, fuel production, or other non-culturing experiments other non-culturing experiments
Studies using commercially Studies using commercially available color change coliform available color change coliform water test kits water test kits
Studies Involving Unknown Studies Involving Unknown MicroorganismsMicroorganisms
BSL 1 ifBSL 1 if Organisms cultured in plastic petri Organisms cultured in plastic petri
dishdish Culture dish remains sealed Culture dish remains sealed
throughout experimentthroughout experiment Culture dish disposed of in Culture dish disposed of in
appropriate mannerappropriate manner BSL 2 if petri dish is openedBSL 2 if petri dish is opened
rDNA technologiesrDNA technologies
Experiments with Experiments with BSL 1BSL 1 organisms can be done in BSL 1 organisms can be done in BSL 1 lab with a QS or trained DSlab with a QS or trained DS
Experiments with Experiments with BSL 2BSL 2 organisms must be done in a organisms must be done in a regulated research institution regulated research institution with a QSwith a QS
TissuesTissues
If animal is euthanized solely for If animal is euthanized solely for student project – vertebrate student project – vertebrate animal study which requires animal study which requires IACUC approvalIACUC approval
If animal is euthanized for a If animal is euthanized for a purpose other than student purpose other than student project – tissue studyproject – tissue study
Classification as BSL 1 or 2 based Classification as BSL 1 or 2 based on source of tissue and possibility on source of tissue and possibility of containing infectious agentsof containing infectious agents
All studies with human or wild All studies with human or wild animal blood are BSL 2. Studies animal blood are BSL 2. Studies with domestic animal blood are with domestic animal blood are BSL 1.BSL 1.
Studies with human body fluids Studies with human body fluids which can be associated with a which can be associated with a person must have IRB approvalperson must have IRB approval
TissuesTissues
Plant tissuesPlant tissues Established cell and tissue Established cell and tissue
culturescultures Meat and meat by-products – Meat and meat by-products –
grocery stores, restaurants, grocery stores, restaurants, packing housespacking houses
HairHair Sterilized teethSterilized teeth Fossilized tissue/archeological Fossilized tissue/archeological
specimens specimens Prepared fixed tissue slidesPrepared fixed tissue slides
Exempt as PHBA tissuesExempt as PHBA tissuesPotentially Hazardous Biological AgentsPotentially Hazardous Biological Agents
Form 6BForm 6B
Required for all projects using Required for all projects using Fresh/frozen tissueFresh/frozen tissue Primary cell culturesPrimary cell cultures Blood and blood productsBlood and blood products Body fluidsBody fluids
HAZARDOUS CHEMICALS, HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICESACTIVITIES OR DEVICES
Hazardous chemicals, Hazardous chemicals, activities or devices includeactivities or devices include
ChemicalsChemicals EquipmentEquipment DEA-Controlled SubstancesDEA-Controlled Substances Prescription DrugsPrescription Drugs Alcohol and TobaccoAlcohol and Tobacco Firearms and ExplosivesFirearms and Explosives RadiationRadiation
General RulesGeneral Rules
Studies do not require prior SRC Studies do not require prior SRC review and approvalreview and approval
All studies require a Risk All studies require a Risk Assessment documented on Form Assessment documented on Form 33
DEA - controlled substances DEA - controlled substances require a Qualified Scientistrequire a Qualified Scientist
All other studies require a All other studies require a Designated SupervisorDesignated Supervisor
DEA-Controlled SubstancesDEA-Controlled Substances Consult DEA list of controlled substancesConsult DEA list of controlled substances All studies require Qualified ScientistAll studies require Qualified Scientist Controlled substances on Schedule 1 Controlled substances on Schedule 1
require DEA protocol review require DEA protocol review
Firearms and ExplosivesFirearms and Explosives Must adhere to local training and Must adhere to local training and
certification requirements certification requirements
Must follow local laws for purchase, Must follow local laws for purchase, possession and consumptionpossession and consumption
Home production of ethyl alcohol Home production of ethyl alcohol (wine or beer) must follow U.S. (wine or beer) must follow U.S. Alcohol and Tobacco Tax and Trade Alcohol and Tobacco Tax and Trade Bureau (TTB) regulationsBureau (TTB) regulations
Alcohol distillation for fuel production Alcohol distillation for fuel production can be conducted at school with TTB can be conducted at school with TTB permit obtained by school officialspermit obtained by school officials
Alcohol and TobaccoAlcohol and Tobacco
Prescription DrugsPrescription Drugs Cannot be administered to human Cannot be administered to human
subjectssubjects Animal administration must follow Animal administration must follow
ISEF vertebrate animal guidelinesISEF vertebrate animal guidelines
Hazardous ChemicalsHazardous Chemicals Refer to MSDS Sheets for safety and Refer to MSDS Sheets for safety and
handling guidelineshandling guidelines
Hazardous DevicesHazardous Devices Involve level of risk beyond that Involve level of risk beyond that
encountered in student’s everyday encountered in student’s everyday lifelife
RadiationRadiation Non-ionizingNon-ionizing IonizingIonizing
Form 3Form 3
Required for all projects involvingRequired for all projects involving DEA-Controlled SubstancesDEA-Controlled Substances Prescription DrugsPrescription Drugs Alcohol and TobaccoAlcohol and Tobacco Hazardous ChemicalsHazardous Chemicals Hazardous DevicesHazardous Devices Hazardous ActivitiesHazardous Activities RadiationRadiation