School of Population and Public Health
Faculty of Medicine
2206 East Mall
Vancouver, BC, V6T 1Z3
University of British Columbia
Tel.: (604) 707-2743
Consent Form
Study title: Food reservoir for Escherichia coli causing human extraintestinal infections
Investigators: Amee R. Manges, MPH, PhD
Main study institution: University of British Columbia
Collaborating study institutions: McGill University
University of Guelph
University of Toronto
St. Mary’s University
Financial support: Canadian Institutes of Health Research (CIHR)
The Public Health Agency of Canada (PHAC)
PURPOSE OF THE STUDY
Urinary tract infections (UTIs), also known as bladder infections or cystitis, often affect young, otherwise healthy women. Fifty to 60% of women will have a UTI at some point in their lives. Most UTIs are caused by a bacterium called E. coli. The purpose of this study is to investigate the sources of the E. coli that cause urinary tract infections in young, healthy women. You are being invited to participate in this study because you have been diagnosed with a urinary tract infection.
STUDY PROCEDURES
If you agree to take part in this study, the E. coli bacteria found in your urine sample will be sent to the University of British Columbia (UBC) to be analyzed. The E. coli from your urine sample will be compared to the E. coli that caused urinary tract infections in other students at your university and at other universities across Canada. Your personal information will be kept confidential. An anonymous code, instead of your student ID and date of birth will be used to identify the sample after it arrives at UBC. The bacterial sample will be archived for 20 years in a locked freezer at UBC. Once the sample is archived anonymously, it cannot be linked to you in any way. Therefore at this point you will no longer be able to withdraw your consent to participate. You will not be contacted again if the coded sample is used in later studies.
Before beginning the survey, you will be asked some questions to verify that you are eligible. You will then be provided with information about the study and you may choose to give your consent to participate. Finally, if you agree to participate, you will spend approximately 15 minutes filling out a secure on-line questionnaire. The questions will mostly relate to your urinary tract infection and your eating habits. We will use the information in the questionnaire to investigate whether dietary habits are related to urinary tract infections. Individual results will not be made available. However the collective results of the study will be published and made available at http://www.ncbi.nlm.nih.gov/pubmed?term=manges.
RISKS OF PARTICIPATION IN THIS STUDY
There are no known risks to participating in this study. You will receive the same standard of care and treatment from your doctor regardless of whether or not you choose to participate in this study.
POSSIBLE BENEFITS
You should not expect any direct benefit from participating in this study. The information from the study may improve our understanding of how and why E. coli cause urinary tract infections.
STUDY CONTACTS
University of British Columbia
Dr. Amee Manges
Study Investigator
Phone: (604) 707-2743
Email: amee.manges@ubc.ca
Dr. Patricia Mirwaldt
Local Investigator
Phone: (604) 822-7011
Email: patricia.mirwaldt@ubc.ca
Office of Research Services
Phone: (604)-587-4681
Toll Free: 1-877-822-8598
Email: RSIL@ors.ubc.ca
McGill University
Dr. Pierre-Paul Tellier
Local Investigator
Phone: (514) 398-6017
Email: pierre-paul.tellier@mcgill.ca
Sacha Young
Ethics Review Administrator
Phone: (514) 398-2334
Email: irb.med@mcgill.ca
University of Guelph
Prof. Patrick Boerlin
Local Investigator
Phone: (519) 824-4120 x54647
Email: pboerlin@uoguelph.ca
Sandy Auld
Research Ethics Director
Phone: (519)-824-4120 x56606
Email: sauld@uoguelph.ca
University of Toronto
Dr. David Lowe
Local Investigator
Phone: (416) 978-8030
Email: david.lowe@utoronto.ca
Daniel Gyewu
Research Ethics Manager, Health Sciences
Phone: (416)-946-5606
Email: d.gyewu@utoronto.ca
St. Mary`s University
Jane Collins, RN
Local Investigator
Phone: (902) 496-8778
Email: jane.collins@smu.ca
Orshy Torok
Office of Research Ethics
Phone: (902) 420-5728
Email: ethics@smu.ca
COST AND REIMBURSEMENT
At the end of the questionnaire, you may enter a draw to win one of five new iPads.
CONFIDENTIALITY
All personal information obtained during this study will be kept confidential. The E. coli bacteria isolated from your urine sample, and your questionnaire responses, will be identified only by your unique study identifier, which cannot be linked to you personally. The on-line questionnaire will be completed on a secure website to protect the confidentiality of your responses. The questionnaire data will be stored for 20 years.
This study has been approved by your University’s Research Ethics Board. Monitors from the following organizations may review these records for quality assurance and data analysis: (1) The Quality Assurance Officer from the participating universities’ Research Ethics Board; and (2) Governmental regulatory agencies, including Health Canada, or their authorized representatives. Information may be provided to these agencies in a way that maintains your privacy according to Canadian regulations. The results from this study may be published, however no individual level information will be included, only combined results.
VOLUNTARY PARTICIPATION/STUDY WITHDRAWAL
Your participation in this study is voluntary. You may refuse to participate or discontinue your participation at any time without explanation, and without penalty or loss of benefits to which you are entitled. If you decide not to participate, the quality of your medical care will not change. The participating universities` Research Ethics Boards or a national regulatory authority may terminate the study without your consent.
QUESTIONS AND/OR CONTACT INFORMATION
Before deciding to participate, you should understand the content of this consent form, the risks and benefits to make an informed decision. If you have any questions or concerns, please contact Dr. Amee Manges at (604) 707-2743 or by email at amee.manges@ubc.ca. If you have any questions regarding your rights as a research patient, or if you wish to report a research-related injury, you may contact your Research Ethics Office, as listed to the right of this paragraph.
DECLARATION OF CONSENT
If you wish to participate, please indicate below.
I have read the contents of this consent form, and I agree to participate in this research study. I have had the opportunity to ask questions and all my questions have been answered to my satisfaction. I have been given sufficient time to consider the above information and to seek advice if I choose to do so. By signing this consent form, I am not giving up any of my legal rights. Participation in this research is voluntary and I am free to withdraw from this study at any time. My decision to participate will have no influence on my treatment or patient status. I provide my informed consent to participate in this study
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