Letter of Information and Consent

 

DOWNLOAD: Letter of Consent

1.        Introduction
You are being asked to take part in a research study. Please read the information about the study presented in this form. The form includes details on study’s risks and benefits that you should know before you decide if you would like to take part. You should take as much time as you need to make your decision. You should ask the study team by emailing ellen.choi@uhnresearch.ca to explain anything that you do not understand and make sure that all of your questions have been answered before signing this consent form.  Before you make your decision, feel free to talk about this study with anyone you wish including your friends, family, and family doctor.  Participation in this study is voluntary.

2.       Purpose and Background of this Study
The purpose of this study is to learn about whether wellness programs build resilience in work and life.  Current research suggests that wellness programs reduce stress but more research is needed to understand how different types of wellness programs impact stress and ultimately, resilience.

You are being asked to participate because you have some interest in participating in a wellness program and you are an employee at the University Health Network (UHN).  We will be comparing how these interventions (mindfulness and Pilates programs) influence resilience in work and life.

Up to 300 UHN employees will participate in this study.  We anticipate it will take 1 year to complete data collection.  While mindfulness and Pilates programs are currently offered through the UHN Wellness Centre, no one has participated in this wellness intervention study.

3.       Eligibility
Participants who indicated that they are over 18 years old and are employees of UHN are eligible to participate.  All participants should be physically and mentally fit enough to participate in Pilates or mindfulness meditation exercises.  If you are personally acquainted with the principal investigator or any co-investigators, you are not eligible to participate. 

If you are currently being treated for a psychological condition such as depression, eating disorder, drug/alcohol addiction, anxiety disorder, psychosis, schizophrenia, mania or any other psychological condition, OR you have frequent pains in your heart/chest, dizzy spells, or any condition that might require medical approval to exercise, please consult your personal physician and obtain their approval before signing up for the study. 

4.       Study Procedures
This is a randomized study. If you decide to participate you will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. You may not choose what group you will be in. You will have a 1 in 3 chance of being placed in any group. You will receive either an 8-week Pilates training program, an 8-week mindfulness training program, or an 8-week no-treatment/wait-list control group that receives no training.  Again, you will not be able to choose which condition you are allocated to.  Any participants who get assigned to the control group and wish to enroll in either the mindfulness or Pilates training program will have an opportunity to do so at a later date.

Participants will be asked to complete a series of surveys (pen & paper and online).  The final survey will be an online survey delivered through Qualtrics.  As the Qualtrics servers are located in the United States, any information that you provide will be subject to the Patriot Act and will be accessible by the United States Government.  Some of the questions may be of a personal and sensitive nature about your performance at work.  Your participation in this study is wholly voluntary as such you may elect not to respond to any question or set of questions at your own discretion.  Participants will also be invited to take part in an optional one-on-one interview with a member of the study team.  If a participant agrees to be interviewed, they will have the choice of whether or not audio-recording or note taking will be permitted during the interview.

For the mindfulness and Pilates programs participation entails:
• Weekly one-hour meetings and approximately 10-minutes of daily self-practice of the techniques learned in class for a total of approximately 20.5 hours of participation.
• There will be 8 site visits: one hour each week per class (8 classes total)
• During the study, you will also be asked to complete a questionnaire at the beginning of each weekly session.  The first and last week questionnaire will take less than 30-minutes to complete while the other surveys will take less than 5-minutes to complete.  If you cannot attend in person, you will be able to complete an online survey.  A final survey will be administered online 4 weeks after the completion of your program. 
• The questionnaires will include statements about your perceptions, attitudes, and behaviours, including negative job performance behaviour, and asks you to rate your level of agreement with them.  For example, “overall I am satisfied with myself”, “I have a good understanding of why I do the things I do”, and “I Intentionally worked slower than I could have worked”.

For the no treatment/waitlist condition, participation entails:
• Completion of three questionnaires that take approximately 30 minutes each, for a total of 1.5 hours of participation.
• The first two questionnaires will be conducted in person onsite to establish a baseline and end of study visit at week 1 and week 8; a third questionnaire will be administered online to establish a post study assessment during week 12 of the study.
• The questionnaires will include statements about your perceptions, attitudes, and behaviours, including negative job performance behaviour, and asks you to rate your level of agreement with them.  For example, “overall I am satisfied with myself”, “I have a good understanding of why I do the things I do”, and “I Intentionally worked slower than I could have worked”.

A no-treatment control group is necessary to reduce the chances that any observed changes are due to the passing of time, or certain context effects taking place at UHN.

5.       Possible Risks and Harms
Taking part in this study has risks. Some of these risks we know about. There is also a possibility of risks that we do not know about and have not been seen in humans to date. Please contact the study team by emailing ellen.choi@uhnresearch.ca or paul.smits@uhn.ca if you have any side effects even if you do not think it has anything to do with this study.
This mindfulness program of study is designed to help individuals learn mind and body awareness techniques to cope with physical or psychological symptoms from stress, chronic pain and illness and/or stress-related illnesses.  Previous studies administering mindfulness training have used these meditations without encountering any known negative effects. 

The risks we anticipate may be related to the time consuming nature of the 8-week research program; however, the in-person training takes place within the participants’ workplaces, and all measures have been made to provide a training program that is as autonomous and accessible as possible for participants to minimize such inconveniences. Furthermore, some of the items in the questionnaires may cause psychological discomfort such as anxiety, distress, embarrassment, or feelings of sadness.  There are no right or wrong answers to these questions and we encourage participants to answer honestly. While multiple steps will be in place to protect the anonymity and confidentiality of the data, since you will be asked questions about your job performance behaviours it is possible that if your study information were to be identified, your employment/academic status could be affected.  More on confidentiality is explained in this letter.

6.       Possible Benefits
You may or may not receive direct benefit from being in this study.  Participants may benefit from the Pilates or mindfulness training in a myriad of ways related to their general health and wellness. Pilates is a mode of exercise that cultivates body awareness and builds core strength.  Benefits of mindfulness programs have been conceptualized along four categories: physical wellbeing, mental wellbeing, behavioural self-regulation, and interpersonal relations.  Those participants that are placed in the control group will have an opportunity to take either the Pilates or the mindfulness training at a later date.

7.       Compensation
There is no compensation for your participation. Any participants that get assigned to control condition and wish to take one of either the mindfulness program or Pilates program will be eligible to do so at no cost.  There is no cost to participate in this study.

8.       Reminders and Responsibilities
It is important to remember the following things during this study:
• Ask your study team about anything that worries you
• Attend all sessions to the best of your ability
• Comply with the home practice to the best of your ability
• Complete the questionnaires to the best of your ability
• Tell your study team if you change your mind about participating in this study

9.       Voluntary Participation
Your participation in this study is voluntary. You may refuse to participate, refuse to answer questions, refuse to participate in any interviews, or withdraw from the study at any time with no effect on your employment/academic status.  You may decide not to be in this study, or to be in the study now, and then change your mind later. We will give you new information that is learned during the study that might affect your decision to stay in the study.

Withdrawal From Study
If you decide to leave the study, you have the right to request withdrawal of information collected about you.  Please let your study team know.  If you leave the study, the information that was collected before you left the study will still be used in order to help answer the research question unless you indicate otherwise. No new information will be collected without your permission.

10.       Rights as a Participant
If you are harmed as a direct result of taking part in this study, all necessary medical treatment will be made available to you at no cost.  By signing this form you do not give up any of your legal rights against the investigators, sponsor or involved institutions for compensation, nor does this form relieve the investigators, sponsor or involved institutions of their legal and professional responsibilities.

11.       Confidentiality
Your responses are strictly confidential. We will only identify your responses based on your participant identification number. Only the researchers directly involved in the study will have access to the survey responses. The survey data will be stored in a secure database and will be destroyed no more than ten years after publication.  If the results are published, your name will not be used.  If you leave the study, the information that was collected before you left the study will still be used in order to help answer the research question unless you indicate otherwise. Representatives of UHN’s Research Ethics Board or Western University’s Non-Medical Research Ethics Board may contact you or require access to your study-related records to monitor the conduct of the research.

The study team will keep any personal health information about you in a secure and confidential location for 10 years. A list linking your study number with your name will be kept by the study team in a secure place, separate from your study file.

Personal Information
If you agree to join this study, the study team will collect only the information they need for the study.  Personal information is any information that could identify your data and includes your:
• Name
• Email
• Occupation
• Ethnicity
• Age (no specific reference to date of birth required)

Study Information that Does Not Identify You
Some study information will be sent outside of the hospital to researchers from the Ivey School of Business at Western University, Canada. Any data about you that is sent out of the hospital will be in aggregated form.  No identifying information will be shared outside of the UHN research network; data will include a participant ID number and will not show your name, email address, or any information that directly identifies you.

The Study Team may use the study information and share it with its funding sources (MITACS and Sun Life-Ivey Canadian Wellness ROI study) or with national and international regulatory agencies to help answer the study question, and/or to develop future studies for research related to this study.

All information collected during this study, including your personal information, will be kept confidential and will not be shared with anyone outside the study unless required by law.  You will not be named in any reports, publications, or presentations that may come from this study.

12.       Publication
If the results of the study are published, your name will not be used. If you would like to receive a copy of any potential study results, please contact ellen.choi@uhnresearch.ca

13.       Funding Sources
This research is funded jointly by MITACS and Sun Life-Ivey Canadian Wellness ROI study.  This research is conducted in collaboration with researchers from the Ivey School of Business at Western University, Canada.

14.       Conflict of Interest:
Sun Life-Ivey Canadian Wellness ROI study and MITACS will reimburse the hospital and researcher for the costs of doing this study. All of these people have an interest in completing this study. Their interests should not influence your decision to participate in this study.

15.      Questions About the Study
If you have any questions, concerns or would like to speak to the study team for any reason, please call a member of the study team: Ellen Choi, Co-Investigator (416-738-0750, ellen.choi@uhnresearch.ca); or Paul Smits, Principal Investigator (416-340-4800, paul.smits@uhn.ca).

If you have any questions about your rights as a research participant or have concerns about this study, call the Chair of the University Health Network Research Ethics Board (UHN REB) or the Research Ethics office number at 416-581-7849. The REB is a group of people who oversee the ethical conduct of research studies. The UHN REB is not part of the study team. Everything that you discuss will be kept confidential. 
 
Please note that the security of e-mail messages is not guaranteed. Messages may be forged, forwarded, kept indefinitely, or seen by others using the Internet. Do not use e-mail to discuss information you think is sensitive. Do not use e-mail in an emergency since e-mail may be delayed.

You will be given a signed copy of this consent form.

16.       Consent
Signing the following consent form indicates that this study has been explained to me and any questions I had have been answered.  I know that I may leave the study at any time. I agree to the use of my information as described in this form. I agree to take part in this study.

To be clear and in your best interest, signing this Consent Form does NOT waive any of the legal rights you are entitled to.

If you agree to participate in a one-on-one interview with a member of the research team during the 8-week training program, please check this box.

If you agree to be audio recorded during the interview, please provide your consent by checking the box to the right.

If you agree to allow the researcher to take notes during the interview, please provide your consent by checking the box to the right.