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Irb Protocol Sep081-1

This document provides guidelines for researchers at An-Najah University to apply for human subjects research review by the Institutional Review Board (IRB). It outlines the application process, including submitting a completed protocol form providing details of the research methods, participants, risks and benefits, informed consent process, and privacy and confidentiality protections. Researchers must assure they will follow all applicable ethics principles and regulations regarding human subjects protection. The IRB will review applications to ensure the rights and welfare of participants are adequately safeguarded.

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58 views

Irb Protocol Sep081-1

This document provides guidelines for researchers at An-Najah University to apply for human subjects research review by the Institutional Review Board (IRB). It outlines the application process, including submitting a completed protocol form providing details of the research methods, participants, risks and benefits, informed consent process, and privacy and confidentiality protections. Researchers must assure they will follow all applicable ethics principles and regulations regarding human subjects protection. The IRB will review applications to ensure the rights and welfare of participants are adequately safeguarded.

Uploaded by

mahmoud fuqaha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 6

AN-NAJAH UNIVERS

PROTOCOL FOR HUMAN SUBJECTS RESEARCH

NEW PROJECTS ONLY

Investigator’s Assurance
By submitting this protocol, I attest that I am aware of the applicable principles,
policies, regulations, and laws governing the protection of human subjects in
research and that I will be guided by them in the conduct of this research.
___________________________________________________________________________________

To apply for human subjects IRB review:

1. Download this New Projects IRB Protocol and save it on a floppy disk or on your
hard drive. You may then open it, type in all requested information, save the file
(please use your last name and New Project Protocol as the title: e.g., Musmar New
Project Protocol), and send the file as an e-mail attachment, along with your
informed consent letter(s), to the Institutional Review Board at
“ [email protected]”.

It is essential that you answer all questions on this form since this is the
primary source of information used by Board members to make their
decisions. Also, only include information necessary to answer the questions.
Please keep your responses as free of jargon as possible.

2. Please also send, by campus mail, all supporting materials that cannot be e-mailed
(e.g., measures, permission letters from off-campus sites) to the IRB at An-Najah
University, Nablus, Palestine. If your research requires review by the full Board,
you will be so notified and asked to provide an additional 12 copies of the
supporting materials.

PLEASE DO NOT INCLUDE THIS PAGE WITH YOUR SUBMISSION


0
REV 9/08
Office of the Institutional Review Board

1
PLEASE BE SURE TO COMPLETE ALL SECTIONS

Current Date of Submission: ____________________________


IRB office use only: Date received in IRB office (stamp)___________________

If this is a revision in response to an IRB Report of Action (ROA)-approval pending, indicate the
date of the ROA: _______________________

Title of Research: ____________________________________________________________

Principal Investigator: _________________________________________________________


Department/School_______________________
Room # where mail can be sent ______________
Phone ______________ E-mail _______________________
Other Investigator: _________________________________________________________
Department/School_______________________
Room # where mail can be sent ______________
Phone ______________ E-mail ________________________
**Faculty Sponsor (for Student Research): ____________________________________
Department/School_______________________
Room # where mail can be sent ______________
Phone ______________ E-mail _______________
Student Street Address ________________________________________
City ________________________State_________ Zip _______________
Type of Research (please check):
Dissertation ______ (PLEASE NOTE: IRB review of dissertation research
requires prior successful proposal defense.)
PhD Defense Date: ______________________
Master’s Thesis _____
Class project _____
all other projects_____
** If the primary investigator is a student, check here to indicate that your faculty sponsor has read the
entire application, including cover letters, informed consents, and data collection instruments, and asserts that this
application is accurate and complete.

Dates Human Subjects Portion of Research Scheduled: from: _______ to _______.

Site(s) of Human Subject Data Collection: ______________________________________________

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(NOTE: If sites are administratively separate from the University, please submit approval letters, or
indicate when they will be forthcoming.)
Funding Agency (if applicable):______________________________________

I. NATURE OF THE RESEARCH

In the judgment of the Principal Investigator, this research qualifies for which of the following
types of review:
Review Type: exempt (category) expedited (category) full Board1

II. PURPOSE OF RESEARCH

Briefly describe the objective(s) of the research (please keep description jargon free and use 100
words or less; the IRB will file this information in our descriptions of approved projects).

III. METHODS

Approximate number of subjects: _____________________________

Subjects will be (check only if applicable):


minors (under 18)
involuntarily institutionalized
mentally handicapped

Describe in detail how the subjects will be selected and recruited:

1
All research that is either externally funded or greater than minimal risk must be reviewed by the full Board
3
Describe exactly what will be done to subjects once they have agreed to participate in the project:

What incentives will be offered, if any? ________________________

IV. RISKS/BENEFITS TO PARTICIPANTS

Identify possible risks to subjects:


(NOTE: These may be of a physical, psychological, social or legal nature. If subjects are vulnerable
populations, or if risks are more than minimal, please describe what additional safeguards will be
taken.)

What are the benefits and how will they be optimized?

Do benefits outweigh risks in your opinion? Yes No _______

Are there potential legal risks to the Principal Investigator or University? Yes No _______

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V. INFORMED CONSENT

Describe how participants will be informed about the research before they give their consent. Be sure
to submit with this protocol a copy of the informed consent/assent letter(s) you will use. Please prepare
your informed consent letter at the 8th grade reading level or lower as dictated by the needs of the
subjects. (See IRB website for required elements of an informed consent.)

VI. PRIVACY/CONFIDENTIALITY

Please describe whether the research would involve observation or intrusion in situations where
subjects have a reasonable expectation of privacy. If existing records are to be examined, has
appropriate permission been sought; i.e. from institutions, subjects, physicians? What specific
provisions have been made to protect the confidentiality of sensitive information about individuals?

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