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NTU Institutional Review Board (IRB) Application Form – Biomedical Research

Type of Application: Expedited review Full IRB review

I. BASIC INFORMATIONProtocol Title:

Applicant:Title Name Role Position Dept/ Institution

PI or Corresponding PI/ Supervisor

(Please complete section III for all co-investigators)

Sponsor:BMRC NMRC NTU SUG AcRF Tier 1 AcRF Tier 2 NRF MINDEF Others None

If others, please specify: _________________Total amount of grant/fund: $ _____________Status of grant: Approved Pending Not applicable

Nature of Research: Basic Research Clinical Research Clinical Trial Database Retrospective Medical Records Review Questionnaire / Survey Medical Devices Others, please specify:

Phase of Clinical Trial (for clinical studies only): Phase I Phase II Phase III Phase IV

Research May Involve:Human Subjects (Target Number: _____)

Healthy Volunteers Children Pregnant Women Outpatients Inpatients Prisoners Cognitively 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, please provide details: ____________________________________

Site Details: of 11

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: Not applicable (refer to Appendix for Names of Organizations)

Singhealth SGH NHC NCC CGH SERI KKH NDC NNI SHP

NHG DSRB A DSRB B DSRB C DSRB D DSRB E NUS SMU

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 NTU-IRB approval and

regulatory authority approval (if applicable).b. I will not initiate any change in protocol without prior written approval from NTU-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 recognise that the NTU-IRB staff and regulatory

authorities may inspect these records.e. I understand that failure to comply with all applicable regulations, institutional and NTU-IRB

policies and requirements may result in the suspension or termination of this research.f. I declare that this is no existing or potential conflict of interest for any of the investigators

participating in this research.g. I will submit the final report/summary of research to NTU-IRB within 3 months after completion

of the study.

Remarks (if any):

__________________________ ________________Principal Investigator’s signature Date:

Phone: Fax:Mailing Address:

Email:

III. CO-INVESTIGATORS

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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: E-mail:Position: Phone:Division: Fax:School:

______________________________ ______________________________Signature of Co-investigator Date







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IV. COMMENTS OF ASSOCIATE CHAIR (RESEARCH)* (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. Innovations:Does the research challenge existing paradigms?Does it employ novel concepts, approaches and methods?

YES NO

4. Principal InvestigatorIs 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 cost appropriate (i.e. accurate)?Is the overall budget reasonable for the significance of the research?

YES NO

Comments

I acknowledge that this research is keeping with standards set by the Principal Investigator’s school.

_____________________________________________________ _______________________

Signature of Associate Chair (Research)/Chair/Dean* Date

Name:

Title: Position

*If the PI or co-PI is the Associate Chair (Research), this section should be completed by the Chair of the School.

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V. ABSTRACT OF RESEARCH PROPOSAL (Not applicable for Exempt review)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.

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VI. PROTOCOL CHECKLISTOrganise 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 proposal2.2. State concisely the importance of the research described in this application2.3. Relevant references

3. Preliminary Studies/Progress Reports3.1. 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 research4.2. Describe 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.4.3. 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

procedures involved). For studies with multiple visits, please attach visit schedule.4.5. 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 details in section 5.3.

4.6. What are the anticipated benefits and risks to human subjects participating in this research?4.7. Discuss the potential difficulties and limitations of the proposed procedures and alternative

approaches to achieve the aims.4.8. Will 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 If research involves databases, please complete the following:

5.1.1 Where will the data be stored? 5.1.2 Who will have access to the data 5.1.3 What will happen to the data after research completion? 5.1.4 Any other remarks?

5.2 If research involves placebo, please complete the following: 5.2.1 Explain what ‘standard of care’ therapy is available for this condition 5.2.2 Discuss the ethical implications of using placebo instead 5.2.3 Address the issues of safety and efficacy of other available therapies

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5.2.4 The total duration the subject would be on placebo arm of the research 5.2.5 Greatest potential harm that the subject might be exposed to as a result of not receiving

effective therapy 5.2.6 Protocols in place to safeguard participants receiving placebo 5.2.7 Any other remarks?

5.3 If research involves tissues/body fluids, please complete the following: 5.3.1 Please state the amount and frequency at which these samples are taken 5.3.2 Describe the biological samples that will be collected and stored 5.3.3 What tests will be performed on these biological samples? 5.3.4 What will happen to the biological samples after the research is completed? 5.3.5 How are the biological samples identified? No identifier Biological samples are coded and the code is maintained with the PI Identifiers present Others, please specify 5.3.6 Will results from the tests be communicated to the subjects? 5.3.7 Any other remarks?

e.g. when bioethical approval is sought for collection of blood samples from volunteers for research, the PI must provide the following relevant information: How much blood will be drawn from each volunteer? How many times and over what time period will blood be drawn from each volunteer? How many volunteers will be recruited? Who is the qualified phlebotomist? Qualification and experience? Where and in what kind of room will blood drawing be carried out? Will volunteers be asked personal and sensitive questions (e.g., HIV positive or negative,

sexual practices and inclination, etc.) before blood is drawn from them? If personal and sensitive questions are to be asked, what appropriate protocols for

protecting privacy and confidentiality are in place? Blood drawing is an invasive procedure. What precautionary measures are in place if

volunteers feel unwell or develop hematomas after blood withdrawal? Will blood drawn from volunteers be stored in a secured room or equipment? For how long? Will there be ‘left over’ blood sample drawn from a volunteer? What will happen to it? Will the blood samples be used for other unspecified purpose or purposes? DNA, the genetic material, can be extracted from blood and genetic information can

subsequently be accessed from the DNA, if so desired. Will the blood samples collected be de-identified and rendered anonymous to protect the genetic privacy of volunteers?

Is there an informed consent form for each volunteer to sign?

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5.4 If research involves cell cultures/cell lines, please complete the following: 5.4.1 Describes the cells that will be used for the research 5.4.2 Indicate the source of the cell cultures/lines. Please provide proof of purchase or catalog

details of the cells

5.5 If research involves archived tissues or data from the Clinical Department, approval from the custodian is required. The custodian is the Head of School (HOD) or Chairman of the Medical Board (if PI is the HOD).

(An e-mail/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:

6.1 What is the number of subjects to be enrolled? Give a breakdown by institution for multi-centre studies (if applicable).

Institution/ Site of Recruitment Total Men Women Children

6.2 Lower Age Limit: Upper Age Limit (if any):6.3 Total Number of subjects targeted for enrolment worldwide (for international studies):6.4 Are there any subject recruitment restrictions based on race of the subject?6.5 Inclusion criteria6.6 Exclusion criteria6.7 Are the subjects vulnerable or in a dependent relationship with the researchers?

Yes (If yes, please provide details.) No Not Applicable

7. Participant Information Sheet and Written Informed Consent Form:

7.1 The 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.

7.2 Summarise the consent procedure. Please specify how will informed consent be obtained and who will obtain consent.

7.3 If waiver of consent is required, please specify how your research meets the following criteria: (The NTU-IRB may waive the requirement to obtain informed consent if the NTU-IRB finds that the research meets the following 4 criteria.)

7.3.1 The research involves no more than minimal risk to the subjects7.3.2 The waiver or alteration will not adversely affect the rights and welfare of the subjects.7.3.3 Whenever appropriate, the subjects will be provided with additional pertinent

information after participation.7.3.4 The research could not practicably be carried out without the waiver or alteration.

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8. Recruitment Process:8.1 Explain 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.

8.2. Will 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

9.1. Please 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:

10.1 What are the estimated start and end dates of the research? Start Date: End Date:10.2 Indicate the duration of subject involvement in the research. Please also state the recruitment

period.

11. Financial Aspects/ Conflicts of Interest:

11.1 Who will be responsible for research related costs? For sponsored research, list the costs that will be borne by the sponsor.

11.2 For industry sponsored research, please complete the following.11.2.1 Name of the sponsor company?11.2.2 Address of the sponsor?11.2.3 Sponsor contact person?11.2.4 Have any of the investigators received any financial support, sponsorship from the

company supporting this research? Yes No

11.2.5 Do any of the investigators hold any ownership interest, e.g. stock options in this company?

Yes No11.2.6 Is the sponsor offering any incentive connected with subject recruitment or completion of

research (e.g. finder’s fee, recruitment bonuses, etc.) that will be paid to the research staff?

Yes No11.2.7 If you have answered yes to Q5 above, please elaborate.11.2.8 Any other remarks?

11.3 Will subjects receive financial payment/ incentive for participation? If yes, please elaborate.

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VII. ATTACHMENT CHECKLISTDocument Attached Not Applicable

Research Protocol (latest version)*

Grant Application Form

Participant Information Sheet and Consent Form

Investigator(s)’ CV

Investigator’s 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

* if information is not included in sections V and VI of the application form

APPENDIX

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Singhealth Singapore Health Services

SGH Singapore General Hospital

NHC National Heart Centre Singapore

NCC National Cancer Centre Singapore

CGH Changi General Hospital

SERI Singapore Eye Research Institute

KKH KK Women’s and Children’s Hospital

NDC National Dental Centre

NNI National Neuroscience Institute

SHP Singhealth Polyclinics

NHG National Healthcare Group

DSRB A Domain Specific Review Board A

DSRB B Domain Specific Review Board B

DSRB C Domain Specific Review Board C

DSRB D Domain Specific Review Board D

DSRB E Domain Specific Review Board E

NUS National University of Singapore

SMU Singapore Management University

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