CIRB EXEMPTION APPLICATION FORM
I. Basic InformationProtocol Title:
Text Field
Protocol Number (if available) and Current Version Date (if available):
Text Field
Study Team Members:
Note: For a multi-centre study, please appoint a Site Principal Investigator (PI) for each Institution in addition to the PI (who will also be the corresponding PI for the multi-centre study). All investigators who have a responsibility for the consent process or direct data collection for this study should be listed below. Multiple copies of this page may be submitted as necessary. Additional copies of this page can be downloaded at
Title / Full Name / Study Role / Institution/Department
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
ChooseDrProfA/ProfClin ProfMsMrMdm / Text Field / Choose from listPrincipal InvestigatorSite PICo-InvestigatorCollaborator / Text Field
Has this proposal been rejected by any IRB /CIRB/DSRB?
No Yes If yes, please provide details for the rejection:
Study Site details:
Single-Centre Study / Multi-Centre Study:- No. of local sites: No. of overseas sites:
SingHealth Study site: / CGH SGH / KKH
SHP / NCC
SNEC / NDC IMU / NHC / NNI
This Application is submitted to:
SingHealth CIRB A CIRB B CIRB C CIRB D CIRB E
Is this a USFDAIND / IDE study?
NoYesIND Study. Please provide the IND number:
IDE Study. Please provide the IDE number:
Which category of research activities does this application involve? (Tick all applicable)
IMPORTANT: The criteria for exemption do not apply when the research involves:
(a)Prisoners
(b)Children, when the research involves survey or interview procedures or observations of public behaviour, except when the investigator(s) do not participate in the activities being observed
(c)FDA-regulated research activity
Category 1 – Normal Educational Practices and Settings
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.
Category 2 – Anonymous Educational Tests, Surveys, Interviews, or Observations
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.
Category 3 – Identifiable Subjects in Special Circumstances
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 Exemption category 2, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category 4 – Collection of Existing Data
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.
Category 5 – Public Benefit or Service Program
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.
Category 6 – Taste and Food Evaluation and Consumer Acceptance Studies
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.
Category 7 – Reporting of Individual patients’ clinical results
Writing up or reporting of individual patients’ clinical results by the patients’ doctors, provided that the patients’ consent for procedures and interventions in clinical management have been obtained and the patients’ privacy protected, for example, the review of a clinical programme that includes demographic, clinical and outcome parameters, which are useful in the audit of the programme; or the review of a procedure or treatment (a surgical technique or drug treatment outcome) by a physician or surgeon, where the choice of the drug or technique is based on the clinical judgment of the physician or surgeon and on best practices and not on any randomisation procedure. Researchers who are not the attending physicians in the programme but wish to have access to such information should send their proposals to the IRB in the usual way.
Category 8 – Research using unidentifiable data
Research using appropriately designed data escrow or other arrangements in which personal or other identity information is securely withheld from researchers by a third party provider ofinformation, there being no possibility of researchers by themselves being able to trace or reconstruct significant information on the identity of subject donor.
Category 9 – Commercially available cell lines, anonymous DNAs, RNAs and fixed tissues
Research using established commercially available cell lines or commercially available anonymous DNAs, RNAs and fixed tissues.
Category 10 – Development of Diagnostic Tests
The development of diagnostic tests using existing samples for test validation purposes provided that the necessary consent for the taking and use of the samples has been obtained.
Protocol Title: Text Field
II. Declaration of the Principal InvestigatorFor a Multi-centre study, the PI and each Site PI must sign this page. Please submit multiple copies of this page. Additional copies of this page can be downloaded at
I confirm that the information provided in this application is correct and that I will conduct the study in compliance with the protocol, applicable regulations, institutional and CIRB policies and requirements. I declare that there are no conflicting interests for any of the research personnel participating in this research study. (Important: Should you or any of the research personnel have any conflicting interest in this research study, please complete Annex B – Conflict of Interest Declaration Form for each individual having the conflict)
______/ ______
Principal Investigator’s Signature / Date
Full Name: / Text Field
Institution: / Text Field / Position Held: / Text Field
Department: / Text Field / Email address: / Text Field
Telephone: / Text Field / Fax: / Text Field
Mailing Address: / Text Field
*All fields must be completed.
III. Comments of Department Representative
*The Department Representative can be the Head / Chief / Research Head of the PI’s Department. Should the Head or Chief be the PI or Co-Investigator, then their reporting officer should complete this Section. It is assumed that all Departments involved concur with the PI’s Department Representative. The validity of this assumption rests solely on the PI. Should views differ, multiple declarations by the other Department Representatives may be submitted. Additional copies of this page can be downloaded atComments:
I acknowledge that this research is in keeping with standards set by the Principal Investigator’s Department.
______/ ______
Department Representative’s Signature / Date
Full Name: / Text Field / Position Held: / Text Field
Institution: / Text Field / Department: / Text Field
IV. Declaration of the Institution Representative*
* The Institution Representative has been determined by your institution as the authority that declares whether your research is in keeping with the institution’s research objectives, reputation and standards. The role of the Institution Representative is not to evaluate the scientific or ethical aspects of your study, although they may offer their comments.
For a multi-centre study, a copy this section must be completed by each institution. Additional copies of this page can be downloaded at
Comments:
I acknowledge that this research is in keeping with standards set by my Institution.
______/ ______
Institution Representative’s Signature / Date
Full Name: / Text Field / Position Held: / Text Field
Institution: / Text Field / Department: / Text Field
V. Abstract of Research Proposal
In no more than 300 words, describe concisely the specific aims, hypotheses, methodology and approach of the application, indicating where appropriate the application’s importance to science or medicine. The abstract must be self-contained so that it can serve as a succinct and accurate description of the application when separated from it. Please use lay terms. If this not possible, the technical and medical terms should be explained in simple language.
Text Field
VI. Research Details
1. Specific Aims
State concisely and realistically what the research described in this application is intended to accomplish and/or what hypothesis is to be tested.
Text Field
2. Methodology
Discuss in detail the experimental design and procedures to be used to accomplish the specific aims of the project.
Text Field
Describe the protocol(s) to be used.
Text Field
Include details on sample size calculation and the means by which data will be analysed and interpreted.
Text Field
List all trial related procedures. Please also describe the study participant visits (frequency and procedures involved).For studies with multiple visits, please attach study schedule.
Text Field
If samples of body fluids or tissues are taken as part of this research, state the amount and frequency at which these samples are taken. Will these samples be stored? If so, please include completed Annex C.
Text Field
What are the anticipated benefits and risks to study participants in this research?
Text Field
Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.
Text Field
3. Sample/Data Source (if applicable)
Please describe the source of samples/data.
Text Field
4. Characteristics of Target Study Participants (if applicable)
What is the number of Study Participants to be enrolled? Give a breakdown by institution for multi-center studies within Singapore.
Institution / Total Recruitment Number
Choose from listAlexandra HospitalChangi General HospitalInstitute of Mental HealthKK Women's and Children's HospitalNational Cancer CenterNational Dental CenterNational Healthcare Group PolyclinicsNational Neuroscience InstituteNational Skin CenterNational University HospitalSingapore General HospitalNational Heart CentreSingapore Eye Research InstituteSinapore National Eye CentreSingHealth PolyclinicsTan Tock Seng HospitalJohns Hopkins S'pore IMCSingHealth - IMU
Choose from listAlexandra HospitalChangi General HospitalInstitute of Mental HealthKK Women's and Children's HospitalNational Cancer CenterNational Dental CenterNational Healthcare Group PolyclinicsNational Neuroscience InstituteNational Skin CenterNational University HospitalSingapore General HospitalNational Heart CentreSingapore Eye Research InstituteSinapore National Eye CentreSingHealth PolyclinicsTan Tock Seng HospitalJohns Hopkins S'pore IMCSingHealth - IMU
Choose from listAlexandra HospitalChangi General HospitalInstitute of Mental HealthKK Women's and Children's HospitalNational Cancer CenterNational Dental CenterNational Healthcare Group PolyclinicsNational Neuroscience InstituteNational Skin CenterNational University HospitalSingapore General HospitalNational Heart CentreSingapore Eye Research InstituteSinapore National Eye CentreSingHealth PolyclinicsTan Tock Seng HospitalJohns Hopkins S'pore IMCSingHealth - IMU
Study Participants’ Lower Age Limit: Study Participants’ Upper Age Limit:
Total number of Study Participants targeted for enrollment worldwide (for international studies):
5. Informed Consent Process and Consent Document (if applicable)
The PI is responsible for ensuring that all Study Participants give informed consent before enrolling into the study. Please submit a copy of the Consent Document. For guidelines on preparing a Participation Sheet and Consent Form compliant with Good Clinical Practice Guidelines please contact the CIRB Secretariat. A Consent Form template can be downloaded at
Please describe the consent procedure. Please specify the following:-
Whenwill consent be taken?
Text Field
Where will consent be taken?
Text Field
Who will conduct the consent process?
Text Field
Do you anticipate a situation where obtaining informed consent from a potential Study Subject is not possible and informed consent will be taken from the legally acceptable representative (including spouse, parent, and guardian)?
Text Field
Describe provisions to protect the privacy interests of Study Subjects, where “privacy interests” refer to interests of individuals to be left alone, free from intrusion and comfort with the proposed settings
Text Field
Besides the Consent document, will any other materials or documents be used to explain the study to potential Study Subjects? (eg. scripts, handouts, brochures, videos, logs, etc)
Text Field
6. Recruitment Process (if applicable)
Explain the process of recruitment in detail. For example, state how the list of potential Study Participants will be obtained. (e.g. whether from attending doctor who will refer potential subjects.)
Text Field
Will subjects be chosen from medical records? If so, how will you obtain names and NRIC numbers of Study Participants?
Text Field
Please submit a copy of any advertisements/posters that will be used.
Text Field
7. Research Data Confidentiality
In general, to protect Study Participant’s confidentiality, research data should be coded, and the links between the Participant’s identifiers and the codes should be stored separately from the research data.
Will coded research data be sent to the sponsor, and no research database will be created in NHG/SingHealth?
Yes,If ‘Yes’, please skip this question and go to next section.
No, If ‘No’, please answer the following questions:-
Describe where the research data will be stored? (i.e.: network or Stand alone PC and the physical location)
Text Field
Who will have access to the research data and how will access to the research data be controlled and monitored?
Text Field
Are there any research data sharing agreements with individuals or entities outside the Institution, to release and share research data collected?
No
Yes, If yes, please describe the agreement
Text Field
Describe what will happen to the research data when the study is completed.
Text Field
Are there any other measures in place to protect the confidentiality of the research data?
Text Field
8. Financial Aspects
This study is initiated by: Investigator Pharmaceutical Company:Text Field
Source of funding for study: Text Field
Total amount of grant/fund: $
Status of grant: Pending approval Approved. Please submit a copy of the grant approval letter.
Financial benefits to Subjects (if any): $
9. Application Checklist:
Attached? / Document
Choose OneYesNoNot Applicable / Study Protocol (latest version)
Choose OneYesNoNot Applicable / Approved Grant Application (including DHHS approved Study Protocol and Sample Consent Form, if one exists)
Choose OneYesNoNot Applicable / Participant Information Sheet and Consent Form
Choose OneYesNoNot Applicable / Principal Investigator’s CV
Choose OneYesNoNot Applicable / CITI Certificate (SingHealth: For all investigators)
Choose OneYesNoNot Applicable / Survey Forms/Questionnaires / Diary Card
Choose OneYesNoNot Applicable / Data Collection Form
Choose OneYesNoNot Applicable / Posters for Advertisement
Choose OneYesNoNot Applicable / Relevant Publications
Choose OneYesNoNot Applicable / Cheque payment for Industry Sponsored Trials
Choose OneYesNoNot Applicable / Annex B – Conflict of Interest Declaration Form
Choose OneYesNoNot Applicable / Annex C – Biological Materials Storage
Choose OneYesNoNot Applicable / Annex D – Industry Sponsored Studies
Choose OneYesNoNot Applicable / Annex E – Waiver of Informed Consent
Choose OneYesNoNot Applicable / Any other materials/documents?Please list here:-
Text Field
~ End of Application Form ~
CIRB Exemption Application Form, Version 1.0, 18Sep 2012 / Page 1 of 8