Titre Du Projet

Titre Du Projet

Evaluating the need for biomusic technology in an outpatient pediatric rehabilitation setting

Hôpitaljuif de réadaptation

Consent and information form for Clinicians

  1. Title of the Project

Evaluating the need for biomusic technology in an outpatient pediatric rehabilitation setting

  1. Principal Investigator(s)

Approuvé par le CÉR des établissements du CRIR le:Page 1

Evaluating the need for biomusic technology in an outpatient pediatric rehabilitation setting

Stefanie Blain-Moraes, Ph.D

Assistant Professor, School of Physical and Occupational Therapy

Faculty of Medicine, McGill University

514-398-1325

Joyce Fung, Ph.D

Associate Professor, School of Physical and Occupational Therapy,

Faculty of Medicine, McGill University

514-398-5734

Marta Czyzykiewicz

MSc Occupational Therapy Candidate

Faculty of Medicine, McGill University

Luc Nguyen

MSc Physical Therapy Candidate

Faculty of Medicine, McGill University

Sarah Plamondon

MSc Physical Therapy Candidate

Kassia Yong

MSc Physical Therapy Candidate

Faculty of Medicine, McGill University

Chen Zhang

MSc Occupational Therapy Candidate

Faculty of Medicine, McGill University

Approuvé par le CÉR des établissements du CRIR le:Page 1

Evaluating the need for biomusic technology in an outpatient pediatric rehabilitation setting

  1. Collaborator

Lora Salvo,

Physiotherapist

Jewish Rehabilitation Hospital

450-688-9550 ext 645

  1. Funding Agency

This study is not funded.

  1. Preamble

You are invited to participate in a research study that aims to evaluate the needs for biomusic technology amongst pediatrics population. Please read the following form carefully and take all the time you need to consider and ask questions before signing. The form will explain to you the objective of the study, what would be requested of you as a study participant, the benefits and risks of participation, your rights as a research participant, and gives the contact information of the investigators. The form may include words or terms that you may not be familiar with. Please do not hesitate to ask for clarification with the research team.

  1. Project Description and Objectives

Biomusic is a novel technology that records electrical signals from the body and translates them into musical output. Preliminary studies have shown that biomusic allowed parents and caregivers of children in complex continuing care to develop richer interactions with patients by allowing them to ‘tune in’ to changes in their body. We aim to explore the applicability of biomusic technology to various scenarios at the Jewish Rehabilitation Hospital.

The goals of our study are:

  1. To characterize cases and scenarios where therapists in an outpatient rehabilitation setting experience frustration and a breakdown in communication with clients.
  2. To characterize experiences of communication with family and caregivers of children who have difficulty communicating.
  3. To develop a set of criteria, constraints and recommendations for the development of biomusic technology for children and therapists in an outpatient rehabilitation setting.
  1. Participating in the study

We presented biomusic technology during the March meeting for pediatric therapists at the Jewish Rehabilitation Hospital. You indicated your interest in sharing your experiences and opinions. During a 15-20 minute interview at the Jewish Rehabilitation Hospital, we will ask you questions about different scenarios where you have experienced difficulty communication with clients, and scenarios where you believe biomusic technology may be useful. The interview will take place during your working hours in your office.We will record this interview with a digital recorder, as well as taking notes to ensure accuracy. We may follow up with you via email to verify the accuracy of our records of the interview.

  1. Benefits of Participating

The information you provide will enable us to identify common areas of difficulty experienced by therapists at the Jewish Rehabilitation Hospital when working with outpatient pediatric clients. This may provide the foundation for a discussion of solutions and the development of best practices. Additionally, the information you provide will help us identify clients who may benefit from biomusic technology in future.

  1. Risks and Discomforts

There are no expected risks of participating in the study. The information collected will only be used for research purposes. Answering some questions may make you feel uncomfortable. If this occurs, please inform the interviewer/leaders, and you may choose which questions to answer or not.

  1. Access to the Study Results

It is expected that the results of this study will be disseminated. A presentation will be organized for all involved clinicians during the month of August 2016 to share the results of the study. You can also contact the person in charge for this project to get the results if you so wishat the end of the study.

  1. Confidentiality

All information gathered during the study will be coded in order to ensure confidentiality. Audio and video recordings will be identified using the same code and will be locked away and then destroyed after seven years and once the information collected has been verified for accuracy. Only the members of the research team will have access to study information. However, in order to monitor the research project, the research files could be consulted by a person mandated by the ethics committee of CRIR or by the Department of Ethics of the Ministry of Health and Social Services of Quebec. This person subscribes to a policy of strict confidentiality.

The information gathered will be kept under lock and key at the Jewish Rehabilitation Hospital by Stefanie Blain-Moraes, Ph.D, for seven years after which it will be destroyed. If the results of this study are published or presented, no information regarding the participants will be included.

  1. Audio and Video Recordings

All video and audio recordings will be destroyed after seven years. No recordings will be used for presentations or other purposes.

  1. Voluntary Participation and Withdrawal from the Study

Your participation in this project is completely voluntary. You can decide to withdraw from the study at any time and all data provided by you and associated with you can be destroyed upon request.

  1. Responsibility Clause of the Research Team

While agreeing to participate in this study, you do not give up any of your legal rights nor release the researchers, sponsors or institutions involved of their legal and professional obligations.

  1. Compensatory Indemnity

You will not be paid for your participation in the study.

  1. Contact Information

You have the right to ask, and have answered, any questions you may have about this research. If you would like additional information or have any questions or concerns regarding the study, please contact Stefanie Blain-Moraes, School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Tel: 514-398-1325 email: or Chen Zhang, MSc Occupational Therapy Candidate, Faculty of Medecine, McGill University, email:

All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject you may contact, anonymously if you wish, Me AnikNolet, CRIR Institutions Research Ethics Officer. Tel: 514-527-4527 ex. 2649;Email:

If you have any questions or concerns, you also may contact the local complaints officer of your institution, Ms. Hélène Bousquet, tel (450) 668-1010, ex. 23628 email:

  1. Consent

I, ______(print), agree to voluntarily participate in the study described above. I give permission to the research team to use the information that I provide. I am aware that the child will participate in this research by being present at the focus group. All questions that I had regarding the study have been answered to my satisfaction. I have read and understand the procedures, the risks and benefits of the study and willingly give my consent to participate in it. I am aware that I can withdraw from the study at any time without prejudice of any sort.

______

Participant’s Signature Date and location

______

Participant’s Name (Block letters)

  1. Responsibility of the Principal Investigator

I, the undersigned ______(print), certify:

a) having explained to the research participant the terms of this form,

b) having answered all the questions that he/she has asked in this regard,

c) having clearly indicated that he/she remains free, at any time, to end his/her participation in the above described research study

d) that I will give him/her a signed and dated copy of the form.

______

Signature of the Principal Investigator

or representative

Signed at ______, the ____ of ______, 20___.

Approuvé par le CÉR des établissements du CRIR le:Page 1

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