Regulatory agencies like FDA require that Clinical Research Trials be conducted in order to develop new treatments, preventions and devices for diseases or conditions. Clinical Research Trials are also referred to as Clinical Studies, Clinical Trials, or Research Trials.
There are strict regulations that the trial doctors and their staff must follow when conducting Clinical Research Trials.
There are important things to know about participating in a Clinical Research Trial:
- Your participation is voluntary and you may withdraw at any time.
- All information about you will be kept confidential.
- Before you participate in a study a Doctor or Member of the Clinical Research Team will explain all the details about the study to you, including any potential risks or benefits and answer all your questions.
- You will have as much time as you need to decide if you want to participate.
- 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 which contains additional information about the Clinical Research Trial.
Every Clinical Research Trial is submitted to an Independent Research Ethics Board for approval before the study can be performed.