In order to participate in a clinical research trial, certain guidelines or criteria need to be met for you to be eligible. The criteria are based on things like your age, gender, medical history, diseases, or conditions. These criteria are used to determine the appropriate participants and to ensure the safety of each participant.
To start, you will be provided with an informed consent form to review and sign. When you sign the informed consent form you are telling the research team that you would like to participate in the clinical research trial. Once you agree to participate in a clinical research trial, you will enter into a “Screening” period to determine if you are eligible for the trial. During this time, the clinical research team will:
If it is determined that you are eligible to participate you will return to the research site for additional visits as directed by the clinical research team. At these visits, your health and progress will be monitored. These visits may include physical exams, blood work, or specialized assessments to monitor your disease or condition.
An Informed Consent Form (ICF) provides potential participants with a detailed description of the clinical research trial. The ICF will describe:
ICFs are reviewed by Independent Research Ethics Boards to ensure the information in the form is correct.
A consent form will be presented to you by the clinical research team. You will have as much time as you need to read and review the consent form. You may take home an unsigned copy of the consent form to discuss with family or friends before making your decision. You should ask the trial doctor or the research staff to explain any words or information that you do not clearly understand. A copy of the signed consent form will also be provided to you. Your participation in a clinical research trial is always voluntary.
Benefits and Drawbacks
The following is a list of potential benefits from participating in a clinical research trial:
The possible drawbacks of participating in a clinical research trial may include:
You will always be informed of changes throughout a clinical research trial and your condition will be monitored closely by health care professionals.
Following Trial Completion
When the clinical research trial is over, the trial doctor will discuss treatment options with you. In many instances, it will not be possible for you to remain on the treatment you received during participation in the clinical research trial. You may need to return to your regular doctor for treatment of your condition.