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Irb Application

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0% found this document useful (0 votes)
51 views5 pages

Irb Application

Uploaded by

raheel252
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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IRB Application Form

Study ID:
(To be filled by CRO)

1. FULL TITLE OF RESEARCH PROPOSAL:

2. STUDY PERSONNEL:

Names of research team (affiliation and contact details)

Sr. Document Attached If Not applicable, provide


No. with this reasoning
application
1 IRB application Form Yes/No
2 Research synopsis- soft copy Yes/No

3 Informed Consent Form- soft copy (English & Yes/No


Urdu version) for patients, if applicable
4 Informed Consent Form- (English & Urdu Yes/No
version) for healthy controls, if applicable
5 Questionnaire/Clinical data collection Yes/No
forms/interview guide
6 Itemized budget with indication of source of Yes/No
funding
7 A copy of the Investigator Brochure and any Yes/No
other available safety information
8 Information about payments and Yes/No
compensation available to subjects
9 The Investigator’s current curriculum vitae Yes/No
10 Conflict of interest declaration Yes/No
11 Collaborator/Sponsor/Contract Research Yes /No
Organization undertaking (as applicable)
12 Material Transfer agreement/Collaboration Yes/No
Agreement/Indemnity Insurance
documentation, where applicable
13 Waiver of informed consent (provide written Yes/No
justification for waiver request)
3. Documents attached with this application

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i. Does the research staff have relevant training? (E.g. protocol training of co-PIs, study nurses,
GCP training etc.)

ii. Are all relevant resources and protections for the research secured? (financial, staff, insurance
indemnity)

iii. Are there any other parties involved in the research? What potential interests of these parties
might be in conflict?

iv. What will happen when the research is either stopped or is complete?

v. How will the findings be disseminated? (E.g. publication plans etc.)

vi. How do you plan to access, store and distribute any collected biological material? If
applicable. Guidelines for Collection, Usage, Storage and Export of Human Biological Materials
are available at http://nbcpakistan.org.pk/guidelines.html

4. Template for Writing Synopsis

I. Study Title
II. Investigator(s) with institutional affiliations
III. Introduction (What is the research question? Why is it important?)
IV. Objectives
V. Definitions
VI. Hypothesis
VII. Materials and Methods

A. Study Design: Describe in detail the design and methodology of the study. Identify
and distinguish between those procedures that are standard of care and those that
are experimental. Provide a detailed description of the planned data collection,
specific outcomes, and criteria for evaluation and endpoint definition.

B. Setting

C. Duration: Include the frequency and duration of each activity and the total length of
subject participation.

D. Sample Size and Sampling Techniques: If applicable, include information on


stratification or randomization plans, the maximum number of subjects you plan to
recruit for this study. If this is a multi-site study, indicate the projected total subject
accrual.

E. Inclusion and Exclusion Criteria

F. Study Procedures: Include details on medical procedures

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G. Data analysis and Statistical methods: Describe the statistical considerations for the
study, how the sample size was determined, and how the results will be analyzed, if
applicable.

H. For Interviews/Focus groups: Attach copies of any scripts and/or questions that will
be used to guide the interviews/groups. Indicate the member(s) of the study team
who will conduct the interviews/focus groups and any necessary qualifications such
as special training, supervision etc.

I. For Studies involving Surveys/Questionnaires: List all of the measures/instruments


that will be used for this study and attach copies. Indicate the member(s) of the
study team who will use these measures/instruments and any necessary
qualifications such as special training or licenses.

J. For Studies involving the use of existing data/specimen

K. When using Existing data/specimen and Applying for exemption, describe the
following

 the source of data/specimen

 the process used to delink the data or specimen/make it anonymized/ (the process
by which identified data is recorded in a way that individuals cannot be identified)

 how is the above process effective

 the unlinking of the data/samples will not unnecessarily reduce the value of the
research.

 Describe how the data/specimen will be labelled at the time of retrieval

VIII. Human Research Subject Protection

A. RISK/BENEFIT ASSESSMENT:
Risks, Discomforts and Potential Harms:
Describe the risks associated with each research intervention (physical,
psychological, social, and other factors) with the estimated probability that given
harm may occur and the potential reversibility. Describe the safety precautions that
will be taken to minimize risks/harms. When appropriate, include a study monitoring
plan for the safety of participants and for the validity and integrity of data.

Potential Benefits and Alternatives:


Describe any potential for direct benefits to participants in the study. There may be
no direct benefits. Also include information on the importance of the knowledge
that may reasonably be expected to result. Also, describe the alternatives available
to patients in cases of non-participation in research.

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B. INFORMED CONSENT:
Indicate the types of consent that will be involved in this study and attach copies of
the informed consent/assent document that will be used for this study.
If the waiver of informed consent is considered justified, describe with reasoning.

C. DATA PRIVACY AND CONFIDENTIALITY


 How will the data for this study be collected and recorded? Describe the provisions
to protect the privacy of the individual

 Where will the research data be stored? & how it will be secured.

 Who will have access to the study records or data? Specify their name, role and
affiliation.

IX. Resource Requirement


Monetary, logistic and administrative or other

X. References

5. Guidance for Investigators:

1. IRB approval is needed before the start of data collection for any research activity. Take some
time to find out: Is your project Human Subject Research? And what type of IRB review is
needed?
Comprehensive guidance is made available in research guidelines at the following link:
https://shaukatkhanum.org.pk/health-care-professionals-researchers/research/research-
guidelines/. You may find the following resources, helpful for making IRB application.
 Is my project Human Subject Research
 What type of IRB review is needed?
 Decision chart to determine what type of IRB review is needed
 How to prepare for IRB (for full quorum review as well as for exemption)
 Complete Application for IRB review
 Requirements for IRB submission (checklist)
 Prepare your study documents (Find Templates Below)
 Template for writing a synopsis
 Template for developing informed consent
 Conflict of interest declaration
 Maintaining your IRB approval
 Continuing review
 Final report (study completion)
 Amendment (changes in study protocol)
 Notifications (change of title, changes in study team)

2. Provide complete and accurate information. Contact the clinical research office, if you need
help in the completion of any section of this application.

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Research submissions received at clinical research office, by 5 th of each month, will be reviewed
in monthly SRC and IRB meetings (generally to be planned during last week of each month).
Studies submitted after fifth (5th) each month will be reviewed in meeting in the following month.
Many minimal risk studies are reviewed through exempt procedures. Review of complete
submissions, which qualify for exemption, will be completed in four (4) weeks. Submissions for
IRB should reach IRB office by fifth (5 th) of each month, and IRB will meet preferably on last
Friday, each month.

By submitting this form, the PI attests to the following:

 Research team engaged in human subject research is responsible for compliance with
SKMCH&RC research guidelines (https://shaukatkhanum.org.pk/health-care-professionals-
researchers/research/research-guidelines/) and other applicable laws and regulations including
that of National Bioethics Committee (NBC) Pakistan and Drug Regulatory authority of Pakistan,
DRAP (www.nbcpakistan.org.pk). The Principal Investigator (and supervisor in case the Principal
Investigator is a trainee) is responsible for assuring all study team members review and adhere
to these guidelines for the conduct of human subjects research.
 Compliance requirements include approval from the National Bioethics Committee (NBC),
Pakistan, and regulatory body (Drug Regulatory Authority, Pakistan (DRAP) or other relevant
bodies, as applicable.
 Principal investigator is responsible for keeping study records (including copies of IRB approved
proposal, information sheets and consent forms, signed consent forms, safety information, IRB
correspondence and all other important documents). These study records will be reviewed at the
time of continuing review or audits and will be retained in the clinical research office.
 A study proposal is solely the work of the author(s) stated, has not been previously conducted or
published elsewhere. No plagiarism, duplicate publication, and text recycling has been carried
out to the best of my knowledge.

Name of Researcher: ___________________________________

Signatures of Researcher: _______________________________________________

Date: ____________________

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