D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 1 of 6 PRP Initial
REC-H
APPLICATION FOR APPR...
D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 2 of 6 PRP Initial
REC-H
a) Concise descripti...
D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 3 of 6 PRP Initial
REC-H
b) Has the personadm...
D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 4 of 6 PRP Initial
REC-H
f) Do yourequire con...
D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 5 of 6 PRP Initial
REC-H
If NO, motivate: Typ...
D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN)
Form dd 28 July 2010 Page 6 of 6 PRP Initial
REC-H
APPENDIX 3: Writteni...
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REC-H Application Form

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REC-H Application Form

  1. 1. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 1 of 6 PRP Initial REC-H APPLICATION FOR APPROVAL NMMU RESEARCH ETHICS COMMITTEE (HUMAN) TO BE FILLED IN BY A REPRESENTATIVE FROM THE FACULTY RTI COMMITTEE: Applicationreference code: H ………… ………… ………… ………… HUMAN YEAR FACULTY DEPARTMENT NUMBER ResolutionofFRTI Committee:  Ethics approval given(for noting by the REC-H)  Referredto REC-H for consideration(if referred to REC-H, electronic copy of application documents to be emailed to Kirsten.Longe@nmmu.ac.za) Resolutiondate: Faculty RTI representative signature: BEFORE YOUFILL INTHIS FORM PLEASE READ THE FOLLOWING DOCUMENTS:  “Research Ethics (Human)ApplicationProcess” (http://www.nmmu.ac.za/default.asp?id=4619&bhcp=1)  “Code of Conduct for Researchers at NMMU” (Students: http://portal.nmmu.ac.za/default.asp?id=71&sp=0&bhcp=1 or Staff: http://my.nmmu.ac.za/default.asp?id=308&bhcp=1). WHO NEEDS TO FILL THIS FORM IN? Any projectin which humans are the subjects of research (hereafter called a study) requires completion of this form and submission for approval firstto their Faculty RTI Committee (FRTI). The FRTI will refer projects to the Research Ethics Committee (Human) (REC-H) where deemed necessary. WHEN SHOULD THIS FORM BE HANDED IN? The research proposal should firsthavebeen approved by the FRTI before Ethics approval may be given. Itshould also havefi rst been reviewed by the FRTI for Ethics clearancebefore it is referred to the REC-H. HOW TO FILL THIS FORM IN: 1) Complete Sections 1 to 8 in typescript(Tab between fields,selectfrom pull-downs,information may be pasted from existing Word® documents), and save(filename must contain your name). Handwritten forms will notbe accepted. 2) Use the “Save as” option to savethe application formwith a filename containingyour name (e.g. “J Smith REC-H Application Form.doc”). 3) Complete Sections 1 to 8 in typescript(Tab between fields,selectfrom pull-downs,information may be pasted from existing Word® documents), and save(filename must contain your name). Handwritten forms will notbe accepted. 4) Append the necessary information e.g. Research methodology, Informed consent form, Written information given to participantprior to participation,Oral information given to participantprior to participation (examples of these may be found on the Research Ethics webpage: (http://www.nmmu.ac.za/default.asp?id=4619&bhcp=1) 5) Electonic copy: Email all thefiles (includingany appendices) to the Faculty RTI Committee representative in the relevant Faculty. 6) Hard copy, signed: Printthe document, get each page initialled on the lower righthand corner and get Sections 9 and 10 signed by the relevant parties. Hand the signed hardcopy and attachments in to the Faculty RTI Committee representative in the relevant Faculty. Please delete this instruction block before you save and print. 1. GENERAL PARTICULARS TITLE OF STUDY
  2. 2. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 2 of 6 PRP Initial REC-H a) Concise descriptive title of study(mustcontainkeywordsthatbestdescribe the study): Type title here PRIMARY RESPONSIBLE PERSON (PRP) b) Name of PRP (mustbe memberof permanentstaff. Usuallythe supervisorinthe case of students): Type PRP name here Type PRP office address here c) Contact number/s of PRP: Type PRP contact details here d) Affiliationof PRP: Faculty Select Faculty Specify here, if “other” Department (orequivalent): Type department name here PRINCIPLE INVESTIGATORSAND CO-WORKERS e) Name and affiliationof principal investigator(PI) /researcher(maybe same asPRP): Type PI name here Gender:Select gender f) Name(s) andaffiliation(s) of all coworkers(e.g.co-investigator/assistant researchers/supervisor/co- supervisor/promoter/co-promoter).If namesare notyetknown,state the affiliationsof the groupstheywill be drawnfrom,e.g.Interns/M-students,etc.andthe numberof personsinvolved: Type names and affiliations of all co-workers here STUDY DETAILS g) Scope of study:Select an item h) If for degree purposes: Selectan item i) Funding:Select an item Additional information(e.g.source of fundsorhow combinedfundingissplit) Type details here or select “Not applicable” j) Are there any restrictionsorconditionsattachedtopublicationand/orpresentationof the studyresults? Select an item If YES, elaborate (Anyrestrictionsorconditionscontainedincontractsmustbe made available tothe Committee): Type response here or select “Not applicable” k) Date of commencementof datacollection:Click here select a date Anticipated date of completion of study:Type duration here l) Objectivesof the study(the majorobjective(s)/GrandTour questionsare tobe statedbrieflyandclearly): Type objectives here m) Rationale forthisstudy:briefly(300wordsor less) describe the backgroundtothisstudyi.e.whyare youdoing thisparticularpiece of work. A few(nomore than 5) keyscientificreferences maybe included: Type rationale here METHODOLOGY n) Brieflystate the methodology(specificallythe procedure inwhichhumansubjectswillbe participating) (thefull protocol isto be includedas Appendix 1): Type summarised method here o) State the minimumandmaximum numberof participantsinvolved(Minimumnumbershouldreflectthe number of participants necessary to make the study viable) Min: Type minimum number here Max: Type maximum number here 2. RISKS AND BENEFITS OF THIS STUDY a) Is there anyriskof harm,embarrassmentoroffence,howeverslightortemporary,tothe participant,thirdparties or to the communityat large? Select an item If YES, state eachrisk,and for eachriskstate i) whetherthe riskis reversible, ii) whetherthere are alternative proceduresavailable andiii) whetherthere are remedialmeasuresavailable. Type response here or select “Not applicable”
  3. 3. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 3 of 6 PRP Initial REC-H b) Has the personadministeringthe projectpreviousexperience withthe particular riskfactorsinvolved? Selectan item If YES, please specify: Type response here or select “Not applicable” c) Are any benefitsexpectedtoaccrue to the participant(e.g.improvedhealth,mental state,financial etc.)? Select an item If YES, please specifythe benefits: Type response here or select “Not applicable” d) Will yoube usingequipmentof anysort? Select an item If YES, please specify: Type response here or select “Not applicable” e) Will anyarticle of property,personal orcultural be collectedinthe course of the project? Select an item If YES, please specify: Type response here or select “Not applicable” 3. TARGET PARTICIPANT GROUP a) If particularcharacteristicsof any kindare requiredinthe targetgroup (e.g.age,cultural derivation,background, physical characteristics,disease statusetc.) please specify: Type response here or select “Not applicable” b) Are participantsdrawnfromNMMU students? Select an item c) If participantsare drawn fromspecificgroupsof NMMU students,pleasespecify: Type response here or select “Not applicable” d) Are participantsdrawnfroma school population? Selectan item If YES, please specify: Type response here or select “Not applicable” e) If participantsare drawn froman institutionalpopulation(e.g.hospital,prison,mentalinstitution),please specify: Type response here or select “Not applicable” f) If any recordswill be consultedforinformation,please specifythe source of records: Type response here or select “Not applicable” g) Will eachindividualparticipantknowhis/herrecordsare beingconsulted? Selectan item If YES, state howthese recordswill be obtained: Type response here or select “Not applicable” h) Are all participantsover18 yearsof age? Select an item If NO, state justificationforinclusionof minorsinstudy: Type response here or select “Not applicable” 4. CONSENT OF PARTICIPANTS a) Is consent to be givenin writing? Select an item If YES, include the consentformwiththisapplication[Appendix 2]. If NO, state reasonswhywrittenconsentisnotappropriate inthisstudy. Type response here b) Are any participant(s) subjecttolegal restrictionspreventingthemfromgivingeffective informedconsent? Select an item If YES, please justify: Type response here or select “Not applicable” c) Do any participant(s) operateinaninstitutional environment,whichmaycastdoubton the voluntaryaspectof consent? Select an item If YES, state whatspecial precautionswill be takentoobtainalegallyeffective informedconsent: Type response here or select “Not applicable” d) Will participantsreceiveremunerationfortheirparticipation? Selectan item If YES, justifyandstate onwhatbasisthe remunerationiscalculated,andhow the veracity of the informationcan be guaranteed. Type response here or select “Not applicable” e) Whichgatekeeperwill be approachedforinitial permissiontogainaccessto the target group?(e.g.principal, nursingmanager,chairpersonof school governingbody) Type response here or select “Not applicable”
  4. 4. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 4 of 6 PRP Initial REC-H f) Do yourequire consent of an institutional authorityforthisstudy? (e.g.Departmentof Education,Departmentof Health) Select an item If YES, specify: Type response here or select “Not applicable” 5. INFORMATION TO PARTICIPANTS a) What informationwill be offeredto the participantbeforehe/sheconsentstoparticipate? (Attachwritten informationgiven as[Appendix 3] andanyoral informationgiven as[Appendix 4]) b) Who will provide thisinformationtothe participant? (Give name androle) Type name of information provider here Type role of information provider here c) Will the informationprovidedbe completeandaccurate? Select an item If NO, describe the nature andextentof the deceptioninvolvedandexplainthe rationaleforthe necessityof this deception:Type response here or select “Not applicable” 6. PRIVACY, ANONYMITY AND CONFIDENTIALITY OF DATA a) Will the participantbe identifiedbyname inyourresearch? Select an item If YES, justify: Type response here or select “Not applicable” b) Are provisionsmade toprotectparticipant’srightstoprivacyandanonymityandto preserve confidentialitywith respectto data? Select an item If NO, justify. If YES,specify: Type response here or select “Not applicable” c) If mechanical methodsof observationbe are tobe used(e.g.one-waymirrors,recordings,videosetc.),will participant’sconsenttosuchmethodsbe obtained? Selectan item If NO, justify: Type response here or select “Not applicable” d) Will datacollectedbe storedinanyway? Select an item If YES, please specify:(i) Bywhom? (ii) Howmanycopies? (iii)Forhow long? (iv) Forwhatreasons? (v) How will participant’sanonymitybe protected? Type response here or select “Not applicable” e) Will storeddatabe made available forre-use?Selectan item If YES, howwill participant’sconsentbe obtainedforsuchre-usage? Type response here or select “Not applicable” f) Will anypart of the projectbe conductedonprivate property(includingshoppingcentres)? Selectan item If YES, specifyandstate howconsentof propertyowneristobe obtained: Type response here or select “Not applicable” g) Are there any contractual secrecyor confidentialityconstraintsonthisdata? Select an item If YES, specify:Type response here or select “Not applicable” 7. FEEDBACK a) Will feedbackbe giventoparticipants? Selectan item If YES, specifywhetherfeedbackwill be written,oral orbyothermeansand describe how thisistobe given(e.g. to each individual immediatelyafterparticipation,toeachparticipantafterthe entire projectiscompleted,toall participantsina groupsetting,etc.): Type response here or select “Not applicable” b) If you are workingina school or otherinstitutional setting,will yoube providingteachers,school authoritiesor equivalentacopyof yourresults? Select an item If YES, specify,if NO,motivate: Type response here 8. ETHICAL AND LEGAL ASPECTS The Declarationof Helsinki (2000) or the BelmontReport will be includedinthe references:Selectan item
  5. 5. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 5 of 6 PRP Initial REC-H If NO, motivate: Type response here or select “Not applicable” (A copy of the Belmont Report is availableatthe followinglink for reference purposes:http://www.nmmu.ac.za/documents /rcd/The%20Belmont%20Report.pdf) a) I wouldlike the REC-Htotake note of the followingadditionalinformation: Type response here or select “None” 9. DECLARATION If any changesare made to the above arrangementsorprocedures,Iwill bringthese tothe attentionof the Research EthicsCommittee (Human).Ihave read,understoodandwillcomplywiththe GuidelinesforEthical Conductin Research and Education at the Nelson Mandela Metropolitan University andhave takencognisance of the availability (on-line) of the Medical ResearchCouncilGuidelinesonEthicsforResearch (http://www.sahealthinfo.org/ethics/). All participantsare aware of any potential healthhazardsorrisksassociatedwiththisstudy. I SELECT AN ITEM aware of potential conflict(s) ofinterestwhich shouldbe consideredby the Committee. If affirmative,specify: Type response here or select “Not applicable” 30 January 2015 SIGNATURE: Type name here (Primary Responsible Person) Date 30 January 2015 SIGNATURE: Type name here (Principal Investigator/Researcher) Date 10. SCRUTINY BY FACULTY AND INTRA-FACULTY ACADEMIC UNIT Thisstudyhas beendiscussed,andissupported,atFacultyandDepartmental (orequivalent)level. Thisis attestedtoby the signature belowof aFaculty(e.g.RTI) and Departmental (e.g.HoD) representative,neitherof whommay be a previoussignator. NAME and CAPACITY (e.g. HoD) SIGNATURE Date NAME and CAPACITY (e.g. Chair:FacRTI) SIGNATURE Date 11. APPENDICES In orderto expeditethe processingof thisapplication,please ensure thatall the requiredinformation,asspecified below,isattachedtoyour application. Examplesof some of these documentscanbe foundonthe ResearchEthics webpage (http://www.nmmu.ac.za/default.asp?id=4619&bhcp=1).You are notcompelledtouse the documents whichhave beenprovidedasexamples –theyare made available asa convenience tothose whodonotalreadyhave themavailable. APPENDIX 1: Researchmethodology Attach the full protocol andmethodologytothisapplication,as"Appendix1”and include the datacollection instrumente.g.questionnaireif applicable. APPENDIX 2: Informedconsentform If no writtenconsentisrequired,motivate at4a). The intentionisthatyoumake sure youhave coveredall the aspectsof informedconsentasapplicable toyourwork.
  6. 6. D/496/05: APPLICATION FORM:ETHICS APPROVAL (HUMAN) Form dd 28 July 2010 Page 6 of 6 PRP Initial REC-H APPENDIX 3: Writteninformationgivento participant prior to participation Attach as "Appendix3". The intentionisthatyoumake sure you have coveredall the aspectsof writteninformation to be suppliedtoparticipants,asapplicabletoyourwork. APPENDIX 4: Oral informationgivento participant prior to participation If applicable,attachthe requiredinformationtoyourapplication,as"Appendix 4". APPENDIX 5, 6, 7: Institutional permissions Attach anyinstitutionalpermissionsrequiredtocarryout the research e.g.Departmentof Education permissionfor researchcarriedout inschools.

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