PARTICIPANT INFORMATION AND CONSENT FORM
STUDY TITLE: An Exploratory Study of Cannabis Use in People with Osteoarthritis
PRINCIPAL INVESTIGATORS:
Holly Mansell, PharmD, PhD, Associate Professor, College of Pharmacy and Nutrition, U of S
SUB-INVESTIGATORS:
Erin Yakiwchuk, BSP, MSc, Assistant Professor, College of Pharmacy and Nutrition, U of S
Jane Alcorn, DWM, PhD, Dean and Professor, College of Pharmacy and Nutrition, U of S
STUDENTS:
Gabriela Louriero, College of Pharmacy and Nutrition, University of Saskatchewan
STUDY CONTACT INFORMATION:
Phone: 306-966-1013
Email: cannabis.osteoarthritis.study@usask.ca.
SPONSORS:
College of Pharmacy and Nutrition, University of Saskatchewan
INTRODUCTION:
You are invited to take part in this study if you are an adult over the age of 18 years with a diagnosis of osteoarthritis and you are using cannabis to manage your arthritis pain.
Please read the information in this consent form carefully. The researcher will follow up with you by phone, if you indicate that you are interested in learning more by leaving your contact information. If you have any questions about the study, please ask the study researcher. If you do not understand any part of the study or need more information, please ask the study researcher. You may ask as many questions as you need. Please feel free to discuss the study with your family, friends, and other health care professionals involved in your care before you decide.
Your participation is voluntary. It is up to you to decide whether or not you wish to take part. If you decide to participate, you are still free to withdraw at any time and without giving any reasons for your decision.
If you do not wish to participate, you will not lose the benefit of any medical care to which you are entitled or are presently receiving. You do not need to give a reason if you decide to not take part. If you do decide to take part, you can stop the study at any time without having to give any reason.
WHO IS CONDUCTING THE STUDY?
The study is being sponsored by the University of Saskatchewan with funding from the College of Pharmacy and Nutrition. None of the study researchers are receiving any direct payment from the sponsor for doing this study.
WHY IS THIS STUDY BEING DONE?
This study is being done to gather information about cannabis use in people with osteoarthritis.
Osteoarthritis is a common condition, and it can affect how people are able to move and function. There are treatments available to help manage osteoarthritis, but many people still experience pain and are turning to alternative medications to help. Some people use cannabis to manage the pain that comes with osteoarthritis. Cannabis has shown potential in managing some types of chronic pain, but more research is needed to determine its benefits as well as potential risks.
We are interested in learning more about the cannabis you are using and how it is working for treating arthritis. We hope to learn more about the type and amount of cannabis that people are using, how well the cannabis is working, and whether they have noticed any side effects. We would also like to collect a blood sample from people who are taking cannabis to determine how much cannabis is in their blood.
To collect the blood sample, we will use a technique called Volumetric Absorptive Microsampling (VAMS). With VAMS the participant is provided with a kit and is asked to take the blood sample from their finger. This blood sample can be taken at home and does not require visiting a laboratory.
WHO CAN PARTICIPATE IN THE STUDY?
You are invited to take part if you are an adult over the age of 18 years with a diagnosis of osteoarthritis in any joint and you are currently using cannabis to manage your arthritis pain.
WHO SHOULD NOT PARTICIPATE IN THE STUDY?
People who are not using cannabis to treat their osteoarthritis or who are using cannabis for other reasons will not be invited to participate.
WHAT WILL HAPPEN DURING THE STUDY?
The study has three parts:
Part 1: Survey about Cannabis Use
The first part of the study is a survey that can be completed electronically by using the QR (Quick Response) code. The QR code will be emailed to you after consent is taken by the research team. The survey will ask some background questions about you and your osteoarthritis pain and the type of cannabis and other medications you are using. The survey will also ask about how cannabis is working for you, and about any side effects you may be experiencing. Your responses will be submitted directly into REDCap, a secure electronic database. All survey responses will be kept confidential. We expect this will take about 20 minutes.
Part 2: Finger poke blood sample
This part of the study involves an at home finger poke blood test to check the amount of cannabis that is in your body. You will be mailed or delivered a kit to take a blood sample from your finger using a needle poke. Detailed instructions about how to use the kit will be provided. Once you have taken the blood sample you will mail it back to the Research Lab using a pre-paid envelope. The researchers will measure the amount of cannabinoids in your blood from the blood sample. Cannabinoids are substances in cannabis that have an effect in the body. We expect this will take about 10 minutes.
Part 3: Survey about Cannabis Use
The kit will also include another survey that can be completed electronically by using a QR (Quick Response) code or completed on paper and mailed back with the kit. This survey will ask you about your experience with using the blood collection kit to take the blood sample. We are interested in learning whether it is easy or difficult for people to use this kit at home. We expect this will take about 10 minutes.
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART IN THE STUDY?
If you choose to participate in the study, there will not be direct benefits to you. We hope that the information gained from the study can be used to help with further research on the use of cannabis for osteoarthritis, and to inform and educate health care professionals about the use of medical cannabis.
WHAT ARE THE POSSIBLE RISKS OF TAKING PART IN THE STUDY?
There is minimal risk associated with this study. There is a risk of discomfort from answering the survey questions and the risk of inadvertent release of personal health information. The Research Team will be taking precautions to safeguard personal information, so the risk of inadvertent release of personal health information is considered to be small.
For Part 2, there are additional risks that come with a finger poke. The risks of drawing blood by using a single needle poke include temporary discomfort and pain from the needle, bruising, and rarely infection.
WHAT HAPPENS IF I DECIDE TO WITHDRAW FROM THE STUDY?
Your participation in this research is voluntary. You may withdraw from this study at any time. You do not have to provide a reason. Your future medical care will not be affected. If you choose to enter the study and then decide to withdraw later, all data collected about you during your enrolment will be retained for analysis.
WHAT HAPPENS IF SOMETHING GOES WRONG?
In the case of a medical emergency related to the study, you should seek immediate care and, as soon as possible, notify the research team. Inform the medical staff you are participating in a research study. Necessary medical treatment will be made available at no cost to you. By signing this document, you do not waive any of your legal rights against the sponsor, investigators, or anyone else.
WHAT WILL THE STUDY COST ME?
There is no cost associated with participating in the study. Return postage will be provided for returning the survey. Return postage will be provided for returning the blood sample test kit.
WILL I BE COMPENSATED FOR PARTICIPATING?
As compensation for your time you will receive a $20 gift card.
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
Your personal information will remain private throughout the study. Once the study is complete, your name and identifying information will be removed from the study results. The Research Team will present the results of the study in an article and may present the results at a medical conference or publish them in a medical journal. The data presented in publications or at conferences will be pooled and deidentified so that you cannot identify the people who participated in the study.
In Saskatchewan, the Health Information Protection Act (HIPA) defines how the privacy of your personal health information must be maintained so that your privacy will be respected. The study data will be stored securely. Information collected during the study will be kept in a locked cabinet within a locked office of the primary investigator (Dr. Holly Mansell) in the College of Pharmacy and Nutrition. Electronic information will be stored on a password-protected computer, with backup storage on the University of Saskatchewan secure cabinet. The data collected during the survey will be stored in REDCap (Research Electronic Data Capture), which is a secure web-based computer program for managing surveys and databases which is hosted at the University of Saskatchewan. Your personal health information will be de-identified prior to being entered into REDCap. Blood samples used to analyze the cannabinoids will be kept in Dr. Jane Alcorn's lab (Health Sciences Building lab 3D10), which is always locked. A master list will be used to link the participant names to the study materials, but this will be stored separately from the data. All study materials will be appropriately destroyed after the study has been completed and a 5-year time period post publication has expired.
Research records and medical records identifying you may be inspected by the University of Saskatchewan Biomedical Research Ethics Board, or regulatory authorities for quality assurance and monitoring purposes.
WILL I BE INFORMED OF THE RESULTS OF THE STUDY?
Results of the study will be shared with you at the end of the study if you would like. There will be an option at the end of this consent form for you to provide your contact information if you would like to receive a copy of the study results.
WHO SHOULD I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY?
If you have any questions or need further information about the study before or during participation, you can contact: 306-966-1013 or email: cannabis.osteoarthritis.study@usask.ca.
If you have any concerns about your rights as a research participant and/or your experiences while participating in this study, contact the Chair of the University of Saskatchewan Research Ethics Board, at 306-966-2975 (out of town calls 1-888-966-2975). The Research Ethics Board is a group of individuals (scientists, physicians, ethicists, lawyers, and members of the community) that provide an independent review of human research studies. This study has been reviewed and approved on ethical grounds by the University of Saskatchewan Research Ethics Board.
