1. 2012 Coriell Science Fair Guide For Successful Completion Of ISEF Forms (And Getting Approval Without Correction And Resubmission) (Revision B-092311)

2. Download the Forms and Rules From Coriell’s web page: http://www.coriell.org/education/science-fair/http://www.coriell.org/education/science-fair/ download all of the following “2012” documents 1 : Coriell Student Guide for Basic Fair Information & Project Elements Coriell Guide for Successful Completion of ISEF Forms 2 Coriell Student Contact Information form 3 (The contact form is Absolutely Required, and only on Coriell web) ISEF Forms 4 ISEF Rules 4 ISEF Rule Change Summary 4 ISEF Student Handbook 4 1Do not use the 2011 ISEF forms 2For more help with forms, use the on-line Intel ISEF Forms Wizard: http://apps.societyforscience.org/isef/students/wizard/index.asp 3Absolutely Required, and only downloadable from the Coriell web 4Downloadable from both the Coriell and the ISEF web: http://www.societyforscience.org/isef/documenthttp://www.societyforscience.org/isef/document

3. Coriell Student Contact Information Form Coriell will not approve your project if this form is not submitted with the ISEF forms*. This form is needed because: DVSF requires us to provide them with student home addresses, emails, phones, genders, and ages (including all team members). ISEF forms do not have fields for gender and age and do not have fields for student addresses unless the project is done in the home. *This form is now separate and no longer imbedded in the Coriell ISEF forms, and must be downloaded separately, but still submitted with the ISEF forms. ** The top of this form also has information on deadlines **

4. Forms Required for ALL Projects And Requirements for Pre-Approval Signatures Coriell Student Contact Information Form – Information required by Coriell and DVSF Checklist for Adult Sponsor (1) – Signature verifying adult sponsor (A.S.) review of project and student paperwork A.S. signature may be an after-the-fact acknowledgement of SRC/IRB/Qualified Scientist or Designated Supervisor pre-approvals on other forms, but should be within two weeks of the actual start date on Student Checklist form 1A – Instructs students if additional risk forms and special approvals are needed – Provides contact information for the adult sponsor Student Checklist (1A) – Identifies students, team members, where work is to be done – Provides actual start date Actual start date must be AFTER approval signatures on forms 1B, and if needed on forms 1C, 2, 3, 4, 5A, 5B, 6A,& 6B Research Plan – Describes what student plans to do and how student plans to do it – Is the basis for determining if additional forms and approvals are required before starting – Follows the ISEF guidelines on “Research Plan Instructions” in the ISEF forms package Approval Form (1B) – Signatures documenting parental approval (Line 1B) Parent approval signature date must come BEFORE “Actual Start Date” on Student Checklist form 1A) – Signatures of Coriell SRC documenting review and approval or acknowledgement of review and approval by a regulated institute or school IRB (Boxes 2a or 2b) If Coriell SRC or IRB signature in 2A is required, it must be BEFORE “Actual Start Date” on Student Checklist form 1A) Coriell signature in 2B may an after-the-fact acknowledgement of a regulated institute SRC/IRB approval – Signatures of DVSF documenting review and approval for projects advancing to DVSF (Box 3)

5. Supervision Requirements for Studies Involving Biological, Physical, & Chemical Risks, Human Participants, & Animals And Documentation on Forms Project TypeForm 2 PLUS FrequencyWho decides if a QS or DS is needed, and which ? (If a QS/DS is needed – research can’t begin without one.) Risks (General)Form 3Fairly OftenCoriell SRC (Usually only a designated supervisor) Human Participants Form 4RareOnly if IRB determines it needed to protect subjects Vertebrates at Non-regulated Inst. Form 5A OftenOnly if the Coriell SRC determines it necessary Vertebrates at Regulated Inst. Form 5B ALWAYS QS or DS Coriell or Regulated Institute SRC decides if a Designated Supervisor is sufficient or a Qualified Scientist is required. Coriell & RI-SRC must agree. Hazardous Bio-Agents Form 6A ALWAYS QS or DS Coriell or Regulated Institute SRC decides if a Designated Supervisor is sufficient or a Qualified Scientist is required. Coriell & RI-SRC must agree. TissueForm 6B Almost Always QS or DS Coriell or Regulated Institute SRC decides if a Designated Supervisor is sufficient or a Qualified Scientist is required, or if project is exempt. e.g. “Tissue” from grocery store is exempt

6. Additional Forms for Risk Projects-1 And Requirements for Pre-Approval Signatures Qualified Scientist Form 2 (See ISEF Rules Pg 5) – A qualified scientist (QS) with an advanced degree, or a trained designated supervisor (DS) may be required by the Scientific Review Committee (SRC) if the project involves significant physical, chemical, or biological risks, controlled drugs, or animals, or for some types of human subjects projects. See ISEF rules page 5. – The QS/DS may not be a member of the SRC/IRB that determines the need for a QS/DS – The QS/DS signature(s) on Form 2 must be BEFORE the actual state date on the Student Checklist form 1A – The QS/DS may also be required to sign forms 3, 5A, 5B, 6A, and 6B before the actual start date on 1A Risk Assessment Form 3 (See ISEF Rules Pg 9, 13 & 17-19) – Required when hazardous chemicals, devices or activities are involved (as determined from the Research Plan) – Form 3 is NOT REQUIRED for studies on human participants: Use form 4 and Informed Consent (ISEF Rules Pg 7-9) But Form 3 is REQUIRED when the humans performing the experiment are at risk – Risk projects require direct supervision of a Designated Supervisor (DS) or Qualified Scientist (QS) – Form 3 IS REQUIRED for non-pathogenic non-exempt micro-organisms that are NOT GROWN on CULTURE MEDIA Protists, Archaea, Compost Manure, Sealed coliform test kits Mold growth on FOOD that is terminated on first evidence of growth – Form 3 and a DS/QS are NOT REQUIRED for exempt organisms that are NOT GROWN on CULTURE MEDIA Exempt: Lactobacillus, Bacillus thurgensis, algae-eating bacteria, slime mold, nitrogen-fixing bacteria, oil-eating bacteria – Form 6A (not 3) and a QS/DS (Form 2) is REQUIRED if ANY* organisms ARE GROWN on CULTURE MEDIA Because culture media is subject in accidental pathogen contamination (*ANY means either exempt or non-exempt organisms) – Signature of DS or QS on Form 3 must come BEFORE “Actual Start Date” on Student Checklist form 1A – Form 3 is not acceptable for pathogenic organism or sources of potential pathogens: Use forms 5A, 5B, 6A, 6B

7. Additional Forms for Risk Projects-2 And Requirements for Pre-Approval Signatures Potentially Hazardous Biological Agents Form 6A (See ISEF Rules Pg 13-14 & 25) – Required for use of microorganisms excluding non-cultured exempt microorganisms (see form 3 rules) – Required for use of rDNA – Required for human or animal fresh or frozen tissue, blood or body fluids (Form 6B also required for these) – Not required for use of tissue purchased in a grocery store (food tissue) unless grown on culture media – Requires direct supervision of a Qualified Scientist or Designated Supervisor, and Form 2. – The QS/DS signature(s) on Form 6A must be BEFORE the actual state date on the Student Checklist form 1A – Requires SRC approval on Form 6A must be BEFORE the actual state date on the Student Checklist form 1A – The SRC must determine and specify the appropriate BioSafety Level on form 6A BSL-1 & BSL-2 General Guide Culture media inoculated with environmental swabs, but not incubated in the home and sealed immediately Culture media may be inoculated with non-pathogenic microorganisms in the school under DS supervision Sealed inoculated cultures of non-pathogens may be incubated in a school, but never opened unless to add bleach If culture media is opened after inoculation and incubation, work must be done in a regulated BSL-2 lab If known pathogens are used, work must be done in a regulated BSL-2 lab under QS/DS supervision Work with MRSA and VRE are now permitted in a regulated institute BSL-2 lab under QS supervision Human and Vertebrate Animal Tissue Form 6B (See ISEF Rules Pg 13-15 & 7-8 ) – Required for human or animal fresh or frozen tissue, blood or body fluids (Form 6A is also required) – Form 5A or 5B may be required for animal tissue, and form 4 may be required for human tissue – Not required for use of tissue purchased in a grocery store (food tissue) unless grown on culture media – Requires Blood Borne pathogen training in accordance with 29 CFR Subpart Z 1910.1030 – The QS/DS signature(s) on Form 6B must be BEFORE the actual state date on the Student Checklist form 1A – Exception: Self sampling of human blood and testing with a glucometer may be done in the home

8. Additional Forms for Risk Projects-3 And Requirements for Pre-Approval Signatures Vertebrate Animal Form 5A (For work at home, school, or in the field) (See ISEF Rules Pg 13-14 & 25) – Exempt studies (from SRC approval, form 5A and Form 5B) »Livestock using only standard agricultural practices »Capture and release of fish »Strictly observational studies (e.g. Observation at a zoo without interaction) »Fertilized zebrafish embryos less than 7 days after fertilization – Animal research done at these locations must not involve Interaction, Invasiveness, or Intrusion – Research that involves Interaction, Invasiveness, or intrusion must be done at a regulated institute (Form 5B) – Requires direct supervision of a Veterinarian or Designated Supervisor, and Form 2. – The SRC will determine if which of the following are required »Designated Supervisor »Veterinarian and Designated Supervisor »Veterinarian, Qualified Scientist and Designated Supervisor – The QS/DS/Vet signature(s) on Forms 5A/2 must be BEFORE the actual state date on Student Checklist form 1A – Required SRC approval on Form 5A must be BEFORE the actual state date on the Student Checklist form 1A Vertebrate Animal Form 5B (For work at a Regulated Institute) (See ISEF Rules Pg 10-12) – For animal research involving Interaction, Invasiveness, or Intrusion that must be done at a regulated institute »Includes vertebrate eggs/embryos within 3 days before hatching, and zebrafish more than 7 days after fertilization – Prohibited Studies: Toxic substances, pain study, adverse stimuli conditioning, predator/prey, weight loss > 15%, Studies designed to cause death as distinguished from humane euthanasia. Euthanasia for sole purposes of the student project is prohibited (ISEF Rules Pg 10) – Requires QS/ Principal Investigator signature(s) on Forms 5B/2 BEFORE the actual state date Form1A – Requires documentation of IACUC approval BEFORE the actual state date on the Student Checklist form 1A

9. Additional Forms for Risk Projects-4 And Requirements for Pre-Approval Signatures Human Participants Form 4 (See ISEF Rules Pg 7-9) – Form 4 is Required when human participants are the subject of the research »Use Form 3 Risk Assessment when humans doing the experiment are at risk, but are not subjects of the experiment – Form 4 is Required when human participants are at more than minimal risk (ISEF Rules Pg 9) »Risk: When probability of harm or discomfort may exceed that in ordinary daily life in routine activity Physical Risks: Exercise, Ingestion, tasting, smelling, application of substances, exposure to hazardous materials Psychological Risks: Emotional stress, depression, low self esteem, anxiety, viewing violent of distressing material Privacy Risks: Invasion of privacy, breach of confidentiality, disclosure of non-anonymous data to the public Protected Groups: Lack of protection of mentally disabled, pregnant women, physically ill, economically disadvantaged – Institutional Review Board for Human Subjects Research (IRB) »Option 1: Your School – an administrator, a health professional, an educator other than the adult sponsor »Option 2: Coriell will serve as your IRB upon request – IRB signatures are REQUIRED on Form 4 to document decisions about consent/assent if risk is more than minimal »Recommendation: Obtain IRB review for almost everything »Recommendation: Do informed consent/assent for almost everything »Note: The Coriell SRC/IRB may over-rule school IRB decisions if we feel that the participants rights are not protected – IRB signatures on Forms 4 & 1B (box 2A) must be BEFORE the actual state date on the Student Checklist form 1A Informed Consent/Minor Assent (See ISEF Rules Pg 7-9 & ISEF Forms Pg 36) – You may use the Human Informed Consent Form on Pg 36 as your Consent/Assent form or use your organization’s form – When submitting paperwork to Coriell for approval or acknowledgement of previous regulated institute approval »Include one example consent form with the top information completed and participant identifiers on the bottom blank »Do NOT include fully completed consents with materials submitted to Coriell for review – it violates HIPAA »Have fully completed consents available at the Science Fair to produce upon request as evidence consent was done

10. Other Additional Forms Regulated Research Institute/Industrial Setting Form 1C – Form 1C must be filled out by: » Designated Supervisor or Qualified Scientist, or other Supervisor at setting »It is not filled out by the student – Submit to Coriell after the work is completed »This form does not require pre-review, but »This form must be attached to the paperwork Coriell forwards to DVSF – Attach a copy of Form 1C to Poster for Judges to see Continuing Projects Form 7 – Submit with pre-review paperwork if a project is a continuance of previous work – Previous year(s)’ Research Plan(s) and Abstract(s) must also be submitted

11. Pre-Approvals Summary (Required Signatures BEFORE Work Can Begin & BEFORE Actual Start Date on Form 1A) Adult Sponsor signature verifying pre-review of project (Form 1) Approval Form 1B – Student Signature, Parent Signature, – Coriell SRC and Coriell or School IRB Signatures if required (i.e. if risks, humans, or animals are involved) Qualified Scientist &/or Designated Supervisor signature on Form 2 – Only if project involves risks (forms 3 or 6), human subjects (form 4), or animals (form 5) Qualified Scientist &/or Designated Supervisor signature on Form 3 – If project involves hazardous chemicals, devices, activities, or non-cultured microorganisms Institutional Review Board signatures on Form 4 for human subjects projects – Medical professional, School Administrator, Educator other than your adult sponsor on form 1 OR – Coriell IRB if you choose to have Coriell serve as your IRB instead of school personnel Adult Participant or Parent Guardian signatures on Informed Consent Form – Do not submit signed consents to Coriell. Keep them for proof of consent only upon Fair request – Submit only an example blank Consent Form with the signature areas blank to protect participant privacy Coriell SRC signature on Form 5A for vertebrate animals research at home/school – Veterinarian and Designated Supervisor signatures if Coriell SRC indicated they are required on Form 5A Qualified Scientist/P.I. and IACUC Chair signatures on Form 5B – For animal work done at a regulated Institute – A letter from the QS/PI is not sufficient, IACUC letter required Qualified Scientist or Designated Supervisor & Coriell SRC signatures on Form 6A – For research involving potential sources of bio-hazardous materials (including culture of “exempt” microbes Qualified Scientist or Designated Supervisor signature on Form 6B – For research involving human or animal tissue (except for food-tissue purchased in a grocery store) Student signature for continuing projects on Form 7 Adult Sponsor signature on Regulated Institute Form 1C but AFTER work is done

12. Common Errors Which Will Cause Coriell’s SRC to Disapprove Your Project or Require Correction and Resubmission - 1 We recommend you print out a copy of the ISEF forms and consult them while reading these slides Missing Documents – Coriell Student Contact Info Form – Basic all project Forms 1, 1A, 1B or research plan – Submitting the ISEF Research Plan Instructions instead of a Research Plan – Additional required risk, human participant, or animal forms ( Forms 3,4,5A, 5B, 6A, 6B, Informed Consent) – Submitting an Abstract instead of a Research Plan for pre-review – Form 5 if vertebrate egg/embryo is used within 3 days of hatching/zebrafish 7 days after fertilization Missing / Incorrect Approvals – Signatures missing (See previous slide on pre-approval summary) – Missing copy of a Regulated Institute IACUC (Animal Comm.) approval letter – Adult sponsor signed as “educator” on IRB Form 4 instead of a teacher without conflict of interest – Regulated Institute documentation of student training in vertebrate animals on Form 5B – School SRC signed Form 1B Box 2a where Coriell signature is required (School IRB signature for human subjects is OK) – School assigned bio-safety level on Form 6A that Coriell or a regulated institute SRC should sign Missing Required Information on Forms: Common Examples: – Adult sponsor did not check risk boxes on Form 1A – Qualified Scientist/Designated Supervisor did not check boxes on Form 2 – IRB signed but did not check boxes for type of consent required on Form 4 i.e. Getting school signatures on Form 4 without the school IRB actually doing a review – Abstract or Research Plan for previous year’s research on a continuing project, Form 7

13. Common Errors Which Will Cause Coriell’s SRC to Disapprove Your Project or Require Correction and Resubmission – 2 Be conservative to protect yourself and others – When in doubt, fill it out! Cutting corners, trying to avoid paperwork, avoiding getting approvals, misinterpretations of rules & underestimating risks: Common examples – Your Research Plan has: – Things that could explode, corrode, burn, cut, blind, smash, electrocute, poison, etc. and you didn’t fill out Form 3 – Research Plan / Form 3 reference to risks with inadequate detail, e.g. “acid” without type and concentration – Culture of “exempt” (pathogenic contaminant risk) microbes and you filled out Form 3 instead of Form 6A or 6B – Things that could infect, and you did not fill out Form 6A or 6B – Opening a bacterial culture in a BSL-1 school other than for adding disinfectant (Requires Form 6A & BSL-2) – Use of pathogens in other than a BSL-2 facility (or use of any BSL-3 or 4 organism at all) – Use of human or animal tissue (Form 6B) and you did not also complete biohazard Form 6A. – Animal interaction, invasiveness or environment manipulation at school or home and your did not fill out Form 5A – Euthanasia of animals specifically for the student project (Form 5B) (ISEF rules Pg 10) – Vertebrate eggs use within 3 days of hatching without Form 5A or 5B – Alternatives to animal use were not explored (Replace, Reduce, Refine, Respect) – Prohibited animal studies: toxins, studies of pain, aversive response stimuli, predator-prey, weight loss > 15% – Human participant/subject activities and you did not obtain IRB review on Form 4 – Human activities involving more that minimal risk and your IRB did not require informed consent. e.g. Invasion of privacy or confidentiality, lack of special protections for naturally-at-risk groups, exercise, ingestion, tasting, smelling, application of a substance, viewing stimuli or answering questions that could result in emotional distress, depression, anxiety or low self-esteem (ISEF rules pg 9). The Coriell SRC/IRB will over-ride a school IRB decision if we feel consent/assent is required – Medical records were reviewed without having patient names removed

14. HELP, I’m Confused!!! Contact Gary Butler, Ph.D., Coriell Science Fair Director if you need assistance: (856) 757-9716 gbutler@coriell.org &/OR Visit the Coriell, DVSF and ISEF help sites: http://www.coriell.org/education/science-fair/ http://www.drexel.edu/dvsf/students.htm http://www.societyforscience.org/isef/rulesandguidelines

15. Basic Science Help for Students Please download and review the PowerPoint or pdf: 2012 Student Science Guide Student Guide for Basic Fair Information & Basic Project Elements posted on Coriell’s Web: http://www.coriell.org/education/science-fair/ for assisting students in doing science projects well and improving their judge scores and competitiveness