Rights and protections

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All clinical research projects must comply with strict standards to protect participants and ensure their rights are respected. Here are some of the questions that you might ask yourself about what is termed "ethical aspects."

Who approves research projects?

Clinical research projects are supervised and checked by health authorities every step of the way. Each project must meet the requirements of the research ethics committee of the institution where the research is being conducted. This committee monitors the project from start to finish. The committee can consult your research record and, if necessary, your medical file to ensure that standards are being respected. The committee checks the validity of the consent form that you must read and sign prior to taking part in a project.

What is a consent form? 

This document must provide you with all the information needed for you to make an informed decision. It contains information about how the project will be conducted; what is expected of participants; and what risks, benefits, and disadvantages may be involved as well as the rules governing confidentiality. After asking the research officer any questions you have, you can read and sign the form if you wish to take part in the project. You will be given a copy of it to keep. You should be aware that agreeing to take part in a project does not bind you to anything. You can withdraw from the project at any time. 

Who can take part in a clinical research project? 

The participation criteria are clearly indicated in the call-for-research-participant documents (e.g., age, sex, state of health). 

Are you a natural caregiver for an incapacitated person? 

Of course, you can take part in a project that interests you. An incapacitated person can take part in such projects if authorized by you and/or the person's legally mandated representative. 

What information about you will be collected? 

The investigator in charge of a clinical trial is obligated to safeguard the confidentiality of your information. Information about you will be kept in a secure location for a set number of years and then destroyed. 

Will my identity be protected? 

Your only identification in all the documents will be a number code. Only the researcher and his or her staff will know which number corresponds to which participant. No unauthorized third-party will ever be able to identify you in any way whatsoever unless you have given your express consent. This also holds true if the researcher wants to present or publish your research data. 

Will my attending physician be informed about my participation in a clinical study? 

That is your decision. You can do so yourself, if you wish, or ask the research team to take care of it for you. 

Can I have access to my research record? 

Yes, for example, to check and correct certain information. Nevertheless, the researcher may only give you access to certain information once the project has been completed. 

Will my health be monitored during a clinical trial? 

Clinical trials are monitored by competent medical staff to ensure your safety at all times. Should a problem arise, you will receive all the care and services required by your state of health at no charge to you. 

Can there be side effects? 

As with any medication, even those already available on the market, there are sometimes a risk of side effects. These side effects will be explained in detail before you join a clinical study. 

Will placebos be involved? 

Placebos are used in certain clinical studies. Placebos are "inert pills" or "sugar pills" that have no physical effects. Participants are informed beforehand that placebos may be used and told why they are needed for the purposes of the study. 

What do I do if I have a problem related to the project? 

You can, at any time, ask the researcher or his or her staff any additional questions that you might have about the research project.

Can the research results be commercialized? 

Research results can lead to the creation of commercial products. Nevertheless, unless otherwise indicated by the researcher, you will derive no financial benefits from such commercialization. 

Are there any costs related to my participation in clinical research? 

Participants in clinical studies pay nothing for the treatment or care that they receive within the framework of the study. Moreover, there is no cost to the health-care system or your insurance program. Participants in some projects receive compensation. Check with the research team to find out the nature of the compensation. 

You still have questions? 

Get in touch with one of our clinical research centre whose contact information can be found on this site. You can also find more detailed documentation on this Quebec-government Web site (in french only) : http://ethique.msss.gouv.qc.ca/site/176.300.0.0.1.0.phtml