Clinical research is an integral part of the drug development and fine-tuning process. The so-called fundamental phases (discovery phase and pre-clinical) occur prior to research carried out in a clinical setting, that is, in humans. Only potentially effective and safe drugs will go into the clinical research phase in which four distinct phases are found. The evaluation and analysis of each of these phases will tell us about the effects of the drug, its effectiveness and the safe and therapeutic aspect of it. These steps are necessary to obtain Health Canada’s approval for their marketing. In general, this is a long process and can take up to 15 years.
What is a study consent document?qt_oaxi012021-11-22T22:00:44+00:00
A consent document is a document explaining everything the participant needs to know in order to make an informed choice before engaging in clinical research. Consent, however, is not a contract: the participant can withdraw at any time. A copy of this document is always given to the patient during the selection visit. It is imperative that the participant take the time necessary to read the information and ask any questions they may have about the recruitment study.
How am I protected?qt_oaxi012021-11-22T22:00:31+00:00
Health Canada and other government agencies carefully review and audit each research program involving study participants. In addition, each clinical study is also evaluated and approved by an independent ethics committee to protect the rights and health of participants. These projects are governed by very strict standards and regulations. At Q&T Research Sherbrooke, all projects are carried out rigorously and with respect for the well-being of volunteers.
Who can participate?qt_oaxi012021-11-22T22:00:22+00:00
Anyone wishing to participate in a project must undergo a full medical evaluation specific to the recruitment project. Several selection criteria are evaluated to ensure the eligibility of the participant. However, no one aged 18 and under, as well as anyone pregnant or breastfeeding, are eligible. No medical reference is required to participate in a research project.
What are the possible benefits?qt_oaxi012021-11-22T22:00:12+00:00
You benefit from close monitoring, a complete medical evaluation, as well as specific and specialized tests as needed. You have access to new drugs that are potentially more effective and better tolerated that may improve your health. In addition, you contribute significantly to the advancement of science, since it is thanks to the participants that clinical research can occur. Without clinical research volunteers, no medication could be approved or available.
What are the potential risks?qt_oaxi012021-11-22T22:00:02+00:00
Like drugs already on the market, side effects are possible. However, if this is the case, the effects will be detailed in the consent document for the study, so that you can be informed and can make a fair and balanced decision.
Do I have to pay money to participate in a research project?qt_oaxi012021-11-22T21:59:42+00:00
The costs of treatment or care (drug, physical examination, medical history, etc.) are incurred by the pharmaceutical sponsor of the study. You do not have to pay any fees. Compensation is awarded for your travel and the inconveniences incurred by your participation in the study. You can ask a nurse at the clinic.
Can I cease my participation at any time?qt_oaxi012021-11-22T21:59:34+00:00
You are free to withdraw from the study at any time, without having to justify the reason for the withdrawal. Your participation is entirely voluntary. Whatever your decision, no harm or loss of benefits will be incurred.
Although the pandemic is over, in the event of symptoms, we maintain basic hygiene measures such as washing hands and wearing a mask.
These measures are simple and effective ways of reducing the risk of contamination.
Thank you for your understanding,
The Q&T team
AVIS CONCERNANT LE CORONAVIRUS / COVID19
Bien que la pandémie soit terminée, en cas de symptômes, nous conservons les mesures d’hygiène de base telles que le lavage des mains et le port du masque.
Ces mesures restent des méthodes simples et efficaces pour diminuer les risques de contamination.
Merci de votre compréhension,
L’équipe de Q&T
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