Institutional Review Board (IRB)
Dow University of Health
Sciences Baba-e-Urdu Road
Karachi, Pakistan
Tel: 021-32745827
Web: www.duhs.edu.pk
Email: irb@duhs.edu.pk
APPLICATION FORM
Checklist
Three copies of Research Protocol with checklist.
Three copies of Drug Brochure or any supplementary information
enclosed (if applicable).
Three copies of informed consent both in English and Urdu or any
other local language of the population study.
Three copies of Questionnaire being administered during the study
(if applicable).
Three copies IRB Application form.
Soft copies of all above documents will be sent irb@duhs.edu.pk at
the time of submission.
Signature: Principal Investigator Date
Signature of supervisor (if applicable) Date
------------------------------------------- ------------------------
Signature of Chairman/ Incharge Department Date
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Institutional Review Board
Dow University of Health Sciences
How to complete this form and begin the IRB review process
1. This form must be typed and not handwritten.
2. Fill all of the questions on this form completely. For any queries
please contact the Research Office, Dow University of Health
Sciences. Email: irb@duhs.edu.pk (Please wait for 7 – 10 days for
the response).
3. Students’ research project has to be signed by the supervisor.
4. Fill and attach the appropriate appendices required in this
application.
5. Attach supporting documentation: consent form(s), protocol, survey
instruments, interview schedules, advertisements, letters of
permission, etc. Consent form and questionnaire should also be
submitted in local languages where ever applicable.
6. Complete the accompanied checklists ensure there all requirements
for submission are completed so that review is not delayed.
7. Submit this application and appendices along with the supporting
documents to the Research Department Dow University of Health
Sciences, Baba-e-Urdu Road Karachi Pakistan.
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Principal Investigator Information:
Title: Name:
Designation: Department or Unit:
Mailing address (Office):
Phone: Email:
Signature of PI: Date:
Co Investigators Information:
1.
Title: Name:
Designation: Department or Unit:
Mailing address (Office):
Phone: Email:
Signature of Co Investigator: Date:
2.
Title: Name:
Designation: Department or Unit:
Mailing address:
Phone: Email:
Signature of Co Investigator: Date:
If, there are more than three authors, please write down only the
names and institution for of remaining other authors.
1. Title of Research/Project:
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2. Select one of the category for your research project.
a. Clinical trial on a medicine/drug
b. Clinical trial on a medical device
c. Experimental/ surgical procedure/s
d. Study administering questionnaires/interviews for
quantitative or mixed qualitative/quantitative methods.
e. Study involving qualitative methods only
f. Study limited to working with human tissue samples, other human
biological samples and/or data
g. Research data base (secondary data analysis only)
h. Research involving animal subjects
If any other category then please write down in the space given below
Note: Please provide details if study is related to Experimental
drug(s) or Non- approved use or non-approved dos age for approved
drugs
3. Do you plan to include any participants who are children or pregnant
women?
Yes No
(If yes please justify why it is important to include this study population)
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4. Please provide one page summary of the, research, project, including
details of research methodology (use simple language but give details of
how study will take place).
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5. Aims & Objectives of the proposed research.
5. What is the scientific justification for this research?
6. Please enlist the principal inclusion criteria
7. Please enlist the principal exclusion criteria
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8. Please give in detail methodology and procedures involved in this study.
9. How long do you expect each participant to be in the study?
10.Please complete the columns for each intervention/procedure as
follows:
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a.. Total number of interventions/procedures to be received by each
participant as part of the research protocol.
b. If this intervention/procedure would be routinely given to
participants as part of their care outside the research, how many of
the total would be routine???
c. Average time taken per intervention/procedure (minutes, hours or days)
d. Who will conduct the intervention/procedure, and where, it would take
place.
11. What are the potential risks for research participants and how will you
minimise them? (Describe any potential adverse effects, pain, discomfort,
distress, intrusion, inconvenience or changes to lifestyle. Only describe
risks or burdens that could occur as a result of participation in the
research. Say what steps
would be taken to minimize risks and burdens as far as possible)
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12.Will interviews/ questionnaires or group discussions include topics
that might be sensitive, embarrassing or upsetting?
Yes No
If yes give details.
13.What are the potential benefits for the research participants?
14.How and by whom will potential participants first be approached?
15.How long will you allow potential participants to decide whether or not
to take part?
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16.What arrangement have been made for persons who might not
understand verbal explanations or written information given in
Urdu/English, or who have special communication needs? (E.g. translation,
use of interpreters)
17. Please describe the physical security arrangements for storage of
personal data during the study.
18.How will you ensure the confidentiality of personal data? Please
provide a general statement of the policy and procedures for
ensuring confidentiality, e.g. anonymisation or pseudonymisation of
data.
19.Who will have access to participants' personal data during the study?
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20.Ownership of the data.
21.Laboratory and Radiological studies:
a) Will any tests be performed which are not routinely included as
part of the work-up for these types of patients?
b) Who or what agency will pay for these tests?
22.How do you intend to report and disseminate the results of the study?
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23.Will you inform participants of the results of the study?
Yes No
Please give details of how you will inform the participants or justify if not
doing so.
24.What is the primary outcome measure for the study?
25.What is the sample size for the research? How many
participants/samples/data records do you plan to study in total?
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26.How was the sample size decided upon? If a formal sample size
calculation was used, indicate how this was done, giving sufficient
information to justify and reproduce the calculation.
27. Has funding for the research been secured?
Funding secured from one or more funders
Funding application to one or more funders in progress
No application for external funding will be made
Give details.
28.Has this or a similar application been previously rejected by a
Research Ethics Committee in Pakistan or another country?
Yes No
29.How long do you expect the study to last in Pakistan?
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30.Is this study?
Single centre
Multicentre
Did you acquire many permission for the incharge of centre/s for this
study.
31.Where will the research take place?
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Declaration by Principal Investigator
1. The information in this form is accurate to the best of my knowledge
and belief and I take full responsibility for it.
2. I undertake to abide by the ethical principles underlying the Declaration
of Helsinki and good practice guidelines on the proper conduct of
research.
3. If the research is approved I undertake to adhere to the study protocol,
the terms of the full application as approved and any conditions set out by
review bodies in giving approval.
4. I undertake to notify review bodies of substantial amendments to the
protocol or the terms of the approved application, and to seek a
favourable opinion from the Ethical Review Board before implementing
the amendment.
5. I undertake to submit annual progress reports setting out the progress
of the research, as required by review bodies.
6. I am aware of my responsibility to be up to date and comply with the
requirements of the law and relevant guidelines relating to security and
confidentiality of patient or other personal data, including the need to
register when necessary with the appropriate Data Protection Officer. I
understand that I am not permitted to disclose identifiable data to third
parties unless the disclosure has the consent of the subjects’ data.
7. I understand that research records/data may be subject to inspection
by review bodies for audit purposes if required.
Signature: Principal Investigator Date
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