1 1 INFORMED CONSENT FORM 2 3 4Study title: 5 6Study number: **-HCLM-**-*** 7(and protocol number, 8if applicable) 9 10Sponsor / funding 11agency: 12 13Principal investigator: 14 15Co-investigators : 16 17 18Phone number: 450 466-5000, extension XXXX 19 514 406-XXXX pager 20 21We are asking for your participation in a research study, because… (reason to recruit this 22particular participant should be stated). However, before you accept to participate, take the time 23to read, understand and carefully consider the following information. If you accept to take part 24in this research study, you will have to sign the consent form at the end of this document and we 25will give you a signed copy for your own records. 26 27In this Informed Consent Form you will find explanations about the goal of the study, its 28procedures, its risks and inconveniences, its advantages as well as the names of the people to 29reach if needed. This document may contain information or words that you do not understand. 30You should ask the study investigator or members of the study staff to answer your questions 31and explain any word or information you do not understand. 32 33NATURE AND OBJECTIVES OF THE RESEARCH STUDY 34Describe the nature and goal of the study, its objectives, in a simple and accessible language. 35Indicate the number of participants to be recruited locally and globally in the study. 36 37STUDY PROCEDURES 38Indicate total time of participation in the study (in terms of weeks, months or years) as well as 39the number of visits included in the study.

2 3Consent Form: Version XX – Write complete date of this version 4 53120, boul. Taschereau, Greenfield Park (Québec) J4V 2H1 6Phone number 450-466-5024 Fax 450-466-5025 7Site Internet : http//crhclm.ca 8Study title: xxxxxxxxxxx. Write number protocol in bold 9Study number: **-HCLM-**-*** Page 2 of 7

10 11 40 Ex: If you accept to participate in the study, you will have to visit the Research Centre 8 times 41 over a 4-month period. 42 43Describe separately and chronologically the different types of visits. 44 45Meeting (visit) 1: 46 Ex: During this meeting, of a rough duration of 2 hours, we will proceed in… 47 48Meeting (visit) 2: 49 Ex: Two weeks after the first meeting, we will proceed in…This meeting will last about 2 50 hours. 51 52Then proceed with a single listing of the study tests and procedures while describing the more 53complicated and complex ones. 54 55Ex: Here is a description of the different tests and procedures that will be done during your 56participation in the study. Please refer to the study schedule at the end of this document for 57a global vision of these interventions during the study. (Not necessary if there are only 1 or 582 meetings) 59 60  Questionnaire about (mention here the subject/theme of the questionnaire and not the 61 questionnaire’s name. For example, indicate quality of life and not « Questionnaire 62 QoL ») and indicate the time needed to fill them in 63  Mention if the meeting(s) is(are) recorded (audio, video or both) 64 65PARTICIPANT’S COOPERATION 66In this section, clearly indicate what the participant is expected to do or is not allowed to do 67while participating in the study. 68Ex: 69 Make a commitment to respect the confidentiality of the discussions held during focus group 70 71RIKS ASSOCIATED WITH PARTICIPATION IN THIS RESEARCH STUDY 72In addition to the potential risks related to the research, indicate the theoretical risk of 73confidentiality leaking 74 75 Ex: A theoretical risk of confidentiality leaking exists. Indeed, even though we asked all the 76 participants to not repeat what was said in the focus group, we cannot guarantee it. 77 78INCONVENIENCES ASSOCIATED WITH PARTICIPATION IN THE STUDY 79List all possible inconveniences the participant may suffer from her/his participation in the study. 80 81 Ex: Answering questions about XYZ may cause discomfort, embarrassment or a 82 psychological distress. We will make all efforts to minimise those inconveniences. You can 83 choose to not answer certain questions or to stop the interview. At all times, you can 84 communicate with a research staff member who will direct you to get the help you need. 85 86BENEFITS RESULTING FROM YOUR PARTICIPATION IN THE RESEARCH STUDY (adapt if 87necessary) 88You may personally benefit from your participation in this research study, but it cannot be

12 13Consent Form: Version XX – Write complete date of this version 14Centre de recherche – Hôpital Charles-Le Moyne 15Study title: xxxxxxxxxxx. Write number protocol in bold 16Study number: **-HCLM-**-*** Page 3 of 7

17 18 89guaranteed. 90However, the information resulting from this study may help increase our knowledge about XYZ. 91OR 92You will not personally benefit from your participation in this research study. However, the 93information resulting from this study may help increase our knowledge about XYZ. 94 95VOLUNTARY PARTICIPATION In AND WITHDRAWAL FROM THE RESEARCH STUDY 96(adapt if necessary) 97Your participation in this research study is voluntary. So, you are free to refuse to participate. 98You can also withdraw from the study at any time, without having to give any reason, by 99informing the study investigator or an assistant. 100 101Your decision not to participate or to withdraw from the study will have no consequences on (the 102quality of care and services you are entitled to / on your relationship with the investigator and 103other stakeholders / doctor / colleague / employer). 104 105During the course of this study, we will give you any new information that could affect your 106decision to continue participating. 107 108TERMINATION OF STUDY (adapt if necessary) 109The investigator in charge of the study, the funding agency (or the sponsor), or the Research 110Ethics Board (REB), may end your participation in the study, without your consent, for the 111following reasons: 112 113  New scientific developments show that it is in your best interest to terminate your 114 participation; 115  The study investigator responsible for the study thinks it is in your best interest; 116  You do not follow the study instructions; 117  There are administrative reasons to abandon the study. 118 119CONFIDENTIALITY (adapt if necessary) 120While you take part in this research project, the study investigator and study staff will collect and 121record information about you in a research file. Only the information needed to meet the 122scientific objectives of the study will be collected. 123 124This information could include the transcript interviews and results from tests, exams and 125procedures you will undergo during the study. Your file could also contain other information, 126such as your name, gender, date of birth and ethnic origin. 127All the information collected during the study will be kept strictly confidential to the extent 128permitted by law. To protect your identity and privacy, you will be identified by a code number. 129The code key linking your identity and your research file will be kept safely by the study 130investigator. 131 132The interviews will be transcript by a research agent. The collected data, the transcription of 133interviews and the video / audio recording will be kept for XX years by the study investigator. 134After that, they will be destroyed. 135 136The study data may be published in specialized journals or shared with other persons during 137scientific meetings. No publication or scientific communication will contain anything which can 138allow your identification. The video / audio recording will not be distributed.

19 20Consent Form: Version XX – Write complete date of this version 21Centre de recherche – Hôpital Charles-Le Moyne 22Study title: xxxxxxxxxxx. Write number protocol in bold 23Study number: **-HCLM-**-*** Page 4 of 7

24 25 139 140For monitoring and control purposes, your research and medical records could be inspected by 141a person mandated by the Research Ethics Board or by the institution, by a person mandated 142by authorized public organisations as well as by the sponsor’s representatives. All of these 143people and organisations are bound by confidentiality policies. 144 145For safety purposes, in order to be able to reach you quickly if needed, the study investigator 146will keep your name, surname, contact information and dates of your participation in the study in 147a separate secured log, for one year after the end of the study. 148 149You have the right to examine your study records in order to check the information collected 150about you and to correct it, if necessary, for as long as this information is available from the 151study investigator or the Centre de recherche de l’Hôpital Charles-Le Moyne. However, some of 152this information may be made available to you only once the study has ended, in order to 153protect the scientific integrity of the study. 154 155COMPENSATION (adapt if necessary) 156You will receive a global amount of (indicate global amount) for each visit to compensate for 157expenses and inconveniences due to your participation in this research study. 158 159OR (if the interview is done on the working hours) 160Your employer accepted that the interview takes place during working hours, without financial 161penalty for you. 162 163You will be reimbursed for your travel and parking expenses up to a maximum amount of 164(indicate maximum amount). 165 166OR (if no compensation is provided) 167You will not receive any compensation for expenses and inconveniences due to your 168participation in this research study. 169 170PARTICIPANT’S RIGHTS AND INDEMNIFICATION IN CASE OF PREJUDICE (adapt if 171necessary) 172If you suffer any harm whatsoever resulting from any procedure related to your participation in 173this research study, you will be provided with all the necessary care and services, at no cost to 174you. 175 176By accepting to take part in this study, you do not waive any of your legal rights nor do you 177release the investigators, the sponsor or the institution where this research study is being 178conducted from their civil and professional responsibilities. 179 180FUNDING OF THE RESEARCH STUDY 181The investigator in charge of the study and the institution received funding from the funding 182agency to carry out this study. 183 184CONTACT PERSONS (adapt if necessary) 185If you have questions about your participation in this research study, please contact Dr. name of 186the principal investigator, principal investigator or his/her research nurse at phone number or by 187pager pager number. 188

26 27Consent Form: Version XX – Write complete date of this version 28Centre de recherche – Hôpital Charles-Le Moyne 29Study title: xxxxxxxxxxx. Write number protocol in bold 30Study number: **-HCLM-**-*** Page 5 of 7

31 32 189For any question about your rights as a participant in this study or if you have comments or wish 190to file a complaint, you can contact the local Commissioner for Complaints and Quality Services 191of the CISSS de la Montérégie-Centre at the following number 450 466-5434. 192 193MONITORING OF ETHICAL ASPECTS OF THE STUDY 194The Research Ethics Board approved this study and is in charge of its monitoring. Furthermore, 195we guarantee that any modification to the study protocol or to this information and consent form 196will be submitted to the REB’s approval. 197 198If you want to contact the REB, please reach the secretariat at the following number: 199450 466-5000, ext. 2564. 200

33 34Consent Form: Version XX – Write complete date of this version 35Centre de recherche – Hôpital Charles-Le Moyne 36Study title: xxxxxxxxxxx. Write number protocol in bold 37Study number: **-HCLM-**-*** Page 6 of 7

38 39 201 SCHEDULE OF STUDY VISITS AND PROCEDURES

202

40Consent Form: Version XX – Write complete date of this version 41Centre de recherche – Hôpital Charles-Le Moyne 42Study title: xxxxxxxxxxx. Write number protocol in bold 43Study number: **-HCLM-**-*** Page 7 of 7

44 45 203CONSENT 204The nature of the study, the procedures, risks and benefits about my participation and the 205confidential aspects of the collected data have been explained to me by a member of the 206research staff. 207 208I had all the opportunities to ask questions about the different aspects of the study and I 209received satisfactory answers. I declare that I had the necessary time to take my decision. 210 211I freely agree to participate in this research study. I am free to withdraw my consent at any time, 212without possible harms to my relationship with my doctor and the other members of the 213research or healthcare teams, without any kind of prejudices. 214 215I will receive a signed and dated copy of this consent form and the original one will be placed in 216my medical record. 217 218

Name of the participant Signature of the research participant Date

Name of the person who Signature of the person who obtained Date obtained consent consent 219 220INVESTIGATOR’S COMMITMENT 221 222I make a commitment to respect what was agreed in the consent form and to give a copy signed 223and dated to the participant. 224 225

Name of the principal Signature of the principal investigator Date investigator 226

46 47Consent Form: Version XX – Write complete date of this version 48Centre de recherche – Hôpital Charles-Le Moyne