For those who have never participated in a clinical study, the terminology and details used in the process of such a study might be intimidating. Like many other research and medical areas, complex terms and labels are often used, but in reality, the process is relatively straightforward and simple.
At AGA Clinical Trials, we’re dedicated to ensuring all potential trial participants completely understand the clinical trials we offer – from their purpose and benefit to the specific expectations and requirements for participants and researchers alike. With that in mind, let’s go over a few areas of terminology you might hear at some point before or during a clinical study, helping you understand what they really mean.
Investigators and Principal Investigator
“Investigator” is one of the single most common terms you’ll hear during any research study, and many people’s minds naturally drift to Sherlock Holmes or whatever their favorite detective story is. They imagine a monocle-wearing private eye solving cases using a magnifying glass and only his smarts.
Silliness aside, this is obviously not the actual meaning of this term in this situation. Rather, an investigator in a research study is any board-certified doctor who is involved in managing the study itself. Most studies will have a principal investigator, a doctor who is leading the study and makes the final decision on proceedings.
Institutional Review Board
All trial participants need to have their rights and welfare protected during any study, and this is guaranteed by what’s called an institutional review board. This is a committee that’s formed with the task of reviewing and considering every research study in advance of it taking place, ensuring that the rights of individual participants will be protected throughout a suggested trial. The IRB will assess areas like safety, privacy, health concerns and several related areas.
Informed Consent
“Informed consent” does not refer or to a person or group, but rather to a concept that’s vital for all research studies. Essentially, it refers to any research subject’s personal decision to participate in a study, a decision they make once they’ve been given all the relevant information and have had a chance to evaluate it.
Informed consent must be maintained throughout a study – if any new information is learned that might impact the participants in any way, they have the right to review it and potentially withdraw if they are uncomfortable. This protects participants at every stage.
Placebos
In many studies, items called placebos will be used. These are non-treatment options that are given to people who do not know whether they’ll receive this or the true treatment being studied, and they’re given for the purposes of comparison and larger understanding of the actual medicine involved. Even trial participants who receive placebos can benefit significantly from things like diagnostic testing for the condition, medical monitoring they couldn’t get elsewhere, and more, and compensation is generally provided even if you get a placebo.
For more on important terms and areas to know within a clinical trial, or to learn about any of our research studies, contact the staff at AGA Clinical Trials today.
