Application for Prior Approval of Research

Replace red italicized text with information relevant to your research study.

Name of Instructor:Mrs. Barbara Khirallah

Department:Education

Course(s):Edu/Psy 3327 Child Growth and Development

Name(s) of investigator(s):

Include thename, classification, major,andemail addressforeachUD student involved in the research study as shown in the example below:

  1. Last name, First NameJuniorPsychology majorEmail Address
  2. Last name, First NameJuniorEducation major Email Address

Identity of sponsor(s):NA

Source(s) of funding:NA

Objective(s) of research:

  1. Write one sentence (two maximum) to explain the purpose of the research study,AND
  2. Include the research questions that drive the research study.

N. B. If you have completed the Theoretical Foundation portion of the proposal, then you will be able to copy/paste the relevant information from there.

Example of the precision required in this section:

The purpose of this research study is to investigate whether there is a correlation between evaluated levels of conservation achievement as determined by performances on specified Piagetian conservation tasks and evaluated levels of moral reasoning as determined by responses on a specified Kohlberg dilemma.In particular, this research study seeks to answer the following questions:

(1)Do conserving children achieve a higher stage of moral reasoning than non-conserving children as indicated on Kohlberg’s stage theory of moral development?

(2)Do children who can conserve volume achieve a higher stage of moral reasoning than children who can only conserve number as indicated on Kohlberg’s stage theory of moral reasoning?

(3)Are there patterns of difference among conserving boys and conserving girls with respect to their stages of moral reasoning?

Begin date of research:March 9, 2018End date of research:May 1, 2018

Suggestion:Give yourself more time than needed in case there is a delay in getting your application approved. I suggest one-two months even though you may be collecting data for only a few days.

Scope of concrete activities:

This section must provide specific details of what you will ask or do with the study participants. Thus, if you are going to interview them, then you must provide a copy of all interview questions. If you are going to ask students to fill out a questionnaire, then you must provide a copy of the questionnaire. If you are going to ask children to draw a picture, then you need to include the specific instructions that you will offer the students. Here is an example of the precision needed in this section:

Example:

Researchers will visit the research site (provide name of school, place, home, plus address, etc.) three times. The researcher will work with 5 boys and 5 girls from kindergarten, 5 boys and 5 girls from 2ndgrade, and 5 boys and 5 girls from 6thgrade. :

  1. On the first visit, the participants will complete the number conservation task. (See Appendix One at the end of this document.) The Researcher(s) will record results on the Number Conservation Task Worksheet.

•BE SURE TOINCLUDE THE ACTUAL DOCUMENT/INSTRUMENT TO BE USED WITH THE CHILDREN. As an example, the Number Conservation Task Worksheet can be found at the end of this document. It is labeled Appendix One.

  1. On the second visit, the participants will complete the volume conservation task. (See Appendix Two at the end of this document.) The Researcher(s) will record results on the Volume Conservation Task Worksheet.

•BE SURE TOINCLUDE THE ACTUAL DOCUMENT / INSTRUMENT TO BE USED WITH THE CHILDREN. As an example, the Volume Conservation Task Worksheet can be found at the end of this document. It is labeled Appendix Two.

  1. On the third visit, the researcher will read a Kohlberg dilemma to each student individually and then ask each student to respond orally to a set of questions relevant to the dilemma. The Researcher(s) will record responses on the Kohlberg Dilemma Interview Protocol. (See Appendix Three at the end of this document.)

•BE SURE TO INCLUDE THE ACTUAL DOCUMENT/INSTRUMENT TO BE USED WITH THE CHILDREN. As an example, the Kohlberg Dilemma Interview Protocol can be found at the end of this document. It is labeled Appendix Three.

General identification of the subjects of research:

1. Identify all grade levels and ages of the students that will be involved in the study

2.Describe the location/context where interaction with children will occur (in other words,provide the name and address of the schooland/or agency, name/address of family, and any other pertinent information that identifies the children in the study.

Example:

Researchers will conduct their research atName of School/Family Home/Agency PLUS Address. Researchers will work with 5 male students and 5 female students from each of the following grades: Kindergarten, 2nd, and 6thgrades.

Specific investigational techniques to be used:

Identify techniques and procedures to be used.

Examples:

The researchers will perform the conservation tasks as described in Appendix One and Appendix Two. The researchers will work with one child at a time, read the script exactly as written, and record results on the Conservation Data Collection Instrument. See a copy of this instrument in Appendix Four.

In addition, the researcher(s) will conduct a face-to-face oral interview with each child. The researcher will read the Kohlberg Dilemma to each child individually and then ask specific questions relevant to the dilemma. The researcher will record in writing the child’s responses under each question on the Kohlberg Dilemma Interview Protocol. Each participants will be identified only by gender and age. The Kohlberg Dilemma Interview Protocol is available in Appendix Three.

A Second Example:

The researcher(s) will visit the classroom three (3) times. During each visit, the researcher will observe and record the movement and interactions among the students and teacher based on the strict criteria and questions established in the Classroom Observation Instrument. The researcher will use the representative diagram of the classroom on the Classroom Observation Instrument to record all interactions and to write notes. No teacher and/or student names will be collected. Instead, all students and the teacher will be assigned numbers, such as B1, B2, G1, G2, T (to indicate boy students, girl students, and the teacher).

A Third Example:

The researcher(s) will meet with and distribute questionnaires to a selected group of 4th, 5th, and 6th grade students who have signed assent forms agreeing to participate in the study and whose parents have completed, signed, and returned the parent consent forms agreeing to allow their children to participate in the research. The researcher(s) and students will meet in the library at XYZ School for 30 minutes. During that time, researchers will distribute the questionnaires and ask students to respond in writing to the questions. All questionnaires will be anonymous. No names will be written on the questionnaires – participants will identify themselves only by gender and age. A copy of the questionnaire is attached. Responses from the questionnaire will later be coded, sorted, and analyzed.

A Fourth Example:

The researcher(s) will conduct a face-to-face oral interview with each child. The researcher will read the Kohlberg Dilemma to each child individually and then ask specific questions relevant to the dilemma. The researcher will use video recording equipment (video camera) to record the all interactions between the researcher(s) and children. All responses to each question on the Kohlberg Dilemma Interview Protocol will be recorded on video tape. Each participant on the video will be identified only by gender and age. The Kohlberg Dilemma Interview Protocol is attached.

N.B. In cases where researcher(s) plan to record participants using video and/or audio equipment, they may need to distribute and collect separate, specialized consent and assent forms from parents, administrators, and children.

Notes to Researchers:

Remember to include at the end of the application all ACTUAL instruments / tools / instructions to be used directly with the children in the study. Remember, this means that if you are planning to interview children, then you must provide the interview questions. If you are planning to give students a paper and pencil task to perform, then provide a copy of the directions and any instrument that you will distribute to the students. Examples of ACTUAL instruments are found in Appendices One, Two, and Three.

How the results of the research are expected to be published or otherwise disseminated or used:

Important Information: Include a statement similar to the following:

All raw data and results from the research study will be collected and submitted for a grade to Barbara Khirallah, a faculty member in the Department of Education at the University of Dallas. In addition, the researcher(s) will present the study, its data, and results to the Child Growth and Development class during an oral, formal presentation. Outstanding research studies may be available online in future semesters as examples.

Please explain briefly the justification for involving human subjects in the proposed research:

Here, you need a statement justifying the involvement of human subjects in the proposed research.Use information learned during the Human Subjects Research Tutorial to craft a statement that insures the safety and well-being of all participants of your study. The following is an example of a statement that you might include:

Since I/we are studying ______(your topic/concept) and ______(your topic/concept), theoretical models or animal subjects are not sufficient to complete our research.

Please specify the concrete measures to be taken to safeguard the rights and welfare of the human subjects:

The following statement is an excellent statement to modify and adapt for this portion of the IRB application. Do NOT take short cuts or abbreviate details in this section of the IRB as this is the section that is most closely scrutinized by the University of Dallas IRB.

Because the researchersunderstand the importance of the privacy, safety, and well-being of children, we have taken the following steps to protect the children in our research study. First, we have earned certification from the National Institute of Health on the protection of children in research studies. Second, we will collect no personal information about the child. Each child in the study will be identified only by number (here include the exact information that will be collected and used to identify the children in your study), and it will not be possible to match a child, his/her family, or school with any of the data collected. In addition, no mention of names, families, schools or the addresses where the research takes place will be included in any of the information publicly presented or made available.Furthermore, the researcher(s) will safeguard all recorded data collected by securing it in – choose the one that best fits your study (1) a password-protected folder on a password-protected computer or (2) a locked file cabinet / drawer to which only the researcher(s) have access. Only the researcher(s) and the course instructor (B. Khirallah) will have access to any information that identifies the child by name, family, school, or specific location.Third, the parent and the school administrator are required to sign consent letters before the child can participate in the study. Fourth, the child has to voluntarily agree (in writing) to participate in the study. Finally, the school administrator, parents, teacher, or the child can withdraw participation at any time during the study.

The parent's decision to allow any child to participate in this study and the child’s decision whether or not to participate are completely voluntary, and there are no negative consequences for those who do not wish to participate. And, to the best of our knowledge, for those who do participate, there are no known economic, legal, physical, psychological, or social risks to any child – either now or in the future. While we understand that it is not possible to identify all potential risks in a research study, we do believe that we have taken reasonable safeguards to minimize both the known and the potential, but unknown risks.

Required Attachments:

*(NIH) Certificate of Completion for“Protecting Human Research Participants”.

YouMUSTinclude a copy of the certificate you earned for completing the National Institute of Health “Protecting Human Research Participants” tutorial.The certificate cannot be more than one year old. The tutorial is available on the Internet at the following URL:

Below is a Sample Certificate from the NIH:

Certificate of Completion for “Protecting Human Research Participants”

/ Certificate of Completion
The National Institutes of Health (NIH) Office of Extramural Research certifies that Your Name Here successfully completed the NIH Web-based training course “Protecting Human Research Participants”.
Date of completion: 00/00/2012
Certification Number: XXXXXX
/

*Consent Letter(s):

YouMUSTinclude with your IRB application permission letters that include signature and date lines for collecting the consent signature(s) of those adult(s) responsible for the children to be involved in the study and the dates on which they gave consent.

(1)CREATE ONE LETTER FOR PARENTS / GUARDIANS – students who conduct their studies at HFN may use a common consent form. See B. Khirallah for more information.

(2)CREATE ONE LETTER FOR THE SCHOOL / AGENCY ADMINISTRATOR – students who conduct their students at HFN are exempted from this requirement

Below is a sample parent consent letter:

DearParent[B1]

I/We am/are(two)University of Dallas (UD) students enrolled in Child Growth and Development, under the direct supervision of Ms. Barbara Khirallah, a faculty member in the UD Department of Education. I/We am/are required to conduct a research study involving children. Weask for your consent to allow your child’s participation in our study. [Here explain exactly what is expected of the children in the study. The following is an example:During the study, children will complete three tasks. First, they will examine groups of pennies and answer oral questions about which group has more pennies and why. Second, they will watch water poured into different cups and answer oral questions about which cup has more water and why. Third, they will listen to a brief moral dilemma and answer oral questions about whether the choice made by a character in the story was right or wrong and why. We will record all of the children’s oral responses on paper and then later analyze them for insights into the development of children’s thinking and moral reasoning.

Because[B2]we understand the importance of the privacy, safety, and well-being of your child, I/we have taken the following steps to protect the children in our research study. First, we will collect no personal information about your child, family, school, or its specific location. Your child will be identified only by number, and it will not be possible to match him or her, his/her family, school, or specific location with any of the informationcollected. Second, you, the parent (and the school administrator – if study is at a school) is required to sign a consent letter before your child can participate in the study. Third, your child has to agree (in writing) to participate in the study. Fourth, you, the parent (plus teacher and administrator – if at a school) or the child can withdraw participation at any time during the study.Finally, the research has been approved by the University of Dallas Institutional Review Board, whose charge is to protect the well-being and rights of human research participants. If you have any questions about the rights of your child(ren), please contact Dr. Gilbert Garza, Chairman of the University of Dallas Institutional Review Board, at .

Your[B3]decision to allow your child to participate in this study and your child’s decision whether or not to participate are completely voluntary, and there are no negative consequences for those who do not wish to participate. And, to the best of our knowledge, for those who do participate, there are no known economic, legal, physical, psychological, or social risks to any child – either now or in the future. While we understand that it is not possible to identify all potential risks in a research study, we do believe that we have taken reasonable safeguards to minimize both the known and the potential, but unknown risks.

Because I/we actually believe that your child will enjoy participating in the study and consider it fun, I/we are hopeful that you will give consent. If you have any questions or concerns about the nature of this study, please contact:

Name, Telephone, Email of Researcher1[B4]

Name, Telephone, Email of Researcher 2

Ms. Barbara Khirallah (972-721-5334) Email:[B5]

Sincerely,

______

(Researcher Signature)(Researcher Signature)

Parent and/or Guardian, your signature below indicates that you have read and understood the information provided above, that you willingly agree to allow your child to participate, that you and/or your child understand that you may withdraw consent at any time and discontinue participation without penalty, that you have received a copy of this consent form, and that you are not waiving any legal claims.

Name of Child ______Parent Signature______(Date______

[B1]Sample letter for parents – Also needed is a letter to the School Administrator or the person in charge of a facility if you are conducting research outside the home. This letter can be slightly modified to serve as the administrator’s letter.

[B2]Required statement.

[B3]Required statement.

[B4]Be sure to include the names of all researchers, their telephone numbers, and email addresses.

[B5]Required information.

*Assent Form(s):

YouMUSTcreate and include with your IRB Application AN ASSENT FORM to be signed by the actual children to be involved in the study.Assent form(s) should be written in a language that allows the child to understand what he/she is agreeing to voluntarily participate in the research study. Thus, if you are using widely different age groups in your study, you may need different assent forms for different ages.