Study title:xxxxxxxxxxx. Write number protocol in bold
Study number: **-HCLM-**-***Page 1of7
INFORMED CONSENT FORM
Study title:
Study number:**-HCLM-**-***
(and protocol number,
if applicable)
Sponsor / funding
agency:
Principalinvestigator:
Co-investigators:
Phone number:450466-5000, extension XXXX
514 406-XXXX paget
We are asking for your participation in a research study, because… (reason to recruit this particular participant should be stated). However, before you accept to participate, take the time to read, understand and carefully consider the following information. If you accept to take part in this research study, you will have to sign the consent form at the end of this document and we will give you a signed copy for your own records.
In this Informed Consent Form you will find explanations about the goal of the study, its procedures, its risks and inconveniences, its advantages as well as the names of the people to reach if needed. This document may contain information or words that you do not understand. You should ask the study investigator or members of the study staff to answer your questions and explain any word or information you do not understand.
NATURE AND OBJECTIVES OF THE RESEARCH STUDY
Describe the nature and goal of the study, its objectives, in a simple and accessible language. Indicate the number of participants to be recruited locally and globally in the study.
STUDY PROCEDURES
Indicate total time of participation in the study (in terms of weeks, months or years) as well as the number of visits included in the study.
Ex: If you accept to participate in the study, you will have to visit the Research Centre 8 times over a 4-month period.
Describe separately and chronologically the different types of visits.
Meeting (visit) 1:
Ex: During this meeting, of a rough duration of 2 hours, we will proceed in…
Meeting (visit) 2:
Ex: Two weeks after the first meeting, we will proceed in…This meeting will last about 2 hours.
Then proceed with a single listing of the study tests and procedures while describing the more complicated and complex ones.
Ex: Here is a description of the different tests and procedures that will be done during your participation in the study. Please refer to the study schedule at the end of this document for a global vision of these interventions during the study. (Not necessary if there are only 1 or 2 meetings)
- Questionnaire about (mention here the subject/theme of the questionnaire and not the questionnaire’s name. For example, indicate quality of life and not «Questionnaire QoL») and indicate the time needed to fill them in
- Mention if the meeting(s) is(are) recorded (audio, video or both)
PARTICIPANT’S COOPERATION
In this section, clearly indicate what the participant is expected to do or is not allowed to do while participating in the study.
Ex:
- Make a commitment to respect the confidentiality of the discussions held during focus group
RIKS ASSOCIATED WITH PARTICIPATION IN THIS RESEARCH STUDY
In addition to the potential risks related to the research, indicate the theoretical risk of confidentiality leaking
Ex: A theoretical risk of confidentiality leaking exists. Indeed, even though we asked all the participants to not repeat what was said in the focus group, we cannot guarantee it.
INCONVENIENCES ASSOCIATED WITH PARTICIPATION IN THE STUDY
List all possible inconveniences the participant may suffer from her/his participation in the study.
Ex: Answering questions about XYZ may cause discomfort, embarrassment or a psychological distress. We will make all efforts to minimise those inconveniences. You can choose to not answer certain questions or to stop the interview. At all times, you can communicate with a research staff member who will direct you to get the help you need.
BENEFITS resulting FROM YOUR PARTICIPATION IN THE RESEARCH STUDY (adapt if necessary)
You may personally benefit from your participation in this research study, but it cannot be guaranteed.
However, the information resulting from this study may help increase our knowledge about XYZ.
OR
You will not personally benefit from your participation in this research study. However, the information resulting from this study may help increase our knowledge about XYZ.
VOLUNTARY PARTICIPATION In AND WITHDRAWAL FROM THE RESEARCH STUDY (adapt if necessary)
Your participation in this research study is voluntary. So, you are free to refuse to participate. You can also withdraw from the study at any time, without having to give any reason, by informing the study investigator or an assistant.
Your decision not to participate or to withdraw from the study will have no consequences on (the quality of care and services you are entitled to / on your relationship with the investigator and other stakeholders / doctor / colleague / employer).
During the course of this study, we will give you any new information that could affect your decision to continue participating.
TERMINATION OF STUDY (adapt if necessary)
The investigator in charge of the study, the funding agency (or the sponsor),or the Research Ethics Board (REB), may end your participation in the study, without your consent, for the following reasons:
- New scientific developments show that it is in your best interest to terminate your participation;
- The study investigator responsible for the study thinks it is in your best interest;
- You do not follow the study instructions;
- There are administrative reasons to abandon the study.
CONFIDENTIALITY(adapt if necessary)
While you take part in this research project, the study investigator and study staff will collect and record information about you in a research file. Only the information needed to meet the scientific objectives of the study will be collected.
This information could include the transcript interviews and results from tests, exams and procedures you will undergo during the study. Your file could also contain other information, such as your name, gender, date of birth and ethnic origin.
All the information collected during the study will be kept strictly confidential to the extent permitted by law. To protect your identity and privacy, you will be identified by a code number. The code key linking your identity and your research file will be kept safely by the study investigator.
The interviews will be transcript by a research agent. The collected data, the transcription of interviews and the video / audio recording will be kept for XX years by the study investigator. After that, they will be destroyed.
The study data may be published in specialized journals or shared with other persons during scientific meetings. No publication or scientific communication will contain anything which can allow your identification. The video / audio recording will not be distributed.
For monitoring and control purposes, your research and medical records could be inspected by a person mandated by the Research Ethics Board or by the institution, by a person mandated by authorized public organisations as well as by the sponsor’s representatives. All of these people and organisations are bound by confidentiality policies.
For safety purposes, in order to be able to reach you quickly if needed, the study investigator will keep your name, surname, contact information and dates of your participation in the study in a separate secured log, for one year after the end of the study.
You have the right to examine your study records in order to check the information collected about you and to correct it, if necessary, for as long as this information is available from the study investigator or the Centre de recherche de l’Hôpital Charles-Le Moyne. However, some of this information may be made available to you only once the study has ended, in order to protect the scientific integrity of the study.
COMPENSATION (adapt if necessary)
You will receive a global amount of (indicate global amount) for each visit to compensate for expenses and inconveniences due to your participation in this research study.
OR (if the interview is done on the working hours)
Your employer accepted that the interview takes place during working hours, without financial penalty for you.
You will be reimbursed for your travel and parking expenses up to a maximum amount of (indicate maximum amount).
OR (if no compensation is provided)
You will not receive any compensation for expenses and inconveniences due to your participation in this research study.
PARTICIPANT’S RIGHTS AND INDEMNIFICATION IN CASE OF PREJUDICE(adapt if necessary)
If you suffer any harm whatsoever resulting from any procedure related to your participation in this research study, you will be provided with all the necessary care and services, at no cost to you.
By accepting to take part in this study, you do not waive any of your legal rights nor do you release the investigators, the sponsor or the institution where this research study is being conducted from their civil and professional responsibilities.
FUNDING OF THE RESEARCH STUDY
The investigator in charge of the study and the institution received funding from the funding agencyto carry out this study.
CONTACT PERSONS (adapt if necessary)
If you have questions about your participation in this research study, please contact Dr.name of the principal investigator, principal investigator or his/her research nurse at phone number or by pagerpager number.
For any question about your rights as a participant in this study or if you have comments or wish to file a complaint, you can contact the local Commissioner for Complaints and Quality Services of the CISSS de la Montérégie-Centre at the following number 4504665434.
MONITORING OF ETHICAL ASPECTS OF THE STUDY
The Research Ethics Board approved this study and is in charge of its monitoring. Furthermore, we guarantee that any modification to the study protocol or to this information and consent form will be submitted to the REB’s approval.
If you want to contact the REB, please reach the secretariat at the following number: 4504665000, ext. 2564.
Consent Form: Version XX – Write complete date of this version
Centre de recherche – Hôpital Charles-Le Moyne
Study title:xxxxxxxxxxx. Write number protocol in bold
Study number: **-HCLM-**-***Page 1of7
SCHEDULE OF STUDY VISITS AND PROCEDURES
Consent Form: Version XX – Write complete date of this version
Centre de recherche – Hôpital Charles-Le Moyne
Study title:xxxxxxxxxxx. Write number protocol in bold
Study number: **-HCLM-**-***Page 1of7
CONSENT
The nature of the study, the procedures, risks and benefits about my participation and the confidential aspects of the collected data have been explained to me by a member of the research staff.
I had all the opportunities to ask questions about the different aspects of the study and I received satisfactory answers. I declare that I had the necessary time to take my decision.
I freely agree to participate in this research study. I am free to withdraw my consent at any time, without possible harms to my relationship with my doctor and the othermembers of the research or healthcare teams, without any kind of prejudices.
I will receive a signed and dated copy of this consent form.
Name of the participant(block letters) / Signature of the research participant / Date
Name of the person who obtained consent (block letters) / Signature of the person who obtained consent / Date
INVESTIGATOR’S COMMITMENT
I make a commitment to respect what was agreed in the consent form and to give a copy signed and dated to the participant.
Name of the principal investigator (block letters) / Signature of the principal investigator / DateConsent Form: Version XX – Write complete date of this version
Centre de recherche – Hôpital Charles-Le Moyne