Purpose of the Informed Consent Form Process

Clinical lab
Photo by Walter Otto on Unsplash

After working as a family doctor, Dr. Hanid Audish became a principal investigator for Encompass Research. As an investigator, Dr. Hanid Audish performs clinical trials in areas including osteoarthritis, ADHD, diabetes, and testosterone, among other conditions. Informed consent is an important part of the clinical trial process performed at the research site.

Informed consent is a crucial aspect of clinical trials because it provides participants with the autonomy to make sound, informed decisions regarding their care. This form usually explains the clinical procedure (clinical plan), what will happen to them, and the risks and possible side effects (discomfort). The form will also ask the participant to acknowledge their consent to participate in the trial.

To protect the integrity of clinical trials, the FDA believes this process is very important to a clinical trial. Signing the document, providing information, and giving the participant enough time to decide whether they want to participate (given all of the factors) are central to informed consent. Before receiving a signature from the participant, the investigator and participant usually will discuss any questions or concerns regarding the trial.