PATIENT INFORMED CONSENT
Study Title:
Sponsor:
Principal Investigator:
Primary Contact:
Daytime telephone number(s):
24-hour contact number(s):
This sample consent is provided as a guide to you in designing your Informed
Consent Form (ICF) for your study. There may be other sections you wish to include
which are pertinent to your project.
INTRODUCTION
You are being asked to participate in a research study. Before you agree to participate,
however, it is important that you read this informed consent form carefully. Please ask the
study doctor or the study staff to explain any words or procedures that you do not clearly
understand. You should not sign this form if you have any questions that have not been
answered to your satisfaction.
The purpose of this form is to give you information about the research study and, if signed,
will give your permission to take part in the study. The form describes the purpose,
procedures, benefits, risks, discomforts and precautions of the research study. You should
take part in the study only if you want to do so. You may refuse to take part or withdraw from
this study at any time without penalty or loss of benefits to which you are otherwise entitled.
PURPOSE OF STUDY
The main purpose of this study is to assess xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx in patients with
xxxxxxxxxxxxxxx. You have been asked to participate in this research study because you
have xxxxxxxxxxxxxxx.
DURATION OF STUDY
Approximately xxxx patients will participate in this study. Your participation in the study will
last approximately xxxx weeks (inpatient or outpatient) and require at least xxxx clinic visits.
The study requirements are included below.
RESEARCH VISITS AND PROCEDURES
After reading this information and discussing the research study with your doctor, if you
decide to take part in this study, you will be asked to sign this form confirming that you agree
to participate. After your signature, the study procedures can begin.
Include a description of all procedures – For reference, a sample is included below.
SAMPLE PROCEDURE DESCRIPTION
Screening (Visit 1)
Only after you voluntarily agree to participate and sign the Informed Consent Form can the
screening procedures be done.
The Screen phase may take up (insert time period) to complete in order for all of the
necessary assessments to be done.
At the first visit (screening visit), you will have a detailed evaluation that will include the
following:
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A physical examination, including a full exam.
A medical history to include information about you and any risk factors
A pregnancy test. If you are a woman, the study doctor will discuss acceptable methods
of birth control that are available. You must use one of these acceptable methods
throughout the study if you are sexually active. If you become pregnant during this study,
you will be withdrawn from further participation.
Blood samples will be collected for routine safety labs (approximately xxx teaspoonfuls of
blood will be taken from a vein in your arm)
Vital sign measurement (blood pressure, height and weight)
If you qualify to participate in the study, you will be asked to return within 2 weeks for the
baseline visit. Your doctor or nurse will tell you if you qualify.
Baseline Phase (Visit 2)
At the baseline visit, prior to taking your first dose of study drug, you will be asked to:
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Treatment Phase
During the next 7 weeks, your study medication will gradually increase until you reach a
target maintenance dose. Once you reach the target dose, you will stay at this dose for 12
weeks. Your doctor will monitor you closely during this phase, and you will be required to
come in the clinic for 2 scheduled visits during this phase (at the end of weeks xx and xx).
At the Week 8 visit, you will begin the Maintenance Phase, you will need to continue to take
your same medication as before. However your study doctor may adjust your doses during
this phase, if clinically appropriate. The study staff will give you detailed instructions on how
to take the medication. Your doctor will continue to monitor you closely during this phase.
You be required to come in the clinic for 2 scheduled visits during this phase (at the end of
weeks 12 and 20/withdrawal. You should bring your study medication with you to each
clinic visit.
The first visit will take about 1 ½ hours. The rest of the visits will take about 30 minutes each.
Evaluations done during clinic visits may include the following:
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Completion of a number of questionnaires
Blood samples will be collected for routine safety labs
Vital sign measurement (blood pressure, height and weight)
A brief or full physical exam
At each visit, you will be interviewed to determine your response to treatment, any side
effects, activity level, or problems you may have experienced. You must notify your study
doctor of any new medications you are taking and return the unused study medication
bottles, to your study doctor. You should not take any additional medications (over
the counter prescriptions or herbal) without consulting with your study doctor first.
If there is a worsening of side effects, or a change in frequency, severity, or character, you
may be withdrawn from the study. If you are withdrawn from the study early, this could
involve tapering some of your medications. You will need to undergo final visit procedures.
Your doctor will ensure that your follow-up care is arranged.
If you complete the study you will be treated using the standard of care practices of your
doctor.
Follow-Up Phase
After the Treatment Phase, you will be asked to return to your study doctor’s office xxx
weeks following your last Treatment visit. This visit is to follow-up on any side effects or
other health concerns you may have related to the study.
RISKS AND DISCOMFORTS
The most common side effects of xxxxxxxxxxxxxxx in adults include dizziness, weakness,
coordination difficulties, drowsiness, headache, double vision, blurred vision, nausea,
vomiting, and rash. It is possible that you may experience side effects that have not been
observed or that are unknown at this time.
During the course of this study your (disease state) may worsen, stay the same, or improve
either in severity or frequency.
When you begin to take new medications, there is a risk that an allergic reaction may occur.
Such reactions can be serious or fatal. If you suffer from allergies to other medications, food
products, or environmental elements, you should tell the study doctor.
When a blood sample is taken, there may be a small amount of discomfort and bruising
where the needle is put in your arm. There is a chance of bruising or infection at the site
where the blood is taken from your arm. You may feel dizzy or faint.
You should use caution when operating heavy equipment (machinery) or driving a motor
vehicle while taking the study medication. Only you should take the study drug. Study drug
must be kept out of reach of children or persons of limited capacity to read or understand.
REPRODUCTION RISKS
Not all of the effects of xxxxxxxxxxxxxxx on unborn children are known. It is important that
an adequate method of birth control (acceptable to you and the requirements of the study) be
used throughout the study. Your study doctor or nurse will help you determine if the method
of birth control you wish to use is acceptable.
If you are pregnant, suspect you are pregnant, or are trying to become pregnant or breastfeeding, you should not participate in this study. If you become pregnant at any time during
the study, you will be withdrawn from the study. You should notify the study doctor of the
pregnancy and follow the study withdrawal procedures the study doctor considers necessary
for your own safety. The pregnancy will be followed to determine the outcome. Generally,
follow-up will be no longer than six to eight weeks following the estimated delivery date.
NEW FINDINGS
Any significant new findings identified during this research study which may affect your
condition or willingness to continue participation in this study will be provided to you and your
doctor.
POTENTIAL BENEFITS OF THIS STUDY
Knowledge gained as a result of your participation in this study may be of benefit to others
with this type of condition. You may see an improvement in your condition. However, this
benefit cannot be guaranteed.
COSTS
You will receive the study medication free of charge. There will be no charge to you for
procedures and visits that are done solely for the purpose of this study. If you become sick
or hurt because you are taking part in the study, the hospital and doctors will treat you. Any
expenses for treatment will be billed to you or your insurance company. Saint Luke’s
Hospital does not have a policy of paying the medical expenses for patients who become
sick or injured while taking part in research studies.
ALTERNATIVE TREATMENT
You do not have to participate in this study to receive treatment for your symptoms. If you
choose not to participate in this study, alternative treatments are available. The study doctor
can discuss with you the risks and benefits of the alternative treatments.
CONFIDENTIALITY
Your identity in this study will be kept as confidential as possible under local, state, and
federal laws. Your medical records related to the study may be released to the study
sponsor, ____________________, and the United States Food & Drug Administration (FDA)
(list any other persons/entities that might have access) as described in the Saint Luke’s
Hospital Authorization to Share Private Health Information for Research. The results of this
research project may be presented at meetings or in publications; however, your identity will
not be disclosed in those presentations.
LEGAL RIGHTS
You do not give up any of your legal rights by signing this document.
WHO TO CONTACT
If you have questions about this study, or believe that you have sustained an injury, or
believe you have experienced a reaction to the study drug, please contact the person(s)
listed on the first page of this consent form.
If you have questions about your rights as a research subject, you may contact Saint Luke’s
Hospital Institutional Review Board at (816) 932-3661.
VOLUNTARY PARTICIPATION:
Your participation in this study is voluntary. If you do not want to be in this study, you do not
have to enroll. Your refusal to participate will not result in penalties or loss of benefits that
you would otherwise be entitled to. In addition, if you decide to participate, you may withdraw
from the study at any time without interfering with your regular medical treatment and without
penalty or loss of benefits.
WITHDRAWAL FROM THE STUDY:
Your participation in this study may be stopped at any time by your doctor or by the sponsor
for any reason. Some reasons for stopping the study may include that your doctor decides
that it is not in your best interest of your health or if you experience a reaction to the study
drug. The doctor will explain the procedures for withdrawal from the study.
SUBJECT’S STATEMENT OF CONSENT
I have read this informed consent form and have been given the chance to ask questions
and have received satisfactory answers. I voluntarily agree to participate in this study. I have
been told that I will be given a signed and dated copy of this consent form.
By signing this consent form, I have not waived any of the legal rights which I otherwise
would have as a subject in a research study.
Name of Subject (Print)
Signature of Subject
Date
Name of Legally Authorized Representative (Print)
Signature of Legally Authorized Representative
Date
Name of Person conducting informed consent discussion (Print)
Signature of Person conducting informed consent discussion
Date