1. CONSENT BY SUBJECT FOR
PARTICIPATION IN RESEARCH
Prof Omar Hasan Kasule
Department of Bioethics
Lecture for 4th year medical students 7th May 2012

2. INFORMED CONSENT TEMPLATE
INSTRUCTIONS
 Final consent must be in 12 pt, as are sample text in this
template
 The investigator should fill in the appropriate information.
Some places have example text that must be replaced
 This template is intended to be used electronically. If so, be
sure to delete everything that doesn’t belong
 This template is an attempt to be comprehensive, to
facilitate preparing ICDs (Informed Consent Documents) for
all occasions.

3. PROJECT IDENTIFICATION
INFORMATION
 Protocol Number:
 Study Title:
 Name of Subject:
 Medical Record Number:
 Principal Investigator
 Address:
 Telephone:

4. INTRODUCTORY REMARKS
 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. 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.

5. WHY IS THIS STUDY BEING DONE?
 To investigate the effects of Sildenafil
(Viagra) on the parameters of the
pulmonary function test in Asthma patients
who have been prescribed the drug for
erectile dysfunction treatment.
 The study is funded by KFMC

6. HOW MANY PEOPLE WILL TAKE
PART IN THE STUDY?
 80 Male Patients
 All recruited at KFMC
 Saudi and non-Saudi

7. WHAT WILL HAPPEN IF I TAKE
PART IN THIS STUDY?
 A pulmonary function test will be
performed on you once before and
once two-hours after intake of
Sildenafil (50mg) orally weekly
 Test will be repeated for 6 weeks
during your routine doctor visits to
Urology Clinic at KFMC.

8. STUDY LOCATION:
 KFMC, MAIN HOSPITAL
 Pulmonology Department
 Spirometry Lab

9. WHAT IS EXPECTED OF ME
DURING THE STUDY?
 Attend the clinic for the duration of
the study which is 6 consecutive
weeks
 Take the medication
 Undergo the spirometry test

10. CAN I STOP BEING IN THE STUDY?
 You can decide to stop at any time.
 Tell the study doctor if you are thinking
about stopping or you’ve decided to
stop.
 He or she will tell you how to stop your
participation safely.
 No one will try to get you to change
your mind.
 There are no risks associated with
stopping being in the study

11. WHAT SIDE EFFECTS OR RISKS CAN I
EXPECT FROM BEING IN THE STUDY?
 Waiting for 2 hours in the hospital after
oral intake of 50 mg Sildenafil
 Slight headache might occur
 Slight blurred vision might occur
 Minor discomfort of undergoing the
spirometery for a few minutes

12. ARE THERE BENEFITS TO
TAKING PART IN THE STUDY?
 We hope the results would give a
positive indications to establish the drug
for the treatment of asthma
 Taking part in this study may or may not
make your health better.
 The doctors hope the drug will be more
effective / have fewer side effects than
the standard (usual) treatment, there is
no proof of this yet.

13. WHAT OTHER OPTIONS ARE
THERE?
 No other options are available

14. WHAT HAPPENS IF I AM INJURED
BECAUSE I TOOK PART IN THIS STUDY?
 It is important that you tell Dr. …. if you feel that you
have been injured because of taking part in this study.
You can tell the doctor in person or call him atxxxxxx.
 If you are injured as a result of being in this study,
treatment will be available.
 The costs of the treatment may be covered by KFMC or
the study sponsor, depending on a number of factors.
 KFMC and the study sponsor do not normally provide
any other form of compensation for injury.
 For further information about this, you may call the
office of the Institutional Review Board (IRB) at 288-
9999 ext 8391 or 1299.

15. 15.0 WHAT ARE THE COSTS OF
TAKING PART IN THE STUDY?
You will not be charged for any study
activities.

16. WILL I BE PAID FOR MY TAKING
PART IN THIS STUDY?
 In return for your time, effort and travel
expenses, you will be paid taking part in
this study.
 You will be paid xxx SR for participating
each week.
 Since the study is 6-weeks, you will be
paid a total of xxxSR for the entire
duration of the study.


17. WILL MY MEDICAL INFORMATION
BE KEPT PRIVATE?
 We will do our best to make sure that the
personal information in your medical record is
kept private. However, we cannot guarantee
total privacy.
 Your personal information may be given out if
required by law.
 If information from this study is published or
presented at scientific meetings, your name
and other personal information will not be
used.


18. WHAT ARE MY RIGHTS IF I TAKE PART IN THIS
STUDY?
 Taking part in this study is your choice. You may choose
either to take part or not to take part in the study. If you
decide to take part in this study, you may leave the study at
any time.
 No matter what decision you make, there will be no penalty
to you and you will not lose any of your regular benefits.
 Leaving the study will not affect your medical care. You can
still get your medical care from KFMC.
 We may use information that was collected prior to your
leaving the study.
 We will tell you about new information or changes in the
study that may affect your health or your willingness to
continue in the study.
 In the case of injury resulting from this study, you do not lose
any of your legal rights to seek payment by signing this form.


19. WHO DO I CALL IF I HAVE
QUESTIONS OR PROBLEMS?
 Before you agree to be in this study, you
will talk to a study team member
qualified to tell you about this study. You
can ask questions about any aspect of
the research.
 If you have further questions about the
study, you may ask them at any time.
You may call xxxxxxx

20. SIGNATURE 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.Subject
 Signature
 Date
 Place
 Time (AM PM )

21. SIGNATURE BY PERSON
OBTAINING CONSENT
 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.
 Signature of Person Obtaining Consent
 Date
 Place
 Time (AM PM )

22. SIGNATURE BY PRINCIPAL
INVESTIGATOR
 Signature of Principal Investigator
 Place
 Date
 Time (AM PM )