Download Appendix I: Consent Forms

Appendix 1: Consent Forms
December 14, 2009
The forms in Appendix I are template Consent Forms for the CODIACS pilot
study. The content of these forms should not be altered, to ensure consistency
across the field centers. However, if the IRB requirements at your site require a
certain format or additional information to be included, these consent forms can
be modified to accommodate those needs.
There are 2 forms in the appendix:


Screening Consent Form to be completed at the initial screening
Trial Consent Form to be completed once the patient has been
screened for eligibility into the study
For each of these forms, the highlighted sections should be updated at each
Field Center to reflect the correct information before submission to the IRB.
[ INSERT INSTITUTION Name ] Informed Consent Form
Attached to Protocol:
Principal Investigator:
IRB Protocol Title:
[Insert protocol number]
[Insert name of site PI]
Comparison of Depression Interventions after
Acute Coronary Syndrome (CODIACS)
Consent Number:
Participation Duration:
Anticipated Number of Subjects:
Contact
Contact’s Name
Title
[Insert name of site PI]
CF-AAAF3212
6 months
225
Contact Type
Principal
Investigator
Numbers
Telephone: [Insert #]
Research Purpose
The purpose of this screening is to see if you are eligible for our CODIACS study.
The purpose of CODIACS is to explore patient satisfaction, safety, and
depressive symptom reduction in a distress/depression intervention as compared
to usual cardiology care.
Information on Research
We would like to ask you some “screening” questions to see if you are eligible to
participate in a study. Many people will not be eligible.
The purpose of the study or which you are being screened is to see whether
treatments for distress symptoms and/or depressed mood decrease the risk of heart
disease happening again. The study will also collect information for a future grant
submission. You qualify to be screened for this study because you have heart
disease and because you can read and write in English or Spanish.
Approximately 2,160 subjects will be screened for this study; about 225 patients will
be screened at [Insert Institutional Name].
What am I being asked to do?
We will ask you questions about your symptoms of distress or depressed mood,
your alcohol and substance use, your memory and understanding and if you are
experiencing or have experienced symptoms of a major mental disorder. We will
also collect some medical information from your medical record, including
information on heart disease that is related to your past hospitalization. If your
answers tell us that you are eligible, we will ask you to participate in our study.
In order to decide whether or not you wish to be screened for eligibility for this
study, you should know enough about its risks and benefits to make an informed
judgment. This Information Sheet gives you detailed information about the
screening we are doing to see if patients are eligible, and a member of the
research team will discuss this information with you. Once you understand the
screening process, you will be asked if you wish to participate.
What happens if I am eligible for the study?
If you agree to answer our screening questions, and your answers show that you
are eligible for the study we will ask you to participate in our study. The study
lasts 6 months, and you will be asked to complete 4 study visits: today, in 2
months (by phone), in 4 months (by phone), and in 6 months (at our study
offices). Each time, we will ask you some questions about your health and
feelings. In addition, you may be asked to complete a questionnaire over the
phone 2 weeks from today to help determine eligibility.
We will ask for your permission to collect information from your medical record
that relates to the study.
What if I do not finish the questions today?
If you are not able to complete the screening and Visit 1 study measures today,
we may contact you and ask you to complete these questions over the phone.
We will not know if you are eligible for the study until these questions are
completed.
Benefits
The information collected and the understanding we gain about heart disease
and symptoms of distress and depressed mood may help others who have heart
disease in the future.
Risks
Some stress is typical when answering questions about oneself.
Alternative Procedures
The alternative to participation is to not participate. Your decision whether or not
to participate in this screening will have no effect on your medical care at this
hospital.
Compensation
You will receive $10 for completing this screening interview.
Additional Costs
There are no costs to your for being screened.
Confidentiality
Your identity as a participant in the screening for this research study will be kept
confidential, and you will not be indentified as a participant in any publication of
the results of this study. Your name or other identifying information will not be
recorded on any of the study questionnaires.
Additional Information
Questions/Concerns
If you have questions or concerns about the study, you may contact [insert name
and contact info for PI here].
If you have any questions about your rights as a subject, you may contact:
Institutional Review Board
[Insert name, address and phone for IRB here]
An Institutional Review Board is a committee organized to protect the rights and
welfare of human subject involved in research.
Voluntary Participation
Statement of Consent
I voluntarily consent to be screened for this study. I have thoroughly read this
consent form and understand the nature and the purpose of the screening. I have
fully discussed the screening procedures with the investigator or study staff, have
had the opportunity to ask questions and have received satisfactory answers. The
explanation I have been given has mentioned both the possible risks and benefits to
participating in the study and the alternatives to screening.
I understand that I am free to not be screened for the study or to withdraw at
anytime. My decision to not participate or to withdraw from the study will not affect
my future care or status with this investigator.
I understand that I will receive and may keep a copy of this signed and dated
consent form. By signing and dating this consent form, I have not waived any of the
legal rights that I would have if I were not a participant in the study.
Signature
Study Subject
Print Name
Signature
Date
Signature
Date
Person Obtaining Consent
Print Name
[ INSERT INSTITUTION Name ] Informed Consent Form
Attached to Protocol:
Principal Investigator:
IRB Protocol Title:
[Insert protocol number]
[Insert name of site PI]
Comparison of Depression Interventions after
Acute Coronary Syndrome (CODIACS)
Consent Number:
Participation Duration:
Anticipated Number of Subjects:
Contact
Contact’s Name
Title
[Insert name of site PI]
CF-AAAF3584
6 months
45
Contact Type
Principal
Investigator
Numbers
Telephone: [Insert #]
Research Purpose
The purpose of CODIACS is to explore patient satisfaction, safety, and
depressive symptom reduction in a distress/depression intervention as compared
to usual cardiology care.
Information on Research
You are being asked to participate in a research study. Research on people with
heart disease has shown that if they have symptoms of distress or depressed mood
the possibility of heart problems happening again is increased. The purpose of this
study is to see whether treatments for distress symptoms and/or depressed mood
decrease this possibility. Two hundred and twenty-five subjects will be enrolled in
this study, meaning they will be eligible for the research study based on their
screening information; 45 of these subjects will be enrolled at [Insert Institutional
Name].
You qualify for participation in this study because you have heart disease and you
report symptoms of distress or depressed mood.
You have already answered some screening questions and questionnaires to see if
you have symptoms of distress or depression and whether you are eligible for this
study.
Baseline Visit
If you agree to participate in this study, then today:
1) you will be asked questions about your reaction to stress and your interest in
things/people;
2) we may measure your height and weight
Follow-up Visits and Phone Calls
You will be asked to complete up to 4 visits after today. The first visit will be
completed in 2 months over the phone. The second visit will be in 4 months over
the phone. The third and final study visit will be in 6 months and you will again
be asked to come to the study offices.
During the 6 month visit you will be asked questions similar to those asked today.
This visit will also take between 45 to 60 minutes to complete.
The 2 and 4 month visits, where you will be contacted by phone, are to follow-up
on your general health. These visits will be shorter.
Groups
If you are eligible, you will be assigned randomly, that is, as if by the flip of a coin,
to one of two groups.
In some cases, we may not be able to determine today if you are eligible. If this
happens, the study coordinator will inform you, and we will ask to call you in 2
weeks to ask you about your symptoms of distress and depression. If you are
eligible after that phone call, the study coordinator will inform you and you will be
randomized.
One group, the Referred Care Group, will receive usual care as provided by their
primary doctor and cardiologist. The other group, the Stepped Care Group, will
receive treatment for their symptoms of distress and/or depressed mood by the
research study team. We don’t know if this treatment is helpful for these
symptoms, and we are trying to find out in this study.
If you are assigned to the group that receives treatment for symptoms of distress
and/or depressed mood from the research team, then at this visit you will also be
asked to read a brochure that explains in detail the two types of treatment being
used by the study team for symptoms of distress and depressed mood. One is
problem-solving treatment and the other is prescribed depression medication. A
research team member will be available to discuss these options with you,
answer your questions and advise you in your choice.
After reading the brochure, you will be asked to choose which type of treatment
you prefer, and you will be assigned a treatment specialist from the research
study. You may decide at any time during the study to switch the type of
treatment you receive. If you need more time to decide on a treatment, you will
be sent home with information about the two treatments. A treatment specialist
will call you several days later to find out which treatment you chose.
PROBLEM SOLVING TREATMENT
If you choose Problem Solving Treatment, you will be asked to complete 6-8
sessions with the treatment specialist. At these meetings you will learn several
steps that help people solve problems effectively. You will also be taught how to
use these steps in your daily life.
If you do not show signs that your symptoms are improving then the treatment
specialist will discuss other options with you, such as trying a depression
medication or increasing the number of sessions you attend.
Visits with the treatment specialist may happen in person, by phone, or via
secure video web-chat. The audio portion of the visits may be recorded for
quality control.
DEPRESSION MEDICATION
If you choose depression medication for treatment, a psychiatrist, under the
supervision of [Insert study psychiatrist name here], will meet with you in our
office to ask you questions about your symptoms and your past experience with
medications like these. The psychiatrist will also discuss the type and dosage of
medication that is best for you. You will have another visit after one week. Then
the psychiatrist or the Study Treatment specialist will call you on the phone
regularly to make sure the prescription has been filled and that you are not
experiencing any side effects. If you are experiencing side effects or do not see
any improvement in your symptoms of distress or depressed mood within a
certain period of time, you may be asked to come in for additional visits with the
psychiatrist. The psychiatrist will follow established treatment guidelines to make
sure that you get the best medication for your individual needs.
The medications that are recommended for treatment of distress symptoms are
called Selective Serotonin Reuptake Inhibitors (SSRIs). In some instances, the
psychiatrist may prescribe to you a different kind of depression medication,
depending on your individual needs.
If you do not show signs that your symptoms are improving then the psychiatrist
will discuss other options with you. These options may involve switching the
medication, adding other medications, and/or adding problem solving treatment.
If you choose medication and are already taking an antidepressant medication
but are still having symptoms of distress or depression, we will contact the
physician prescribing the medication to you and coordinate an adjustment in the
medication with them so that your symptoms are better addressed.
Also, if you decide to take an antidepressant (depression medication), we ask
you to inform us immediately of any changes in any other medication that you are
prescribed by your primary physician or any other doctor. This is important so
that we can ensure your safety. Please call [Insert phone #] in the event your
medication is being changed.
All patients who receive one of the study treatments for symptoms of distress or
depressed mood will be monitored closely for their symptoms by members of the
study team. If at any time during the study you experience a significant increase
in depressive symptoms, or if you have thoughts of harming yourself, you will
meet with the study psychiatrist or a licensed psychologist to decide if you should
continue in the study. If it is decided that you should stop participating in the
study, we will refer you to appropriate treatment.
Visits with the psychiatrist may happen in person, by phone or via secure video
web-chat. The audio portion of the visits may be recorded for quality control.
Audio Recordings
As part of this study, if you are randomized to the Stepped Care group and meet
with a study treatment provider, the audio portion of these visits my be recorded.
The recording will be stored electronically on a secure computer located in the
study offices and will be destroyed upon publication of study results. The files
will be labeled with your study ID number and the number of the visit (for
example. ID 12345, Visit 1); your name or other identifying information will not be
included in the file name. These files will only be accessible by members of the
study teams, including the study treatment provider and the principal investigator,
[insert name here]. The recordings may be reviewed by a member of the study
team for quality control, that is, to monitor the work of the study treatment
provider.
Questions
1) We would like to notify your physician that you are participating in this study. We
would also like to send a letter with your results to your physician. Do you consent
to have your physician notified?
Please initial your choice: Yes
No
2) If during your participation in the study any of the symptoms suggest that you are
unsafe, such as having suicidal thoughts, a brief consultation with the appropriate
professional such as a psychiatrist or a qualified physician/advanced nurse
practitioner will be scheduled. Additionally, if you would like, we can contact your
primary physician to inform him/her of these symptoms.
Do you agree to have your physician contacted about these symptoms, if
appropriate?
Please initial your response: Yes
No
3) In the event of future hospitalizations, we will obtain all pertinent records from this
institution, and/or other physicians or hospitals at which you received care, and, in
the event of death, those related documents will be obtained and reviewed. Do you
consent to have the medical records and/or death certificate obtained for this study?
Please initial your choice: Yes
No
3) Are you interested in being contacted in the future about other research studies
being conducted in the [insert name of institution here].
Please initial your choice: Yes
No
Additional Costs
There is no cost to your for participation in the study. All study evaluations and
treatments are provided at no charge.
Compensation
If you are found to be eligible for the study, and you choose to participate, you
may receive up to $105. You will receive the following payment for each
completed study visit:
Visit 1 (today): $25
2-month (phone): $15
4-month (phone): $15
6-month (office): $50
Risks
You may feel some anxiety and stress while answering questions during the
study, but this is generally mild and goes away quickly. If you feel upset, or
continue to feel upset, members of the study will be available to talk to you and
discuss appropriate care.
If you are in the Stepped Care group, and choose to meet with a therapist, you
may feel temporarily upset when talking about difficult situations in your life, but
again this is generally mild and goes away quickly. If you feel upset, or continue
to feel upset, members of the study team will be available to talk with you and
discuss appropriate care.
If you are in the Stepped Care group, and choose to take depression medication,
there is a possibility of side effects or an adverse reaction to the drug(s). These
side effects are explained in more detail below:
If you receive depression medication as part of the study, you and the study
psychiatrist will discuss the medication being used in the study. Two of the
medications are part of a group of drugs called Selective Serotonin Reuptake
Inhibitors, or SSRIs, because they change the amount of a chemical in the brain,
serotonin, which is thought to be related to depression. The two medications are
Sertraline and Citalopram. Initially, you will only be on one of these drugs at a
time. You may experience side effects while on either medication. Side effects
cannot be anticipated. If any side effects develop or change in intensity, tell the
psychiatrist or the Study Treatment specialist as soon as possible. Only they can
determine if it is safe for you to continue taking the medication. Please inform
them before starting any other new medications while you are taking Sertraline or
Citalopram.
The most common side effects of Sertraline include: trouble sleeping, dry mouth,
sexual side effects in men and women, feeling unusually sleepy or tired, tremors,
sweating, decreased appetite, feeling agitated, and diarrhea, upset stomach and
indigestion which generally go away in a week or two.
In clinical studies like this one few patients were bothered enough by side effects
of Sertraline to stop taking their medicine.
The most common side effects of Citalopram include: nausea, dry mouth,
insomnia, and increased sweating. Other side effects that occur less frequently
include: trembling, diarrhea, tiredness and sexual problems.
You should not take Sertraline or Citalopram if you have had an allergic reaction
to them or to similar medications. Serious, sometimes fatal, reactions can occur
(1) when Sertraline or Citalopram is taken with other antidepressant drugs know
as MAO inhibitors, or (2) when Sertraline or Citalopram is discontinued and an
MAO inhibitor is started. Never take Sertraline or Citalopram with an MAO
inhibitor. If you stop taking Sertraline or Citalopram, allow 5 weeks or more
before starting an MAO inhibitor, especially if you have been taking Sertraline or
Citalopram in high doses or for a long time. If you are taking any prescription or
nonprescription drugs, notify the study psychiatrist or treatment specialist before
taking Sertraline or Citalopram. If you do not know if you are taking an MAO
inhibitor, you can ask your doctor or the study psychiatrist.
It is uncertain whether these drugs cause worsening symptoms of distress or
depression, or may increase the risk for suicide. Your study psychiatrist will
carefully monitor you for possible worsening of these symptoms, or for
suicidiality, especially at the beginning of therapy or when the dose either
increases or decreases. If your symptoms of distress and/or depressed mood
get worse over time, or if you have thoughts or feeling of harming yourself,
please inform your study psychiatrist or Study Treatment specialist immediately
so that he or she can decide what changes are needed in your treatment.
Also, if you feel increasingly angry, irritable, or restless, you should inform your
study psychiatrist or Study Treatment specialist. Once you are feeling better, do
not stop the medication right away. Your doctor may recommend taking the
medication for six to nine months or longer to prevent your symptoms from
starting again. If a decision is made to stop treatment, some antidepressants will
need to be taken at lower and lower doses over some time, to avoid symptoms of
withdrawal.
If there is a reason that one of Sertraline or Citalopram might not be best for you,
then the study psychiatrist will talk to you about other options. If the psychiatrist
decides that Sertraline or Citalopram would not be the best medication to help
you, you will be given a list of the side effects for the drug that is recommended;
one of the possible recommended medications may be Bupropin. The side
effects of the recommended medication will be given to you at that time.
Depression medications can take up to 8 weeks to work. It usually takes two to
four weeks until people start feeling emotionally and physically better. The
improvement may be gradual, and often family members or friends may notice a
difference in how you are doing before you do. Your sleep and appetite may
improve first, and your mood, energy, and negative thinking may take some more
time to improve.
If you stop taking your depression medication suddenly, you can experience
withdrawal symptoms. These symptoms, if they occur, are similar to flu
symptoms, and can include headache, diarrhea, nausea, vomiting, chills,
dizziness, fatigue, and insomnia. These symptoms can last anywhere from one
to seven weeks and vary in intensity. If you want to stop taking your
antidepressant medication, it is important that you discuss this with your Study
Psychiatrist first.
Benefits
If you participate in this study, you may get additional treatment for your
symptoms of distress or depressed mood. However, some patients in this study
will not be assigned to the Stepped Care Group visits with a research specialist.
They will be assigned to the Referred Care Group where they receive usual care
from their physician. If you do receive treatment from a specialist on the
research team, the treatment is provided at no cost to you. The treatment could
potentially benefit you by decreasing your symptoms of distress or depressed
mood and helping your manage your feelings better. Your symptoms may not
improve with the treatment provided in this study. If you are in the group that
receives usual care from their physician instead of the study treatment visits,
your symptoms may improve without the treatment provided in this study.
Research Related Injuries
Taking part in this research study may result in injury or harm to you. In the
event of an emergency you should go to an emergency room. If you require
immediate medical care and are not a hospitalized patient you should seek
immediate medical treatment.
Otherwise, [insert site name] will help you get the care you need. You will be
sent a bill for whatever medical care you receive. All or part of you bill may be
paid by your health insurance. [Insert hospital(s) name] will not pay for the care.
Likewise, [insert hospital(s) name] will not pay you for pain, worry, lost income, or
non-medical care costs that might occur from taking part in this study.
You do not waive your legal rights by signing this form.
Alternative Procedures
The alternative to participation is to not participate. If you choose not to
participate, there are many options available to you outside of the study that have
been shown help with symptoms of distress and/or depressed mood. You may
choose to get Problem Solving Treatment, the kind of counseling provided in this
research study, privately. There are also other kinds of treatment that have been
shown to help people with problems similar to yours. Some examples of these
treatments are Cognitive Behavioral Therapy, Interpersonal Therapy and
Reminiscence Therapy.
You may also choose to seek out medications to help with your problems. The
medications used in this study, for example Sertaline, are available outside this
study. There are also other medications from different classes of drugs that have
been shown to help with symptoms of distress or depressed mood.
A common way that patients can find out which option is best for them is to
consult their physician. There is also information about the evidence for the
different options that can be found by going to the web and looking at evidencereviews on depression at www.cochrane.org.
Confidentiality
Any information collected during this study that can indentify you by name will be
kept confidential. We will do everything we can to keep your data secure,
however, complete confidentiality cannot be promised.
Your questionnaire responses will be assigned a code number. The research file
that links your name to the code number will be kept in a locked file cabinet and
only the investigator and study staff will have access to the file.
The following individuals and/or agencies will be able to look at and copy your
research records:
 The investigator, study staff and other medical professionals who may be
evaluating the study
 Authorities from [Insert name of site] and [Insert name of site hospital],
including the Institutional Review Board (‘IRB’)
 The United States Food and Drug Administration (‘FDA’) and/or the Office of
Human Research Protections (‘OHRP’)
 The sponsor of this study, the National Institutes of Health, including persons
or organizations working with or owned by the sponsor
 Other government regulatory agencies (including agencies from other
countries) if the sponsor is seeking marketing approval for new products
resulting from this research.
Certificate of Confidentiality
To help us protect your privacy, we received a Certificate of Confidentiality from the
National Institutes of Health (NIH). With this Certificate, we cannot be forced to
provide information that may identify you, even by a court subpoena, in any federal,
state, or local civil, criminal, administrative, legislative, or other proceedings. We will
use the Certificate to resist any demands for information that would identify you,
except as explained below.
The Certificate of Confidentiality does not stop you or a member of your family from
telling others about yourself or your involvement in this research. If an insurer,
employer, or other person gets your written consent to receive research information,
then we cannot use the Certificate to withhold that information.
The Certificate cannot be sued to resist a demand for information from
representatives of the United States Government that is used for auditing or
evaluation of projects they are responsible for overseeing or for information that
must be provided in order to meet the requirements of the federal Food and Drug
Administration (FDA).
You should also know that this Certificate does not protect you from our
responsibility to report certain communicable diseases, suspected child abuse, or
danger of physical or mental harm, to appropriate agencies or authorities.
Additional Information
If you have questions or concerns about the study, you may contact [insert name
and contact info for PI here].
If you have any questions about your rights as a subject, you may contact:
Institutional Review Board
[Insert name, address and phone for IRB here]
An Institutional Review Board is a committee organized to protect the rights and
welfare of human subject involved in research.
Voluntary Participation
Statement of Consent
I voluntarily consent to participate in the study. I have thoroughly read this consent
form and understand the nature and the purpose of the study. I have fully discussed
the study with the investigator or study staff, have had the opportunity to ask
questions and have received satisfactory answers. The explanation I have been
given has mentioned both the possible risks and benefits to participating in the study
and the alternatives to participation.
I understand that I am free to not participate in the study or to withdraw at any time.
My decision to not participate or to withdraw from the study will not affect my future
care or status with this investigator.
I confirm that I have informed the investigator or study staff to the best of my
knowledge of: any medication/drug that I have taken before the start of the study;
and any medication/drug that I am taking or plan to take, whether prescribed or not.
I agree to cooperate with the study investigator/staff and will report any unexpected
or unusual symptoms.
I understand that I will receive and may keep a copy of this signed and dated
consent form. By signing and dating this consent form, I have not waived any of the
legal rights that I would have if I were not a participant in the study.
Signature
Study Subject
Print Name
Signature
Date
Signature
Date
Person Obtaining Consent
Print Name