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Application For Exempt Status

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Dickinson State University 1

DickinsonStateUniversity

InstitutionalReviewBoard(IRB)fortheProtectionofHumanSubjectsinResearch

PROTOCOLAPPLICATIONFORTHEUSEOFHUMANSUBJECTSINRESEARCH



REQUESTFOREXEMPTIONFROMFEDERALREGULATIONS



Inaccordancewithfederalregulations,theIRBdetermineswhetherresearchprotocolsinvolvinghumansubjectsmaybeexempted.Eventhough

the research may qualify as exemptfrom federal regulations, the committee still has a responsibility to decide whether the protocol represents

ethicalresearch.



PrincipalInvestigator(s)/PrincipalResearcher(s) Information:ThePrincipal Investigator(s)(PI) conductsand directs the  study.She/he actsas 

themaincontactpersonfortheIRB,andcarriesfullresponsibilityforthestudy.PrincipalInvestigator(s)/PrincipalResearcher(s)mustprovide

documentationofcompletedHuman Subjectstraining.

Name:  Title: 

Department:  E‐Mail: 

CampusAddress:  Phone: 



TitleofResearchProject:(Ifinternalorexternalfundingwillberequested,thetitleoftheresearchprojectmustbethesameastheproposal

title.)

Title: 



Funding Source/Agency: (Provide name of funding source/agency and indicate if funds are internal or external.If funding will not be

requested,markN/A.)

Name: 

Internal: External: N/A:



PeriodofProject: From: To:



Co‐Investigators: Co‐investigators are those other than the Principal Investigator(s) who conduct, direct, and are responsible for the study.

Please list the name, degree, department, telephone number, and e‐mail address of each co‐investigator.Co‐Investigators listed here must

providedocumentationofcompletedHuman Subjectstraining.







Other Personnel: Other Personnel includes all team members other than the Principal Investigator(s) or Co‐Investigator(s) who assist in the

executionofthestudy,especiallythosewhohavesubjectcontact.Thismayincludestudentsorgraduateassistants.Pleaseprovidethenames

ofanypersonwhowill have contactwithsubjects inconnectionwiththisstudy.Oth

erPersonnel listedhere mustprovidedocumentationof

completedHuman Subjectstraining.







Dickinson State University 2

Forthecategoriesofresearchlistedbelow,researchersmayrequestthattheIRBexempttheirprotocolsfromfederalregulations.Ifyoubelieveyour

research protocol may be eligible for consideration as exempt from the federal regulations, consider which of the categories from the list below

appliesandcheckallthatapply.



EXEMPTCATEGORIES–46 .101(b)



1. Researchconductedinestablishedorcommonlyacceptededucationalsettings,involvingnormaleducationalpractices,suchas:

 (i) researchonregularandspecialeducationinstructionalstrategies;or



(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management

methods.



2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview

proceduresorobservationofpublicbehavior,unless:



(i) informationobtainedisrecordedinsuchamannerthathumansubjectscanbeidentified,directlyorthroughidentifierslinkedto

thesubjects;and



(ii) anydisclosureof the  humansubjects’responsesoutside the researchcouldreasonably place thesubjectsatriskof criminalor

civilliabilityorbedamagingtothesubjects’financialstanding,employability,orreputation.



3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview

procedures,orobservationofpublicbehaviorthatisnotexemptunderparagraph(b)(2)ofthissection,if:

 (i) thehumansubjectsareelectedorappointedpublicofficialsorcandidatesforpublicoffice;or



(ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be

maintainedthroughouttheresearchandthereafter.



4. Research involvingthecollection orstudyof existing data,documents,records,pathological specimens, ordiagnosticspecimens,if

these sources are publicly available or if the information is recorded by the investigator in such a mannerthat subjects cannot be

identified,directlyorthroughidentifierslinkedtothesubjects.



5. ResearchanddemonstrationprojectswhichareconductedbyorsubjecttotheapprovalofDepartmentorAgencyheads,andwhich

aredesignedtostudy,evaluate,orotherwiseexamine:

 (i) publicbenefitorserviceprograms;

 (ii) proceduresforobtainingbenefitsorservicesunderthoseprograms;

 (iii) possiblechangesinoralternativestothose programsorprocedures;or

 (iv) possiblechangesinmethodsorlevelsofpaymentforbenefitsorservicesunderthoseprograms.

 6. Tasteandfoodqualityevaluationandconsumeracceptancestudies:

 (i) ifwholesomefoodswithoutadditivesareconsumed;or



(ii) ifafoodisconsumedthatcontainsafoodingredientatorbelowthelevelandforausefoundtobesafe,oragriculturalchemical

orenvironmentalcontaminantatorbelowthelevelfound tobesafe,bytheFoodandDrugAdministrationorapprovedbythe

EnvironmentalProtectionAgencyortheFoodSafetyandInspectionServiceoftheU.S.DepartmentofAgriculture.

Theexemptionsat45CFR46.101(b)donotapplytoresearchinvolvingprisoners,SubpartC.Theexemptionat45CFR46.101(b)(2),forresearch

involving survey or interview procedures or observation of public behavior, does not apply to research withminors, Subpart D, except for 

researchinvolvingobservationsofpublicbehaviorwhentheinvestigator(s)donotparticipateintheactivitiesbeingobserved.



Justification:Pleaseprovideajustification forwhythis research meetstheexemptcategory(i.e.,explainhowthe research youareproposing

belongstotheselectedcategoriesabove):(Boxeswillexpand,orifnecessary,attachadditionalpages.)







Dickinson State University 3

PROJECTDESC RIPTION



Abstract:Provideanabstractoftheproposedresearchinlanguagethatcanbeunderstoodbyalayperson.Theabstractshouldsummarizethe

objectivesofthisprojectandtheprocedurestobeused,withanemphasisonwhatwillhappentothesubjects.Feelfreetouseasmuchspaceas

neededtoprovideathoroughabstract.(Boxeswillexpand,orifnecessary,attachadditionalpages.)







Subjects:Describeand quantify the subject population for this study, including the numberof subjects expected to be enrolled, and describe

howthe subjectswill be recruited for participation. Noteinclusion and exclusion criteria.(Boxes will expand,or ifnecessary, attach additional

pages.)







Consent:Describetheprocessbywhichconsentwillbeobtainedanddocumentedfromsubjects.Ifconsentordocumentationofconsentisnot

being obtained, you  must formally request a waiver from the IRB and fully justify why the informed conse n t and/or signed informed consent

requirement(s)shouldbewaived.(Boxeswillexpand,orifnecessary,attachadditionalpages.)







AreDSUstudentsubjectsbeingrecruited?YESNO



Ifyouansweredyes,clearlyaddressallitemsinthe“DSUSTUDENTSASSUBJECTS”sectionbeforesubmittingyourprotocolapplication.Ifyou

answeredno,simplyindicatethattheitemsarenotapplicabletoyourresearch.



Dickinson State University 4

DSUSTUDENTSASSUBJECTS



Thefollowingsectionsmustbecompletedifapplicabletoyourresearch.(Note:Theinformationalsomustbeincludedintheinformedconsent

documentsasrequiredbyfederalandIRBregulations.)



Clearlyaddressallitemsbelowbeforeproceedingtothenextquestionorifyouansweredno,simplyindicatethattheitemsarenotapplicableto

yourresearch.

Instructor(notsubject)Safeguards:

Describehowpermissiontousesubjectswillbeobtained.(Boxeswillexpandor,ifnecessary,attachadditionalpages.)





IfDSUstudentsarerecruitedassubjectsinaninstructor’sclass,explainhowyouwillinforminstructorsthattheycanrefusetoallowtheresearchto

beconductedintheirclass.(Boxeswillexpandor,ifnecessary,attachadditionalpages.)





AdditionalInformation:

Clearlyindicatewhetherparticipationasaresearchsubjectinthisstudyfulfillsacourserequirement(i.e.,allstudentsareexpectedtoparticipatein

exchange for course credit) or will be conducted without fulfilling a course requirement (i.e., students may choose whether or not to participate

without considering course requirements).If participation will fulfill a course requirement, clearly indicate that the instructors for the courses

involvedwillestablishappropriatealternativeassignmentsthatstudentsmaycompleteiftheychoose nottobeasubjectinthisresearch.(Boxeswill

expandor,ifnecessary,attachadditionalpages.)







Dickinson State University 5

Clearly indicate how the students will be informed that no penaltywill be incurred for non‐participation in the research.(Boxes will expand or, if

necessary,attachadditionalpages.)





AreanyoftheDSUstudentsubjectsintheresearcher’sclassorunderher/hisdirectsupervision?



YESNO



NOTE: Researchermustuseathirdpartytosolicitparticipation,administerthestudy,andcollectdatafromsubjectswhentheyarestudents

intheresearcher’sclassorwhentheyareemployeesorsuperviseesoftheresearcher.



Ifyouansweredyes,clearlyaddressallitemsinthesubjectsafeguardssectionbelowbeforeproceeding.Ifyouansweredno,simplyindicatethat

theitemsarenotapplicabletoyourresearch.



SubjectSafeguards:

Identifythirdpartywhowillsolicitsubjects,administerandcollectinformedconsentandallinstruments,andretaindocumentsuntilfinalgradesare

submitted.(Boxeswillexpandor,ifnecessary,attachadditionalpages.)







Identifythirdpartyasacontactforsubjectstonotifyiftheywishtowithdrawfromtheresearchproject.(Boxeswillexpandor,ifnecessary,attach

additionalpages.)





Dickinson State University 6

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Online training in the protection of human subjects in research is required for all researchers. Once you have completed your online 

training,pleaseattachacopyofyourCertificateofCompletiontoyourcompletedprotocolapplication.



Afteryouhavecompletedallotherpartsofyourprotocolapplication,readtheinformationbelowandsignifyouagreewiththeresearcher

assurancesandresponsibilities.



ResearcherAssurancesandResponsibilities:

As principal investigator(s)/researcher(s), I hereby assure that I will follow procedures to safeguard and protect the rights and welfare of the

subjectsofmyresearch.IwillnotbegindatacollectionuntilIrece iveawrittenapprovalfromtheIRB.



If data are to be collected from students and/orother DSU employees,I will use a third party to solicit part

icipation,administer the study, or

collectdatawhensubjectsareeitherstudentsinacourseforwhichIamtheinstructororundermydirectsupervision.



Asprincipalinvestigator(s)/researcher(s),Iacknowledgeresponsibilityforprotectingtherightsandwelfareofhumansubjects;complyingwithall

applicable federal and IRB regulations; conducting the research according to the IRB exempt protocol; reporting any changes in previously

approvedprotocolstotheIRBpriortoimplementation;reportingunanticipatedinjuriesorproblemsinvolvingriskstohumansubjectstotheIRB;

maintaining all approved protocol documents and notifications for three years after completion of the protocol; and supervising research

conductedbystudents.



If your study is determined to be exempt by the IRB committee, you are not required to complete continuation or final review reports.

However,ifanyrevisionsaremadetoaprojectorifanyunexpectedrisksariseduringaninvestigation,itisyourresponsibilitytonotifythe

IRBbysubmittingaPartH(ChangeofStatus)fullyexplainingallchangesorunexpectedrisks,priortomakinganychangestothestudy.Please

notethatchangesmadetoanexemptprotocolmaydisqualifyitfromexemptstatusandmayrequireanexpeditedorfull‐boardreview.



Afteryourapplicationis approved, The Officeof Academic Affairswillhold yourexemptionapplicationforsix years,afterwhich yourprotocol

willbeclosed.Ifyourprojectisstillongoing,youwillneedtocontacttheOfficeofAcademicAffairsandcompletea newexemptionapplication.



Itshouldbenotedthatresearch

involvingminorsmaynotqualifyfor exemption.



Pleasesubmittwo (2) copies ofthe completed DSURequest forExemptionFromFederalRegulations,Human SubjectTraining Docu mentation,

Consent Documents (if applicable), Questionnaires/Surveysetc., (if applicable), Support Letters or any otherdocumentation that would

be useful in reviewingtheprotocolapplicationtotheAdministrativeAssistantintheOfficeofAcademicAffairs.





SignatureofPrincipalInvestigator(s)/Researcher(s)





Date



Asfacultyadvisor,Iherebyacceptresponsibilityfortheconductofthisproject.





SignatureofFacultyAdvisor





Date

Donotwritebelowthisline

DateReceived: ProtocolReviewNumber:

ReviewCompleted: NotificationSent:



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Completed 15 November 2019

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