Frequently Asked Questions (FAQs)
- What is a research study?
- What is a research subject?
- What is a protocol?
- Can anyone be in a research study?
- What is a PI?
- What is an IRB?
- What is an informed consent?
What is a research study?
A research study is a very careful way of looking at something and collecting data about what is being looked at. It can be something as simple as asking questions, giving a survey or looking at a particular behavior. On the other hand, it can be more complicated and may look at a specific disease or condition.
What is a research subject?
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 participating in the study at any time you want.
What is a protocol?
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 of this is done to protect the research subject, and this protocol is reviewed by the Institutional Review Board.
Can anyone be in a research study?
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.
What is a 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. There may be people who look at all the data that is collected in the study and other individuals involved in operating the study.
What is an IRB?
The Institutional Review Board (IRB) is made up of a group of people such as scientists, non-scientists, and some community people. The IRB looks at every protocol or research study before it is conducted on any 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.
What is an informed consent?
If you decide to volunteer in a research study, the facts of 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 make up your mind about participating, or not participating, in the study. The informed consent document will outline all the rights you have as a volunteer in a research study. Giving a research subject a consent form to read is a helpful process because it gives you enough time to ask as many questions as you want to 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 form, you can make your final decision about participating in the proposed study.