Human Subjects Participant FAQs

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.

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.

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.

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.

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.

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.

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