Fillable Irb educational protocol form 2015-2016

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Irb educational protocol form 2015-2016

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EducationalprotocolsinvolveprojectsdonebyTrinestudentsforaTrineUniversityclass.

Theprojectsmustconformtothefollowingcriteria:



 AllprojectsshouldbeExemptfromfullcommitteereview(asdefinedbyFederal

Guidelines)

 Subjectswillnotprovideandresearcherswillnotkeepanyidentifiersthatwill

linktheresultsbacktotheparticipants.

 Projectswillnotmanipulatebehaviorofthesubjectsbeyondtherangeofusual

classroomactivityorcollegelife

 Projectswillnotinvolvephysicallyinvasiveorcontactwithsubjects.



EducationalprotocolsshouldbeturnedintotheIRBasearlyaspossibleduringthe

semester.EducationalprotocolswillbereviewedbytheIRBChairandacommittee

memberastheyaresubmittedtotheIRB.Anyprojectthatisnotconsistentwiththeabove

criteriashouldbesubmittedtotheIRBforstandardreview.



ProcessforReviewofEducationalProtocols:



a) TheinstructorwillsubmittheEducationalProtocolApplicationtotheIRB.

b) Theprotocolshouldbesubmittedeachyeartheclassisoffered

c) TheinstructorwilleducatetheclassontheIRBprocessandstatethattheyhave

completedtheeducationalprotocolonthestudent’sbehalf.

d) Projectsshouldnotbeinitiateduntiltheeducationalprotocolhasbeenreviewed

andapproved.

e) Theinstructorwillberesponsiblefortheoversightofallprojectstoensurethat

ethicalstandardsarefollowed.Theinstructorwillberesponsiblefordealing

withanyethicalviolations,andwillreportsuchviolationstotheIRB.

f) Ifquestionsariseconcerningeducationalprotocols,theinstructorshouldcontact

theIRBchairorothercommitteememberforhelp. 

TrineUniversity

InstitutionalReviewBoard

EducationalProtocols

ApplicationForm2015‐2016



DateofApplication:

Indicatetypeofreview: Exempt Expedited Full



Educationalprotocolsshouldfitintooneofthefollowingcategories.Pleasecheckallthosethat

apply:



1.NormalEducationalPractices

2.EducationalTests

3.Surveyand/orInterviewProcedures

4.Observation

5.SecondaryuseofData



InstructorName:



CourseNumberandTitle:



DepartmentandCampus(ifnotTrinemaincampus):



InstructorMailingAddress:



InstructorEmailAddress:



InstructorTelephone:



DatesofClassProjects:



TrineUniversity

InstitutionalReviewBoard

EducationalProtocols

ApplicationForm2015‐2016



ProjectTitle:



NatureoftheProject(Includeabriefdescriptionofwhatparticipantswillormaydo)



SubjectsandRecruitment

 AgeRangeofSubjects:



Numberinvolved:



 RecruitmentLocation:



RisksandBenefitsofParticipation



ConfidentialityofData



InformedConsent



 Howwillthestudentsgainconsent?Willstandardconsentdocumentationbeused?



 Whenwillthestudentobtainconsent?(thatday,daysorweeksbeforeprojectstarts?)



 Howwillthestudentassessthatthesubjectunderstandswhathe/sheisaskedtodo?



AssurancesandSignatures

 Theinformationfurnishedconcerningtheprocedurestobetakenfortheprotectionof

humansubjectsiscorrect.

 Theinstructor,tothebestofhis/herknowledge,iscomplyingwithFederalregulations

governinghumansubjectsinresearch.

 TheinstructorwillseekandobtainpriorwrittenapprovalfromtheCommitteeforany

substantivemodificationintheproposal,including,butnotlimitedtochangesin

cooperatinginvestigators,proceduresandsubjectpopulation.

 Theinstructorand/orstudentinvestigatorwillpromptlyreportinwritingtotheCommittee

anyunexpectedorotherwisesignificantadverseeventsthatoccurinthecourseofthe

study.

 TheinstructorwillpromptlyreportinwritingtotheCommitteeandtothesubjectsany

significantfindingswhichdevelopduringthecourseofthestudywhichmayaffecttherisks

andbenefitstothesubjectswhoparticipateinthestudy.

 TheresearchwillnotbeinitiateduntiltheIRBprovideswrittenapproval.

 Thetermofapprovalwillbeforoneyear.Toextendthestudybeyondthatterm,anew

applicationmustbesubmitted.

 Theresearch,onceapproved,issubjecttocontinuingreviewandapprovalbythe

Committee.

 TheinstructorwillcomplywithallrequestsfromtheIRBtoreportonthestatusofthe

studyandwillmaintainrecordsoftheresearchaccordingtoIRBguidelines.

 Iftheseconditionsarenotmet,approvalofthisresearchmaybesuspended.



AsafacultymemberIassumeresponsibilityforensuringthatthestudentcomplieswiththe

classroomprotocolregardingtheuseofHumanSubjectsinthisresearchexercise



SignatureofFacultyMember Date



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