Office of the Institutional Review Board
PLEASE BE SURE TO COMPLETE ALL SECTIONS
Current Date of Submission: 28/9/2019
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: Quality of life for chronic heart failure
Principal Investigator: Shaher Abood
Other Investigator: : Mahmoud Fuqha ,Mohannad Sabbah ,Osama wael Sawalha
and Mohammed Abu Aseeda
Department/School: :An-Najah National University, Faculty of Medicine and Health
Sciences, Nursing andMidwifery department
Phone: 0598403988
E-mail: shahrbwd95@gmail.com
**Faculty Sponsor (for Student Research): : Dr. Fatima Hirzallah
Department/School: An-Najah National University, Faculty of Medicine and Health
Sciences, Nursing andMidwifery department
Room # where mail can be sent:
Phone 0599149318 E-mail : fatimahirzallah@najah.edu
Student Street Address:
City: nablus
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 _X_
all other projects_____
X* 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: Oct 1 to Nov 15.
Site(s) of Human Subject Data Collection:
In cardic care unit on north west bank, al-Watani Governmental Hospital An-Najah National
University hospital,
(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) X expedited (category) full Board
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).
The aim of this study is to identify patients' perceptions about how chronic heart failure affects
their health-related quality of life
Objective:
1. To identify how CHF impact on everyday life.
2. To identify what are the most common patterns of coping strategies.
3. To identify the Physical and Psychological Symptoms of chronic heart failure for patients.
III. METHODS
Approximate number of subjects: 60
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:
The study population are consist of the all patients between the age 45-85 years with a
confirmed HF diagnosis verified by a cardiologist in selected hospital in nablus city .
Describe exactly what will be done to subjects once they have agreed to participate in the
project:
Once the patient with heart failure have agreed to participate in the study, the study data will be
collected from the sample of the study by patient with heart failure through interviews to fill out
questionnaires containing a set of questions divided between general questions and questions and
sub-paragraphs related to the subject of the study
What incentives will be offered, if any? No incentives ,are volunteered by individuals
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.)
No any risk becouse this stude just observe qulity of life for patient with heart failure
What are the benefits and how will they be optimized?
To patient and their family: the results of this study will hopefully provide information about
quality of life for chronic heart failure, and the suitable way to deal with chronic heart failure
disease.
Do benefits outweigh risks in your opinion? Yes
Are there potential legal risks to the Principal Investigator or University? No
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.)
Attached
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?
No one will look at the questionnaires except researchers. In addition, the names of the participants
will not be attached.
Participation in the study is voluntary.
No one will have access to information and data except the researchers.
All data will be coded and no names will be used.
Data will be locked in a safe place, and after a time it will be destroyed
