What You Can Expect

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:

  • Ask questions about your current health and medical history
  • Review medications you are currently using or have used in the past
  • Perform evaluations to assess your condition or disease
  • Determine if you are an appropriate candidate for the trial and if it is safe for you to participate

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.

Phases of Clinical Research Trials


Informed Consent

An Informed Consent Form (ICF) provides potential participants with a detailed description of the clinical research trial. The ICF will describe:

  • the trial procedures
  • the drug or device being investigated
  • the duration of the trial
  • the potential risks and benefits
  • how your personal health information will remain confidential

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:

  • Taking an active role in your own health care
  • Thorough monitoring of your condition
  • Receiving care from physicians who specialize in the treatment of your condition
  • Contributing to research that may benefit others with your condition
  • Access to treatments before they are widely available

The possible drawbacks of participating in a clinical research trial may include:

  • A new approach that may not work for you
  • Unknown risks or side effects that the research team is unaware of
  • Ineffective or less effective treatments than currently available treatments
  • A greater time commitment than required for standard treatment

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.

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