Learn About Clinical Trials

Clinical research trials are designed to evaluate the safety and effectiveness of new drugs, devices, or behavioural therapies. Clinical research trials are also referred to as clinical studies or clinical trials.

Regulatory agencies such as the FDA, Health Canada, and Australia's Therapeutic Goods Administration have national regulatory rules. This is to ensure a drug is safe and effective before it is available to the public. Each regulatory agency controls the availability, approval, and supply of therapeutic products in their respective countries. Clinical research trials provide the information needed in order to evaluate these products. The health authority will review this info on the safety profile of every product before it is available to the public.

Probity Medical Research has created a list of important things to know about joining a Clinical Research Trial.

  1. Your participation is voluntary and you may withdraw at any time.
  2. All information about you will be kept confidential.
  3. Before you participate in a study a member of the research team will explain the study to you. They will review any potential risks or benefits and answer all your questions.
  4. You can ask questions.
  5. You will have as much time as you need to decide if you want to participate.
  6. If you decide to participate you will be asked to sign a consent form. You will get to keep a copy of this consent form. The consent form contains all the information about the clinical research study including all procedures, potential risks and benefits, information about protecting your privacy, other procedures or treatments to consider, and who to contact with questions.

You can also find information about clinical trials on Probity Medical Research's website dedicated to patients: ResearchTrials.org.

In addition to the country's regulatory agency, every clinical trial is submitted to an Independent Research Ethics Board for approval before it can begin. IREBs are also referred to as Institutional Review Boards (IRB), Research Ethics Boards (REB), and ethics committees (EC). The ethics committee will review the research study to help protect the rights and safety of research participants. Once the ethics committee has determined that the study is safe for subjects they will give the study unconditional approval.

Along with reviewing each protocol the research ethics board will also review the locations where the research will take place. Each doctor and their clinical research site are reviewed by the ethics committee again to protect the rights and welfare of the research participant. An ethics committee will provide each doctor and their location with an approval to begin research activities.

REBs must follow guidelines set out by the health authorities in their province/state and country.

If you ever have any questions concerning your participation in a particular study you may contact the REB that reviewed that particular study. The REB's contact information is provided in your informed consent form.

 

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