Download The Hospital for Sick Children

iPHFR DRAFT CONSENT FORM
This document contains suggested wording/responses regarding the iPHFR. It is just a guideline to
facilitate the IRB application in individual institutions joining the iPHFR.
Not all
sections/questions/answers are required by every IRB. Please note that all information contained
herein must be individualized per institution by the PI applying for IRB approval with wording
appropriate to their center procedure and practices.
Title of Research Project: The International Pediatric Heart Failure Registry (iPHFR)
Investigator(s):
Principal:
Collaborators:
Introduction
You are being asked to be in a medical research study. This form is designed to tell you everything you need
to think about before you decide to consent (agree) to be in the study or not to be in the study. It is entirely
your choice. If you decide to take part, you can change your mind later on and withdraw from the research
study. The decision to join or not join the research study will not cause you to lose any medical benefits. If
you decide not to take part in this study, your doctor will continue to treat you.
Before making your decision:
• Please carefully read this form or have it read to you
• Please listen to the study doctor or study staff explain the study to you
• Please ask questions about anything that is not clear
You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether
you would like to participate. You may wish to discuss your decision with family or friends. Do not
sign this consent form unless you have had a chance to ask questions and get answers that make sense
to you. By signing this form you will not give up any legal rights.
Background
The International Pediatric Heart Failure Registry (iPHFR) combines information from a large
number of pediatric cardiology centers that specialize in heart failure management into a single
database to learn more about children aged less than 18 years of age with heart failure.
The primary purpose of the study is to obtain a comprehensive registry database from institutions
worldwide in order to examine risk factors, presentation, manifestation and outcomes of children with
heart failure. Heart failure in children can develop for a variety of reasons; ranging from genetic
abnormalities of the heart muscle (cardiomyopathy), to acquired dysfunction of the heart
(myocarditis), as well as presenting in children with congenital heart disease before and after cardiac
surgeries. Because the presentation, manifestation and degree of heart dysfunction can vary
dramatically by age, it is important to combine data across multiple centers to better understand and
advance our knowledge about this disease.
The iPHFR will examine: 1) information about children presenting with heart failure such as their
age, gender, weight and symptoms of presentation; 2) severity of heart failure based on symptoms
and other organ involvement; 3) medicines used for treatment of heart failure; 4) events that occur in
children with heart failure; 5) outcomes of children with heart failure.
There is a central data collection centre at the United Network for Organ Sharing (UNOS) in the
United States. Each center is assigned a code (e.g., ABC 001) and all patients are given codes at the
host center so that only an ID number is sent and no private or personal information can be
determined about the codes.
You/your child are/is being asked permission to allow us to submit your/your child/s clinical
information to the registry. No names or medical records numbers are included in this database. You
will not be required to fill out any forms.
Purpose of the Research: To better understand what happens to children with heart failure and the
response to the current medications used to treat heart failure.
Description of the Research:
You have been approached by your doctor or a nurse to participate in this research study. If you agree
to participate, the following things will happen.
A nurse or specially trained data collector will review your medical record and will record your date
of birth and test results such as cardiac diagnoses, laboratory values, as well as some medication and
family history information. This information will go into a central file at UNOS, along with the same
information on hundreds of other children who have the same disease. The doctors who are involved
with this research will then be able to compare information concerning how these children are doing,
and what treatments work best.
If you agree to participate we would like our nurse or study data collector to review your medical
record from when your child was diagnosed, at the time of any hospital admission and once a year.
Potential Harms:
There are no potential harms or discomforts in participating in this registry study.
Potential Benefits:
You may receive no direct benefit from participation in this study. However, if clinically important
information is obtained as a result of the findings, future generations of heart failure patients might
benefit.
It is hoped that this research will benefit children and their families by offering a clearer picture of
heart failure, a better understanding of which treatments are the most effective, and outcomes after the
diagnosis of heart failure. In addition, your participation may help medical doctors and researchers
better understand life after a diagnosis of heart failure. We can provide you with a copy of
publications that result from this research if you are interested.
Alternatives to participation:
You have the right to choose not to sign this form. However, if you decide not to sign, you cannot
participate in the research. Refusing to sign will not affect the present or future care you receive at
this hospital.
Confidentiality:
We will respect your privacy. Confidentiality will be respected and no information that discloses your identity
will be released or published without consent unless required by law. This legal obligation includes a number
of circumstances, such as suspected child abuse and infectious disease.
Hospital Clinical Research Monitors may see your health record to check on the study. By signing this
consent form, you agree to let these people look at your records. We will put a copy of this research consent
form in your patient health record and give you a copy as well. For your information, the research consent
form will be inserted in to your patient health record. Health records identifying the patient may be given to
and inspected by the hospital Clinical Research Office Monitor.
Your name and medical record will be accessed by the medical doctor and/or nurse who is enrolling
you in this research project. This information will never be shared with anyone else assisting in this
research.
The researchers participating in the study will use information such as date of birth and hospital
admission and discharge dates (in some cases) to help conduct this research. In addition the
Committee on Clinical Investigation that oversees the research and other hospital staff with oversight
or quality improvement responsibilities may have access to this health information. Under Study
documents approved by the Committee on Clinical Investigation, the researchers and their staff will
determine if your protected health information will be used or shared with others outside of this
institution for purposes directly related to conduct of the research, including for example to other
researchers, research sponsors and certain government oversight agencies. In addition, the Committee
on Clinical Investigation has the authority to determine if information should be shared for oversight
or compliance purposes.
Your protected health information (date of birth, hospital admission and discharge dates in some
cases) may be shared with the following – without identifying information such as name:


Other medical centers/ institutions/investigators outside of this institution participating in
the research
United States and Canadian Federal , State and Provincial agencies that have authority
over the research (for example the Department of Health and Human Services, the Food and
Drug Administration, the National Institutes of Health, the Office of Human Research
Protections, the Department of Social Services or other governmental offices as required by law)
The data produced from this study will be stored in a secure, locked location. Only members of the research
team (and maybe those individuals described above) will have access to the data. This could include external
research team members. Following completion of the research study the data will be kept as long as required
then destroyed as required by hospital policy. Published study results will not reveal your identity. There is
no scheduled date at which this information will be destroyed or no longer used. This is because information
that is collected for research purposes continues to be analyzed for many more years and it not possible to
determine when this will be complete.
Subject to certain legal limitations, you have the right to access your protected health information that
is created during this research that relates to your treatment. You may access this information only
after the study analyses are complete. To request this information, you will need to contact the
Principal Investigator of this Study, Dr xxxx (phone number).
Reimbursement:
There are no costs to you as a consequence of your child’s participation in this research study.
Patients who agree to participate in this research will not be paid.
Participation:
Participation in research is voluntary. If you choose not to participate, you will continue to have access to
quality care at this hospital. It is your choice to take part in this study. You can stop at any time. The care you
get at the hospital will not be affected in any way by whether you take part in this study.”
New findings developed during the course of the research which may impact on your willingness to continue
will be provided to you and your consent will be requested again, if necessary.
Your participation may contribute to the creation of new diagnostic tests, new medicines or other events that
may have commercial value. However, your participation in this study will not entitle you to a share in any
future economic benefits”. You will be given a copy of this consent form for your records
In no way does signing this consent form waive your legal rights nor does it relieve the investigators,
sponsors or involved institutions from their legal and professional responsibilities.
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
During this research, information about your or your child's health will be collected. In general, under federal
law, information about patients is private, but there are exceptions and you should know who will have access
to this information and might see it.
Researchers may be collecting information about you or your child from medical records. They may also
learn things from procedures that are part of the research itself such as tests, office visits, questionnaires and
interviews.
The following people will be able to see this information:
 As HIPAA permits, medical and research staff at the Hospital, including people listed on your
informed consent.
 Medical staff who are directly involved in your care that is related to the research or arise from it.
 People who oversee, advise or conduct research at the Hospital, and people who oversee or
evaluate research and care, including the Committee on Clinical Investigation, staff working on
quality improvement, and other clinicians and administrative staff of the Hospital..
 People from agencies and organizations that provide independent accreditation and oversight of
research
 Sponsors or others involved in funding the research
 Federal agencies that oversee or review research information.
 Government agencies and sponsors.
 If some law or court requires us to share the information, we would have to follow that law or final ruling
Sponsorship:
This research is funded in part by the International Society for Heart and Lung Transplantation (ISHLT).
Conflict of Interest:
The investigators for this research study have no competing interests (or conflicts of interest); i.e., a situation
in which the investigator(s) has gained or stands to gain personally from the research from a source outside
the hospital.
Consent
By signing this form, I agree that:
1) The study has been explained to me. All my questions were answered.
2) Possible harms and the possible benefits (if any) of this study have been explained to me.
3) I know about the alternatives to taking part in this study. I understand that I have the right not to
participate and the right to stop at any time. The decision about whether or not to participate
will not
affect my health care at the hospital.
4) I am free now, and in the future, to ask any questions about the study.
5) I have been told that my medical records will be kept confidential, except where release of
information is required by law, e.g., suspected child abuse, public health.
6) No information that would identify me, will be released or printed without asking me first.
7) I have read and understood pages 1 to 5 of this consent form. I agree, or consent, to take part in this study.
I give my permission to participation in the International Pediatric Heart Failure study. I agree to
allow information from my medical record to be reviewed annually and to be recorded in the study
database.
I will allow the use of the associated protected health information as described above. I know that Dr.
xxxx, the Primary Investigator, may be reached at (xxx) xxx-xxxx and he/she or his/her colleagues will be
available to answer any questions that I may have. If I have any questions regarding my rights as a
research subject, the use of protected health information or questions regarding compensation in the event
of a research-related injury, I may request to speak with a member of the Hospital Research Ethics
authority by calling (xxx) xxx-xxxx. I understand that I am free to withdraw this consent/authorization
and discontinue participation in this project at any time, even after signing this form, and it will not affect
my care. I have been given a copy of this form.
________
Date
________________________________________________
Name of Patient/Participant
________
Date
______________________________________
Signature of Patient/Participant
________
Date
________________________________________________
Witness to Signatures (only required if consent document
needs to be read to participant/parent/guardian)
Name of person who obtained consent
Signature & Date
For answers to questions about research subjects’ rights and research-related injury, please contact the Research
Ethics Board Manager at (xxx) xxx-xxxx