This completed form is required for ALL projects.

To be completed by the Adult Sponsor in collaboration with the student researcher(s): Students Name(s): Project Title: 1) o I have reviewed the Intel ISEF Rules and Guidelines. 2) o I have reviewed the students completed Student Checklist (1A) and Research Plan. 3) o I have worked with the student and we have discussed the possible risks involved in the project. 4) o The project involves one or more of the following and requires prior approval by an SRC, IRB, IACUC or IBC: o Humans Potentially Hazardous Biological Agents o Vertebrate Animals o Microorganisms o rDNA o Tissues 5) o Items to be completed for ALL PROJECTS o Adult Sponsor Checklist (1) o Student Checklist (1A)
o

Checklist for Adult Sponsor (1)

o Research Plan o Approval Form (1B)

Regulated Research Institutional/Industrial Setting Form (1C) (when applicable after completed experiment) Continuation/Research Progression Form (7) (when applicable)

6) Additional forms required if the project includes the use of one or more of the following (check all that apply): o Humans (Requires prior approval by an Institutional Review Board (IRB); see full text of the rules.) o Human Participants Form (4) or appropriate Institutional IRB documentation o Sample of Informed Consent Form (when applicable and/or required by the IRB) o Qualified Scientist Form (2) (when applicable and/or required by the IRB) o Vertebrate Animals (Requires prior approval, see full text of the rules.) o Vertebrate Animal Form (5A)for projects conducted in a school/home/field research site (SRC prior approval required.) o Vertebrate Animal Form (5B)for projects conducted at a Regulated Research Institution. (Institutional Animal Care and Use Committee (IACUC) approval required prior experimentation.) o Qualified Scientist Form (2) (Required for all vertebrate animal projects at a regulated research site or when applicable) o Potentially Hazardous Biological Agents (Requires prior approval by SRC, IACUC or Institutional Biosafety Committee (IBC), see full text of the rules.) o Potentially Hazardous Biological Agents Risk Assessment Form (6A) o Human and Vertebrate Animal Tissue Form (6B)to be completed in addition to Form 6A when project involves the use of fresh or frozen tissue, primary cell cultures, blood, blood products and body fluids. o Qualified Scientist Form (2) (when applicable) Note: Certain projects involving microorganisms are exempt from the PHBA review and form requirements. See the full text for details

o Hazardous Chemicals, Activities and Devices (No prior approval required, see full text of the rules.) o Risk Assessment Form (3) o Qualified Scientist Form (2) (required for projects involving DEA-controlled substances or when

applicable)

Adult Sponsors Printed Name

Signature

Date of Review

Phone Email
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This form is required for ALL projects.

Student Checklist (1A)

1) a. Student/Team Leader:

Grade:

Email: Phone: b. Team Member: 2) Title of Project: c. Team Member:

3) School: School Address:

School Phone:

4) Adult Sponsor: Phone/Email: 5) Is this a continuation/progression from a previous year? o Yes o No If Yes: a) Attach the previous years o Abstract and o Research Plan b) Explain how this project is new and different from previous years on o Continuation/Research Progression Form (7)

6) This years laboratory experiment/data collection: (must be stated (mm/dd/yy))

Start Date: (mm/dd/yy)

End Date: (mm/dd/yy)

7) Where will you conduct your experimentation? (check all that apply)

o Research Institution

o School

o Field

o Home

o Other: ________________________

8) List name and address of all non-school work site(s): Name: Address:

Phone: 9) Complete a Research Plan following the Research Plan instructions and attach to this form. 10) An abstract is required for all projects after experimentation.

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A complete research plan is required and must accompany Checklist for Student (1A)
Provide a typed research plan and attach to Student Checklist (1A). Please include your name on each page. The research plan for ALL projects is to include the following: A. Question or Problem being addressed B. Goals/Expected Outcomes/Hypotheses C. Description in detail of method or procedures (The following are important and key items that should be included when formulating ANY AND ALL research plans.) Procedures: Detail all procedures and experimental design to be used for data collection Risk and Safety: Identify any potential risks and safety precautions to be taken. Data Analysis: Describe the procedures you will use to analyze the data/results that answer research questions or hypotheses D. Bibliography: List at least five (5) major references (e.g. science journal articles, books, internet sites) from your literature review. If you plan to use vertebrate animals, one of these references must be an animal care reference. o Choose one style and use it consistently to reference the literature used in the research plan o Guidelines can be found in the Student Handbook

Research Plan Instructions

Items 14 below are subject-specific guidelines for additional items to be included in your research plan as applicable: 1. Human participants research: Participants. Describe who will participate in your study (age range, gender, racial/ethnic composition). Identify any vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged). Recruitment. Where will you find your participants? How will they be invited to participate? Methods. What will participants be asked to do? Will you use any surveys, questionnaires or tests? What is the frequency and length of time involved for each subject? Risk Assessment o Risks. What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to participants? How will you minimize the risks? o Benefits. List any benefits to society or each participant. Protection of Privacy. Will any identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected? Will data be confidential or anonymous? If anonymous, describe how the data will be collected anonymously. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will the data be stored? Who will have access to the data? What will you do with the data at the end of the study? Informed Consent Process. Describe how you will inform participants about the purpose of the study, what they will be asked to do, that their participation is voluntary and they have the right to stop at any time. 2. Vertebrate animal research: Briefly discuss potential ALTERNATIVES to vertebrate animal use and present a detailed justification for use of vertebrate animals Explain potential impact or contribution this research may have Detail all procedures to be used o Include methods used to minimize potential discomfort, distress, pain and injury to the animals during the course of experimentation o Detailed chemical concentrations and drug dosages Detail animal numbers, species, strain, sex, age, source, etc. o Include justification of the numbers planned for the research Describe housing and oversight of daily care Discuss disposition of the animals at the termination of the study 3. Potentially Hazardous Biological Agents: Describe Biosafety Level Assessment process and resultant BSL determination Give source of agent, source of specific cell line, etc. Detail safety precautions Discuss methods of disposal 4. Hazardous Chemicals, Activities & Devices: Describe Risk Assessment process and results Detail chemical concentrations and drug dosages Describe safety precautions and procedures to minimize risk Discuss methods of disposal
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A completed form is required for each student, including all team members.

Approval Form (1B)

1) To Be Completed by Student and Parent

a) Student Acknowledgment: I understand the risks and possible dangers to me of the proposed research plan. I have read the Intel ISEF Rules and Guidelines and will adhere to all International Rules when conducting this research. I have read and will abide by the following Ethics statement

Scientific fraud and misconduct are not condoned at any level of research or competition. Such practices include plagiarism, forgery, use or presentation of other researchers work as ones own, and fabrication of data. Fraudulent projects will fail to qualify for competition in affiliated fairs and the Intel ISEF.

Students Printed Name Signature Date Acknowledged (mm/dd/yy) (Must be prior to experimentation.) b) Parent/Guardian Approval: I have read and understand the risks and possible dangers involved in the Research Plan. I consent to my child participating in this research.

Parent/Guardians Printed Name Signature

Date Acknowledged (mm/dd/yy) (Must be prior to experimentation.)

2) To be completed by the local or affiliated Fair SRC

a) Required for projects that need prior SRC/IRB approval BEFORE experimentation (humans, vertebrates or potentially hazardous biological agents)

(Required for projects requiring prior SRC/IRB APPROVAL. Sign 2a or 2b as appropriate.)

b) Required for research conducted at all Regulated Research Institutions with no prior fair SRC/IRB approval. OR This project was conducted at a regulated research institution (not home or high school, etc.), was The SRC/IRB has carefully studied this projects Research reviewed and approved by the proper institutional Plan and all the required forms are included. My signature board before experimentation and complies with the indicates approval of the Research Plan before the Intel ISEF Rules. Attach (1C) and required institutional student begins experimentation. approvals (e.g. IACUC, IRB).
SRC/IRB Chairs Printed Name
Signature Date of Approval (mm/dd/yy)
(Must be prior to experimentation.)

SRC Chairs Printed Name

Signature Date of Approval (mm/dd/yy)

3) Final Intel ISEF Affiliated Fair SRC Approval

(Required for ALL Projects)

SRC Approval After Experimentation and Before Competition at Regional/State/National Fair I certify that this project adheres to the approved Research Plan and complies with all Intel ISEF Rules. Regional SRC Chairs Printed Name State/National SRC Chairs Printed Name
(where applicable)

Signature Signature

Date of Approval Date of Approval

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This form must be completed AFTER experimentation by the adult supervising the student research conducted in a regulated research institution, industrial setting or any work site other than home, school or field.

Regulated Research Institutional/Industrial Setting Form (1C)

This form MUST be displayed with your project; responses must be on the form.

Students Name(s) Title of Project To be completed by the Supervising Adult in the Setting (NOT the Student(s)) after experimentation:
(Responses must remain on the form as it is required to be displayed at students project booth.) The student(s) conducted research at my work site: a) o to use the equipment b) o to perform experiment(s)/conduct research

1) Is this research a subset of your work? 2) Have you reviewed the Intel ISEF rules relevant to this project?

o Yes o No o Yes o No

3) How did the student get the idea for her/his project? (e.g. Was the project assigned, picked from a list, an original student idea, etc.)

4) Did the student(s) work on the project as a part of a research group? o Yes o No If yes, how large was the group and what kind of research group was it (students, group of adult researchers, etc.)

5) What specific procedures or equipment did the student(s) actually use for the project? Please list and describe. (Do not list procedures student only observed.)

6) How independent or creative was the students/students work?

Student research projects dealing with human participants, vertebrate animals or potentially hazardous biological agents require review and approval by an institutional regulatory board (IRB/IACUC/IBC). Copy of approval(s) must be attached, if applicable.

Supervising Adults Printed Name

Signature

Title Date Signed (must be after experimentation)

Institution

Address Email/Phone

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May be required for research involving human participants, vertebrate animals, potentially hazardous biological agents, and DEA-controlled substances. Must be completed and signed before the start of student experimentation.

Qualified Scientist Form (2)

Students Name(s) Title of Project

To be completed by the Qualified Scientist:

Scientist Name: Educational Background: Experience/Training as relates to the students area of research: Degree(s):

Position: Institution: Address: Email/Phone: 1) Have you reviewed the Intel ISEF rules relevant to this project? 2) Will any of the following be used? a) Human participants b) Vertebrate animals c) Potentially hazardous biological agents (microorganisms, rDNA and tissues, including blood and blood products) d) DEA-controlled substances 3) Was this study a sub-set of a larger study? 4) Will you directly supervise the student? a) If no, who will directly supervise and serve as the Designated Supervisor? b) Experience/Training of the Designated Supervisor:

o Yes o Yes o Yes o Yes o Yes o Yes o Yes

o No o No o No o No o No o No o No

To be completed by the Qualified Scientist:

I certify that I have reviewed and approved the Research Plan prior to the start of the experimentation. If the student or Designated Supervisor is not trained in the necessary procedures, I will ensure her/his training. I will provide advice and supervision during the research. I have a working knowledge of the techniques to be used by the student in the Research Plan. I understand that a Designated Supervisor is required when the student is not conducting experimentation under my direct supervision.

To be completed by the Designated Supervisor when the Qualified Scientist cannot directly supervise.
I certify that I have reviewed the Research Plan and have been trained in the techniques to be used by this student, and I will provide direct supervision.

Designated Supervisors Printed Name

Qualified Scientists Printed Name Signature Date of Approval

Signature Phone Email

Date of Approval

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Required for projects using hazardous chemicals, activities or devices and microorganisms exempt from pre-approval. Must be completed before experimentation. Students Name(s) Title of Project To be completed by the Student Researcher(s) in collaboration with Designated Supervisor/Qualified Scientist: (All questions must be answered; additional page(s) may be attached.) 1. List/identify microorganisms exempt from pre-approval (see Potentially Hazardous Biological Agent rules), and all hazardous chemicals, activities, or devices that will be used.

Risk Assessment Form (3)

2. Identify and assess the risks involved in this project.

3. Describe the safety precautions and procedures that will be used to reduce the risks.

4. Describe the disposal procedures that will be used (when applicable).

5. List the source(s) of safety information.

To be completed and signed by the Designated Supervisor (or Qualified Scientist, when applicable):
I agree with the risk assessment and safety precautions and procedures described above. I certify that I have reviewed the Research Plan and will provide direct supervision.

Designated Supervisors Printed Name

Signature

Date of Review (mm/dd/yy)

Position & Institution

Phone or email contact information

Experience/Training as relates to the students area of research

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Required for all research involving human participants not at a Regulated Research Institution. If at a Regulated Research Institution, use institutional approval forms for documentation of prior review and approval. (IRB approval required before experimentation.)

Human Participants Form (4)

Students Name(s)

Title of Project

Adult Sponsor Contact Phone/Email Must be completed by Student Researcher(s) in collaboration with the Adult Sponsor/Designated Supervisor/Qualified Scientist: 1. o I have submitted my Research Plan which addresses ALL areas indicated in the Human Participants Section of the Research Plan Instructions. 2. o I have attached any surveys or questionnaires I will be using in my project. o Any published instrument(s) used was /were legally obtained. 3. o I have attached an informed consent that I would use if required by the IRB. Are you working with a Qualified Scientist? If yes, attach the Qualified Scientist Form 2 4. o Yes o No

Must be completed by Institutional Review Board (IRB) after review of the research plan. The submitted Research Plan must address all areas indicated on the Human Participants section of the Research Plan Instructions. Check one of the following: o Research project requires revisions and is NOT approved at this time. IRB will attach document indicating concerns and/or requested revisions. o Research project is Approved with the following conditions below: (All 5 must be answered) 1. Risk Level (check one) : o Minimal Risk o More than Minimal Risk 2. Qualified Scientist (QS) Required: o Yes o No 3. Written Minor Assent required for minor participants: o Yes o No o Not applicable (No minors in this study) 4. Written Parental Permission required for minor participants: o Yes o No o Not applicable (No minors in this study) 5. Written Informed Consent required for participants 18 years or older: o Yes o No o Not applicable (No participants 18 yrs or older in this study) IRB SIGNATURES (All 3 signatures required) None of these individuals may be the adult sponsor, designated supervisor, qualified scientist or related to (e.g., mother, father of) the student (conflict of interest). I attest that I have reviewed the students project and agree with the above IRB determinations.

Medical or Mental Health Professional (a psychologist, medical doctor, licensed social worker, licensed clinical professional
counselor, physicians assistant, or registered nurse) Printed Name Signature Degree/Professional License Date of Approval (Must be prior to experimentation.)

Educator
Printed Name Signature Degree Date of Approval (Must be prior to experimentation.)

School Administrator
Printed Name Signature Degree Date of Approval (Must be prior to experimentation.)

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Human Informed Consent Form

Instructions to the Student Researcher(s): An informed consent/assent/permission form should be developed in consultation with the Adult Sponsor, Designated Supervisor or Qualified Scientist. This form is used to provide information to the research participant (or parent/guardian) and to document written informed consent, minor assent, and/or parental permission. When written documentation is required, the researcher keeps the original, signed form. Students may use this sample form or may copy ALL elements of it into a new document. If the form is serving to document parental permission, a copy of any survey or questionnaire must be attached. Student Researcher(s): Title of Project: I am asking for your voluntary participation in my science fair project. Please read the following information about the project. If you would like to participate, please sign in the appropriate box below. Purpose of the project: If you participate, you will be asked to: Time required for participation: Potential Risks of Study: Benefits: How confidentiality will be maintained: If you have any questions about this study, feel free to contact: Adult Sponsor: __________________________ Phone/email: ____________________________________________ Voluntary Participation: Participation in this study is completely voluntary. If you decide not to participate there will not be any negative consequences. Please be aware that if you decide to participate, you may stop participating at any time and you may decide not to answer any specific question. By signing this form I am attesting that I have read and understand the information above and I freely give my consent/assent to participate or permission for my child to participate. Adult Informed Consent or Minor Assent Printed Name of Research Participant: Date Reviewed & Signed: Signature:

Parental/Guardian Permission (if applicable)

Date Reviewed & Signed:

Parent/Guardian Printed Name:

Signature:

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Required for all research involving vertebrate animals that is conducted in a school/home/field research site.

Vertebrate Animal Form (5A)

(SRC approval required before experimentation.) Students Name(s) Title of Project To be completed by Student Researcher:
1. Common name (or Genus, species) and number of animals used.

2. Describe completely the housing and husbandry to be provided. Include the cage/pen size, number of animals per cage, environment, bedding, type of food, frequency of food and water, how often animal is observed, etc.

3. What will happen to the animals after experimentation?

4. Attach a copy of wildlife licenses or approval forms, as applicable 5. The Intel ISEF Vertebrate Animal Rules require that any death, illness or unexpected weight loss be investigated and documented by a letter from the qualified scientist, designated supervisor or a veterinarian. If applicable, attach this letter with this form when submitting your paperwork to the SRC prior to competition.
To be completed by Local or Affiliate Fair Scientific Review Committee (SRC) BEFORE experimentation

Level of Supervision Required for agricultural, behavioral or nutritional studies:

o Designated Supervisor REQUIRED. Please have applicable person sign below. o Veterinarian and Designated Supervisor REQUIRED. Please have applicable persons sign below. o Veterinarian, Designated Supervisor and Qualified Scientist REQUIRED. Please have applicable persons sign below and have the
Qualified Scientist complete Form (2). The SRC has carefully reviewed this study and finds it is an appropriate study that may be conducted in a non-regulated research site.

Local or Affiliate Fair SRC Pre-Approval Signature:

SRC Chair Printed Name

Signature

Date of Approval (must be prior to experimentation) (mm/dd/yy)

To be completed by Veterinarian:

o I certify that I have reviewed this research and animal

husbandry with the student before the start of experimentation.

To be completed by Designated Supervisor or Qualified Scientist when applicable:

o I certify that I have reviewed this research and animal

o I certify that I have approved the use and dosages of

prescription drugs and/or nutritional supplements. care in case of illness or emergency.

husbandry with the student before the start of experimentation and I accept primary responsibility for the care and handling of the animals in this project.

o I certify that I will provide veterinary medical and nursing

Printed Name Email/Phone Signature
Date of Approval

o I certify that I will directly supervise the experiment.

Printed Name Email/Phone Signature

Date of Approval

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Required for all research involving vertebrate animals that is conducted in at a Regulated Research Institution.

Vertebrate Animal Form (5B)

(IACUC approval required before experimentation.) Students Name(s) Title of Project Title and Protocol Number of IACUC Approved Project To be completed by Qualified Scientist or Principal Investigator:
1. Species of animals used: Number of animals used:

2. Describe, in detail, the role of the student in this project: animal procedures and related equipment that were involved, oversight provided and safety precautions employed. (Attach extra pages if necessary.)

3. Was there any weight loss or death of any animal? If yes, attach a letter obtained from the qualified scientist, designated supervisor or a veterinarian documenting the situation and the results of the investigation.

4. Does the students project also involve the use of tissues? p No p Yes, Be sure to complete Forms 6A and 6B 5. What laboratory training, including dates, was provided to the student?

6. Attach a copy of the Regulated Research Institution IACUC Approval. A letter from the Qualified Scientist or Principal Investigator is not sufficient.

Qualified Scientist/Principal Investigator

Printed Name Signature Date

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Required for research involving microorganisms, rDNA, fresh/frozen tissue (including primary cell lines, human and other primate established cell lines and tissue cultures), blood, blood products and body fluids. SRC/IACUC/IBC approval required before experimentation.

Potentially Hazardous Biological Agents Risk Assessment Form (6A)

Students Name(s) Title of Project

To be completed by Student Researcher(s) in collaboration with Qualified Scientist/Designated Supervisor:
(All questions are applicable and must be answered; additional page(s) may be attached.)

1. Identify potentially hazardous biological agents to be used in this experiment. Include the source, quantity and the biosafety level risk group of each microorganism. 2. Describe the site of experimentation including the level of biological containment. 3. Describe the procedures that will be used to minimize risk. (personal protective equip., hood type, etc.) 4. What final biosafety level do you recommend for this project given the risk assessment you conducted? 5. Describe the method of disposal of all cultured materials and other potentially hazardous biological agents.

To be completed by Qualified Scientist or Designated Supervisor

1. What training will the student receive for this project? 2. Do you concur with the biosafety information and recommendation provided by the student researcher above? o Yes o No If no, please explain. 3. Experience/training of Designated Supervisor as it relates to the students area of research (if applicable)

QS/DS Printed Name

Signature

Date of Signature (mm/dd/yy)

To be completed by Local or Affiliate Fair SRC: (Check all that apply.)

o The SRC has carefully studied this projects Research Plan and the risk level assessment above prior to experimentation and approves this study as a BSL-1 study, which must be conducted at a BSL-1 or above laboratory. Date of SRC approval (prior to experimentation) _____________________ o The SRC has carefully studied this projects Research Plan and the risk level assessment above prior to experimentation and approves this study as a BSL-2 study, which must be conducted at a BSL-2 or above laboratory. Date of SRC approval (prior to experimentation) _____________________ o This project was conducted at a Research Institution and was reviewed and approved by the appropriate institutional board (e.g. IACUC, IBC) before experimentation at a BSL-1 or BSL-2 laboratory and complies with the Intel ISEF rules. The required institutional forms are attached. Date of SRC approval (after experimentation) _____________________ o The Research Institution where this study was conducted does not require approval for this type of study. The student has received proper training and the project complies with Intel ISEF rules. Attached is institutional documentation certifying the above. Date of SRC approval _________________________________________ Signature

SRC Chairs Printed Name

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Human and Vertebrate Animal Tissue Form (6B)

Required for research involving fresh/frozen tissue (including primary cell lines, human and other primate established cell lines and tissue cultures), blood, blood products and body fluids. If the research involves living organisms please ensure that the proper human or animal forms are completed. All projects using any tissue listed above must also complete Form 6A.

Students Name(s) Title of Project To be completed by Student Researcher(s):

1. What vertebrate animal tissue will be used in this study? Check all that apply. o Fresh or frozen tissue sample o Fresh organ or other body part o Blood o Body fluids o Primary cell/tissue cultures o Human or other primate established cell lines

2. Where will the above tissue(s) be obtained. If using an established cell line include source and catalog number.

3. If the tissue will be obtained from a vertebrate animal study conducted at a research institution attach a copy of the IACUC certification with the name of the research institution, the title of the study, the IACUC approval number and date of IACUC approval.

To be completed by the Qualified Scientist or Designated Supervisor:

o I verify that the student will work solely with organs, tissues, cultures or cells that will be supplied to him/her by myself or qualified personnel from the laboratory; and that if vertebrate animals were euthanized they were euthanized for a purpose other than the students research.

o I certify that the blood, blood products, tissues or body fluids in this project will be handled in accordance with the standards and guidance set forth in Occupational Safety and Health Act, 29CFR, Subpart Z, 1910.1030 - Blood Borne Pathogens.

AND/OR

Printed Name

Signature

Date of Approval
(Must be prior to experimentation.)

Title Phone/Email

Institution

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Required for projects that are a continuation/progression in the same field of study as a previous project. This form must be accompanied by the previous years abstract and Research Plan.

Continuation/Research Progression Projects Form (7)

Students Name(s) To be completed by Student Researcher:

List all components of the current project that make it new and different from previous research. The information must be on the form; use an additional form for 20102011 and earlier projects.

Components
1. Title

Current Research Project

Previous Research Project

20122013 20112012

2. Change in goal/purpose/ objective

20122013 20112012

3. Changes in methodology

20122013

20112012

4. Variables studied

20122013

20112012

5. Additional changes

20122013 20112012

Attached are: o 20122013 Abstract and Research Plan

o 20112012 Abstract

I hereby certify that the above information is correct and that the current year Abstract & Certification and project display board properly reflect work done only in the current year.

Students Printed Name(s)

Signature

Date of Signature

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