Physicians, Scientists and others called ‘Investigators’ conduct research to add to our general knowledge about the world. Research is completed because Investigators and Scientists don’t know for sure what will work best for you. You may see the following terms that describe research: clinical trial, survey, experiment or protocol. Research is not the same as treatment.
If you agree to volunteer in research you may find that volunteers in research are sometimes referred to as ‘participants’, ‘volunteers’, ‘human subjects’ or ‘subjects’.
People often think of research as medical research or "clinical trials". However, there are different types of research including Clinical Trials.
A clinical trial is research study in human volunteers to answer specific health questions. The most commonly performed clinical trials evaluate new drugs , medical devices, biologics , or other interventions on patients in strict scientifically controlled settings, and are required for regulatory authority approval of new therapies (in the USA- it is the Food and Drug Administration - FDA).
However, research also includes research in non-medical departments such as Psychology, Business, Anthropology and Sociology. In these areas investigators may not be evaluating drugs or devices but may be evaluating different approaches, methods, or experiences to produce new knowledge about an area.
When you receive medical care from your own doctor, s/he develops a plan of care just for you.
When you take part in a clinical research study, you and the investigator must follow a set plan called the “study protocol.”
The investigator usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well.
If you are interested and seem to fit the study requirements, the research team will explain the research to you. They will give you a consent form to read. Then they will go over the consent form with you. They will describe what happens during the research study, the possible side effects, and other information you need to know about the research study.
The research team will give you time to ask questions. You should ask as many questions as you want.