Darden College of Education Human Subjects Review Committee

Updated 8/21/2017

The Darden College of Education Human Subjects Review Committee is charged with reviewing all applications for exempt research that involve human subjects. Exempt research is defined by Federal law 45 CFR 46.101(b) which is intended to expedite research with human subjects that presents a minimal risk or presents no risk to participants. The material on this site is intended to provide college researchers, including students at all levels, with information that assists with preparing an application for exempt research.

For information regarding ODU’s policies for compliance when human subjects are involved in research studies, see the ODU web page at http://ww2.odu.edu/ao/research/compliance/humans.shtml.

Prior to submitting an Application for Exempt Research to the Darden College of Education Human Subjects Review Committee, researchers must determine that the research project is eligible for exempt status. See the Human Subjects Decision Tree to determine whether a Human Subject Research Review Application Form should be submitted to the ODU Institutional Research Board (IRB) or whether an Application Form for Exempt Research should be submitted to the Darden College of Education Human Subjects Review Committee. Also, see the possible exempt categories (categories 6.1, 6.2, 6.3, 6.4, or 6.6) listed on the Application for Exempt Research to determine whether the research project fits into one of the exempt categories. The Human Subjects Decision Tree and the Application for Exempt Research may be accessed at the following web page: http://ww2.odu.edu/ao/research/compliance/humans.shtml.

Review Committee Members

Dr. Jill Stefaniak , Chair jstefani@odu.edu Dr. Kristine Sunday (Teaching and Learning) ksunday@odu.eduDr. David Branch (Human Movement Sciences) dbranch@odu.eduDr. Narketta Sparkman-Key (Counseling and Human Services) nsparkma@odu.edu Dr. Cherng-Jyh Yen (Educational Foundations and Leadership) cyen@odu.edu Dr. Laura Chezan (Communication Disorders and Special Education) lchezan@odu.edu

DCOE Human Subjects Committee Review Process

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Applications for Exempt Research are considered as they are submitted throughout the calendar year (including summer term).

Throughout the process of review, correspondence from the committee chair is sent to the RPI with copies to the additional investigators associated with the research project who are listed on the application.

Applications for dissertation or thesis projects may be submitted once the dissertation or thesis committee chair has determined the research project plan is complete. It is not necessary that the dissertation or thesis project have been previously formally approved by the student’s committee. Dissertation or thesis committee chairs are cautioned, however, to avoid submitting applications prematurely that would result in changes to the project having to be resubmitted to the Darden College of Education Human Subjects Review Committee at a later time for approval.

Step One:Responsible Project Investigator (RPI) submits to Irbnet. For more info please visit:

https://www.odu.edu/education/research/human-subjects-review

General Comments:

MAKE SURE YOU SIGN electronically your project submission - this must be done by the LEADFACULTY MEMBER (RPI), not a grad student.

Use Appendix B for Exempt submissions - NOT the University IRB Form.

Address issues of confidentiality and data destruction/protection/security in your "6.x" descriptions.

Fill out the 6.x criteria, don't just put an "x" - you must explain HOW your study meets at least one of the exemption criteria.

DO NOT ... DO NOT ... send applications for exemption via e-mail to the Chair of DCOE Human Subject, The Chair will send them back. IRBNet is the only way to submit.

Lastly, you submit BOTH exempt (DCOE Human Subjects) and non-exempt (University IRB) through IRBNet, make sure you know which of the two you are sending it to.

Step Two:Committee members conduct an initial review after an application has been submitted

to the committee chair and one of the following three determinations is made: the Application for Exempt Research (1) does not meet the criteria for exempt research; (2) is approved as exempt; or (2) is eligible for exemption if required modifications are made to the application.

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Step Three:If the committee determines that an Application for Exempt Research does not meet the

criteria for exemption, researchers are notified by the committee chair by email message that a different ODU Human Subjects Research Review Application must be submitted to the university Institutional Research Board (IRB).

If an Application for Exempt Research is determined to be exempt by the committee, the committee chair notifies the researchers by email message, attaches a copy of the letter of exemption, and sends a signed hard copy of the exemption letter to the RPI through the ODU campus mail.

If an Application for Exempt Research will be exempt if required modifications are made to the application, the committee chair notifies the researchers by email message of modifications to the application that are required to be exempt and may also make suggestions regarding the application. The RPI modifies the application and resubmits it (in one PDF document) to the committee chair. Once the chair determines the required modifications have been met, the committee chair notifies the researchers by email message that the exempt application has been approved, attaches a copy of the letter of exemption, and sends a signed hard copy of the exemption letter to the RPI through the ODU campus mail.

Step Four:Once an application has been approved, a number is assigned to the application. The

first four digits represent the academic year (academic year 2012-2013 is noted as 2013). The 5th and 6th digits represent the semester (01=fall; 02=spring; 03=summer). The 7th, 8th, and 9th digits represent the order in which applications were approved for the semester (starting with 001).

Instructions, Information, and Suggestionsfor Completing the

Application for Exempt Researchto be Submitted to the

Darden College of Education Human Subjects Review Committee

Introduction

These instructions, information, and suggestions were developed by the committee to assist faculty members, staff members, and students in submitting applications. This document supplements the instructions and information provided on the Application for Exempt Research form.

A current version of the Application for Exempt Research form may be obtained at http://ww2.odu.edu/ao/research/compliance/humans.shtml.

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Completed applications must be signed by the Responsible Project Investigator (RPI) and submitted in one PDF document as an email attached sent to the Darden College of Education Human Subjects Review Committee chair, Dr. Jill Stefaniak at jstefani@odu.edu. The signature of the RPI is essential and applications cannot be reviewed without signatures. Signatures must be affixed prior to scanning the application package into one PDF document.

A Collaborative Institutional Training Initiative (CITI) certificate awarded after completing the on-line Program entitled Basic Course in the Protection of Human Research Participants – Social and Behavioral Focus is required for each faculty member or graduate student listed as an investigator on an exempt application. Follow these guidelines regarding CITI certificates:

Certifications must be updated annually. Out of date certificates will not be accepted. If your certificate is more than one year old, go to the website and complete the refresher course and after you pass the refresher course, submit your updated certificate.

The website for taking the required module is located at https://www.citiprogram.org. If the study is part of a master’s thesis or doctoral dissertation, the graduate student

completing the thesis or dissertation must be listed as an investigator. The CITI Human Subjects module is different from the CITI Responsible Conduct of

Research module that must be completed by all graduate students at ODU by the end of their first year of graduate studies.

Faculty members or students who are assisting with a research project in minimal ways (such as data entry) should not be listed on the application. Responsible Project Investigators (RPIs) are responsible for making sure that all individuals involved in a study conduct it in an ethical manner.

Parts of the Form

Responsible Project Investigator (RPI)

Under “Code Name (One word):” please select one word from the title of your research project and insert that word as the code name.

Investigators

If this research project is the dissertation or thesis research of graduate students, then the student must be listed in this section.

Faculty members or students who are assisting with a research project in minimal ways (such as doing data entry or serving as dissertation/theses committee members) should not be listed on the application.

Others who are significantly involved in the research project should be listed in this section. A CITI certificate must be submitted for each investigator listed on the application.

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Type of Research

Self-explanatory.

Funding

Self-explanatory.

Research Dates

3.a. Indicate as the wished for start date a date in the future that is no sooner than two weeks after the application is submitted. Regardless of the date listed here, the research project may not begin and data may not be collected until after the exemption application has been approved and approval has been communicated to the researchers.

3.b. The anticipated end date of the study should be listed. It is best to extend the end date anticipated to perhaps a year from the start date. If an application is determined to be exempt, the exemption is for an indefinite period. It is not necessary to request an extension for an exempt application if the end date is exceeded if a project has been determined to be exempt.

Human Subjects Review

4. If ODU is the only entity reviewing this research application related to Human Subjects, then mark Item 4 “No” and leave Items 4a and 4b blank.

5. Do not submit an entire dissertation or thesis proposal document. Instead, describe the proposed study in sufficient detail to allow the Human Subjects Review Committee to determine if the study can be classified as exempt. The Description of the Proposed Study should be no longer than 3-5 single space pages. Descriptions that exceed 5 pages will be returned to be condensed to 3-5 pages. In addition, include all documents checked.

The Description of the Proposed Study should include the following sections:1. Purpose of the study and research questions.2. Study procedures.

a. Research design.b. Instruments to be used.c. Participants. Describe the proposed involvement of humans including their

anticipated number, age range, and other demographic information. Also, identify the criteria for inclusion of exclusion of any subpopulation.

d. Data collection procedures including how and when data will be gathered.e. How anonymity for participants will be ensured (if it will).f. How confidentiality will be maintained (if it will).

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g. Explain steps to be taken to provide options to not participate without penalty. If extra credit in a course is given for participating in the research project, provide an alternative option for students who wish to receive extra credit but who do not wish to participate in the research project.

h. How the data will be managed, stored, reported and kept secure. Also include specific plans for destroying the data five years after the project is completed. Give sufficient details in this section for readers to understand exactly how data will be managed and destroyed.

i. If the proposed research will be conducted in a school system or agency, explain how the research policies for the system will be followed and describe how the system’s or agency’s consent to the research project will be obtained.

3. Risks and Benefits for Participantsa. Specify any potential risks and the levels of potential risks to participants in the

study (if any). In some studies there are none.b. Specify any potential benefits to participants in the study (if any). In some

studies there are none.c. If potential risks exist, describe the procedures planned to protect against or

minimize potential risks.4. Informed Consent (if consent will be obtained)

a. Informed consent usually is not required in exempt studies. Exempt studies are deemed to have little or no risk to participants. Informing participants and securing signatures when such actions are not necessary can inhibit participation in a study. On the other hand, if participants’ privacy may be affected, securing consent may be important from an ethical perspective. Depending on the circumstances of the study, informed consent in some form may be required by the committee to ensure privacy of participants is respected or to ensure parents or guardians are informed of the study if they could be concerned if they were not informed about it. Researchers may choose to obtain informed consent even though it is not required. If informed consent will be obtained from participants (or their parents or guardians), include a copy of the informed consent form.

b. When a study involving minors or legally dependent adults is conducted and, whether exempt or not, includes a consent form that is signed by parents or guardians, then, if children are in the second grade or higher or the legally dependent adult has the capacity, an assent form should be signed by them as well. If assent is not appropriate for participants because of their age, disability, or some other reason, researchers should indicate they will take feedback from participants (verbal or non-verbal) into consideration in order to determine whether participation in the study should be discontinued.

Exemption Categories

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6. Only one exemption category is necessary. Identify and justify all exemption categories that apply. Only one category is necessary to achieve exemption. Most exemptions granted in the Darden College of Education are granted under categories 6.1, 6.2, and 6.4.

6.1. Exemptions under 6.1 sometimes are difficult to determine. If a standard educational process is being studied (as opposed to a process that is unique or experimental), the study could be exempt. It is acceptable if an exempt study introduces something new to the classroom (such as a new instructional tool). However, the addition to the classroom should be in keeping with normal educational practices. That is, the class should seem like a normal class to the students. There are circumstances in which research with minors may be exempt. Research studies with minors may be exempt under 6.1 if it is research conducted in standard educational settings. Questionnaires can be used with minors in the context of the Category 1 exemption. A questionnaire completed by minors would be allowed if the questionnaire is part of the course activity (such as a commonly collected course evaluation).

6.2. This exempt category is appropriate when anonymous surveys and educational tests are used. Minors may not be surveyed under this exemption.

6.3, 6.4, 6.5, and 6.6. Self-explanatory.

Human Subjects Training

1. Human Subject Training Certificationa. List the date the RPI completed Human Subject Protection training or the

refresher course (must have been in the last year). b. See information at the top of this page regarding who must submit certificates

and guidelines regarding certificates.

Signature

Electronic Signature on Irbnet.

Class Projects Policy

1. Class projects that involve data collected for a course or courses that will be presented and/or published or disseminated in any form off campus must go through the usual DCOE human subjects review before data are collected.

2. When the intent to present, publish, or disseminate findings from classroom projects in any off-campus venue is not known in advance, the following is in effect.

3. An application for exempt research must be filed with the DCOE Human Subjects Review Committee.

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a. Participants (students) from whom data were gathered must be notified of the intent to present, publish or disseminate the information, and their assent to have their data used secured.

b. When identifiers are used; such as gathering data about the students from other sources, or as follow up to the class; the application must be submitted to the university IRB.

c. Publication, presentation or any other dissemination of the data may not occur prior to receiving formal approval for the chair of the Human Subjects Review Committee.

4. When the researcher proposes to use archival data, such as data from previous classes, other policies are in effect. See the policy on “Archival Data”.

Informed Consent

As stated above, informed consent usually is not required in exempt studies. Exempt studies are deemed to have little or no risk to participants. Informing participants and securing signatures when such actions are not necessary can inhibit participation in a study. On the other hand, if participants’ privacy may be affected, securing consent may be important from an ethical perspective.

Often, even though it is not required, study participants are given some type of information about a study in a cover letter to a survey or in introductory materials. Researchers may wish to disclose that data being collected will be used in a study and may wish to explain who the researchers are and who participants should contact if they have any concerns. Also, sometimes parents and guardians are informed about studies, but their permission is not sought. Communications of these types may be brief and informal.

Researchers may choose to obtain informed consent even though it is not required. Depending on the circumstances of the study, informed consent in some form may be required by the committee to ensure privacy of participants is respected or to ensure parents or guardians are informed of the study if they could be concerned if they were not informed about it.

When a study involving minors or legally dependent adults is conducted and, whether exempt or not, includes a consent form that is signed by parents or guardians, then, if children are in the second grade or higher or the legally dependent adult has the capacity, an assent form should be signed by them as well. If assent is not appropriate for participants because of their age, disability, or some other reason, researchers should indicate they will take feedback from participants (verbal or non-verbal) into consideration in order to determine whether participation in the study should be discontinued.

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If informed consent or assent will be obtained from participants (or their parents or guardians), you must include a copy of the informed consent forms you will use in your study. Below are some sample forms you may choose to utilize if you determine that informed consent (or assent) should be obtained in your study. Click on the title below to see the sample form.

Informed Consent Form (For study participants who are 18 or older)

(If you use this sample form, delete comments in red. Modify form to fit your study.)

INFORMED CONSENT DOCUMENT(SAMPLE)

OLD DOMINION UNIVERSITY

PROJECT TITLE: (Insert project title here.)

INTRODUCTIONThe purposes of this form are to give you information that may affect your decision whether to say YES or NO to participation in this research, and to record the consent of those who say YES.

RESEARCHERS(Identify the following...Name, Title, Academic Degree of Responsible Principal Investigator, College, and Department...then investigators)

DESCRIPTION OF RESEARCH STUDYSeveral studies have been conducted looking into the subject of (...plain language description of whatever you are researching....) None of them have explained the (...purpose of the research, e.g., the effects of independent variable on dependent variable...).

If you decide to participate, then you will join a study involving research of (.... use a non-technical, plain language explanation of the testing protocol and exactly what is expected of the subject, including a description of which procedures are experimental and their accepted, non-experimental alternatives...) If you say YES, then your participation will last for (...duration of participation...) at the (...location of participation...). Approximately (...number...) of (...similarly situated subjects...) will be participating in this study.

EXCLUSIONARY CRITERIAYou should have completed (....description of screening instrument or questionnaire(s)....). To the best of your knowledge, you should not have (....list of exclusionary criteria....) that would keep you from participating in this study.

RISKS AND BENEFITSRISKS: If you decide to participate in this study, then you may face a risk of (. . . clear description of all foreseeable risks, discomforts, or undesirable outcomes if there are any…if not, say there are none....). The researcher tried to reduce these risks by (...e.g., providing padding, using a licensed nursed, removing all linking identifiers...). And, as with any research, there is some possibility that you may be subject to risks that have not yet been identified.

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BENEFITS: The main benefit to you for participating in this study is (...example of benefit other than payment, e.g., a free eyesight exam…there may be none…if not, say there are none. ). Others may benefit by (...example...).

COSTS AND PAYMENTSThe researchers want your decision about participating in this study to be absolutely voluntary. Yet they recognize that your participation may pose some (...costs, inconvenience, etc., such as parking fees..there may be none…if not, say there are none.). In order to (...e.g., help defray your costs) you will receive (...e.g., five dollars, or "no payment...) to help defray incidental expenses associated with participation.[OR]The researchers are unable to give you any payment for participating in this study.

NEW INFORMATIONIf the researchers find new information during this study that would reasonably change your decision about participating, then they will inform you.

CONFIDENTIALITYAll information obtained about you in this study is strictly confidential unless disclosure is required by law. The results of this study may be used in reports, presentations and publications, but the researcher will not identify you.

WITHDRAWAL PRIVILEGEIt is OK for you to say NO. Even if you say YES now, you are free to say NO later, and walk away or withdraw from the study -- at any time. [If applicable] Your decision will not affect your relationship with Old Dominion University, or otherwise cause a loss of benefits to which you might otherwise be entitled. [Optional: The researchers reserve the right to withdraw your participation in this study, at any time, if they observe potential problems with your continued participation.]

COMPENSATION FOR ILLNESS AND INJURYIf you say YES, then your consent in this document does not waive any of your legal rights. However, in the event of (..harm, injury, or illness...) arising from this study, neither Old Dominion University nor the researchers are able to give you any money, insurance coverage, free medical care, or any other compensation for such injury. In the event that you suffer injury as a result of participation in any research project, you may contact (...the responsible principal investigator or investigators at the following phone numbers....) or Dr. Jill Stefaniak, Chair of the Darden College of Education Human Subjects Review Committee, Old Dominion University, at jstefani@odu.edu, who will be glad to review the matter with you.

VOLUNTARY CONSENTBy signing this form, you are saying several things. You are saying that you have read this form or have had it read to you, that you are satisfied that you understand this form, the research study, and its risks and benefits. The researchers should have answered any questions you may have had about the research. If you have any questions later on, then the researchers should be able to answer them:

(...investigators and phone numbers....).

If at any time you feel pressured to participate, or if you have any questions about your rights or this form, then you should contact Dr. Jill Stefaniak, Chair of the Darden College of Education Human Subjects Review Committee, Old Dominion University, at jstefani@odu.edu.

And importantly, by signing below, you are telling the researcher YES, that you agree to participate in this study.

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Participant's Printed Name & Signature Date

Parent / Legally Authorized Representative’s Printed Name & Signature (If participant is a minor or incapacitated adult)

Date

INVESTIGATOR’S STATEMENTI certify that I have explained to this participant the nature and purpose of this research, including benefits, risks, costs, and any experimental procedures. I have described the rights and protections afforded to human subjects and have done nothing to pressure, coerce, or falsely entice this subject into participating. I am aware of my obligations under state and federal laws, and promise compliance. I have answered the participant's questions and have encouraged him/her to ask additional questions at any time during the course of this study. I have witnessed the above signature(s) on this consent form.

Investigator's Printed Name & Signature

Date

Parent or Guardian Permission Form(when minors or adults who lack capacity are participants)

[insert date]Dear Parents or Guardians:

We are conducting a study involving [insert description]. To conduct this study we need the participation of children [insert description of children, age range, sex, etc.]. The attached “Permission for Child’s Participation” form describes the study and asks your permission for your child to participate.

Please carefully read the attached “Permission for Child’s Participation” form. It provides important information for you and your child. If you have any questions pertaining to the attached form or to the research study, please feel free to contact [insert name of contact persons].

After reviewing the attached information, please return a signed copy of the “Permission for Child’s Participation” form to you child’s teacher if you are willing to allow your child to participate in the study. Keep the additional copy of the form for your records. Even when you give consent, your child will be able to participate only if he or she is willing to do so.

We thank you in advance for taking the time to consider your child’s participation in this study.

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Sincerely,

[Insert contact persons’ names, phone numbers, addresses, etc.]

PERMISSION FOR CHILD’S PARTICIPATION DOCUMENT

The purposes of this form are to provide information that may affect decisions regarding your child’s participation and to record the consent of those who are willing for their child or ward to participate in this study.

TITLE OF RESEARCH: insert title

RESEARCHERS: insert names, titles, and college/university affiliations

DESCRIPTION OF RESEARCH STUDY: insert description

If you decide to allow your child to participate in this study, your child will be [insert what the child will be required to do]. Your child’s participation will take approximately [insert the duration].

EXCLUSIONARY CRITERIA: In order for your child to participate in this study, your child must be [insert requirements].

RISKS: [describe the risks, if any].

BENEFITS: [describe the benefits, direct and/or indirect, if any]. A summary of results will be made available to both teachers and parents.

COSTS AND PAYMENTS: [describe the costs and payments to the participants, if any].

NEW INFORMATION: You will be contacted if new information is discovered that would reasonably change your decision about your child’s participation in this study

CONFIDENTIALITY: Participants will be assigned a code number [edit this if another type of identifier is used] so that your child’s name will not be attached to his or her responses. Only researchers involved in the study or in a professional review of the study will have access to data sheets. All data and participant information will be kept in a locked and secure location.

WITHDRAWAL PRIVILEGE: Your child’s participation in this study is completely voluntary. It is all right to refuse your child’s participation. Even if you agree now, you may withdraw your child from the study at any time. In addition, your child will be given a chance to withdraw at any time if he/she so chooses.

COMPENSATION FOR ILLNESS AND INJURY: Agreeing to your child’s participation does not waive any of your legal rights. However, in the event of harm arising from this study, neither Old Dominion University nor the researchers are able to give you any money, insurance

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coverage, free medical care, or any other compensation. In the event that your child suffers harm as a result of participation in this research project, you may contact [insert the responsible project investigator’s name and phone number] or Dr. Ed Gomez, Chair of the Darden College of Education Human Subjects Review Committee, Old Dominion University, at egomez@odu.edu.

VOLUNTARY CONSENT: By signing this form, you are saying (1) that you have read this form or have had it read to you, and (2) that you are satisfied you understand this form, the research study, and its risks and benefits. The researchers will be happy to answer any questions you have about the research. If you have any questions, please feel free to contact [insert contact persons’ names and phone numbers].

If at any time you feel pressured to allow your child to participate, or if you have any questions about your rights or this form, please contact Dr. Jill Stefaniak, Chair of the Darden College of Education Human Subjects Review Committee, Old Dominion University, at jstefani@odu.edu.

Note: By signing below, you are telling the researchers YES, that you will allow your child to participate in this study. Please keep one copy of this form for your records.

Your child’s name (please print): ______________________________

Your name (please print): ______________________________

Relationship to child (please check one):Parent: _____Guardian: _____

Your Signature: ______________________________

Date: ______________________________

INVESTIGATOR’S STATEMENT: I certify that this form includes all information concerning the study relevant to the protection of the rights of the participants, including the nature and purpose of this research, benefits, risks, costs, and any experimental procedures. I have described the rights and protections afforded to human research participants and have done nothing to pressure, coerce, or falsely entice the parent to allowing this child to participate. I am available to answer the parent’s questions and have encouraged him or her to ask additional questions at any time during the course of the study.

Researcher’s Signature: ______________________________

Date: ______________________________

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Assent Form (for minors or adults who lack capacity)

ASSENT

What is assent?Assent is defined as an “agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.”IRB Guidebook: http://www.hhs.gov/ohrp/irb/irb_glossary.htm

When is assent generally required?Subjects are minors between the ages of 7 and 17. Children below the age of 7 are

generally not asked to provide assent.Subjects 18 or older are intellectually or emotionally impaired and not legally

competent to give their informed consent.

Is a separate assent form needed? Minor subjects who are able to read and understand the informed consent document

(parent's permission form) may provide assent on that form with a separate signature line.

Minor subjects (aged 7 or older) who are too young or intellectually immature to read and understand the parent's permission form should be given the opportunity to provide written assent on a simplified assent form.

Adult subjects (18 or older) who are not legally competent to give their informed consent should be given the opportunity to provide written assent on a simplified assent form.

What should be included in the assent form?Study TitleStudy Purpose-Provide a brief explanation of the purpose of the study.Procedures-Describe what the subject is being asked to do.Withdrawal privilege- Describe how a subject can stop participation later even if

he/she agrees to start.Voluntary participation- Include a statement that the subject does not have to

participate.Confidentiality-Indicate that the experimenter will not tell anyone (parents, teachers)

what the subject says or does in the study. Signature lines-Include a signature line for the subject and for the investigator. Be

sure to include a date line as well.

Language Level

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Write the form using language that is appropriate for the age level and mental capacity of subjects.

SAMPLE ASSENT FORM

EXERCISE AND NUTRITION STUDY

My name is Susan Researcher. I work at Old Dominion University.

I am asking you to take part in a research study because I am trying to learn more about exercise and nutrition. I want to learn about the types of exercises kids your age do and what kinds of food they eat.

If you agree, you will be asked to complete a survey. You will be asked how often you exercise and what kind of exercises you do. You will also be asked the kind of foods you eat. You will be asked to give us your height and weight. Answering these questions will take about 20 minutes. You do not have to put your name on the survey.

You do not have to be in this study. No one will be mad at you if you decide not to do this study. Even if you start, you can stop later if you want. You may ask questions about the study.

If you decide to be in the study I will not tell anyone else what you say or do in the study. Even if your parents or teachers ask, I will not tell them about what you say or do in the study.

Signing here means that you have read this form or have had it read to you and that you are willing to be in this study.

Signature of participant_________________________________________________

Subject’s printed name ___________________________________________________

Signature of investigator__________________________________________________

Date___________________________

Revised 3-14-2016Dr. Katsioloudis

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