By volunteering for a clinical study, you would be participating in research that may result in a new treatment for a deadly or debilitating disease. Before you agree to participate in a study, we recommend that you be completely informed before making any decision.
When agreeing to participate in a trial, you will be given complete information about the study, known as “informed consent”. Informed consent involves two essential components:
- A Document – The informed consent document gives a summary of the research project (including the study’s purpose, research procedures, potential benefits and risks, etc.) and explains the individual’s rights as a research participant.
- A Process – The process consists of conversations with our research team. It is our goal to make sure that you are fully informed before consenting to the trial.
We recommend the following resources:
- The Food and Drug Administration (FDA) provides details about informed consent with the information page: Informed Consent for Clinical Trials [fda.gov].
- The Centers for Disease Control and Prevention (CDC) has a list of questions to help you get the information you need to make a decision about participating: Taking Part in Research Studies: What Questions Should You Ask? [cdc.gov].
Phase I
Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify any possible side effects.
Phase II
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III
The drug or treatment is confirmed in a third phase to test its effectiveness, monitor side effects, compare it to commonly used treatments, and to collect information that will allow the drug or treatment to be used safely.
Phase IV
Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
