Informed Consent Exercise

Description

Review a sample Informed Consent document and determine if it is compliant with the required Elements of Informed Consent outlined in ICH GCP. You will identify any omitted elements and make appropriate corrections to bring the document into compliance.
Review the Sample Informed Consent document and identify (annotate directly on the document) where the required elements are included.
By continuing to annotate the document, identify any missing elements, or elements that are not clearly addressed, and propose language sufficient to address the missing/unclear element(s).MULIT-CENTER PHASE III RANDOMIZED DOUBLE-BLIND PARALLEL GROUP STUDY
COMPARINGTHE EFFICACY OF IMBETTER VERSUS IMGOOD IN THE TREATMENT OF
HYPERTENSION
Introduction
You are being asked to participate in a clinical trial, a type of research study. Your
participation in this research study is voluntary and you may withdraw at any time, for any
reason. If you choose not to be in the study, you will not lose any medical benefits and you
can still participate in future studies.
This document contains information about the study, explains the risks of being in the study,
and explains your role and responsibilities as a participant. Please read it carefully and feel
free to ask any questions you may have.
Description of Study
You are being asked to participate in this study because you have been diagnosed with
Hypertension. The purpose of this study is to determine if an experimental “study drug,”
IMBETTER, is more effective than standard treatment with IMGOOD when given to people
with your condition. An experimental drug is one that has not received approval by the U.S.
Food and Drug Administration (FDA).
Why is this study being done?
The purpose of this study is to compare the effectiveness of two different treatments for
Hypertension. One standard treatment for Hypertension is the drug IMGOOD. The study will
determine whether the experimental drug IMBETTER is more effective in treating
Hypertension than IMGOOD. This study will also collect and compare the side effects of the
two drugs. In this study, you will be randomly selected to receive either IMGOOD or
IMBETTER for 6 weeks during the study.
This study also will look at biologic factors that may help to predict responses to treatment
with different types of medication used to treat Hypertension.
How many people will take part in the study?
About 400 people will take part in this study.
© 2019 Sheri Jacobsen. All Rights Reserved
1
What will happen if I take part in this research study?
Before you begin the study:
You will need to have the following exams, tests or procedures to find out if you can be in the
study. These exams, tests or procedures are part of regular care for Hypertension and may be
done even if you do not join the study. If you have had some of them recently, they may not
need to be repeated. This will be up to your study doctor.






History and physical examination
Blood tests
Vital signs (pulse/heartbeat and respirations)
Blood Pressure
ECG (a test that measures the rhythm of your heart)
Echocardiogram (a test that looks at the inside of your heart and how it is working)
During the study:
If the exams, tests and procedures show that you can be in the study, and you choose to take
part, then you will need the following tests and procedures. They are part of regular medical
care for Hypertension.
• Weekly physical examination
• Weekly vital signs
• Weekly blood tests
• Weekly blood pressure
In addition, if you experience any symptoms during the study that may indicate a worsening of
your Hypertension, additional ECGs and/or Echocardiograms may be performed.
You will need these tests and procedures that are part of regular medical care for your
Hypertension. They are being done more often because you are in this study.
You will be “randomized” into one of the study groups described below. Randomization means
that you are put into a group by chance. A computer program will place you in one of the study
groups. Neither you nor your study doctor can choose the group you will be in. You will have
an equal chance of being placed in any group.
If you are in Group 1 (often called “Arm A”)
You will be required to take the drug IMGOOD – 100mg pill once a day for 6 weeks.
If you are in Group 2 (often called “Arm B” or the experimental arm)…
You will receive the experimental drug IMBETTER – 200mg pill once a day for 6
weeks.
It is very important that you take the medication assigned to you as instructed.
© 2019 Sheri Jacobsen. All Rights Reserved
2
When you are finished receiving all treatment, you will have the following tests and procedures:






History and physical examination
Blood tests
Vital signs (pulse/heartbeat and respirations)
Blood Pressure
ECG (a test that measures the rhythm of your heart)
Echocardiogram (a test that looks at the inside of your heart and how it is working)
Study Plan
Another way to find out what will happen to you during the study is to read the chart
below. Start reading at the top and read down the list, following the lines and arrows.
First Visit: SCREENING
Several tests will be conducted to determine if it is safe for you to participate in the
study
Second Visit: RANDOMIZE
You will be randomly assigned to be in one group or the other
Arm B
Arm A


100mg pill of IMGOOD to be
taken daily for 6 weeks
Weekly visits to the study
doctor


200mg pill of IMBETTER to be
taken daily for 6 weeks
Weekly visits to the study
doctor
Final Visit:
Several tests will be conducted
© 2019 Sheri Jacobsen. All Rights Reserved
3
How long will I be in the study?
You will be asked to take the medication for 6 weeks.
Two weeks after you are finished with the 6 weeks of treatment, the study doctor will ask you
to visit the office for a final exam.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping so that he/she can
evaluate any risks from the treatment. Another reason to tell your study doctor that you are
thinking about stopping is to discuss what follow-up care and testing could be most helpful for
you.
The study doctor may stop you from taking part in this study at any time if he/she believes it is
in your best interest; if you do not follow the study rules; or if the study is stopped.
What side effects or risks can I expect from being in the study?
You may have side effects while on the study. Everyone taking part in the study will be
watched carefully for any side effects. However, researchers don’t know all the side effects
that may happen. Side effects may be mild or very serious. Your health care team may give
you medicines to help lessen side effects. Many side effects go away soon after you stop
taking the treatment. In some cases, side effects can be serious, long lasting, or may never go
away.
You should talk to your study doctor about any side effects that you have while taking part in
the study.
Risks and side effects related to the treatment include those that are:
Common











Tiredness
Dizziness
Headache
Insomnia
Slow heartbeat
Shortness of breath
Very low blood pressure
Congestive heart failure
Palpitations
Wheezing
Runny nose
© 2019 Sheri Jacobsen. All Rights Reserved








Diarrhea
Nausea
Dry mouth
Constipation
Heartburn
Rash
Changes in blood tests that
measure liver function
Dry eye that may be
irreversible
4
Rare but Serious
• Heart Attack
• Worsening of pre-existing heart and circulatory conditions
For more information about risks and side effects, ask your study doctor.
Are there benefits to taking part in the study?
Taking part in this study may or may not make your health better. While researchers hope that
IMBETTER will be more effective than IMGOOD, there is no proof of this yet. We do know that
the information from this study will help researchers learn more about IMBETTER as a
treatment for Hypertension. This information could help future Hypertension patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:
• Getting treatment or care for your Hypertension without being in a study
• Taking part in another study
• Getting no treatment
Talk to your study doctor about your choices before you decide if you will take part in this
study.
Will my medical information be kept private?
Data are housed at Best Day Ever Headquarters in a password-protected database. We will
do our best to make sure that the personal information in your medical record will be 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.
Organizations that may look at and/or copy your medical records for research, quality
assurance, and data analysis include:
• Your local IRB
• Government agencies, such as the the Food and Drug Administration (FDA), involved
in keeping research safe for people
• Monitors working for Best Day Ever to ensure that the study doctor and her staff
are conducting the research study appropriately
What are the costs of taking part in this study?
You and/or your health plan/insurance company will need to pay for some of the costs of
treating your Hypertension in this study. Some health plans will not pay these costs for people
taking part in studies. Check with your health plan or insurance company to find out what they
© 2019 Sheri Jacobsen. All Rights Reserved
5
will pay for. Taking part in this study may or may not cost your insurance company more than
the cost of getting regular Hypertension treatment.
You will be compensated $300.00 for your time and travel to participate in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, Dr. Beverly Crusher, if you feel that you have
been injured because of taking part in this study. You can tell the study doctor in person or call
him/her at 773-123-4567.
You will get medical treatment if you are injured as a result of taking part in this study. You
and/or your health plan will be charged for this treatment. The study will not pay for medical
treatment.
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 our institution.
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.
A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data
related to this study. The Committee members may receive confidential patient information, but
they will not receive your name or other information that would allow them to identify you by
name.
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.
Who can answer my questions about the study?
You can talk to your study doctor about any questions or concerns you have about this study.
Contact your study doctor, Dr. Beverly Crusher, at 773-123-4567.
For questions about your rights while taking part in this study, call the Quorum Institutional
Review Board (a group of people who review the research to protect your rights) at
(815123-4567).
© 2019 Sheri Jacobsen. All Rights Reserved
6
Please note: This section of the informed consent form is about additional research that is
being done with people who are taking part in the main study. You may take part in this
additional research if you want to. You can still be a part of the main study even if you say ‘no’
to taking part in this additional research.
You can say “yes” or “no” to each of the following studies. Below, please mark your choice for
each study.
Quality of Life Study: Consent Form
We want to know your view of how your life has been affected by Hypertension and its
treatment. This “quality of life” study looks at how you are feeling physically and emotionally
during your Hypertension treatment. It also looks at how you are able to carry out your day-today activities.
This information will help doctors better understand how patients feel during treatments and
what effects the medicines are having. In the future, this information may help patients and
doctors as they decide which medicines to use to treat Hypertension.
You will be asked to complete 3 questionnaires at the following times:
• Before you begin treatment on this study,
• After taking 3 weeks of medication
• At the final visit after treatment has been completed
It takes about 15 minutes to fill out each questionnaire.
If any questions make you feel uncomfortable, you may skip those questions and not give an answer.
If you decide to take part in this study, the only thing you will be asked to do is fill out the 3
questionnaires. You may change your mind about completing the questionnaires at any time.
Just like in the main study, we will do our best to make sure that your personal information will be
kept private.
Please circle your answer.
I choose to take part in the quality of life study. I agree to fill out the 3 quality of life
questionnaires.
Yes
© 2019 Sheri Jacobsen. All Rights Reserved
No
7
Use of Blood for Research: Consent Form
About Using Tissue and Blood for Research
As a result of your participation in the trial, you also will have several blood tests performed. We
would like to keep for future research about 3 tablespoons of the blood taken at that time. If you
agree, this blood will be kept and may be used in research to learn more about Hypertension
and other diseases.
The research that may be done with your tissue and blood is not designed specifically to help
you. It might help people who have Hypertension and other diseases in the future.
Reports about research done with your blood will not be given to you or your doctor. These
reports will not be put in your health record. The research will not have an effect on your care.
Things to Think About
The choice to let us keep the blood for future research is up to you. No matter what
you decide to do, it will not affect your care or your participation in the main part of the study.
If you decide now that your blood can be kept for research, you can change your mind at any
time. Just contact us and let us know that you do not want us to use your blood. Then any
blood that remain will no longer be used for research. Remaining blood will be destroyed.
In the future, people who do research may need to know more about your health. While Dr.
Crusher may give them reports about your health, it will not give them your name, address,
phone number, or any other information that will let the researchers know who you are.
Benefits
The benefits of research using blood include learning more about what causes
Hypertension and other diseases, how to prevent them, and how to treat them.
Risks
The greatest risk to you is the release of information from your health records. We will do our best to
make sure that your personal information will be kept private. The chance that this information will be
given to someone else is very small.
© 2019 Sheri Jacobsen. All Rights Reserved
8
Making Your Choice
Please read each sentence below and think about your choice. After reading each sentence,
check “Yes” or “No”. If you have any questions, please talk to your doctor or nurse, or call our
research review board at 815-123-4567.
No matter what you decide to do, it will not affect your care.
1. My blood may be kept for use in research to learn about, prevent, or treat Hypertension,
as follows:
Yes
No
2. My blood may be kept for use in research to learn about, prevent or treat other health
problems (for example: diabetes, Alzheimer’s disease, or heart disease), as follows:
Yes
No
3. Someone may contact me in the future to ask me to take part in more research.
Yes
No
You will get a copy of this form. If you want more information about this study, ask
your study doctor.
I have been given a copy of all 9 pages of this form. I have read it or it has been read to
me. I understand the information and have had my questions answered. I agree to take
part in this study.
Participant Printed Name:
Participant Signature:
Date:
© 2019 Sheri Jacobsen. All Rights Reserved
9
Informed Consent Elements
Name:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Name of the sponsor
Name and address of the Investigator who is responsible for the medical care of the enrolled subjects
Statement that the trial involves research
The purpose of the trial
The trial treatment(s) and the probability for random assignment to each treatment
The trial procedures to be followed, including all invasive procedures
The subject’s responsibilities
Those aspects of the trial that are experimental
The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
nursing infant
10. That the treatment may involve risks to a subject, or embryo, fetus or nursing infant which are currently
unforeseeable
11. The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should
be made aware of this
12. The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
potential benefits and risks
13. The compensation and/or treatment available to the subject in the event of trial related injury
14. The anticipated prorated payment, if any, to the subject for participating in the trial
15. The anticipated expenses, if any, to the subject for participating in the trial
16. That the subject’s participation in the trial is voluntary and that the subject may refuse to participate or
withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise
entitled
17. That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to
the subject’s original medical records for verification of clinical trial procedures and/or data, without violating
the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
signing a written informed consent form, the subject or the subject’s legally acceptable representative is
authorizing such access
18. That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s
identity will remain confidential
19. That the study is posted on ClinicalTrials.gov (templated wording must be used per US law)
20. That the subject or the subject’s legally acceptable representative will be informed in a timely manner if
information becomes available that may be relevant to the subject’s willingness to continue participation in the
trial
21. The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to
contact in the event of trial-related injury
22. The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be
terminated
23. Procedures for orderly termination of participation
24. The expected duration of the subject’s participation in the trial
25. The approximate number of subjects involved in the trial
26. That a signed and dated copy of the consent will be given to the subject or the subject’s legally authorized
representative
27. A place for the subject to sign and date
28. A place for the signature and date of the person who conducted the informed consent discussion.
© International Council for Harmonization of Technical Requirements for Human Use (ICH)
Informed Consent Elements
Name:
29. A place for the subject’s legally acceptable representative to sign and date (if applicable).
© International Council for Harmonization of Technical Requirements for Human Use (ICH)
MULIT-CENTER PHASE III RANDOMIZED DOUBLE-BLIND PARALLEL GROUP STUDY
COMPARINGTHE EFFICACY OF IMBETTER VERSUS IMGOOD IN THE TREATMENT OF
HYPERTENSION
Introduction
You are being asked to participate in a clinical trial, a type of research study. Your
participation in this research study is voluntary and you may withdraw at any time, for any
reason. If you choose not to be in the study, you will not lose any medical benefits and you
can still participate in future studies.
This document contains information about the study, explains the risks of being in the study,
and explains your role and responsibilities as a participant. Please read it carefully and feel
free to ask any questions you may have.
Description of Study
You are being asked to participate in this study because you have been diagnosed with
Hypertension. The purpose of this study is to determine if an experimental “study drug,”
IMBETTER, is more effective than standard treatment with IMGOOD when given to people
with your condition. An experimental drug is one that has not received approval by the U.S.
Food and Drug Administration (FDA).
Why is this study being done?
The purpose of this study is to compare the effectiveness of two different treatments for
Hypertension. One standard treatment for Hypertension is the drug IMGOOD. The study will
determine whether the experimental drug IMBETTER is more effective in treating
Hypertension than IMGOOD. This study will also collect and compare the side effects of the
two drugs. In this study, you will be randomly selected to receive either IMGOOD or
IMBETTER for 6 weeks during the study.
This study also will look at biologic factors that may help to predict responses to treatment
with different types of medication used to treat Hypertension.
How many people will take part in the study?
About 400 people will take part in this study.
© 2019 Sheri Jacobsen. All Rights Reserved
1
What will happen if I take part in this research study?
Before you begin the study:
You will need to have the following exams, tests or procedures to find out if you can be in the
study. These exams, tests or procedures are part of regular care for Hypertension and may be
done even if you do not join the study. If you have had some of them recently, they may not
need to be repeated. This will be up to your study doctor.






History and physical examination
Blood tests
Vital signs (pulse/heartbeat and respirations)
Blood Pressure
ECG (a test that measures the rhythm of your heart)
Echocardiogram (a test that looks at the inside of your heart and how it is working)
During the study:
If the exams, tests and procedures show that you can be in the study, and you choose to take
part, then you will need the following tests and procedures. They are part of regular medical
care for Hypertension.
• Weekly physical examination
• Weekly vital signs
• Weekly blood tests
• Weekly blood pressure
In addition, if you experience any symptoms during the study that may indicate a worsening of
your Hypertension, additional ECGs and/or Echocardiograms may be performed.
You will need these tests and procedures that are part of regular medical care for your
Hypertension. They are being done more often because you are in this study.
You will be “randomized” into one of the study groups described below. Randomization means
that you are put into a group by chance. A computer program will place you in one of the study
groups. Neither you nor your study doctor can choose the group you will be in. You will have
an equal chance of being placed in any group.
If you are in Group 1 (often called “Arm A”)
You will be required to take the drug IMGOOD – 100mg pill once a day for 6 weeks.
If you are in Group 2 (often called “Arm B” or the experimental arm)…
You will receive the experimental drug IMBETTER – 200mg pill once a day for 6
weeks.
It is very important that you take the medication assigned to you as instructed.
© 2019 Sheri Jacobsen. All Rights Reserved
2
When you are finished receiving all treatment, you will have the following tests and procedures:






History and physical examination
Blood tests
Vital signs (pulse/heartbeat and respirations)
Blood Pressure
ECG (a test that measures the rhythm of your heart)
Echocardiogram (a test that looks at the inside of your heart and how it is working)
Study Plan
Another way to find out what will happen to you during the study is to read the chart
below. Start reading at the top and read down the list, following the lines and arrows.
First Visit: SCREENING
Several tests will be conducted to determine if it is safe for you to participate in the
study
Second Visit: RANDOMIZE
You will be randomly assigned to be in one group or the other
Arm B
Arm A


100mg pill of IMGOOD to be
taken daily for 6 weeks
Weekly visits to the study
doctor


200mg pill of IMBETTER to be
taken daily for 6 weeks
Weekly visits to the study
doctor
Final Visit:
Several tests will be conducted
© 2019 Sheri Jacobsen. All Rights Reserved
3
How long will I be in the study?
You will be asked to take the medication for 6 weeks.
Two weeks after you are finished with the 6 weeks of treatment, the study doctor will ask you
to visit the office for a final exam.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping so that he/she can
evaluate any risks from the treatment. Another reason to tell your study doctor that you are
thinking about stopping is to discuss what follow-up care and testing could be most helpful for
you.
The study doctor may stop you from taking part in this study at any time if he/she believes it is
in your best interest; if you do not follow the study rules; or if the study is stopped.
What side effects or risks can I expect from being in the study?
You may have side effects while on the study. Everyone taking part in the study will be
watched carefully for any side effects. However, researchers don’t know all the side effects
that may happen. Side effects may be mild or very serious. Your health care team may give
you medicines to help lessen side effects. Many side effects go away soon after you stop
taking the treatment. In some cases, side effects can be serious, long lasting, or may never go
away.
You should talk to your study doctor about any side effects that you have while taking part in
the study.
Risks and side effects related to the treatment include those that are:
Common











Tiredness
Dizziness
Headache
Insomnia
Slow heartbeat
Shortness of breath
Very low blood pressure
Congestive heart failure
Palpitations
Wheezing
Runny nose
© 2019 Sheri Jacobsen. All Rights Reserved








Diarrhea
Nausea
Dry mouth
Constipation
Heartburn
Rash
Changes in blood tests that
measure liver function
Dry eye that may be
irreversible
4
Rare but Serious
• Heart Attack
• Worsening of pre-existing heart and circulatory conditions
For more information about risks and side effects, ask your study doctor.
Are there benefits to taking part in the study?
Taking part in this study may or may not make your health better. While researchers hope that
IMBETTER will be more effective than IMGOOD, there is no proof of this yet. We do know that
the information from this study will help researchers learn more about IMBETTER as a
treatment for Hypertension. This information could help future Hypertension patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:
• Getting treatment or care for your Hypertension without being in a study
• Taking part in another study
• Getting no treatment
Talk to your study doctor about your choices before you decide if you will take part in this
study.
Will my medical information be kept private?
Data are housed at Best Day Ever Headquarters in a password-protected database. We will
do our best to make sure that the personal information in your medical record will be 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.
Organizations that may look at and/or copy your medical records for research, quality
assurance, and data analysis include:
• Your local IRB
• Government agencies, such as the the Food and Drug Administration (FDA), involved
in keeping research safe for people
• Monitors working for Best Day Ever to ensure that the study doctor and her staff
are conducting the research study appropriately
What are the costs of taking part in this study?
You and/or your health plan/insurance company will need to pay for some of the costs of
treating your Hypertension in this study. Some health plans will not pay these costs for people
taking part in studies. Check with your health plan or insurance company to find out what they
© 2019 Sheri Jacobsen. All Rights Reserved
5
will pay for. Taking part in this study may or may not cost your insurance company more than
the cost of getting regular Hypertension treatment.
You will be compensated $300.00 for your time and travel to participate in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, Dr. Beverly Crusher, if you feel that you have
been injured because of taking part in this study. You can tell the study doctor in person or call
him/her at 773-123-4567.
You will get medical treatment if you are injured as a result of taking part in this study. You
and/or your health plan will be charged for this treatment. The study will not pay for medical
treatment.
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 our institution.
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.
A Data Monitoring Committee (DMC) will be regularly meeting to monitor safety and other data
related to this study. The Committee members may receive confidential patient information, but
they will not receive your name or other information that would allow them to identify you by
name.
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.
Who can answer my questions about the study?
You can talk to your study doctor about any questions or concerns you have about this study.
Contact your study doctor, Dr. Beverly Crusher, at 773-123-4567.
For questions about your rights while taking part in this study, call the Quorum Institutional
Review Board (a group of people who review the research to protect your rights) at
(815123-4567).
© 2019 Sheri Jacobsen. All Rights Reserved
6
Please note: This section of the informed consent form is about additional research that is
being done with people who are taking part in the main study. You may take part in this
additional research if you want to. You can still be a part of the main study even if you say ‘no’
to taking part in this additional research.
You can say “yes” or “no” to each of the following studies. Below, please mark your choice for
each study.
Quality of Life Study: Consent Form
We want to know your view of how your life has been affected by Hypertension and its
treatment. This “quality of life” study looks at how you are feeling physically and emotionally
during your Hypertension treatment. It also looks at how you are able to carry out your day-today activities.
This information will help doctors better understand how patients feel during treatments and
what effects the medicines are having. In the future, this information may help patients and
doctors as they decide which medicines to use to treat Hypertension.
You will be asked to complete 3 questionnaires at the following times:
• Before you begin treatment on this study,
• After taking 3 weeks of medication
• At the final visit after treatment has been completed
It takes about 15 minutes to fill out each questionnaire.
If any questions make you feel uncomfortable, you may skip those questions and not give an answer.
If you decide to take part in this study, the only thing you will be asked to do is fill out the 3
questionnaires. You may change your mind about completing the questionnaires at any time.
Just like in the main study, we will do our best to make sure that your personal information will be
kept private.
Please circle your answer.
I choose to take part in the quality of life study. I agree to fill out the 3 quality of life
questionnaires.
Yes
© 2019 Sheri Jacobsen. All Rights Reserved
No
7
Use of Blood for Research: Consent Form
About Using Tissue and Blood for Research
As a result of your participation in the trial, you also will have several blood tests performed. We
would like to keep for future research about 3 tablespoons of the blood taken at that time. If you
agree, this blood will be kept and may be used in research to learn more about Hypertension
and other diseases.
The research that may be done with your tissue and blood is not designed specifically to help
you. It might help people who have Hypertension and other diseases in the future.
Reports about research done with your blood will not be given to you or your doctor. These
reports will not be put in your health record. The research will not have an effect on your care.
Things to Think About
The choice to let us keep the blood for future research is up to you. No matter what
you decide to do, it will not affect your care or your participation in the main part of the study.
If you decide now that your blood can be kept for research, you can change your mind at any
time. Just contact us and let us know that you do not want us to use your blood. Then any
blood that remain will no longer be used for research. Remaining blood will be destroyed.
In the future, people who do research may need to know more about your health. While Dr.
Crusher may give them reports about your health, it will not give them your name, address,
phone number, or any other information that will let the researchers know who you are.
Benefits
The benefits of research using blood include learning more about what causes
Hypertension and other diseases, how to prevent them, and how to treat them.
Risks
The greatest risk to you is the release of information from your health records. We will do our best to
make sure that your personal information will be kept private. The chance that this information will be
given to someone else is very small.
© 2019 Sheri Jacobsen. All Rights Reserved
8
Making Your Choice
Please read each sentence below and think about your choice. After reading each sentence,
check “Yes” or “No”. If you have any questions, please talk to your doctor or nurse, or call our
research review board at 815-123-4567.
No matter what you decide to do, it will not affect your care.
1. My blood may be kept for use in research to learn about, prevent, or treat Hypertension,
as follows:
Yes
No
2. My blood may be kept for use in research to learn about, prevent or treat other health
problems (for example: diabetes, Alzheimer’s disease, or heart disease), as follows:
Yes
No
3. Someone may contact me in the future to ask me to take part in more research.
Yes
No
You will get a copy of this form. If you want more information about this study, ask
your study doctor.
I have been given a copy of all 9 pages of this form. I have read it or it has been read to
me. I understand the information and have had my questions answered. I agree to take
part in this study.
Participant Printed Name:
Participant Signature:
Date:
© 2019 Sheri Jacobsen. All Rights Reserved
9
Informed Consent Elements
Name:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Name of the sponsor
Name and address of the Investigator who is responsible for the medical care of the enrolled subjects
Statement that the trial involves research
The purpose of the trial
The trial treatment(s) and the probability for random assignment to each treatment
The trial procedures to be followed, including all invasive procedures
The subject’s responsibilities
Those aspects of the trial that are experimental
The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
nursing infant
10. That the treatment may involve risks to a subject, or embryo, fetus or nursing infant which are currently
unforeseeable
11. The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should
be made aware of this
12. The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
potential benefits and risks
13. The compensation and/or treatment available to the subject in the event of trial related injury
14. The anticipated prorated payment, if any, to the subject for participating in the trial
15. The anticipated expenses, if any, to the subject for participating in the trial
16. That the subject’s participation in the trial is voluntary and that the subject may refuse to participate or
withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise
entitled
17. That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to
the subject’s original medical records for verification of clinical trial procedures and/or data, without violating
the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
signing a written informed consent form, the subject or the subject’s legally acceptable representative is
authorizing such access
18. That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s
identity will remain confidential
19. That the study is posted on ClinicalTrials.gov (templated wording must be used per US law)
20. That the subject or the subject’s legally acceptable representative will be informed in a timely manner if
information becomes available that may be relevant to the subject’s willingness to continue participation in the
trial
21. The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to
contact in the event of trial-related injury
22. The foreseeable circumstances and/or reasons under which the subject’s participation in the trial may be
terminated
23. Procedures for orderly termination of participation
24. The expected duration of the subject’s participation in the trial
25. The approximate number of subjects involved in the trial
26. That a signed and dated copy of the consent will be given to the subject or the subject’s legally authorized
representative
27. A place for the subject to sign and date
28. A place for the signature and date of the person who conducted the informed consent discussion.
© International Council for Harmonization of Technical Requirements for Human Use (ICH)
Informed Consent Elements
Name:
29. A place for the subject’s legally acceptable representative to sign and date (if applicable).
© International Council for Harmonization of Technical Requirements for Human Use (ICH)

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