(English original)
Multicultural community health assessment trial (M-CHAT):
A longitudinal study of body fat distribution and cardiovascular risk in four ethnic populations
Participant Consent Form
The University and those conducting this project subscribe to the ethical conduct of research and to the protection at all times of the interests, comfort, and safety of participants. This research is being conducted under permission of the Simon Fraser University and Providence Health Care Research Ethics Boards. This research is supported by the Canadian Institutes of Health Research.
Project Investigator: Dr. Scott A. Lear
Department: School of Kinesiology
Telephone: (604) 624-4344 ext. 64772 or (604) 462-7916
Primary Study Contact: _____________________
Telephone: 604-206-2266
Purpose
You have been invited to participate in this study as a follow-up to the M-CHAT study you participated in earlier. Participation is entirely voluntary so it is up to you to decide whether or not to take part in this study. In the first phase of the M-CHAT study, we found that those of Chinese and South Asian origin tended to have more body fat in the inner-abdominal area (around the organs) than those of Aboriginal and European origin of the same body size. The purpose of this phase of the M-CHAT study is to see how over time body fat changes and how this relates to the possible risk of diabetes and heart disease based on cultural/ethnic background.
What will my participation involve?
You will be asked to participate in the following assessments twice over a 4 year period:
- A morning 14-hour fasting blood sample to be conducted (at your convenience) prior to the scheduled assessments. A portion of this blood sample will be used to immediately measure blood factors related to diabetes and heart disease such as cholesterol and blood sugar. The other portion will be frozen and stored (with an anonymous ID number) for further study of blood and genetic factors (ie: DNA) related to body fat, diabetes and heart disease.
- A brief interview (family history, education, occupation, etc.), blood pressure, body measurements (weight, waist, etc.),
- Lifestyle questionnaires (diet, physical activity, quality of life, body image and cultural perceptions).
- A CT (computer tomography) scan of your stomach to assess the amount of inner fat
- A full-body DEXA (dual energy x-ray absorptiometry) scan to assess the amount of total body fat.
- An ultrasound scan to measure the thickness of the artery walls in your neck
You will be scheduled for the first set of assessments (all 6 items listed above) within the next 4-6 weeks. Approximately two years from now, you will be contacted and scheduled for the second set of assessments which will be the same as the first set. In most cases you will need to attend two visits to complete each set of assessments and the total amount of time should be no more than 3 hours including the time to complete the questionnaires (6 hours over the two years).
The CT scan involves a thin beam of x-rays focused on a specific part of the body. For this study, the CT scan will be done on a thin area of the abdomen. This scan will be done at the St. Paul’s Hospital Radiology Department. The procedure is painless, as you do not feel the x-rays. The DEXA scan uses a very low energy x-ray beam (about one fifth of a plain x-ray) that passes below you as you lay on the bed. This scan will be done at the Community and Health Assessment Facility at the Simon Fraser University Harbour Centre campus (downtown Vancouver). The ultrasound scan involves the use of inaudible sound to outline your internal body parts. This is similar to the procedure used in pregnant women.
What are the risks of participation?
Participation in this study involves minimal risk. The blood samples will be obtained by venipuncture- (standard procedure for blood drawing) a harmless procedure. The side effects are rare but may include bleeding under the skin (hematoma) or, in extremely rare instances, inflammation of the vein (phlebitis). The total volume of all the blood samples required is less than three tablespoons (40 mL). Computed tomography involves exposure to radiation. The exposure involved in the CT scan is less than a dental or chest x-ray, and less than the level of radiation we are exposed to in 1 week of urban living, or that of a four hour plane flight. The DEXA scan involves exposure to low energy radiation (one fifth of a normal x-ray). The exposure involved in the DEXA scan is less than spending 30 minutes in the sunshine.
What are the costs of participation?
There are no direct costs involved with participation in this project. Costs that are incurred related to travelling to and from the assessment locations (ie: parking, public transit costs) will be reimbursed.
What are the benefits of participation?
Participation in this study will provide you with feedback regarding your health that is not normally conducted under routine medical care. You will receive a report of your results and guidance regarding whether your results fall within the desired ranges based on national guidelines. However, all results obtained are for research purposes only and will not be interpreted by a medical doctor as part of the study participation.
How will we protect your confidentiality?
Ensuring your confidentiality is very important to us. Any information that is obtained during this study will be kept confidential to the full extent permitted by the law. Knowledge of your identity is not required. You will not be required to write your name or any other identifying information on research materials (ie: those with data). Research materials will be labelled with an anonymous code number. Data will be entered and maintained in a secure password protected database. Paper materials will be maintained in a locked, secure location. Only the Project Investigator and the project coordinators/nurses involved in data collection will have access to your identity.
Consent:
I, , have read the above information and I have had an opportunity to ask questions to help me understand what my participation would involve. I freely consent to participate in The Multicultural Community Health Assessment Trial (M-CHAT): A longitudinal study of body fat distribution and cardiovascular risk in four ethnic populationsand acknowledge receipt of a copy of the consent form for my records. I understand the procedures to be used in this study, and the potential personal risks and benefits to me in taking part in this study. I also understand that I may refuse to participate in the study or withdraw from the study AT ANY TIME, at which time any stored samples will be destroyed. My refusal to participate or withdraw from the study will not affect any current or future care at St. Paul’s Hospital or Providence Health Care that I may undergo now or in the future. By signing this form, I understand that I do not waive my legal rights.
In addition, I allow the project investigator to contact me in the future regarding other possible studies related to this project. I understand that by signing this form I am in no way consenting to participate in any future research studies. If I am asked to participate in future research studies, I will be asked to provide consent at that time, and I will have the opportunity to refuse.
Should you wish to obtain information about your rights as a participant in research, or about the responsibilities of researchers, or if you have any questions, concerns or complaints about the manner in which you were treated in this study, please contact the Director, Office of Research Ethics by email or phone at 604-462-6693. Alternatively you may contact Research Subject Information Line in the University of British Columbia Office of Research Services’ at 604-244-2692 or The Chair of the UBC/Providence Health Care Research Ethics Board at 604-642-4344 local 64346.
Results of this study can be obtained by contacting Dr. Scott Lear at 604-462-7916.
______________________ _____________________
Date:_______________
Participant’s Signature Name (please print)
______________________ _____________________
Date:_______________
Witness’ Signature Name (please print)
______________________ _____________________
Date:_______________
Principal Investigator’s Signature Name (please print)