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Please use this form for all new initial applications for the Institutional Review Board. Initial Application Data Entry Instructions Most applications at La Verne fall under exempt review. Please review our exempt decision charts website and exempt application policy before starting your application to ascertain if you have an exempt study. Human Subjects Research Is this human subjects research? Yes Select "No" if this is a secondary data study or other type of research that does not use human subjects (e.g., analysis of policy). Review Type Determination Are you a researcher who is NOT affiliated with University of La Verne? No The worksheet below will help you to determine if you should apply for an exemption (exempt review) or if your application is a better fit for an expedited or standard review. Does your study completely fall into any of the exemption categories listed below? None of these categories apply. You must have reviewed the federal regulations at 45 CFR 46.101(b) prior to making a selection as the categories are summarized from the regulations and are not comprehensive. View xForm Initial La Verne IRB Application V2

Transcript of Stage Initial Application Data Entry of xForm Initial La ... · 6/6/2017  · $ uh \ r x d uh v h d...

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Please use this form for all new initial applications for the Institutional Review Board.

Initial Application Data Entry

Instructions

Most applications at La Verne fall underexempt review. Please review our exemptdecision charts website and exemptapplication policy before starting yourapplication to ascertain if you have anexempt study.

Human Subjects Research

Is this human subjects research?

Yes Select "No" if this is a secondary data studyor other type of research that does not usehuman subjects (e.g., analysis of policy).

Review Type Determination

Are you a researcher who is NOT affiliated with University of La Verne?

No

The worksheet below will help you to determine if you should apply for anexemption (exempt review) or if your application is a better fit for an expeditedor standard review.

Does your study completely fall into any of the exemption categories listed below?

None of these categories apply. You must have reviewed the federalregulations at 45 CFR 46.101(b) prior tomaking a selection as the categories aresummarized from the regulations and are notcomprehensive.

View xForm ­ Initial La Verne IRB Application V2

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Your study is better suited as an expedited or standard review application. Pleasereview the IRB Policies and Procedures for determining the best review type and selectthe appropriate review type (expedited or standard) on the next page.

Click "Next" to continue.

Application Header and Instructions

Select the appropriate review for your application

Expedited Use the results of the exempt worksheet onthe prior page and review the La Verne IRBPolicies and Procedures to determine yourreview type.

Submitter

Putter, NatashaEmail: [email protected] Phone:

Title of proposed research study:

Teacher perceptions of the student transition from Elementary to Middle School: A qualitativestudy

Principal Investigator (PI) email address: the name will populate once youmove to the next question

Putter, NatashaEmail: [email protected] Phone:

Please enter the email address of theprincipal investigator. If you are the principalinvestigator please enter your own emailaddress.

Choose the most appropriate research category for this application.

Doctoral Dissertation If you are an external researcher wishingto conduct research at La Verne, select"Outside Research by Non­AffiliatedResearcher"

Principal Investigator (PI) Position:

Doctoral Student Enter the appropriate position for theprincipal investigator.

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Chair/Advisor/Mentor email address:

Chrisco, Kanya Godde Ph.D.Email: [email protected] Phone:

Provide the email address of your supervisor.If you receive a message stating "Contactnot found." it simply means yourChair/Advisor/Mentor does not yet have anIRBManager login. You can click here tocreate a new contact for them right now, andthen continue filling out this form.

Mentor Email StatusNo

Please list the names of all members of your Masters or Dissertation Committee

Arthur Doyle John Watson

Human Subjects Training Attachment

tbd Required Human Subjects TrainingCertification

Attach your NIH or CITI training certificatehere.

Do you have a funding agency associated with this proposed research study.

No

Choose the most appropriate La Verne on­campus department/program.

Education and Teacher Development Program

In which college is your program/department housed?

La Fetra College of Education

Have you reviewed the La Verne IRB policies and procedures located on the on the IRBwebsite?

Yes If you have not reviewed the website, pleasemake sure to review it(http://sites.laverne.edu/institutional­review­board/policies­and­procedures/) prior tosubmission of your application.

Do you have additional proposed research personnel associated with this study?

No Additional proposed research personnel mayinclude; advisor, students, mentor, otherinvestigators, research coordinators, etc...

This field automatically populates the date of your first submission. No action isrequired by you.

5/16/2017

Study Details

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Briefly describe the purpose(s) of the study (include research questions,hypotheses and key variables):

The purpose of this qualitative case study isto explore the perceptions of sixth and eighthgrade teachers regarding students’ academic,procedural, and social concerns intransitioning from elementary school tomiddle school, and to explore teachers’thoughts concerning effective transitionstrategies and activities that will supportstudents in this transition.

This study aims to explore the followingcentral research question: What are the perceptions of sixth andseventh grade teachers regarding the studenttransition from elementary to middle school?

The following sub­questions will also beaddressed in the study:What are the perceptions of sixth grade andseventh grade teachers with regard to theacademic concerns of students whentransitioning from elementary to middleschool?What are the perceptions of sixth grade andseventh grade teachers with regard to theprocedural/organizational concerns ofstudents when transitioning from elementaryto middle school?What are the perceptions of sixth grade andseventh grade teachers with regard to thesocial concerns of students whentransitioning from elementary to middleschool?What do sixth grade and seventh gradeteachers regard as effective strategies oractivities to ensure a successful studenttransition from elementary to middle school?

Give as many details as possible for studypurpose. If this is a Senior Thesis orGraduate Capstone that you plan onpublishing/presenting, you are required tostate this in your application, here.

­or­

If your study does NOT have researchquestions, hypotheses, and/or variables asa result of experimental design, pleasestate this for auditing purposes (e.g. state,"A XX (study type) study does not requirethe use of variables”).

Will all participants be age 18 or older?

Yes

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Describe the characteristics of the expected sample of human participants (i.e.,inclusion and exclusion criteria):

The targeted sample size for this study istwelve (12) teachers, six (6) at the sixthgrade level, and six (6) at the seventh gradelevel. Only teachers meeting the followingeligibility criteria (Appendix XX) will beselected for participation in this study:Teach primarily sixth or seventh grade. Thisis defined by the researcher as a teacher whoteaches at least 3 periods of seventh gradestudents (at the elementary school level) or3 periods of seventh grade students (at themiddle school level) Have taught at least five years Have taught the last three years at the sameschoolAre teachers of English/Language ArtsBe at least 18 years of age

Please make sure to include all characteristicsassociated with the population (e.g. age range,total number of participants, gender, inclusion orexclusion criteria, how you plan to gain access tothe potential participants, etc...)

What is your expected (maximum) sample size?

12 Number of total (or maximum) participantsexpected to recruit for this study.

Please check any of the following “vulnerable populations” included in your proposedsample.

No Vulnerable Populations Proposing to study any of these populationsmay require full (standard) La Verne IRBreview.

Recruitment

Will you be recruiting participants (asking people to take part in your study)?

Yes

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Participant Recruitment Description

Purposeful sampling will be used to selectparticipants for this study. Purposefulsampling is appropriate for this case studysince the researcher desires to findparticipants that can provide directknowledge of the phenomenon beingexplored.

Participants will be recruited via a massemail (recruitment letter) sent to school siteprincipals in districts that have granted theresearcher permission to interview teachers(Appendix E). These emails will aim to solicitthe teachers meeting the criteria forparticipation and will request theirparticipation in the study. If willing, [­participants will be asked to contact theresearcher using the information provided inthe recruitment letter. Upon agreeing toparticipate in the study, each participant willbe sent an informed consent document andwill be asked to provide possible dates andtimes for a one­on­one in person interview.

The researcher has secured authorization tointerview teachers in the Chesterton PineUnified, Pan Diablo Unified, and WaverlySchool Districts (Appendix D).

Describe how participants will be recruited orselected. This should include describing howflyers will be posted, how participant emailswill be obtained for emails to be sent, etc.

Recruitment Sources

Chesterton Pine Unified, Pan Diablo Unified,and Waverly School Districts

From what source(s) will you be recruiting,e.g., hospital, institution, school, class,shopping mall, etc.?

Attach your recruitment materials.

Recruitment Letter Recruitment Materials Attach any recruitment materials, e.g.,letters, postcards, flyers, for IRB review andapproval.

All recruitment materials are required tobe attached to the application duringsubmission if you plan to email, postflyers, or use any other written materialsfor recruiting participants.

Please refer to the IRB Policies andProcedures for information regarding thispolicy.

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Will you need permission to recruit from institutions/agencies from where you arerecruiting participants and/or to name the organization inpresentation/publication/dissemination of the findings?

Yes All permissions to recruit participants orname the institutions/agencies duringdissemination are required to besubmitted with your application.

Please refer to the IRB Policies andProcedures for more information.

Attach organizational permissions for recruitment purposes.

RecruitmentLetter

Off­Site Letters ofApproval/Permissions

Attach letters of permission from allparticipating organizations/off site locationson their official letterhead and/or IRBapproval from the organization related torecruitment.

Contact details for the affiliated organization (for recruitment purposes).

Susie QChesterton Pine Unified, Pan Diablo Unified, Waverly School Districts (xxx)xxx­xxxx [email protected]

Please include affiliated organization nameand contact (person affiliated with researchand organization) details (including emailaddress and phone number).

Proposed Protocol

Data Collection Method (check all that apply)

In person interviewTelephone Interview

Please attach the final version of the survey, interview script, focus group materials,etc. you propose to administer.

tbd Survey/Interview Script

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What will you do with the human participants?

1) Participants will be recruited via a massemail (recruitment letter) sent to school siteprincipals in districts that have granted theresearcher permission to interview teachers.These emails will aim to solicit the teachersmeeting the criteria for participation and willrequest their participation in the study. Ifwilling, participants will be asked to contactthe researcher using the information providedin the recruitment letter. Upon agreeing toparticipate in the study, each participant willbe sent an informed consent document andwill be asked to provide possible dates andtimes for a one­on­one in person interview.

2) The researcher has secured authorizationto interview teachers in the Chesterton PineUnified, Pan Diablo Unified, and WaverlySchool Districts.

3) Interview questions will be asked aboutperceptions of students. The data that will becollected include perceptions only.

4) Interviews will be scheduled for 60minutes, and will last a minimum of 30minutes. Teachers will be asked to beavailable for a follow­up interview of 5­20minutes in the 2­4 weeks following the initialinterview to verify transcripts of the interviewby the researcher participant and if anyadditional questions by the participant needto be answered.

Describe in detail all the methods andprocedures that involve humanparticipants. This section should help theLa Verne IRB Committee understand frominitial contact to completion of theresearch protocol what will happen toparticipants and is the most importantpart of your application. State thefollowing in chronological order andnumber your answer: 1) what theparticipants will be asked to do, 2) wherethe research will occur, 3) what measureswill be used (e.g. test), what data andinformation will be collected, and how, and4) how long it will take to complete theinstrument and/or task (if multiple items,break down by item).

Will you be using audio/visual recording?

Yes

What type of recording will you be using?

Audio

If participants do not agree to be recorded, can they still participate?

Yes

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State when (approximate dates) and where the activities involving human participantswill take place. The beginning date must be after IRB approval. If location(s) requirepermission(s), please attach authorization letters. For on campus research use "LaVerne," otherwise state location.

LocationStartDate End Date

Covina,Ca;Palmdale,CA; Glendora, CA

4/28/2016 4/28/2017

Type in the location, select the appropriatedates, and click "Save."

Are location permissions needed for the proposed research?

Yes If the research takes place at a location off­campus (any non­La Verne campus),permission may be required for the researchto be conducted there. Examples couldinclude school districts, institutions of highereducation, businesses, etc. Thisis different than recruitment locations.

All permissions are required to besubmitted with your application. Pleaserefer to the IRB Policies andProcedures for more information.

If location permission(s) is/are needed, please attach authorization letters.

Location Permissions Off­Site Letters of Approval/Permissions

Is an off­site location IRB involved with the review of this application?

No All permissions from the off­site IRB arerequired to be submitted with yourapplication. Please refer to the IRBPolicies and Procedures for moreinformation.

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Copyright Permissions Signature By signing below you are agreeing to the following: 1) you have reviewed theUniversity policies prohibiting misappropriation of research and agree to conductyour proposed research in accordance with such policies; 2) you understand that itis your responsibility for determining and obtaining appropriate and correctpermission(s) to use instruments, measurements, scales, etc. as dictated by eachindividual item created by someone other than you that you use in your study, 3)you are following the La Verne policy on Copyright, which can be reviewed byclicking here, 4) that you have already determined and obtained the appropriatepermissions for the materials you have attached as a part of this IRB application, 5)you understand that the IRB does not provide approval for or take anyresponsibility for the acquisition of necessary permissions for using work bysomeone other than yourself, and 6) you agree to indemnify and hold harmless theUniversity, the IRB and individual members of the IRB for any claims and liabilitiesresulting from your failure to obtain the necessary and correct permissions for thestudy as submitted in this application.

Signed Tuesday, June 6, 2017 1:14:59 AM ET by Chrisco, Kanya Godde Ph.D.

Inducements

Are incentives being offered to participants?

No Will you offer money or other incentives forparticipants' time?

Proposed Risk

What level of risk does this research present to the dignity, rights, health, welfare, orprivacy of the participants?

Minimal Risk to Participants No Risk to Participants may require anNHSR or Exempt IRB review

Minimal Risk to Participants may requirean Expedited IRB review

More than Minimal Risk to Participantsmay require a Standard IRB review

If unsure what you should select, please visitthe La Verne IRB policy webpage for moredetailed explanations.

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What type of risk is present in the proposed study?

IdentifiablePsychological Social Group Status

Consider: 1) identifiable (the participants'identities can be traced, which can happenin confidential studies), 2) physical(more than the participant may encounteron a daily basis), 3) psychological (morethan the participant may encounter on adaily basis), and 4) social or group risk(when a participant belongs to agroup, is employed, or is a studentand their status may be in jeopardy orimpacted by participating or not in theresearch).

Select options that describe the identifiable risk in your study.

Data are confidential, but protected Only describe identifiable risk

Select options that describe the psychological risk in your study.

Discomfort may result from sensitive questions

Select options that describe the social group risk in your study.

Teachers may experience discomfort answering questions about their institution

Is the risk more than everyday life in your study?

No Please select the appropriate answer for yourstudy. If it is more than everyday life,referrals are required by the IRB.

Please select what you will implement in your study from the following safeguards(check all that apply):

Using strong confidentiality procedures (see Confidentiality Procedures below for moreinformation)Referral to 3 community psychological referrals

Will you be adding the following safeguard to your study and specifically state it in theinformed consent? Safeguard: The participants' positions with their employer,institution, school, etc. will not be jeopardized by participating or not, nor by thecontent of their answers.

Yes

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Describe any benefits to the participant(s) and/or society that may reasonably beexpected from the research.

There are no direct benefits to participants asa result of participating in this study.Participants may however, be prompted toreflect on their practice as a result of theirparticipation, thereby providing them with anopportunity for professional growth.

In addition, this study will add to theknowledge and literature regarding thetransition from elementary school to middleschool. The results of this study may serveto inform schools and districts looking todevelop successful elementary to middleschool transition programs or strongarticulation programs between teachers atthe elementary school and middle schoollevels.

Provide a summary of research findingswhere appropriate, benefits to organizations,professionals, the discipline, or others.

Please select the appropriate description of your study.

Confidential ­ identifiers are present in thedata, but you will not be sharing thisinformation in a manner that can be tracedback to a specific individual, thus protectingthe participant

Most studies are EITHER confidentialOR anonymous. If you have designed astudy thatis only confidential or anonymous, please beconsistent throughout the application andonly use the appropriate term (i.e., don't usethe terms interchangeably)

Check all confidentiality/anonymity procedures you have put in place. Per the La VerneIRB Policies and Procedures, signed informed consent forms must be stored for 3years.

Use of protocol numbers that do not link participants to answersInstitution at which research is conducted will not be namedSigned consents will be stored separate from data so they cannot be re­associated Signed consent forms will be stored for 3 years and then destroyed (REQUIRED IF USINGCONSENTS IN YOUR STUDY) Data will be stored for 3 years and then destroyed (REQUIRED) Audio/visual transcription will be conducted by you

Non­Electronic Storage Procedures

Storage will be in mentor/chair/advisor's office Consents will be stored in a locked cabinet (DO NOT SELECT THIS OPTION IF YOU ARESTORING ONLINE OR ON A PASSWORD PROTECTED COMPUTER THAT CANNOT BE LOCKED INA CABINET)

Electronic Storage Procedures

Data will be stored on a password protected computer (DO NOT SELECT THIS OPTION IF YOUARE STORING PAPER COPIES, ONLY) Data will be stored in a password protected file (DO NOT SELECT THIS OPTION IF YOU ARESTORING PAPER COPIES, ONLY)

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Who all will have access to the data and/or consents/assents?

Me the researcher, and mentor Please name all people and their associationto this study with access to the data and/orconsents/assents.

Will a form of debriefing be needed for this study protocol or for this population?

No If sensitive issues are raised in the researchprotocol, or if deception is used, describe thenature of any debriefing of subjects. (If not,state "No debriefing", and justify yourdecision.)

Informed Consent

Choose your informed consent option.

Informed Consent and/or Informed Assentrequired

An informed consent is the standard(typical) format (paper, oral, electronic,etc.) for informing future participant(s) ofall procedures, risks, benefits, etc. Confirmyou have met the required categories forinformed consent by visiting the IRBwebsite for more information.

A waiver of informed consent is proposedin situations that may require an alteredconsent form (studies involving deception,situational vulnerable populations, etc.).

**Please note, if you choose the waiver oralteration in the usual informed consentprocess option, you will need to state anyrisk(s) to participants caused by theirparticipation in this research and justify thatthe requested waiver or alteration to theusual informed consent procedures will notadversely affect the rights or welfare of theparticipants.

Please mark all conditions that are contained in your study for obtaining informedconsent.

Participants will be in a confidential location Participants can be in a confidential location if they choose (usually only in cases whereparticipants are filling out an electronic survey away from the researcher) I will go over the consent or information sheet The participants can ask questions

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Briefly describe when and how you will get informed consent (or an altered informedconsent) from the participants.

Upon receipt of approval from the Universityof La Verne’s Institutional Review Board (IRB)to conduct this study, the researcher willcontact principals for dissemination of themass email to potential teacher participantsvia email. Once contacted by the participant,the researcher will request an email addressto send the participants informationpertaining to the study which will include theinformed consent document detailing thepurpose and procedures of the study, and thecommitment required of each participant.Once potential participants agree to take partin study, face­to­face (or alternative phone)interviews will be scheduled. Participants willbe asked if they have any questionsregarding the informed consent document orrelated to the protocol for the study. Theywill be informed that they will retain a copyof the informed consent document for theirrecords. Following agreement to participate,a signed informed consent document will becollected from each participant prior to thecommencement of the interview. In the eventthat an interview is being conducted byphone, the informed consent document willbe emailed to the participant and theparticipant will be asked to sign and returnthe document prior to participation via emailor mail. They will be instructed to emailquestions or concerns regarding the informedconsent document or related to the protocolfor the study to the study PI.

See the La Verne IRB Forms and Exampleswebpage for template and examples.

Do all of the sections in your consent/assent/information sheet match the content ofthe answers in your application?

Yes

Is the language appropriate to your participants (e.g. it is at a level of understandingappropriate for their education level)?

Yes

Is the language in your consent/assent/information sheet directed to your audience?In other words, if you copied and pasted text from your dissertation or paper, did youchange the language so that it no longer reads as your dissertation/paper and insteadreads as a document directed to the participants?

Yes

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Is the IRB contact information in your consent/assent/information sheet listed exactlyas follows: IRB Office, University of La Verne, 1950 Third St, CAFE 112, La Verne, CA91750, [email protected], 909­448­4564.

Yes

Is your mentor/chair/advisor listed as your supervisor in the Identification ofInvestigators section of the consent/assent/information sheet (including their contactinformation, specifically phone number)?

Yes

Were you consistent in using the appropriate term (confidential or anonymous) in theapplication and the consent/assent/information sheet? In other words, if your study isconfidential, did you only use that term throughout? Refer to the prior question(previous page) that defines confidential and anonymous in order to ensure you areusing the terms correctly.

Yes

Do you have a separate section in the consent/assent below the description of yourprotocol that contains a checkbox to agree or disagree to the audio or visual recordingand an area for the participants to initial next to their selection (i.e. agree ordisagree)?

Yes

Is your protocol (procedures in your study) described in detail in the informed consentor briefly in the information sheet?

Yes

Did you describe ALL of your inclusion/exclusion criteria?

Yes

Attach your informed consent/assent. Please CHANGE the document type to match thetype of document you are uploading (e.g. consent, assent).

Consent Consent Form (Informed) ­ParticipantIf you have multiple consentforms/information sheets in yourstudy, please upload all consent formsprior to application submission.

All consent forms are required to besubmitted prior to review.Please onlyupload Word versions of theconsent/information sheet.

Optional Informed Consent Oral Explanation/Script.

No answer provided.

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