Greetings,

It is with great pleasure that I would like to welcome you to this very interesting and important section of clinic l'Actuel's web site. It is through clinical research and the advances in medical science that may result from such research that brings hope to all those individuals affected directly or indirectly by HIV/AIDS, STIs or hepatitis.

In fact, for more than 20 years of existence, and now more than ever, clinic L' Actuel is actively engaged and committed to participation in clinical research. It is extremely important that we be able to ensure that our patients have timely access to recent developments and/or innovations with respect to prevention, screening, management and treatment of STI's, HIV/AIDS and hepatitis. With the passing years, these various research projects have enabled us to perfect our knowledge of new antiretroviral (ARV) drugs and combinations of ARV drugs, to explore novel therapeutical strategies, and to evaluate the treatment choices that were made available to us in the past.

We have recently been offered the opportunity to broaden our therapeutic horizon to diseases that can now be treated: viral hepatitis. On occasions, we also take part in clinical studies on other STIs, such as herpes, chlamydia, and the human papilloma virus.

Our research department offers the opportunity to participate in various different clinical projects all managed by our excellent on-site research staff. Many of these scientific research protocols are part of collaborative efforts with other Quebec research centers, canadian or international research initiatives, the department of public health and/or the pharmaceutical industry.

It goes without saying, that none of these achievements would be possible without the active and voluntary participation of our patients. This is why we invite you to contact one of our research team if you or someone close to you is eligible and would like to participate in one of these clinical studies.

The team looks forward to working with you!

Dr. Jason Szabo
Research Director

For further information concerning research protocols, or if you wish to enroll in one of our research protocols, contact your treating physician or our research coordinator, Tévy-Suzy Tep, at 514 524-3642, extension 281.

A GUIDE TO INFORMED CONSENT

A Definition of Informed Consent

You may already have been exposed to signing consent forms for other kinds of medical and/or dental procedures whether it be for interventions such as surgery, or for cancer treatments such as radiation or chemotherapy.

Informed consent for a clinical research trial involves much more than just reading and signing a piece of paper.

The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You can keep a copy and use it as an information resource throughout the course of the trial.

The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial’s purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.

For further information concerning research protocols, or if you wish to enroll in one of our research protocols, contact your treating physician or our research co-ordinator at 514 524-3642, extension 239.

MYTHS & REALITIES

Myth: Informed consent is designed primarily to protect the legal interests of the research team and/or pharmaceutical company.

Reality: The purpose of the process is to protect you and other participants by providing access to information that can help you make an informed choice. It also is designed to make you aware of your rights as a participant.

Myth: The most important part of this process is signing the informed consent document.

Reality: Actually, the heart of this process is communication - your ongoing interaction and discussions with the research team and other medical personnel–before, during, and after the trial. The document is designed to get this conversation started.

Myth: My doctor knows best; he or she can tell me whether or not I should consent to participate.

Reality: Your doctor is likely to be a valuable source of advice and information, but only you can make this decision. No one–not even medical experts–can predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.

Myth: Once I sign the consent form, I have to enroll and stay enrolled in the trial.

Reality: That's not true. Even after you sign the form, you are free to change your mind and decide not to participate. You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment.

Myth: Medical personnel are busy, so I can't really expect them to keep me informed as the trial progresses or listen to my questions.

Reality: The research team has a duty to keep you informed, make sure that you understand the information they provide, and answer your questions. If you ever feel that you are not getting what you need, do not hesitate to speak up. You will be given the name and phone number of a key contact person who can answer your questions throughout the course of the trial. Keep in mind that people like you are making this research possible through their willingness to participate.

For further information concerning research protocols, or if you wish to enroll in one of our research protocols, contact your treating physician or our research co-ordinator at 514 524-3642, extension 239.

THE DEPARTMENT

Director of Research
Dr. Jason Szabo

Research Nurses
Claude Gagné
Blanca Gómez
Bryan Dobson

Research Coordinator
Tévy-Suzy Tep