NUS Institutional Review Board (IRB)
APPLICATION FORM
I. BASIC INFORMATIONProtocol Title:
Applicant:
Title / Name / Role / Position / Dept./Institution
PIorCorresponding PI
/ Supervisor
(please complete section III for all co-investigators)
Source of Funding:
BMRC NMRC NUS ARF Others None
If Others/Pharmaceutical Company, please specify:
Total amount of grant/fund: $
Status of grant: Approved Pending Not applicable
Nature of Research:
Basic ResearchClinical Research Clinical Trial Database
Questionnaire / Survey Retrospective Medical Records Review
Others, please specify
Phase of Clinical Trial (for clinical studies only):
I II III IV
Research May Involve:
Human Subjects: (Target Number: )
Healthy Volunteers Children Pregnant Women Outpatients Inpatients
PrisonersCognitively Impaired Persons, please specify:
Biological Samples: (Target Number: )
Blood Tissues Others, please specify
Research Subjects Will Be:
Paid $ Not paid Not charged for trial procedures
Has this research been rejected by any IRB / REC / DSRB?
No Yes If yes, please provide details.
Site details:
Site(s) of research (Dept. & Institution):
Single-centre study
Multi-centre study - No of local sites: No of overseas sites:
This research is also submitted to or has been approved by:
SingHealth: SGH NHC NCC CGH SERI KKH NDC NNI SHP
NHG: DSRB A DSRB B DSRB C DSRB D Not Applicable
II. DECLARATION OF THE PRINCIPAL INVESTIGATOR
The information provided in this form is correct.
a.I will not initiate this research until I receive written notification of NUS-IRB approval and regulatory authority approval (if applicable).
b.I will not initiate any change in protocol without prior written approval from NUS-IRB except when it is necessary to reduce or eliminate risk to the subject.
c.I will promptly report any unexpected or serious adverse events, unanticipated problems or incidents that may occur in the course of this research.
d.I will maintain all relevant documents and recognize that the NUS-IRBstaffand regulatory authorities may inspect these records.
e.I understand that failure to comply with all applicable regulations, institutional and NUS-IRB policies and requirements may result in the suspension or termination of this research.
f.I declare that there is no existing or potential conflict of interest for any of the investigators participating in this research.
Remarks (if any):
______/ ______
Principal Investigator’s signature / Date
Phone: Fax:
Mailing Address:
Email:
III. CO-INVESTIGATORS
All co-investigators who have a responsibility for the consent process or direct data collection for this research should be listed below. Multiple copies of this form may be submitted as necessary. All co–investigators need not sign on the same form.
Name:Email:
Position:Phone:
Department:Fax:
Institution:
______
Signature of Co-investigator Date
Name:Email:
Position:Phone:
Department:Fax:
Institution:
______
Signature of Co-investigator Date
Name:Email:
Position:Phone:
Department:Fax:
Institution:
______
Signature of Co-investigator Date
Name:Email:
Position:Phone:
Department:Fax:
Institution:
______
Signature of Co-investigator Date
IV. COMMENTS OF HEAD OF DEPARTMENT * (Please circle accordingly)
1. Significance:
Does the research address an important problem? Will the research affect concepts and methods that drive the field? / YES / NO
2. Approach:
Is the conceptual framework adequately developed? Are the design, methods and analyses adequately developed and appropriate? / YES / NO
3. Innovation:
Does the research challenge existing paradigms? Does it employ novel concepts, approaches and methods? / YES / NO
4. Principal Investigator:
Is the Principal Investigator appropriately trained to conduct this research? Does the Principal Investigator have evidence of commitment (e.g. previous track record)? / YES / NO
5. Environment:
Is the Principal Investigator’s environment suited to perform the research? Is there an adequate patient/subject pool and are there adequate resources? / YES / NO
6. Budget:
Are the projected costs appropriate (i.e. accurate)? Is the overall budget reasonable for the significance of the research? / YES / NO
Comments
______
I acknowledge that this research is in keeping with standards set by the Principal Investigator’s department.
______/ ______Signature of Head/Chief/Vice-Dean(Research) / Dean* / Date
Name:
Title: / Position:
*The Head of Department can be the Head / Chief of the PI’s Department.
If the PI or co-investigators is the Head or Chief of PI’s Department, this section should be completed by the Vice-Dean (Research) or Dean of the Faculty.
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.
VI. PROTOCOL CHECKLIST
Organise details of the research protocol under the following headings (in no more than 7 pages).
1. Specific Aims:
1.1 State concisely and realistically what the research described in this application is intended to accomplish and/or what hypothesis is to be tested.
2. Introduction:
2.1 Briefly describe the background to the current proposal.
2.2 State concisely the importance of the research described in this application.
2.3 Relevant references
3. Preliminary Studies:
3.1 Provide an account of the Principal Investigator’s preliminary/pilot studies (if any) pertinent to the application.
4. Methodology:
4.1Discuss in detail the experimental design and procedures to be used to accomplish the specific aims of the research.
4.2Describe the protocol(s) to be used. If the research is a drug trial, please include information of the research drug and any other drugs that will be used in the trial.
4.3Include details on sample size calculation and the means by which data will be analysed and interpreted.
4.4List all subjects’related procedures. Please also describe the subjectresearch visits (frequency and procedures involved).For studies with multiple visits, please attach visit schedule.
4.5If 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 details in section 5.3.
4.6What are the anticipated benefits and risks to human subjects participating in this research?
4.7Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.
4.8Will any part of the procedures be placed on audiotape, film/video, or other electronic media? Yes No
If Yes, what is the medium? Explain how the recorded information will be used? How long will the tapes, etc, be retained and how will they be disposed of?
5. Additional Information on Methodology:
5.1 Please fill in the following information on measures you will take to maintain research data security, storage and confidentiality of the research participants (e.g. identifiers will be discarded upon completion of the research). In addition, if your research involves making use of archived/ existing databases, please furnish the necessary documentation, e.g., permissions to use those databases, if applicable.:
5.1.1Where will the data be stored?
5.1.2Who will have access to the data?
5.1.3What will happen to the data after research completion?
5.1.4Any other remarks?
5.2 If research involves placebo, please complete the following:
5.2.1Explain what ‘standard of care’ therapy is available for this condition
5.2.2Discuss the ethical implications of using placebo instead of ‘standard of care’ therapy in this situation
5.2.3Address the issues of safety and efficacy of other available therapies
5.2.4The total duration the subject would be on placebo arm of the research
5.2.5Greatest potential harm that the subject might be exposed to as a result of not receiving effective therapy
5.2.6Protocols in place to safeguard participants receiving placebo
5.2.7Any other remarks?
5.3 If research involvestissues/body fluids, please complete the following:
5.3.1Please state the amount and frequency at which these samples are taken.
5.3.2Describe the biological samples that will be collected and stored?
5.3.3What tests will be performed on these biological samples?
5.3.4What will happen to the biological samples after the research is completed?
5.3.5How are the biological samples identified?
No Identifier
Biological samples are coded and the code is maintained with the PI
Identifiers present
Others, please specify
5.3.6Will results from the tests be communicated to the subjects?
5.3.7Any other remarks?
5.4 If research involveshuman samples/ tissues/ cell cultures/cell lines, please complete the following:
5.4.1Describes the samples/ cells that will be used for the research.
Type of Human Tissues/ Samples / Name of Human Cell Lines (e.g. HeLa) / Source & Catalog No. (e.g. ATCC, CCL-2) / Quantity / Indicate if tissues / cell cultures are: (Please tick)
Primary / Secondary
5.4.2Indicate the source of the cell cultures/lines. Please provide proof of purchase or catalog details of the cells.
5.5If research involves archived tissues or data from the Department, approval from the custodian is required. The custodian is the Head of Department (HOD) or Chairman Medical Board (if PI is the HOD).
(An email/letter from the HOD or Chairman Medical Board, stating his approval to supply the quantity of tissues for each type, or the data, would suffice.)
6. Characteristics of Target subjects / Target Subject Data:
6.1What is the number of subjects to be enrolled? Give a breakdown by institution for multi-center studies.
Institution/Site of Recruitment / Total / Males / Females / Children
6.2Lower Age Limit: Upper Age Limit:
6.3Total number of subjects targeted for enrolment worldwide (for international studies):
6.4Are there any subject recruitment restrictions based on race of the subject?
6.5Inclusion criteria
6.6Exclusion criteria
6.7Are the subjects vulnerable or in a dependent relationship with the researchers?
Yes No Not applicable
If Yes, please provide details.
7. Participant Information Sheet and Written Informed Consent Form:
7.1The PI is responsible for ensuring that all research subjects give informed consent before enrolling into the research. Please submit a copy of the Participant Information Sheet and Consent Form.
(A sample of Participant Information Sheet and Consent Form is available on the IRB website at )
7.2Summarise the consent procedure. Please specify when consent will be obtained and who will obtain consent.
7.3If waiver of consent is required, please justify if your research meets the following criteria:
(The NUS-IRB may waive the requirement to obtain informed consent if the NUS-IRB finds that the research meets the following 4 criteria.)
7.3.1The research involves no more than minimal risk to the subjects.
7.3.2The waiver or alteration will not adversely affect the rights and welfare of the subjects.
7.3.3Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
7.3.4The research could not practicably be carried out without the waiver or alteration.
8. Recruitment Process:
8.1Explain the process of recruitment in detail. For example state how the list of potential research subjects will be obtained e.g. from attending doctor who will refer potential subjects. Please submit a copy of any advertisements/posters that will be used.
8.2Will subjects be chosen from medical records? If so, how will you obtain names and NRIC Nos of subjects and from whom will you obtain permission for use of these records?
9. Data Safety Monitoring Plan (for clinical trials only):
9.1Please include details on the Data Safety Monitoring Plan (DSMP) for the research. Please discuss the plans in place to ensure the safety and well being of subjects, and integrity of the data collected.
10. Timelines:
10.1What are the estimated start and end dates of the research?
Start Date: End Date:
10.2Indicate the duration of subject involvement in the research. Please also state the recruitment period.
11. Financial Aspects/Conflicts of Interest:
11.1Who will be responsible for research related costs? For sponsored research, list the costs that will be borne by the sponsor.
11.2For industry sponsored research, please complete the following.
11.2.1Name of the sponsor company?
11.2.2Address of the sponsor?
11.2.3Sponsor contact person?
11.2.4Have any of the investigators received any financial support, sponsorship from the company supporting this research? Yes No
11.2.5Do any of the investigators hold any ownership interest, e.g. stock options in this company? Yes No
11.2.6Is the sponsor offering any incentive connected with subject recruitment or completion of research (e.g. finders’ fee, recruitment bonuses etc) that will be paid to the research staff? Yes No
11.2.7If you have answered ‘yes’ to Q 5, please elaborate.
11.2.8Any other remarks?
11.3Will subjects receive financial payment/ incentive for participation? If yes, please elaborate.
VII. ATTACHMENT CHECKLIST:
Document / Attached? / Not Applicable?
Research Protocol (latest version)*+
Grant Application Form
Participant Information Sheet and Consent Form+
Investigator(s)’ CV
Investigator Brochure
Survey Form(s)/Questionnaire(s) / Diary Card+
Data Collection Form+
Catalog Details / Proof of Purchase of Cell Cultures or Lines
Advertisement for Recruitment of Subjects+
Letter of Invitation to Subjects+
Letter to Doctors Requesting Referral
Relevant Publications
Cheque for Industry Sponsored Trials
Subject Payment Details*
Subject Compensation Details*
Financial Agreement
GCP/CITI Training Certificate of PI
+Version number and date is required.
*If information is not included in sections V and VI of the application form.
NUS-IRB Application FormPage1 of 10Version4, dated 23 January 2014
IRB-FORM-010