Before you accept to participate in a research project, you should understand:
- the objectives and expected benefits or lack of immediate benefit;
- what will be your participation and if the project is a clinical trial you need to be informed of the treatment used or the proposed intervention as well the possible side effects;
- which type ofobservations, examinations andtests thatyou will participate to;
- the risks, inconvenience, discomfortand benefitsrelated to your participation in the project;
- how the information collected will be used, stored and destroyed;
- the facts and answers provided to your questions;
- the information sheetand a copy of the consent form given to you;
- that you can withdraw from the project at any time on a verbal notice and you do not have to justify your decision;
- which resources are available to you should and how to contact them should you require more information or if you have a complaint to report.
All these elements are required because they are part of the process the research team needs to follow in order to get your agreement (consent) to participate in their project. This will be documented by the research team. You should be given a sufficient amount of time to decide whether or not he/she wishes to participate.
Refusal to enroll in a research project must not influence or jeopardize the relationship with your physician, nor the services or the treatment you are receiving. Even after accepting to participate (written or oral consent) in project you can reverse your decision at any time without fear of repercussions on the quality of future medical care or your job.
By participating in a research project, you do not waive any of your rights.
For more information about your participation in a research project, you can consult this brochure from the Panel on Research Ethics.
You can access the following database to determine if a clinical trial has met the regulatory requirements. The database may also help you in finding clinical trials that might be relevant to their medical condition.