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Presentation at the Ethics Workshop held at Jizan University on
April 10, 2014 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard),
DrPH (Harvard)
CASE STUDIES 1
(what type of form do you use? /what type of review?)
STUDY #1
Our objective is to compare the efficacy of adding repetitive
sequential doses of xx versus placebo to yy in the management of acute cough in
children. We hypothesize that the addition of xx to yy in the management of
acute asthma is superior to the addition of placebo.
STUDY #2
The
objective of the study is to study the learning methods of nursing students using
a standard questionnaire. The students will be advised that the survey is
voluntary and that the results of the survey will be used to improve teaching
methods in the future.
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STUDY#3
Multicentre Epidemiological study to identify the
types of gene mutations observed in lung cancer and relate them to their degree
of histological differentiation anatomical site, age, and gender. Data will be
from medical records.
STUDY #4:
The
purpose of the study is to demonstrate the feasibility of pacing as a therapy
to prevent future MI. This is a multi-center, prospective, randomized, controlled
study.
STUDY #5:
The aim of the study is to discuss the impacts of
combining the 2 techniques in thyroid surgery. The study will be based on
review of records.
STUDY #6
Objectives (a) Measuring serum xxx level in type 2 diabetic
patients with or without other risk factor e.g., hypertension, hyperlipidemia
and central obesity (b) To explore if there is a relation between the serum xxx
level with blood cholesterol level.
STUDY
#7
The hypothesis is that iron supplementation has positive impact on patients with chronic
respiratory failure. The objective
was to investigate the role of administration of Iron supplementation on
respiratory function.
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CASE STUDIES 2:
Adequacy of the informed consent (several slides)
STUDY
#8
You are
being asked to voluntarily participate in this research study. The purpose of
the study is to understand the relationship of xxx levels in different cancer
patients and at different stages. You are eligible to participate because you
fulfill the criteria to be included in this study. We expect at least 200 subjects will
participate in the study for an approximate period of 6 months.
If you
agree to participate, your participation will involve obtaining a blood sample
that may produce minimal discomfort. It
should take no more than ten minutes. A part of the tissue sample sent to the
laboratory for diagnosis will be used for research. Your name will not appear,
and no identifying information is being collected as part of this study.
Any
questions you have will be answered. You
may leave the study at any time before completing it. Whether you complete the study or not will
not affect your health care. There are
no known risks from your participation.
No direct benefit from your participation is expected. The information may help provide a biochemical
for different types of cancers at different stages. There is no cost to you
except for your time. You will not be
paid for participation in this study. Only the study team will have access to
the information that you provide, which will remain anonymous. Data from all respondents will be summarized
in reports.
You can
obtain further information from the principal investigator, Dr.xxxx at phone
xxx. If you have questions concerning
your rights as a research subject, you may call the KFMC Institutional Review
Board office at xxxx.
Completing
this study indicates your voluntary agreement to participate. By participating in the study, you are giving
permission for the investigator to use your information for research purposes.
STUDY
#9 (several slides)
Why Is This
Study Being Done?
You
are being asked to participate in a research study that will try to learn
if
Iron
supplementation lung function.
How Many People
Will Take Part in This Study?
10
patients
What is
involved in the Study?
You will be "randomized" into
one of the study groups below.
Randomization means that you are put into a group by chance. A computer program will place you in one of
the groups. Neither you nor your doctor
can choose the group you will be in. You
will have an equal chance of being placed in any of the 2 groups. About one
spoonsful of blood will be taken from your vein for analysis. You will be asked
to breath into a machine to assess your lung function
Study location:
All study procedures will be done at the General Hospital
What is
expected of me during the Study?
You will be expected to (a) take the medication regularly (b) keep
a diary about your health and activities (c) visit the clinic for lung function
tests
How Long Will I
Be in This Study?
6 months
Can I Stop
Being in This Study?
You can decide
to stop at any time. Taking part is
purely voluntary.
What are the
Benefits of This Study?
:
There will be no direct benefit to you from taking
part in this study. Study results may be
useful to the patients in the future.
What are the
Risks of This Study?
There
can be some minor discomfort from having blood drawn, and there is a chance you
might get a bruise where the needle was stuck.
Very rarely, an infection may occur.
What if I am
Injured Because I Took Part in This Study?
If
you are injured as a result of being in this study, treatment will be provided
by the hospital at no cost to you.
What are the
Costs of This Study?
There are no
costs to you if you take part in this study.
What are the
Alternatives?
The
alternative is to not take part in this study.
Your care will not be affected if you do or do not take part.
Will I Be Paid
for Taking Part in This Study?
You
are a volunteer and will not be paid anything
Will My
Information Be Kept Private?
Your
personal information will be kept private.
It will be given out only if required by law. Your personal information will not be used in
any reports.
What are My
Rights if I Take Part in This Study?
Taking
part in this study is your choice. You
may choose to take part or not to take part.
If you decide to take part in the study, you can quit at any time. There will be no penalty to you for your
decision. Your medical care will not
change.
Who Do I Call
if I Have Questions or Problems?
If
you have questions about the study, you can call PI at xxxx. If you have any questions about “rights of
human subjects,” you may call the Chairman of the IRB at ( ). If you have an emergency, call ( ).
Subject
consent:
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.
Subject Signature
Date: / /
Time
(AM PM )