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People volunteering for clinical research trials (also called clinical research studies) is an essential part of evaluating new treatments. These trials are used to learn about the safety and effectiveness of new medications, medical devices, and medical therapies and procedures.
There are many types of clinical trials, however all must conform to internationally recognised guidelines and strict rules set by each country’s regulatory authorities. These principles help protect the rights and safety of those who volunteer to take part in clinical trials. There are also special committees (Ethics Committees (ECs) or Institutional Review Boards (IRBs)) who review and approve each trial to ensure they conform to these principles.
Participants will usually not know which treatment they are allocated to, and may not benefit from the investigational therapy they are assigned to.
WHAT IS INFORMED CONSENT?
WHAT IS A CLINICAL TRIAL?
Everyone taking part in a clinical trial must give ‘informed consent’. This is a document that explains what will happen to you if you choose to participate in the trial such as the purpose, duration, required procedures, risks and potential benefits.
To help you decide whether to enter a clinical trial, members of the study team will:
Explain the details of the trial to you.
Give you the ability to ask questions.
Let you discuss the study with family, friends or your own doctor before deciding whether to take part.
If you decide to participate you will be asked to sign the consent document. Signing the consent document means that you are agreeing to take part in the trial and understand what is involved.
If there are any changes to the trial protocol, you will be kept informed and you may be asked to give your consent again before proceeding with the trial.
Informed consent explained
The main purpose of a clinical trial is to study new drugs in people. Clinical trials are research studies that test in humans the safety and effectiveness of new medical therapies and are used to answer questions such as:
Are new drugs safe enough to outweigh the risks related to the underlying condition?
How should the new drug be used?
How effective is the new drug at relieving symptoms, treating, or curing a condition?
It is important for people who are considering participation in a clinical trial to understand their role as a potential research trial participant.
Clinical trials explained
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