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Presentation at an “IRB Training Program” at
the Ministry of Health Riyadh on 8 June 2015 By Professor Omar Hasan Kasule Sr.
MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional
Review Board at King Fahad Medical City.
IDENTIFYING INFORMATION
·
Protocol Number
·
Name of Subject
·
Medical Record Number
·
Study Title
·
Principal Investigator
·
Address
·
Telephone
Introduction - 1
·
A member of the research team will
explain what is involved in this study and how it will affect you.
·
This consent form describes the
study procedures, the risks and benefits of participation, and how your
confidentiality will be maintained.
·
Please take your time to ask
questions and feel comfortable making a decision whether to participate or not.
Introduction - 2
·
This process is called informed
consent. If you decide to participate in
this study.
·
You will be asked to sign this
form and will be given a copy for your records.
·
Throughout this consent form, “you”
will refer to you or your child, as appropriate.
Sections of the
form - 1
·
Why is this study being done?
·
How many people will take part in
the study?
·
What will happen if I take part in
this study?
·
What is expected of me during the
study?
·
How long will I be in the study?
·
Can I stop being in the study?
·
Are there risks if I stop being in
the study? What side effects or risks can I expect from being in the study?
Sections of the
form - 2
·
Are there benefits to taking part
in the study?
·
What other options are there?
·
What happens if I am injured
because I took part in this study?
·
What are the costs of taking part
in the study?
·
Will I be paid for my taking part
in this study?
·
Will my medical information be
kept private?
·
What are my rights if I take part
in this study?
·
Who do I call if I have questions
or problems?
Consent by the
subject
·
The research and procedures have
been explained to me.
·
I have been allowed to ask any
questions I have at this time.
·
I can ask any additional questions
I may think of later.
·
I may quit being in the study at
any time without affecting my health care.
·
I will receive a signed copy of
this consent form.
·
I agree to participate in this
study. My agreement is voluntary. I do not have to sign this form if I do not
want to be part of this research study.
Person Obtaining
Consent
·
I have explained the nature and
purpose of the study and the risks involved.
·
I have answered and will answer
questions to the best of my ability.
·
I will give a signed copy of the
consent form to the subject.
Legally
Authorized Representative
·
The person being considered for
this study is unable to consent for himself/herself because he/she is a minor.
·
By signing below, you are giving
your permission for your child to be included in this study.