Download The University of Calgary Conjoint Health Research Ethics Board

CONSENT FORM
TITLE: Mood and Psychosis Patient Research Registry
SPONSOR: Mathison Centre for Mental Health Research and Education – 1-Year Seed Grant
PRINCIPAL
INVESTIGATORS:
Dr. Anne Duffy
Dr. Scott Patten
(Co-Principal Investigator)
CO-INVESTIGATORS:
Dr. Glenda MacQueen
Mathison Centre for Mental
Health Research & Education
TRW Building, 4th floor
3280 Hospital Drive NW
Calgary, AB T2N 4Z6
Dr. Jean Addington
Dr. Vinhoor Ismail
This consent form is only part of the process of informed consent. It should give you the basic
idea of what the research is about and what your participation will involve. If you would like more
detail about something mentioned here, or information not included here, please ask. Take the
time to read this carefully and to understand any accompanying information. You will receive a
copy of this form.
WHAT IS THE PURPOSE OF THE STUDY?
The overarching aim is to evaluate the differences in outcomes across community and tertiary
care services, and to learn more about risk factors that influence clinical course, treatment
response and outcomes.
This research registry is a feasibility study focusing on voluntary patients suffering from
recurrent mood and psychotic disorders identified from both specialty care and communitybased clinical practice settings. This registry would enable a comparison of treatment practices
and associated outcomes between specialty and community treated patients, suggest better
ways to diagnose, manage and treat these disorders as early in the course of illness as possible
and serve future research by providing a Registry of well-characterized patients to approach for
involvement in other research projects.
The specific objectives of this study include:
(i)
Investigate and compare the clinical course, family history,
medical and psychiatric comorbidities, available treatments and
outcomes across patient populations and treatment settings,
(ii)
Explore candidate risk factors and the association with treatment
and outcomes.
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
1
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
2
WHAT WOULD I HAVE TO DO?
Participation is voluntary. It will involve a clinical research interview with an experienced clinical
research psychologist or a psychiatrist that will take about 2 hours to complete.
You will first complete a descriptive questionnaire including information such as date of birth,
sex, place of birth and ethnicity, handedness, highest formal education, current employment if
any, current income level.
Then, a summary of the clinical course of your illness will be documented. This information will
enable us to estimate your age of onset of illness, major exacerbations or acute episodes,
whether or not these included psychotic features, and the severity of the episodes and quality of
your remissions. Details of your past psychological and medical treatments will also be
documented along with any lifetime history of major medical disorders. Again, age of onset and
treatment will be documented. With your agreement, we will record weight, height, body mass
index, and blood pressure at your research visit.
As part of this research study, we would like to review your medical records when possible, to
ascertain collateral information (i.e. test results, treatment blood levels) and verify interview
information regarding clinical course, treatment and medical history.
We are also interested in your family history because mood and psychotic illnesses run in
families and family history is an important predictor of clinical course and treatment response.
Therefore, with your help, we will draw a family tree detailing your first-degree (parents, siblings
and children) and second-degree (aunts, uncles and cousins) relatives. If known, this will
include information such as their sex, date of birth, and any lifetime history of psychiatric illness
and treatment you are aware of.
We will take your contact details, and ask you whether or not you would like to receive the
Registry newsletter via email or regular mail. This newsletter will be sent every 6 months.
At the end of this interview, we will survey each participant to ascertain whether or not they
might be agreeable in the future to consider:
o
donating a blood sample for genetic and epigenetic research,
o
participating in a neurocognitive test study,
o
taking part in an imaging study.
These questions would be to gauge acceptability only, and are not an indication of consent to
participate. These questions would assume that any such studies would be fully explained to the
individuals and would be approved by our Research Ethics Board.
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
3
How long will I be in the study?
At present, the Mathison Centre for Mental Health Research and Education supports this
Feasibility Registry Study for a year, starting from September 1st, 2013. We will be applying for
subsequent funding and ethics approval to continue and further develop this Registry.
Therefore, it is planned that the Registry Research Coordinator will recall you annually to update
study information and to complete validated questionnaires measuring clinical symptoms,
quality of remission, quality of life and, for those agreeable, complementary assessments.This
yearly assessment that might be offered will only take about 1 hour in total.
At the end of this consent form you may indicate if you do or do not wish to be contacted for
future updates. Furthermore, participation in this Research Registry study is voluntary and you
can withdraw at anytime without consequence. You can also decide at anytime whether or not
you would like the data collected on you destroyed or whether the research team can use the
data up until the point of your departure from the study.
How many people will take part in this study?
With current funding we aim to enroll a minimum of 100 participants in one year. This would
include 50 patients suffering from a mood disorder and 50 suffering from a psychotic disorder,
each group divided equally between community and tertiary settings.
WHO WILL HAVE ACCESS TO MY PERSONAL HEALTH INFORMATION AND WILL MY
RECORDS BE KEPT PRIVATE?
Protecting your privacy is an important part of this study.
A copy of this consent form will be put in your confidential research file. When you sign this
consent form you give us permission to:

collect information from you and your health record

share information with the people conducting the research study

share information with the people responsible for protecting your safety
Members of the research team will see health and study records that identify you by name. The
Conjoint Health Research Ethics Board (CHREB) may need to look at these records. We wish
to emphasize that all your information and responses will be kept strictly confidential and stored
in locked rooms and file cabinets.
To protect your confidentiality, when entering data in our database, we will remove any
identifying information such as your name or date of birth from this database. Your information
will be electronically stored on a password-protected electronic database at the Mathison Centre
for Mental Health. Only members of the research team will have access to the information
collected. In addition, your personal contact information will be stored separately from your
health information.
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
4
WILL I BENEFIT IF I TAKE PART?
If you agree to participate in this study, there may or may not be a direct medical benefit to you.
Your health and functional status may be improved during the study but there is no guarantee
that this research will help you.
The information we get from this study may help improve the future experiences and treatments
for people with similar disorder.
WHAT ARE THE RISKS?
There are no foreseeable risks to you if you participate in this study.
WILL I BE PAID FOR PARTICIPATING, OR DO I HAVE TO PAY FOR ANYTHING?
You will not be paid for participating in the study. You will be offered a small amount of money to
reimburse any out of pocket costs to participate such as parking fees if needed for study visits.
Please bring your receipts with you.
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
5
Authorization Form Signature Page
Your signature on this form indicates that you have understood to your satisfaction the
information regarding your participation in the research project and agree to participate as a
participant. In no way does this waive your legal rights nor release the investigators or involved
institutions from their legal and professional responsibilities. You are free to withdraw from the
study at any time without jeopardizing your health care. If you have further questions concerning
matters related to this research, please contact:
Dr. Emilie Magaud, Research Coordinator @ (403) 210-8657 - [email protected]
Or
Dr. Anne Duffy, Principal Investigator @ (403) 210-6464 - [email protected]
If you have any questions concerning your rights as a possible participant in this research,
please contact the Chair, Conjoint Health Research Ethics Board, University of Calgary at 403220-7990.
“I have read the informed consent form and have had the opportunity to have all of my
questions answered. I understand that this is a voluntary research Registry study and that I can
decide not to take part at anytime without consequence to my treatment or access to health
care. I can also ask for my study data to be destroyed at anytime upon my withdrawal from the
study”.
I agree to take part in the Mood and Psychosis Research Registry
Yes
No
I agree to be contacted on average annually to update my study information
Yes
No
I agree to be contacted to be told about future related REB approved
Research
Yes
No
Participant’s Name
Signature and Date
Investigator/Delegate’s Name
Signature and Date
Witness’ Name
Signature and Date
The University of Calgary Conjoint Health Research Ethics Board has
approved this research study. A signed copy of this consent form has been
given to you to keep for your records and reference.
Ethics ID: REB13-0644
Mood and Psychotic Research Registry
PI: Anne Duffy
Version 1/August 1, 2013
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