For Patients | Overview
What is a research study?
Research is the way doctors and scientists learn about new ways to prevent and treat conditions, and find answers to many questions about health, disease or human behavior. As a participant in a research study, you play a critical role in improving health care and future treatments; however, it is also an important personal decision.
Some participants may have a disease or condition the researchers are studying, while other participants are healthy volunteers. In each research study, there are requirements regarding who can participate. This is called inclusion criteria. There also are reasons why someone might not qualify, known as exclusion criteria.
Being part of a research study is completely voluntary, and you can change your mind at any time.
The research team
Every study has a research team who work together to follow what's called a "protocol" — a detailed plan for the study. The protocol balances the potential benefits and risks to participants, and answer specific research questions.
Research team members include:
- Principal investigator (PI): The PI, who is often a doctor or scientist, is responsible for the entire study. This person plans the study, makes sure activities are done safely and correctly, and decides what each research team member does. The PI supervises all research activities and all of the members of the study team. The PI also makes sure everyone on the team has the proper training.
- Co-Investigators: Many studies have co-investigators — researchers (often doctors or scientists) — who work with the PI. Co-investigators might help the PI design the study or supervise it, but they are not responsible for the entire study.
- Research nurse: A research nurse often has special training and experience. Many studies that involve medical or clinical research have a research nurse on the team who helps carry out the study, focusing on the care and safety of research participants, and is often involved in coordinating daily study activities.
- Research coordinator/research assistant: The research coordinator/research assistant is a person who works with the other research team members to organize and help with daily study tasks.
Other individuals also may help with a research study, such as pharmacists, lab technicians, dieticians who help with participants dietary needs, social workers and office staff.