How Is Clinical Research Conducted?

First, you will be given a consent form, which explains what is involved in the study. Members of the research team will review this form with you and will answer any questions you have about the study. If you decide to be in the study, you will sign the consent form. Being in a study is completely voluntary, and you can change your mind at any time even if you have signed the consent form. The consent form information is based on a carefully controlled protocol, which is a detailed plan of what will be done in the study. All studies have guidelines about who can participate. The guidelines are called inclusion and exclusion criteria. The guidelines or criteria are not used to reject interested participants personally, but to help produce reliable study results. You will be monitored carefully during the study, and you will likely be contacted by the research team after study procedures are completed. Some studies require more tests and doctor/clinic visits than you would normally have for an illness or condition.

How are study participants protected?

US federal Agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the clinical trials in the U.S. to protect the rights and welfare of study participants. Institutional Review Boards (IRB) oversee the centers where clinical trials are conducted. IRB review and approve study protocols to ensure that a clinical trial is ethical and that study participants’ rights are protected. You, as a study participant, have access to the IRB overseeing the clinical trial, including access to a volunteer advocate, the physician and staff conducting the clinical trial.


Federal agencies inspect the individuals and the institution conducting the clinical trial. These agencies also inspect the IRB.

If you are interested in becoming a study participant, please call 626-284-8401.


For more information on participating in clinical trials, please visit:
ww.fda.gov
www.nih.gov
www.clinicaltrials.gov