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Participant Information and Consent Form

Introduction
Thank you for your interest in participating in the SCI Incubate 2023 Focus Group sessions. Your participation is an integral part of our program. Please take the 15 minutes to complete the following application and consent form. Once we have received your submitted forms, we will contact you as soon as possible.
The Praxis SCI Incubate 2023 Program Focus Groups have been developed to engage your insight into the development of solutions being created in the program to address challenges faced by people living with spinal cord injury. These Focus Groups are part of our direct lived experience engagement.

Purpose of the Focus Group
In these Focus Groups, we want to learn more about your experiences and opinions on a product in one of these areas:
•EMG and FES enabled hand and forearm glove that is able to sense your volitional effort and use electrical stimulation to facilitate the desired movement
•A smart wearable device that will sense your bladder fullness and alert you when you need to void 


Voluntary Participation
Your participation in a Focus Group is entirely voluntary. You can decide whether or not to take part in the Focus Group. Before you decide, it is important for you to understand what the Focus Group meeting involves. This consent form will tell you about why the Focus Groups are being done, what will happen during the Focus Group meetings and the possible benefits, risks, and discomforts.

If you wish to participate, you will be asked to sign this form. Once we have received your informed consent and this application form you may be contacted by the Principal Investigator (James J Laskin, PT, PhD) to arrange for a short phone call or zoom visit to confirm your eligibility to participate in these Focus Groups. 
If you do decide to take part in a Focus Group, you are free to withdraw at any time and without giving any reason for your decision.
If you do not wish to participate, you do not have to provide any reason for your decision not to participate.

If you decide to participate in the Focus Group, you may answer as many questions as you wish. If you withdraw, you may request that your data be removed from the Focus Group database. The data will be stored in Praxis's secure servers in Canada and will on
Procedures
The Focus Group will be facilitated by a member of the Praxis PLEX Team (an individual with lived experience). The focus group will be 90 minutes in duration and you will be in a group of no more than 10-12 participants.

Focus groups are group discussions with people who are familiar with the subject being discussed. Focus Groups are ways of findings out people’s thoughts and ideas about a specific topic. There will be a facilitator who will ask questions and facilitate the discussion. The group will be asked pre-prepared questions to help us better understand these topics. You do not need to answer questions that you are not comfortable answering. You, the other participants and the facilitators will be in the “front room”. In addition to the “front room” there will also be a “backroom”, containing the Principal Investigator, the Commercialization Director, the Consumer Lead and Program Coordinator. These individuals will be present during the Zoom session but will be muted and with the video turned off. The purpose of this “backroom” is to provide technical and material support to the Focus Group as well as to observe the discussion to help facilitate the summary reports. 

The sessions will be audio-recorded, with no video will be recorded, to ensure accurate reporting of the information provided. A modified transcript, deidentified summarization of the key points and opinions of the participants, of the audio-recording and chat discussion will be created and shared with the companies whose products are being discussed. Only code numbers will be used to identify text included in the transcript; names or other identifiers will not be included.

At the start of the sessions, everyone will be asked to respect the privacy of the other group members. All participants will be asked not to disclose anything said within the context of the discussion.

At the conclusion of the sessions, you will be emailed a $50 (CDN) Amazon gift card as an appreciation for participating.
Risks and Benefits
We do not anticipate any harm will be caused to you by participating in the Focus Group. Some of the questions we ask may seem sensitive or personal; you do not have to answer a question in the Focus Group if you do not want to.

There may or may not be direct benefits to you from taking part in this Focus Group.

Privacy and Confidentiality
At the start of the sessions, everyone will be asked to respect the privacy of the other group members. The facilitator will ask you to ensure that only your first name appears in your Zoom window or you can participate in the focus group anonymously by setting your name to “anonymous” in Zoom and/or disabling the video function. All participants will be asked not to disclose anything said within the context of the discussion, but it is important to understand that other people in the group with you may not keep information private and confidential.

The information you provide to us will only be used for the purposes we have outlined in this form. Your privacy and confidentiality will be respected at all times. You will not be identified in any reporting, and information that discloses your identity will not be released.

Data Access and Storage
The Focus Group data will be safely stored in Canada within the secure computer network of the Praxis Spinal Cord Institute. The raw data, Recruitment Information Page, Recruitment Survey and the Zoom audio transcript (no video will be recorded nor stored), only will be held for a maximum of 5 years and is only accessible to the Principal Investigator and those directly involved with the evaluation of this data for the purposes of informing the companies of the anonymous thoughts and opinions of the participants. From the Recruitment Survey, each Focus Group will be described by the group characteristics such as average age, range of years living with SCI, and range of lesion level only. No individual identifying characteristics will be provided to the companies nor in any future use of the data. The raw audio will be transcribed by a professional transcriptionist and any identifying information will be removed. In the transcription, individuals will only be identified by a number (e.g., participant 1). The deidentified data will be used to create a report for the companies and for future publication and presentation.

Questions or Concerns
If you have any questions about the Focus Group, please contact the Focus Group project team at SCI_Incubate@praxisinstitute.org or the Principal Investigator, James J Laskin, PT, PhD at jlaskin@praxisinstitute.org.

This study has been reviewed by Veritas Independent Review Board (IRB). If you have any questions about your rights as a research participant or the Investigator’s responsibilities, you may contact the Manager of Veritas IRB 24 hours per day and 7 days per week at 1-514-337-0442 or toll-free at 1-866-384-4221. An IRB is a group of scientific and non-scientific individuals who perform the initial and ongoing ethical review of the research study.
Praxis SCI Incubate 2023 Program: Focus Groups - Participant Consent 

I have read and understood the information in this consent form. I understand that my participation in this Focus Group is voluntary and that I am completely free at any time to refuse to participate or to withdraw from this Focus Group at any time. I understand that I am not waiving any of my legal rights as a result of signing this consent form. Once signed we will email you a copy of this signed informed consent form. 

Question Title

* 1. By submitting my name, email address and date, I consent to participate in this Focus Group.

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