Common Research Terminology
A clinical trial is a prospective biomedical or behavioral research study of participants meant to answer specific questions about interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to see if new interventions are safe, efficacious, and effective. A clinical trial proceeds through four phases. The first phase tests a new biomedical intervention in a small group of people to assess the efficacy and safety of the intervention. The second phase tests the new intervention on a large group of people to further assess the efficacy and safety of the intervention. The third phase further tests the efficacy of the new intervention in a large group of people and compares the intervention to other standard interventions. This phase also tracks adverse effects and ensures the intervention will be used safely. The fourth phase is conducted after the intervention is on the market and the approved intervention is monitored for its effectiveness in the general population.
A group that does not receive any form of treatment that is being studied. The control group is compared to the group receiving a form of treatment (intervention group) to see if the treatment was effective. (NCI 2015)
Inclusion and Exclusion Criteria
Each study has a list of who can and cannot be included in that study. This is written in the protocol. In order to protect research subjects only people who qualify can be in the study.
If you decided to volunteer in a research study, the information about the study will be given to you in a consent form. This is to help you understand exactly what will happen to you in the research study. It is designed to help you decide if you want to participate, or not participate, in the study. The informed consent will outline all the rights you have as a volunteer in a research study.
As a research volunteer, it is helpful to read the consent form because it can help you come up with questions you may want to ask about your voluntary participation in the study. You will be told about all the risks, any benefits that may exist and even alternative options to the study.
After reading the consent you can make your final decision about participating in the proposed study.
A group in a study that receives the drug or treatment being tested. The intervention could include behavior changes such as diet and exercise or medical procedures or devices. The intervention group is also known as an experimental or investigative group. (NCI 2015)
Institutional Review Board (IRB)
The Institutional Review Board (IRB) is made up of a group of people such as scientists, doctors and some people within the community. The IRB looks at every protocol or research study before it is conducted on people. Because some research studies involve risk, the IRB looks at the study to make sure the risks are justified and minimized. In addition, the IRB wants to make sure the Principal Investigator follows all the rules the federal government has set up to protect human subjects who so kindly volunteer to participate in a research study.
Randomization is a process that ensures that each volunteer in a research study has a equal chance of receiving any of the treatments given in a particular study.
All research studies follow a protocol. A protocol is like a cookbook. It tells the researcher what can and cannot be done when he/she is conducting the study. All this is done to protect the research subject and this protocol is reviewed by the Institutional Review Board (IRB).
Research is a scientific study of nature that includes processes involved in health and disease. Research studies that involve people are called clinical trials. Clinical trials can help to screen, prevent, diagnose and treat disease. This type of study can also examine outcomes and specific groups of people by analyzing collected data (NCI 2015). A research study may also ask survey question and explore a particular behavior.
A research subject is a person who decides to participate in a research study. This is completely voluntary. You are helping the researcher look at the questions he/she wants to study. You can quit the study any time you want to.
Principal Investigator (PI)
The PI, or Principal Investigator, is the person who conducts the research study. The PI is also the person who is responsible for making sure everything is done properly. Along with the PI, there may be other persons who help with the study. For example, if it is a medical study, there may be a nurse involved in conducting the study. There are also people who look at all the data that is collected in the study and other individuals involved in operating the study.
Single and Double Blind Studies
A single blind study is a study where only the researcher and/or medical staff know which treatment or intervention the participants receive. A double blind study is a study where the researcher and/or medical staff do not know which treatment or intervention the participants receive.