NTU Institutional Review Board (IRB)
Exempt Review Application Form –
Biomedical Research
Pleaserefer to Guidelines on Res...
I. BASIC INFORMATION
Research May Involve:
Human Subjects(Target Number:_____)
HealthyVolunteers Children PregnantWomen Ou...
III. CO-INVESTIGATORS
All co-investigatorswho havea responsibility fortheconsentprocess or direct data collection for this...
IV. PROTOCOL CHECKLIST
Organise detailsof the researchprotocol under the followingheadings(innomore than 7 pages).
1. Spec...
6. Characteristicsof Target Subjects/Target SubjectData:
6.1 What isthe numberof subjectstobe enrolled?Give abreakdownbyin...
VII. ATTACHMENT CHECKLIST
Document Attached Not Applicable
ResearchProtocol (latest version)*
Grant ApplicationForm
Partic...
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Exemption from full IRB review_Biomedical Research - Research Hub ...

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Exemption from full IRB review_Biomedical Research - Research Hub ...

  1. 1. NTU Institutional Review Board (IRB) Exempt Review Application Form – Biomedical Research Pleaserefer to Guidelines on Research which can be exempted from full IRBReview, before completingthis form 1. Protocol Title 2. Study Site(s)of Research (Dept. and Institution):________________________________________ * Single-Centre / Singapore Multicentered / International Multicentered If single-centered, has a similar studybeenconductedelsewhere? * Yes / No If Yes, state where : ________________________________________ _________________ Previous Ethics Committee submission? * Yes / No (If yes, please provide details separately.) 3. Type of Study (Please refer to our Guidelines On Which Research Can Be Exempted From IRB Review) [ ] Educational settings research [ ] Educational tests or instructional techniques and methods [ ] Surveywithout identifiers [ ] Analysis of publiclyavailable data or dataset storedwithout identifiers [ ] Commercial cell lines, tissues, anonymous biological samples, bodyparts (please see table below) Type of Human Tissues Name of Human Cell Lines (e.g. HeLa) Source & Catalog No. (e.g. ATCC, CCL-2) Indicate iftissues/cell cultures are: (Please tick) Primary Secondary (Please attach separate sheet, if required) 4. Financial Declaration This study is initiated by the * Investigator / Commercial / Pharmaceutical Company Source of funding for study :___________________________________________________ Amount of Sponsorship / Grant : _______________________________________________ Status of grant: Approved / Pending / Not applicable Financial benefits to Subjects (if any) :___________________________________________ The financial benefits or other benefits derived from this study to PI / Co-investigators / School / Institution areas follows:_________________________________________ (Please provide a copy of the financial agreement with sponsor company, if applicable.) 5. Documents Checklist Mandatory (Please submitthe following documents.) Protocol /Proposal Catalog details OR proof of purchase ofcell lines,ifapplicable List of PI & co-investigators with their signatures,together with their CVs 6. Declaration This Research Proposal has the approval of the Associate Chair of School ____________________________________________ ______________________________ Signature of Associate Chair (Research)/Chair/Dean Date Name: Title: Position I confirm that the information submitted in this application is correctand I will conduct the study in accordance with the IRB-approved protocol, IRB requirements/policies,and all applicable rules and regulations. Signature of Principal Investigator : _________________________________Date : ______________________ Name of Principal Investigator : ____________________________________ Contact Number : _______________ Division / School /Institution: __________________________________________ Email : ___________________________
  2. 2. I. BASIC INFORMATION Research May Involve: Human Subjects(Target Number:_____) HealthyVolunteers Children PregnantWomen Outpatients Inpatients Prisoners CognitivelyImpairedPersons,please specify:_____________________ Biological Samples(Target Number: _____) Blood Tissues Others,please specify:__________________ Research SubjectsWill Be: Paid,$__________ Not Paid Not chargedfor trial procedures II. DECLARATION OF THE PRINCIPALINVESTIGATOR The informationprovidedin thisformiscorrect. a. I will notinitiate thisresearchuntil Ireceive writtennotificationof NTU-IRBapproval and regulatoryauthorityapproval (if applicable). b. I will notinitiate anychange inprotocol withoutpriorwrittenapprovalfromNTU-IRBexcept whenitis necessarytoreduce oreliminate risktothe subject. c. I will promptlyreportanyunexpectedorseriousadverse events,unanticipatedproblemsor incidentsthatmayoccur in the course of thisresearch. d. I will maintainall relevantdocumentsandrecognisethatthe NTU-IRBstaff and regulatory authoritiesmayinspecttheserecords. e. I understandthatfailure tocomplywithall applicableregulations,institutionalandNTU-IRB policiesandrequirementsmayresultinthe suspensionorterminationof thisresearch. f. I declare thatthisis noexistingorpotential conflictof interestforanyof the investigators participatinginthisresearch. g. I will submitthe final report/summaryof researchtoNTU-IRBwithin3 monthsaftercompletion of the study. Remarks(if any): __________________________ ________________ Principal Investigator’ssignature Date: Phone: Fax: MailingAddress: Email:
  3. 3. III. CO-INVESTIGATORS All co-investigatorswho havea responsibility fortheconsentprocess or direct data collection for this research should be listed below.Multiple copiesof this formmay be submitted asnecessary.Allco- investigatorsneed notsign on thesame form. Name: E-mail: Position: Phone: Division: Fax: School: ______________________________ ______________________________ Signature of Co-investigator Date Name: E-mail: Position: Phone: Division: Fax: School: ______________________________ ______________________________ Signature of Co-investigator Date Name: E-mail: Position: Phone: Division: Fax: School: ______________________________ ______________________________ Signature of Co-investigator Date
  4. 4. IV. PROTOCOL CHECKLIST Organise detailsof the researchprotocol under the followingheadings(innomore than 7 pages). 1. SpecificAims: 1.1. State concisely and realistically what the research described in this application is intended to accomplish and/orwhathypothesisisto be tested. 2. Introduction: 2.1. Briefly describe the backgroundto thecurrentproposal 2.2. Stateconcisely the importanceof theresearch described in this application 2.3. Relevant references 3. PreliminaryStudies/ProgressReports 3.1. Provide an account of the Principal Investigator’s preliminary/pilot studies (if any) pertinent to the application. 4. Methodology: 4.1. Discuss in detail the experimental design and procedures to be used to accomplish the specific aims of the research 4.2. Describe the protocol(s) to beused. 4.3. Include details on sample size calculation and the means by which data will be analysed and interpreted. 4.4. List all subjects’ related procedures. Please also describe the subject research visits (frequency and proceduresinvolved).Forstudieswith multiple visits,please attach visit schedule. 4.5. Whatare the anticipated benefitsand risksto human subjectsparticipating in thisresearch? 4.6. Discuss the potential difficulties and limitations of the proposed procedures and alternative approachesto achievetheaims. 4.7. Will any part of the proceduresbeplaced on audiotape,film/video,orotherelectronicmedia? Yes No If Yes, what is the medium? Explain how the recorded information will be used? How long will the tapes,etc,be retainedandhowwill theybe disposedof? 5. Additional Informationon Methodology 5.1 Ifresearch involvesdatabases,please completethe following: 5.1.1 Where will the databe stored? 5.1.2 Who will haveaccess to thedata 5.1.3 Whatwill happen to the data afterresearch completion? 5.1.4 Any otherremarks? 5.2 Ifresearch involves cell cultures/cell lines,please complete the following: 5.2.1 Describes the cells thatwill be used forthe research 5.2.2 Indicatethe sourceof thecell cultures/lines.Please provideproof of purchaseor catalog details of the cells 5.3 Ifresearch involvesarchivedtissuesor datafrom the Clinical Department, approvalfrom the custodian isrequired.The custodian is the Head of School(HOD) or Chairman of the Medical Board (if PI is the HOD). (An e-mail/letter fromthe HOD or Chairman MedicalBoard,stating hisapprovalto supply the quantityof tissuesforeach type,orthe data,would suffice)
  5. 5. 6. Characteristicsof Target Subjects/Target SubjectData: 6.1 What isthe numberof subjectstobe enrolled?Give abreakdownbyinstitutionformulti-centre studies(if applicable). Institution/Siteof Recruitment Total Men Women Children 6.2 LowerAge Limit: Upper Age Limit(if any): 6.3 Total Numberof subjectstargetedforenrolmentworldwide (forinternational studies): 6.4 Are there any subjectrecruitmentrestrictionsbasedonrace of the subject? 6.5 Inclusioncriteria 6.6 Exclusioncriteria 6.7 Are the subjectsvulnerableorin a dependentrelationshipwiththe researchers? Yes (If yes,please provide details.) No Not Applicable 7. Participant Information Sheetand WrittenInformedConsentForm: 7.1 The PI isresponsible forensuringthatall researchsubjectsgive informedconsent before enrollingintothe research.Pleasesubmitacopyof the ParticipantInformationSheetand ConsentForm. 7.2 Summarise the consentprocedure. Please specifyhow willinformedconsentbe obtainedand whowill obtainconsent. 7.3 If waiverof consentisrequired,pleasespecifyhow yourresearchmeetsthe followingcriteria: (The NTU-IRBmay waive the requirementtoobtaininformedconsentif the NTU-IRBfindsthat the researchmeetsthe following4criteria.) 7.3.1 The researchinvolvesnomore thanminimal risktothe subjects 7.3.2 The waiveror alterationwill notadverselyaffectthe rightsandwelfare of the subjects. 7.3.3 Wheneverappropriate,the subjectswillbe providedwithadditionalpertinent informationafterparticipation. 7.3.4 The researchcouldnot practicablybe carriedout withoutthe waiveroralteration. 8. RecruitmentProcess: 8.1 Explainthe processof recruitmentindetail.Forexample state how the listof potential research subjectswill be obtainede.g.fromattendingdoctorwhowill referpotentialsubjects.Please submita copyof any advertisements/postersthatwill be used. 8.2. Will subjectsbe chosenfrommedical records?If so,how will youobtainnamesandNRICNosof subjectsandfromwhomwill youobtainpermissionforuse of these records? 9. Data SafetyMonitoringPlan 9.1. Please include detailsonthe DataSafetyMonitoringPlan(DSMP) forthe research.Please discussthe plansinplace to ensure the safetyandwell beingof subjects,andintegrityof the data collected. 10. Timelines: 10.1 What are the estimatedstartandenddatesof the research? Start Date: End Date: 10.2 Indicate the durationof subjectinvolvementinthe research.Please alsostate the recruitment period.
  6. 6. VII. ATTACHMENT CHECKLIST Document Attached Not Applicable ResearchProtocol (latest version)* Grant ApplicationForm ParticipantInformationSheetandConsentForm Investigator(s)’CV Investigator’sBrochure SurveyForm(s)/Questionnaire(s)/DiaryCard Data CollectionForm AdvertisementforRecruitmentof Subjects Letterof Invitationto Subjects Letterto Doctors RequestingReferral RelevantPublications Cheque forIndustrySponsoredTrials SubjectPaymentDetails SubjectCompensationDetails Financial Agreement GCP/ CITITrainingCertificate of PI

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