CATEGORY III PACKET

Category 3 (Full Review) - your proposal fits this category if the research has the potential for harming participants, violates their rights, or requires special protections for participants. Such research includes activities such as:

research which might put participants at risk

research involving psychological or physiological intervention

non-curricular, interactive research in schools

interviews or surveys on sensitive topics (e.g. sexual activity, alcohol or
drug use, illegal behavior)

research on special populations (e.g. prisoners, and the mentally
incompetent) whether or not the research is covered by another assurance (see appendix)

research involving deception (see appendix)

research to be conducted on the Internet on sensitive topics (see appendix)

international research, including class projects conducted in another country. International research requires additional approval from an IRB (or similar body) in that country and a copy of the translation of the informed consent document and any survey or interview questions (see appendix). Please contact the IRB Administrator at (585) 395-2779 for assistance prior to submitting your proposal.

Research conducted in schools, agencies or businesses -
All research conducted in schools requires written permission on letterhead from the school superintendent or principal. Research conducted in a business or other organization also requires written permission of the director of that organization. This must be attached to your proposal when it is submitted. (Signed faxes on letterhead are acceptable).

Informed consent - research under this category requires written documentation of informed consent. The proposal should include written information to assist participants in making an informed decision. If minors are involved (under the age of 18 years) in the research, then written permission of their parent or guardian is required for their participation.

The researcher must detail for the IRB reviewers that legally effective informed consent (examples follow) is:

obtained from the participant or their legally authorized representative for minors or those adults who cannot themselves give informed consent;

be in language understandable to the participant or their representative (in some cases this may involve an interpreter). If the research will be conducted with non-English speaking participants then a copy of the informed consent document(s), survey and/or interview questions must be provided in English and the foreign language to the IRB

be obtained under circumstances that offer the participant or their representative sufficient opportunity to consider whether the participant should or should not participate;
not include language through which the participant or their representative is asked to
waive or appear to waive any of the participant's legal rights, or release or appears to
release the research investigator, the sponsor, the institution, or its agents from liability
for negligence.

Deception research will only be approved if it meets certain conditions (e.g. debriefing).

Category 3 proposals should include in this order:

A. A completed and signed cover sheet with all required signatures.

B. Typed answers to questions 1-16. (Sample follows).

C. Attach a copy of your informed consent statement. If your research involves minors please attach two informed consent forms - one for their parent/guardian to sign and a second one for the minor to sign (depending upon age, it may just be read to them.)

D. If research is to be conducted in a school then please attach a letter of permission from the school superintendent or principal. If the research is to be conducted in a business or other organization please attach a letter of permission from the director of the organization.

E. Attach a copy of any interview or survey questions used and indicate their source.

F. Attach copies of responses to forms 101- 404 (only if applicable. See appendix.)

G. Attach a note to the original proposal only with which of the meeting dates of the IRB posted on the website you (and your faculty supervisor if you are a student) would be available to meet with the IRB Board within the two weeks following submission of your proposal. Or contact Marsha Moss at mmoss@brockport or 585-395-2779 for scheduled committee meetings dates/times.

H. If a faculty member or graduate student submit 8 copies and the original to IRB Administrator, Grants Development Office, 6th floor Allen Administration Building. (585) 395-2779.

If an undergraduate student submit 3 copies and the original to the address above.

Directions for completing a Category III proposal:
A. Attach a completed and signed cover sheet (see next page) with all required signatures.

SUNY BROCKPORT INSTITUTIONAL REVIEW BOARD
Human Participant Research Review Form
Proposal #
(# will be inserted by IRB)

Please follow these steps to submit your application.

Use these two pages as the first pages of your application.

If a Category 1 review send just the original, if a Category 2 send the original and one copy, if a Category 3 review send the original and eight copies if a faculty member of graduate student; 3 copies and the original if an undergraduate student.

Deliver or mail to IRB Administrator, Grants Development Office, 6th Floor Allen, SUNY Brockport, 350 New Campus Drive, Brockport, N.Y. 14420. (585) 395-2779, irboffice@brockport.edu ; fax number is (585) 395-2006.

Please type or neatly print.
1. Investigator(s) name(s) ______________________________________

Department _______________________________________________

Phone Number ________________________________
(where you can be reached during the day - so we can call with questions)

E-mail address: ______________________________________________

Local mailing address: _________________________________________

2. Project Title: ________________________________________________________
_____________________________________________________________________

3. College Status (for each investigator):
Faculty/Staff _________________________________
Undergraduate Student _________________________
Graduate Student _____________________________

4. If the principal investigator is a student, list name, department, and local telephone number of faculty supervisor. Please note that the Faculty/Staff Supervisor must indicate knowledge and approval of this proposal by signing this form.
Faculty /Staff Supervisor's name: ___________________________________________
Department and phone number: _____________________________________________

5. Check appropriate category of research project (complete after reviewing guidelines):
Category 1 (Exempt Review) ____; Category 2 (Expedited Review) ___________
Category 3 (Full Review) _______________

6. The Principal Investigator must sign this form. (If the P.I. is a student, their
faculty/staff supervisor must also sign this form).

I certify that: 1) the information provided for this project is accurate; 2) no other
procedures will be used in this project; 3) any modifications in this project will be
submitted for IRB approval prior to use; 4) I have successfully completed the required
online IRB training program.

____________________________________________________________________

A. Signature of Investigator Date

D. Faculty/Staff Supervisor: 1) I certify that this project is under my direct
supervision and that I am responsible for insuring that all provisions of approval are complied with by the principal investigator. 2) I have successfully completed the required online IRB training program. 3) My signature indicates I have reviewed this proposal and agree it is in final form and ready to be submitted to the IRB.

______________________________________________ ______________________

Signature of Faculty/Staff Supervisor Date

C Siguature of Department Head or Designee Date

____________________________________________________________________

8/06

B. Project Description (sample completed project description follows)

Provide typed answers to items 1-16 (See below)

This information must be typed, and should be carefully checked for spelling and grammar. Please number paragraphs according to the number of the item appropriate for your project. If an item is not applicable please put NA (for not applicable).

Provide a brief project description. Describe: a) The objectives, methods and procedures of the project. b) The purpose of the research - include why it is significant and how it contributes to general knowledge. c) The emphasis should be on the human subject involvement in the project. Discussion of theoretical or statistical aspects of the project should be avoided. d) If a questionnaire, and/or testing instrument is to be used describe how it will be administered, by whom, and indicate its source. If the survey is copyrighted, note when permission to use was given and indicate this at the bottom of page one of the survey form. e) If interviews are to be conducted, describe the nature of the interview and how responses will be recorded by written notes, audio or videotaping, etc. (see appendix).

Number of and the relevant characteristics of subjects.

Describe how subjects will be selected for participation in this project and any fees, extra
credit, or other items they will receive for participation if appropriate.

Status and qualifications of research assistants, if any. They must also complete
appropriate IRB online training.

Source of funding for project, if any.

Expected starting and completion dates for project. (Note that project cannot begin until
approval has been received from IRB. Projects are given approval for a maximum of one
year; if they continue past that point they must again receive IRB approval).

Attach copies of all questionnaires, testing instruments, or interview protocols, and any cover letters or instructions to participants.

Attach a copy of your transcript of completion for the online training course. If you
do not have it indicate that you completed it and records will be verified by the IRB
Administrator.

Specify steps to be taken to guard the confidentiality of participant's responses. Indicate what personal identifying indicators will be kept on subjects (if any). Specify procedures for
storage and ultimate disposal of personal information. This would normally mean keeping
information in a locked file cabinet and shredding information at the end of the research
project.

Attach an informed consent document that includes the basic elements of informed consent
(See attachments below).

If the participants are to be drawn from an institution or organization ( e.g. hospital, social
service agency, prison, school business etc.) that has the responsibility for the participants,
then a copy of that assurance, or if not available, documentation of permission from the
institution must be submitted to the IRB before final approval can be given.

Attach copy of any interview or survey questions and their sources.

Specify any special populations (e.g. minors, prisoners, or people with mental health issues
or developmental delays) involved in this project and describe the procedures for obtaining
the appropriate consent (see appendix).

If the participant(s) will be exposed to any psychological intervention such as deception,
contrived social situations, manipulation of their attitudes, opinions, or self esteem,
psychotherapeutic procedures, or other psychological influences, complete Form 202. See
appendix.

If there will be any treatments upon the body of the participant(s) by mechanical,
electronic, chemical, biological, or any other means complete Form 303. See appendix.

Note: Form 101 should also be completed if any sensory monitoring device(s) will be
employed (e.g. electroencephalograph).

If the participants in the project may be exposed to the possibility of injury,
including physical, psychological or social injury, complete Form 404. See appendix

Attach copies of responses to forms 101-401 only if required (see appendix).

Be sure to submit a final version to the IRB that has been carefully reviewed for spelling and grammatical errors. Doing so will expedite the review process.

Where to submit and how many copies:
a) Faculty and graduate students: Make 8 copies of the proposal in addition to the original
b) Students: Make 3 copies of the proposal in addition to the original
c) Submit to the IRB Administrator, Office of Academic Affairs, 6th Floor Allen
Administration Bldg.
d) Also check the time of the scheduled meetings of the IRB on the IRB website or contact Marsha Moss at mmoss@brockport or irboffic@brockport.edu for times of scheduled meetings of the IRB for the semester. Please tell us in a note attached to your proposal which of tthe meeting times you and your faculty mentor (if available) can meet with the IRB. This is not required but it makes the process go faster if you are there to answer any questions the IRB may have about your proposal.

Review process:

Category 3 proposals are reviewed by the IRB Chair initially and if the proposal is found to meet this category of review a meeting of the full IRB Board with the researcher (and faculty supervisor if a student research project) will be scheduled. We make every effort to have the meeting within one-two weeks after receiving your proposal. The Board is provided with copies of your proposal for review prior to the meeting. The approval time is dependent upon the time of year, the completeness of your proposal, and how quickly you respond to any revisions requested by the IRB Administrator. The average time is within 2-3 weeks of submission unless your proposal is submitted just prior to or during school breaks then it may take several weeks. At the conclusion of the IRB Board meeting you will be told what revisions are needed for final approval (if any). Final approval is given initially by phone or email and then followed by a formal letter within 5 business days. Maximum approval period is for 12 months from the date of the IRB meeting.

Attachments for Category 3 Proposals

A. Cover/signature pages
B. Informed Consent Directions
C. Sample of General Informed Consent
D. Sample of Parental Consent
E. Sample of Minor Consent
F. Sample Letter for Institutional Consent
G. Sample Category III Proposal
H. IRB Proposal Review Checklist
I. See IRB Appendix for Forms 101, 202, 303, and 404 (if applicable)

B. Informed Consent Directions

For all Category 3 proposals, signatures are required at the bottom for participants. If minors are involved you must provide two separate consent forms: 1) One for parent/guardians and 2) one for minors (17 years of age and younger). The minors form should be in a language understandable to their age level.

Proposals are approved more quickly if researchers use the attached sample informed
consent forms and modify them to fit your project. The following elements must be
included:
A. Statement that the study involves research and why it is being conducted.
B. Explanation of the purpose of the research and the expected duration of the participant's involvement (e.g. how long will it take to complete the survey and number of questions).
C. Description of the procedures to be followed, and identification of any procedures
that are experimental.
D. Description of any benefits to the participant's or to others which may reasonably be
expected from the research.
E. Description of any reasonably foreseeable risks and discomforts to the participant.
F. Statement describing the extent, if any, to which confidentiality of records
identifying the participant will be maintained, stored for how long, how destroyed.
G. For research involving more than minimal risk, an explanation as to whether any
medical treatment is available if injury occurs; or counseling available for questions that might be sensitive, and if so, what they consist of, or where further information may be obtained.
H. Name and phone number of whom to contact for answers to pertinent question
about the participant's rights, and whom to contact in the event of a research-related injury to the participant.
I. Statement that participation is voluntary, and refusal to participate will involve no
penalty or loss of benefits to which the participant is otherwise entitled.
J. Statement that participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
K. Name of institution should be fully spelled out (ex. Greater Rochester Collaborative
Masters in Social Work Program through SUNY Brockport and Nazareth College).

Whether presented orally or in writing, to the participants' the IRB must be provided a written description of these elements of informed consent to be presented to them. If the research cannot practically be completed without this requirement being waived or altered, please say so here, and include a debriefing procedure.

If minors are involved - in addition to parental consent adequate provisions must be made for soliciting the assent of the children capable of providing their agreement. According to federal regulations, assent means .."a child's affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, should not be construed as assent. Procedures for obtaining assent of children must be appropriate to their age level, maturity, and psychological state. The essential information given to the child must include a description of the procedures and clear indication that their participation is voluntary. If the research is being conducted in schools, it must be clearly stated that this research is not part of the child's regular school program, not being conducted by the school, and that participation will not affect the child's grade.

In cases where there is inconsistency between the consent of the parent and the agreement of the child, the following rule will be followed: A "no" from the child overrides a "yes" from the parent, but a "yes" from the child does not override a "no" from the parent.

Non-participation in a research project being conducted as part of a class or group (whether or not minors are involved), must detail alternatives for those in the class not participating in the research. For example, if extra credit is being offered for participation then the researcher must detail how those not participating have an alternative method of obtaining extra credit. This is to minimize coercion to participate. Another example would be if an investigator is conducting research in a classroom where they will be observing, interviewing and taping the class. Please explain what procedures will be followed for those children in the class whose parents have not given permission, or where the child does not agree to participate in the research.

9. If the participants are to be drawn from an institution or organization (e.g. hospital, social service agency, prison, school, etc.) that has the responsibility for the participant's, then a copy of that assurance or if not available, documentation of permission from the institution must be submitted to the Board before final approval can be given.

10. If the subjects will come into contact with any mechanical, electrical, electronic or other
equipment, Form 101, must be completed in order for the safety of the equipment to be
checked. See appendix.

Three sample informed consent forms follow.
Please note the following additional items that should be included in any consent form if applicable to your project.

If one of the following applies to your proposal please add this to the consent form above the section regarding whom to contact for information.
6. Payment for participation - include the amount of payment and procedures to be paid. Please note that participants must be paid even if they don't complete the study. If you are paying participants more than $600 annually please contact the IRB Administrator for specific language that must be included in your consent form. Also see attached appendix.

7. Taping (audio and video) - if you are audio/video taping you have two options:
a) If you require participants to consent to the taping in order to participate, you should clearly state this in the consent form in the study description section.
b) If it is acceptable for participants to refuse taping and still participate, you should include a separate section for taping information at the end of the consent form with a separate signature line for consent to the taping.

All participants completing interviews must sign a consent form.

8. Referrals - if the study has the potential to arouse questions and concerns in participants ( i.e. regarding their substance use, etc., include an agency and phone number for participants to contact if they feel the need to do so (ex. College Counseling Center).

9. Studies conducted in classrooms/school settings - you must include on the consent form
a statement that participation in the research will not affect participants' grades or class
standings.

10. Research conducted on the Internet - should include the following statement on the consent form:
"This project has been approved by the SUNY College at Brockport's Institutional Review Board. Approval of this project only signifies that the procedures adequately protect the rights and welfare of the participants. Please note that absolute confidentiality cannot be guaranteed due to the limited protections of Internet access."

C. SAMPLE OF GENERAL INFORMED CONSENT FORM
(not involving minors). This can be modified to fit the needs of your project. Note that it contains the required elements of informed consent.

STATEMENT OF INFORMED CONSENT

The purpose of this research project is to examine some of the ways adults, 65 and older, take care of their health. Four areas will be studied including exercise, diet, taking medications, and seeking medical care. This research project is also being conducted in order for me to complete my masters thesis for the Department of ___________ at the State University of New York College at Brockport.

In order to participate in this study, your informed consent is required. You are being asked to make a decision whether or not to participate in the project. If you want to participate in the project, and agree with the statements below, please sign your name in the space provided at the end (required for all Category 3 proposals). You may change your mind at any time and leave the study without penalty, even after the study has begun.

I understand that:

My participation is voluntary and I have the right to refuse to answer any questions.

My confidentiality is guaranteed. My name will not be written on the survey. There will
be no way to connect me to my written survey. If any publication results from this
research, I would not be identified by name.

There will be no anticipated personal risks or benefits because of my participation in this
project.

My participation involves reading a written survey of X# of questions and answering
those questions in writing. It is estimated that it will take X# of minutes to complete the
survey.

Approximately X # people will take part in this study. The results will be used for the
completion of a masters thesis by the primary researcher.

Data will be kept in a locked filing cabinet by the investigator. Data and consent forms
will be destroyed by shredding when the research has been accepted and approved.

I am 18 years of age or older. I have read and understand the above statements. All my questions about my participation in this study have been answered to my satisfaction. I agree to participate in the study realizing I may withdraw without penalty at any time during the survey process. Returning the survey (and/or completing interview if appropriate) indicates my consent to participate.

If you have any questions you may contact:

Primary researcher Faculty Advisor

Name Name

Phone Number Department and phone number

____________________________________________ _____________________

Participant Signature Date

D. Sample of an Informed Consent Form for parents for research involving minors.

The form should be modified for your proposal. Two forms must be submitted to the IRB for approval if the proposal involves minors. One form for parent/guardian and one for minors. They both must be written in language understandable to the educational level of the parent and child.

STATEMENT OF INFORMED CONSENT FOR PARENTS OF MINORS

This form describes a research study being conducted with young people and their families. The purpose of the research is to learn about the stresses or problems that families face. The person conducting the research is a faculty member (staff or student) at SUNY College at Brockport. You are being asked to give permission for you and your son or daughter to participate in this research. If you agree to participate in this study, you will be asked to complete a questionnaire about your feelings and behaviors, and your child will be asked to do the same regarding feelings and behaviors, family and friends, and school. S/he will also complete a short interview. This study will take about two hours. (Include if appropriate: Your child will be paid XX dollars for the two hours of her/his time.)

A possible risk of being in this study is the feeling that some questions asked are of a personal nature. There are no other anticipated risks. You and your child do not have to answer any question you do not want to. You will have a chance to discuss any questions you have about the study with the interviewer/ researcher after you complete the interview/questionnaire

The possible benefit from being in this study could be that information will be learned that would allow professionals to better help families deal with problems. Information from this study might also suggest ways that young people can get along better in school or with their parents or can avoid legal trouble.

Any information that you and your child give in this study remains confidential and will be known only to the project staff. . [ Sometimes needed with minors when interviewing about high risk behaviors: The only exception that there could ever be to this is that if in talking to your child, project staff find that there is something happening in her/his life that is an immediate and serious danger to her/his health or physical safety. In that case, the study staff may have to contact you as parents and possibly another professional. We would always talk to your child about this first.) Except for this consent form, all questionnaires/interviews will be given a code number and your names will not be on them. If publications in scientific journals arise from this research, results will be given anonymously and in group form only, so that you and your child cannot be identified.

( Include if appropriate: Your child's interview will be tape recorded, so that their answers can be recorded accurately.) If you have any questions during this study you may call (insert name of investigator and phone number).

Your participation in this study and your child's is completely voluntary. (If needed: Being in it or refusing to be in it, will not affect the services or benefits that your child is entitled to through her/his school, agency, etc.). You and your child are free to change your mind or stop being in the study at any time during it.

You are being asked whether or not you want to participate and have your child participate in this study. If you wish to participate, and you agree with the statement below, please sign in the space provided. Remember, you may change your mind at any point and withdraw from the study. Your child can refuse to participate even if you as parent/guardian give permission for your child to participate.

I understand the information provided in this form, agree to participate in this project and to have my child___________________________________ participate.

child's name

If you have any questions you may contact:

Primary researcher Faculty Advisor

Name Name

Phone Number Department and phone number

___________________________________________ ______________________

Signature of parent/guardian Date

E. Sample of an Informed Consent Form for research involving minors.

The form should be modified for your proposal. Two forms must be submitted to the IRB for approval if the proposal involves minors. One form for parent/guardian and one for minors. They both must be written in language understandable to the educational level of the parent and child.

STATEMENT OF INFORMED CONSENT FOR MINORS

This form describes a research study being conducted with young people and their families. The purpose of the research is to learn about the stresses or problems that families face. The person conducting the research is a faculty member (staff or student) at SUNY College at Brockport. If you agree to participate in this study, you will be asked questions about your feelings and behavior, your family and friends, and school. You will also fill out some questionnaires (or complete interviews). Your parents will also do the same kinds of things with a staff member from the study. This study will take about two hours. (Insert if appropriate: You will be paid X dollars for the two hours of your time.)

A possible risk of being in this study is your feeling that some questions asked of you are of a personal nature. There are no other anticipated risks. You do not have to answer any question you do not want to. You will have a chance to discuss any questions you have about the study with the interviewer/ researcher after you complete the interview/questionnaire.

The possible benefit from being in this study could be that information will be learned that would allow professionals to better help families deal with problems. Information from this study might also suggest ways that young people can get along better in school or with their parents or can avoid legal trouble.

Any information that you give in this study remains confidential and will be known only to the project staff. [ Sometimes needed with minors when interviewing about high risk behaviors: The only exception that there could ever be to this is that if in talking to you, project staff find that there is something happening in your life that is an immediate and serious danger to your health or physical safety. In that case, your parents or another professional might have to be contacted. We would always talk to you about this first.) Except for this consent form, all questionnaires/interviews will be given a code number and your name will not be on them. If publications in scientific journals arise from this research, results will be given anonymously and in group form only, so that you cannot be identified.

( Include if appropriate: Your interview will be tape recorded, so that your answers can be recorded accurately.) If you have any questions during this study you may call (insert name of investigator and phone number).

Your participation in this study is completely voluntary. (If needed: Being in it or refusing to be in it, will not affect the services or benefits that you are entitled to through your school, agency, etc.) You are free to change your mind or stop being in the study at any time during it.

You are being asked whether or not you want to participate in this study. If you wish to participate, and you agree with the statement below, please sign in the space provided. Remember, you may change your mind at any point and withdraw from the study. You can refuse to participate even if your parent/guardian gives permission for you to participate.

I understand the information provided in this form, agree to participate as a participant in this project.
___________________________________________ ______________________

Signature of participant Date

______________________________
Birthdate of participant

_________________________________________ ________________________
Signature of a witness 18 years of age or older Date

If you have any questions you may contact:

Primary researcher Faculty Advisor

Name Name

Phone Number Department and phone number

G. Sample Letter for Institutional Consent

Have institution print the consent on its letterhead and sign

To: Institutional Review Board
SUNY Brockport

I have read and approve the research study entitled, "________________________"
By _______________________________ [name(s) of primary researcher(s)] and give consent for the study to be conducted at or through _________________________(name of institution).

The institution may add any other appropriate requirements, such as so long as information regarding the study is shared with staff of the agency after the completion of the study, so long as parental permission is obtained, etc.

___________________________________ _______________________________

Signature Date

Title of person signing (representing the authority to give institutional permission)

H. Sample Category 3 Proposal

Human Subject Research Review Form (Category III)
Impulsivity in Children

1) Brief project description

Objectives and Purpose of the research
Impulsivity is a common child behavior. Impulsivity can be exemplified by choosing a small immediate reinforcer rather than a large delayed one. Impulsivity has been defined and measured in a variety of ways, including measuring hypothetical or real choices, questioning parents or teachers, questioning children themselves, measuring inhibition of responding, measuring reaction times or errors in responding, etc. Two common laboratory measures of impulsivity are the self-control paradigm and the delay of gratification paradigm. Researchers investigating children's choice behavior in each of these procedures have demonstrated that to some degree impulsivity is related to age, gender, and visibility of food cues. In addition, it has been suggested that children's degree of impulsivity may be related to parenting style.

There are three objectives of the current experiment: 1) To establish the concurrent validity of two laboratory measures of impulsivity-the self-control paradigm and the delay of gratification paradigm; 2) To examine the effects of visual food cues on choice behavior in these two paradigms; and 3) To examine the relationship between choice behaviors in these two paradigms and parenting style.

Methods and Procedure

When parents return a permission slip indicating potential interest in having their child participate in our study (see sample Parent Letter and Permission respectively), they will be called at home, will be provided with a description of the study and will be asked some questions (see Phone Protocol).

At the first session the participant's parent's consent will be obtained (see Consent Form) and the parent will complete the Background Questionnaire and the Parenting Questionnaire. Parents will be compensated for the time with $10.

The remaining seven sessions will involve the child only. Five of the sessions will expose the child to the self-control procedure, and 2 of the seven sessions will expose the children to the delay of gratification procedure and. For each of the sessions with the child, a research assistant will escort the child from their classroom down the hall to B-3.

For the self-control procedure sessions, the child will be seated in front of the Children's Choice Apparatus (for further detail of apparatus, see Form 101 #1) and be given a detailed explanation, demonstration, and practice of how to "play the Mickey game" (see Self-Control Experimental Script, for verbatim instructions, identical to instructions used by Forzano & Logue, 1995; Forzano, Szuba, and Figurilli, 2003; and Logue, Forzano, & Ackerman, 1996).

Each session will consist of 14 1-min trials (for identical procedure see Forzano & Logue, 1995; Forzano, Szuba, and Figurilli, 2003). At the beginning of each trial the white light in the middle of Mickey's nose is lit, signaling the availability of a choice. If the left button is pushed, a feedback click is produced, the white light is darkened, the green light above that button is lit, and the left-choice reinforcer delay begins. When this delay is over, reinforcement is delivered (i.e., the left drawer slides out from the apparatus and the participant opens the lid on top of the drawer, removes the food items, and eats them). When the food is removed from the drawer, the drawer slid back in, the green light above the drawer is darkened, and the ITI begins. The next trial begins with the reillumination of the white light in the middle of Mickey's nose. The sequence of events following a right button press is the same except that the red light above that button is lit and the right drawer slides out from the apparatus. During the reinforcer delays, the participant may change their choice by pressing the alternate button.

Each participant will be exposed to 1 training session and two experimental conditions (2 sessions each) for a total of 5 sessions. The first session will be a baseline (training) condition where participants will wait the same delay and will receive the same amount of reinforcement for both responses. For the experimental sessions for one alternative a 30-s prereinforcer delay will be followed by 3 food halves (the self-control alternative), and for the other alternative a 0-s prereinforcer delay will be followed by 1 food half (the impulsive alternative).

For two of the experimental sessions the participants will be exposed to visual food cues (seeing the food item) and for the other two they will not. Participants will be exposed to 1 session per day, approximately 5 days per week.

At the end of each session a participant will be asked questions about which button they liked to press more today (see Daily Self-Control Postsession Questionnaire), and will be asked if they would like to come and play the Mickey game again.

For the delay of gratification procedure sessions, the child will first be instructed on how to ring the bell to make the experimenter return to the room and be given practice doing that. Next the child will receive the delay-of-gratification contingency instructions and his/her comprehension of these contingencies will be assessed and consented to. The experimenter then either leaves the foods visible to the child or removes the cake tin with the food items (depending on the conditions), and records the wait-time (not to exceed 20 minutes). (see Delay of Gratification Experimental Script, for verbatim instructions, identical to instructions used by Mischel & Ebbesen, 1970; and Mischel, Ebbesen, & Zeiss, 1972).

At the end of the last session, the research assistant will complete the Debriefing Notification Form (attached) to be left for Dr. Smith. Within the next few days, if not immediately, Dr. Smith will contact the parent to discuss the study in more detail and answer questions.

2) Number and relevant characteristics of subjects

Approximately 40 children (20 male, 20 female) ages 3 through 5 will be needed. They will be recruited via letters sent home to parents at the Brockport Child Care Center. All children will be, according to their parents' statements, not diagnosed with ADD/ADHD or a learning disability, and not presently receiving any special educational services. Similar criteria have been used in previous research on self-control with children, with which I would like to compare the results of the experiment.

3) Description of how subjects will be selected for participation and description of remuneration to be received by subjects

Participants will be recruited by letters sent home to parents at the Brockport Child Care Center (see Parent Letter and Permission Slip). This recruitment device will indicate that: 1) children (ages 3 through 5) are needed for a study of children's choice behavior in the Department of Psychology at SUNY College at Brockport, 2) there will be one 15-minute session for the parents to complete two forms, for which they will be compensated $10, 3) there will be seven 20-min sessions for the child that will be scheduled while the child is enrolled in at the Brockport Child Care Center, and 4) if they are interested they should complete the Permission Slip so that they can be contacted to discuss the study further.

When potential participants' parents are contacted by the Experimenter, they will be screened to assure that their child satisfies the requirements of being 3 through 5 years old, and not diagnosed with ADD/ADHD or a learning disability, nor presently receiving any special educational services.

Children will receive M&M's or raisins, each session and play a fun game.

4) Status and qualification of research assistants

Aside from the principal investigator, 4 Junior and Senior level, Psychology major, undergraduates will be trained with regard to the safe and sanitary use of the equipment. Each of us has completed the online ethics training course.

All undergraduate students using this equipment will be students enrolled in PSH 499, Independent Study. The Independent Study course allows students to participate in a faculty-supervised research investigation. Students enrolled in this course have been carefully interviewed and screened based on previous knowledge in psychology, evidence of responsibility, and perception of enthusiasm and commitment to psychology and research, and have thus received the PI's permission to enroll in this course. In addition, these research assistants have had ample previous experience with children, a clear enthusiasm for working with children, and will, as required by the Brockport Child Care Center's state regulations, have both Child Abuse Clearance and a state fingerprinting criminal check.

All of the research assistants will be trained, via lecture, handouts of instructions, practice, and performance testing, on all aspects of running the equipment involved in this research. They will be trained in interacting will parents and children, and operating the apparatus. They will be trained as to the correct sterilization techniques for the apparatus, i.e., setting up apparatus for running a subject, cleaning up apparatus after running a subject, preparing sterilization solution, wiping down the apparatus with sterilization solution, and the gloved handling of foods, etc.

5) Source of funding

The PI will personally be funding this research project.

6) Expected starting and completion dates

starting date: November 2005 completion date: October 2006

7) Questionnaires and instructions to subiects

(see attached)

8) Transcipts of completion of online training course

(see attached)

9) Steps to guard anonymity of subjects and the confidentiality of their responses

Anonymity and confidentiality of participants and their responses will be maintained by not recording any names of participants except on consent forms which will be locked in the PI's laboratory. All results will be collected and identified by participant number. A master list matching participants' names and numbers will also be locked in the PI's laboratory. The master list will only be used to ensure that no child participates in subsequent related experiments.

All participant data will be stored in the PI's research laboratory for a minimum of 7 years after completion of the experiments. At that time, all data may be mechanically shredded and disposed of.

10) Informed consent document

(see attached)

11) Assurance from appropriate institution, if drawing subiects from a special institution which has the responsibility for the subjects

(see attached)

12) Specification of subject contact with equipment (Form 101)

(See attached)

13) Specification of special population

Children, ages 3 though 5 will be involved in this research. Written informed consent of parent or legal guardian will be obtained. After the procedures of the study are explained to the child, they will orally be asked if they would like to participate.

14) Psychological intervention,

(Not applicable-Participants will not be exposed to any intervention)

15) Treatments

(Not applicable-Participants will not be exposed to any treatments)

16) Possibility of injury

Potential minimal risk for choking. Note however, that no children have ever choked during any of our other studies. In addition, note that a number of precautions are taken to minimize the risk of choking, including: using mini M&Ms, using raisins that have been cut in half, dispensing of no more than 3 food items at a time, having the children immediately eat these food items and not store up large quantities, an additional research assistant will be viewing each session, close access to Brockport Child Care staff in case of an emergency, Heimlich maneuver poster displayed in lab, and research assistants will have familiarity with this maneuver.

Form 101--Research Utilizing Equipment

Impulsivity in Children

1) Identify and describe in detail the equipment to be utilized

The apparatus to be used is the Children's Choice Apparatus. This apparatus is identical to the apparatus used in approved IRB #99-9, IRB #99-121, and by Forzano and Logue (1995), Forzano, Szuba, and Figurilli, 2003, Logue, Forzano, and Ackerman (1996) and Logue and Chavarro (1992). This apparatus was designed and built under the direction of Richard Reeder by the Social and Behavioral Sciences Electronics Shop at the State University of New York at Stony Brook.

A diagram of the apparatus is attached. The apparatus is a wooden box (76 cm wide, 80 cm high, and 47 cm deep) with an open back. The front panel of the apparatus has a picture of Mickey Mouse's face painted on it with a white light in the middle of Mickey's nose. Below Mickey's face there are two lights. The left light can be illuminated green and the right light can be illuminated red. Located 10 cm below each light is a drawer (each 11 cm wide, 19 cm deep, and 6 cm high). The left drawer is green inside and the right drawer is red inside. During periods of reinforcer access the drawer emerges from the panel. This forward movement causes the drawer to protrude 13.5 cm from the panel and thus allows the subject to open the lid of the drawer and remove the reinforcers. At all other times the drawers remain closed, flush with the front of the apparatus. In front of each drawer, on the base of the apparatus, is a button. This button produces a feedback click when activated.

The panel also will contain a Plexiglas box, located above the drawers. This box, filled with M&M's, or raisins and will allow full view of the food cues. For half of the sessions this box will be filled, and for the other half of the sessions it will empty.

Behind the front panel of the apparatus are electromechanical switches and timers that control the experimental events. The Experimenter sits in back of the apparatus, unobserved by the subject, and operates the apparatus and records the subject's responses. The subject sits in the small chair in front of the apparatus.

2) Identify and describe in detail how the Participant will interact with the equipment

For each of the self-control procedure sessions, approximately 14 minutes each, subjects will be seated in a chair in front of the Children's Choice Apparatus. Each session will consist of 14 1-min trials. At the beginning of each the white light in the middle of Mickey's nose is lit, signaling the availability of a choice. If the left button is pushed, a feedback click is produced, the white light is darkened, the green light above that button is lit, and a left-choice reinforcer delay begins. When this delay is over, reinforcement is delivered: The left drawer slides out from the apparatus and the subject opens the lid on top of the drawer, removes the food items, and eats them. When the food is removed from the drawer the drawer slides back in, the green light above the drawer is darkened, and an ITI begins. The next trial begins with the reillumination of the white light in the middle of Mickey's nose.

The sequence of events following a right button press is the same except that the red light above that button is lit and the right drawer slides out from the apparatus.

3) Indicate the exact location of the equipment

The experiment will be conducted in a small room inside of room B-2 of Cooper Hall. In the middle of the room is a table with chairs both in front and in back. The experimental apparatus, the Children's Choice Apparatus, is placed on the table.

4) Indicate the names and qualifications for all individuals authorized to use the equipment

The principal investigator for this research project is Martha Smith. For a summary of the PI's qualifications please see the attached abbreviated CV. The PI has successfully completed and published the results of many experiments, which have all involved the use of virtually identical equipment and procedures. In addition, every semester for the past 13 years at SUNY College at Brockport the PI has supervised numerous undergraduate research assistants (in Research Topics in Learning and Motivation, and in Independent Studies). Each of these supervisions involved providing the research assistants with extensive training on how to conduct the actual experiments (how to recruit subjects, how to interact with subjects, how to deliver specific scripts to subjects, how to administer various psychological assessments, how to operate computer equipment and programs, how to operate electromechanical apparatuses, etc.).

Aside from the principal investigator, 4 Junior and Senior level, Psychology major, undergraduates will be trained with regard to the safe and sanitary use of the equipment. Each of us 2
has completed the online ethics-training course.

All undergraduate students using this equipment will students enrolled in PSH 499, Independent Study. The Independent Study course allows students to participate in a faculty-supervised research investigation. Students enrolled in this course have been carefully interviewed and screened based on previous knowledge in psychology, evidence of responsibility, and perception of enthusiasm and commitment to psychology and research, and have thus received the PI's permission to enroll in this course. In addition, these research assistants have had ample previous experience with children, a clear enthusiasm for working with children, and will, as required by the Brockport Child Care Center's state regulations, have both Child Abuse Clearance and a state fingerprinting criminal check.

All of the research assistants will be trained, via lecture, handouts of instructions, practice, and performance testing, on all aspects of running the equipment involved in this research. They will be trained in interacting will parents and children, and operating the apparatus. They will be trained as to the correct sterilization techniques for the apparatus, i.e., setting up apparatus for running a subject, cleaning up apparatus after running a subject, preparing sterilization solution, wiping down the apparatus with sterilization solution, and the gloved handling of foods, etc.

5) Indicate in detail specific steps that will be taken to assure the proper operating and maintenance of the equipment

As indicated above, all Research Assistants will be trained in the proper operating of the apparatus. They will all be exposed to lectures and demonstrations regarding the use of all equipment. They will each receive, for their own reference and review, handouts specifying all steps necessary to operate all equipment. All of the research assistants will also practice all procedures in pairs and will be tested on their performance of operation by the PI.

To monitor continued proper operating of all equipment, the Research Assistants will be instructed to monitor each other's performance and to note to PI any deviations for prescribed protocol. In addition the PI will do random spot checks of the equipment.

F. IRB Proposal Checklist (used by IRB reviewers to evaluate each proposal)
Project Description:
Item #1 _____State purpose of the research -
how the proposed study is beneficial to new knowledge/why is the research important?

_____ purpose need to be restated in the informed consent for potential
participants to know the potential value of the research study.

Item #2 _____ the number of participants should be consistent in all parts of the
proposal and in the informed consent, cover letters, etc.

Item# 3 _____ Methods for data collection should be consistent throughout the proposal and the informed
consent regarding questionnaire/survey, interview, audiotaping, videotaping, observations, use of
materials already required for classroom work, etc.

Item #4 Research Instruments:
_____cite sources on each page of instruments if not self-designed
_____explain who designed questionnaire

When using published or unpublished evaluation or measurement tools, surveys, etc. the source
should always be cited on each page of the tool in addition to citing the source in the proposal.
Permission forms to use tools should be attached to the proposal whenever it is required to obtain
such permission.

Institutional Permission:
________ preferable that the permission be on agency letterhead and signed by an employee who has
authority to give permission. (Permission is needed from an organization, business, school, etc.
to recruit participants from its membership, conduct surveys on its premise, etc.). The
investigator can compose the letter and ask organizations to copy it onto letterhead and then
sign and submit it.

Informed Consent Forms:

_______check for consistency between the proposal and consent form for number of participants, forms of
data collection, protection of the identity of the participants as well as organizations from which
recruited.

______ indicate affiliated with SUNY Brockport and include the Department

______ state risks are not anticipated or that time spent or fatigue can be a minor risk

______ if participants will have face to face interviews or be audio or videotaped, then signed consent
forms are needed

______ include the names and phone numbers of both the principal investigator( s) and the faculty
member. If children are part of the research, then both parent consents and child assents should
be developed
______ include statement of " I am 18 years or older. . ." for all adult consents.

Overall
______ proofread and correct proposal, informed consent, and/or questionnaire
_____ check for consistency between the proposal, hypothesis, informed consent, and data collection
instrument.