Who should I contact if I have questions about the research?

A resource person coordinates each clinical trial, often a clinical research nurse, who will be your contact throughout the study. Also, you will have the opportunity to meet the principal investigator for the study, a qualified and experienced doctor, who will offer you the medical care required by the protocol and who will be able to answer any question you may have. You will also be offered the opportunity of having the medical information gathered during the study sent to your family doctor in order to contribute to your follow-up. Finally, your free and informed consent form will include the contact information for the ethics committee monitoring the clinical trial. You can contact them if you have questions about your rights as a subject participating in a research study.

What will happen if I decide to leave the study?

Your participation in a clinical research project is voluntary. That means you are free to refuse to participate. You may also decide to withdraw from the project at any time, without having to justify yourself, by advising the investigator in charge of the project or one of the members of the project's staff. Your decision to refuse to participate in the research project or to withdraw from it will have no incidence on the quality of care and the services to which you are entitled, nor on your relationship with the investigator in charge of the project or other stakeholders. Furthermore, you will still be eligible for compensation based on the prorata of your participation.

How long can a clinical research study last?

The answer to this question can vary greatly. In fact, each clinical trial has its own characteristics. During the free and informed consent process, the length of the study and of the visits, as well as each of the study procedures that will be carried out will be explained to you very clearly. Your involvement will be greatly appreciated, throughout the study, which may last from a few days to a few years.

Who will pay if I am unexpectedly injured during the study?

This question is often a matter of debate, and is very important! First of all, one must remember that each clinical trial must be undertaken and carried out only if the expected benefits justify the risks. Therefore, if you suffer any prejudice, be it following the administration of an experimental drug or any procedure related to this research project, you will receive the care and services required by your state of health, at no cost to you. By accepting to participate in this project, you do not waive any of your rights nor liberate the investigator of the sponsor of their civil and professional liability. Also, the known adverse effects of the experimental drug will be explained to you clearly during the free and informed consent process.

Do I have to declare the money I received for participating in a project on my income tax?

No. You do not have to declare the amount received in compensation for your travel on your income tax or to any other governmental agency.

Will my participation in a clinical trial cost me something?

The answer is no. In fact you will receive the experimental drug free of charge and also receive compensation based on the prorata of your participation and travel. Lab tests, complementary tests and external medical consultations related to the study will completely be the research team's or the study sponsor's responsibility. Also, your meals may be reimbursed, where required.

What will happen to my personal information?

When you participate in a clinical research study, you will be asked to provide your contact information as well as certain personal information regarding your medical history and medication that you are taking. This essential information is necessary to protect you as well as to ensure your well-being. Also, note that each member of the research team is sworn to confidentiality and that your records will remain confidential in accordance with current laws and regulations. In fact, according to the Charter of Rights and Freedoms, every person has a right to respect for his private life; it is a fundamental right. It states that every person has a right to the safeguard of his dignity, honour and reputation, right to respect for his private life and right to respect of professional secrecy.

What are the benefits for me?

The principal motivation for most clinical research study participant is the desire to enrich knowledge, help medicine advance and improve the quality of care offered by our health care system. Also, subjects could benefit from the improvement of their current treatments as well as discover new information on their health condition or their well-being.

What procedures will I have to go through?

As a clinical research participant, you will benefit from a complete physical exam, laboratory blood and urine diagnostic tests, and supplemental tests which may include an electrocardiogram, medical imaging or an external medical consultation requiring a specialist. Also, you will be followed through the entire study by health care professionals qualified through education, ongoing training and experience in clinical research.

Will I know if I received the real medication or a placebo?

All along the study, neither you nor the Diex team who monitors you or the doctor will know what you are receiving. Once the study is finished, the people that take care of results communicate with us to let us know who received which treatment. Once we have this information, we call all research participants to let them know if that is their wish. These results are usually available later after the end of the study, which can be as long as 6 months to several years.

What is a placebo?
A placebo is a “false pill” or “flour pill” that has no recognized physiological effect. In fact, a placebo is a pharmacologically inactive medication that is given in order to evaluate the possible psychological effect of a study medication. In cases where they are used, participants are advised in advance of the possibility that they will receive a placebo, as well as the reasons why the use of a placebo is necessary for the study.
Will I receive the study results?

Study results are always published, but it takes a certain amount of time. There are many sites where one can find study results, such as www.clinicaltrials.gov. One must take into account that all research participants must have completed the study as well as the time necessary to analyze the results. Even the Diex team will not know exactly when the study results will be published, but if you ask, a member of the team will try to contact you when they become available.

Will I be exposed to important risks?

Before any clinical trial may begin, Health Canada, a research on humans ethics committee and the investigating doctor carry out a complete evaluation in order to ensure that the expected benefits justify the risks taken. Also, the study objectives and the possible expected adverse effects will clearly be explained to you during a free and informed consent process. This process will be completed after your interview with qualified personnel and an investigator, after you have discussed with family and parents, and its objective is for you to clearly understand the nature, consequences and potential risks of the clinical trial. It is at that time that you will have to take all the time you need to ask essential questions. Take your time!

Who can participate in a clinical research study?

Different selection criteria are applicable for each clinical research study. To learn about the selection criteria for the clinical trial you are interested in, to get more information or to make an appointment to become a participant, please contact Diex Recherche at 819-346-2887 or at 514-223-3439. They will be able to give you all of the information you require. Appointments can be made in the daytime, in the evening and, on request, on weekends. Please note that you have access to Diex Recherche's professional team at all times. Nursing staff is available 24/7 and access to the doctor is quick, if required.

How can I become a research participant at Diex?

There are 2 fast and easy ways to communicate with a member of the Diex team. First of all, you can call us to speak to one of our nurses or to ask any questions you may have. Then, you can fill out the online participation form by clicking here. Once your information is entered, it will be possible to verify your eligibility for a project that interests you!

Are we guinea pigs?

First of all, a guinea pig is an animal. Many people have a tendency to use the word guinea pig to designate a research participant, but this name is false. Project participant are in no way guinea pigs.