Exemption from full IRB review_Biomedical Research - Research Hub ...
NTU Institutional Review Board (IRB)
Exempt Review Application Form –
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
(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
Catalog No. (e.g.
Indicate iftissues/cell cultures
are: (Please tick)
(Please attach separate sheet, if required)
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.)
Mandatory (Please submitthe following documents.)
Catalog details OR proof of purchase ofcell lines,ifapplicable
List of PI & co-investigators with their signatures,together with their CVs
This Research Proposal has the approval of the Associate Chair of School
Signature of Associate Chair (Research)/Chair/Dean Date
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 : ___________________________
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
e. I understandthatfailure tocomplywithall applicableregulations,institutionalandNTU-IRB
policiesandrequirementsmayresultinthe suspensionorterminationof thisresearch.
f. I declare thatthisis noexistingorpotential conflictof interestforanyof the investigators
g. I will submitthe final report/summaryof researchtoNTU-IRBwithin3 monthsaftercompletion
of the study.
Principal Investigator’ssignature Date:
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.
Signature of Co-investigator Date
Signature of Co-investigator Date
Signature of Co-investigator Date
IV. PROTOCOL CHECKLIST
Organise detailsof the researchprotocol under the followingheadings(innomore than 7 pages).
1.1. State concisely and realistically what the research described in this application is intended to
accomplish and/orwhathypothesisisto be tested.
2.1. Briefly describe the backgroundto thecurrentproposal
2.2. Stateconcisely the importanceof theresearch described in this application
2.3. Relevant references
3.1. Provide an account of the Principal Investigator’s preliminary/pilot studies (if any) pertinent to
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
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
4.7. Will any part of the proceduresbeplaced on audiotape,film/video,orotherelectronicmedia?
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)
6. Characteristicsof Target Subjects/Target SubjectData:
6.1 What isthe numberof subjectstobe enrolled?Give abreakdownbyinstitutionformulti-centre
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?
6.7 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
7.2 Summarise the consentprocedure. Please specifyhow willinformedconsentbe obtainedand
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
7.3.3 Wheneverappropriate,the subjectswillbe providedwithadditionalpertinent
7.3.4 The researchcouldnot practicablybe carriedout withoutthe waiveroralteration.
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
10.1 What are the estimatedstartandenddatesof the research?
Start Date: End Date:
10.2 Indicate the durationof subjectinvolvementinthe research.Please alsostate the recruitment
VII. ATTACHMENT CHECKLIST
Document Attached Not Applicable
ResearchProtocol (latest version)*
Letterof Invitationto Subjects
Letterto Doctors RequestingReferral
GCP/ CITITrainingCertificate of PI