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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 and medicines or devices that are used to treat a disease or condition.

Clinical trials are research studies that explore whether a medical strategy or treatment (drug or device) is safe and/or effective in humans. For example, clinical trials may show which treatment works best for certain illnesses or groups of people. Clinical trials produce information so that physicians, nurses, and other clinicians can better treat their patients.

A research subject is a person who decides to participate in a research study. Your decision to be a research subject 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.

All research studies follow a protocol. A protocol guides the researcher regarding what can and cannot be done when he/she is conducting the study. Protocols are designed to protect the research subject, and is reviewed by the Institutional Review Board.

The Institutional Review Board (IRB) is made up of a group of people such as scientists, non-scientists, and individuals who live and work in our local community or state. The ßÙßÇÂþ»­ IRB reviews and approves all research conducted at the University to ensure the study is safe and ethically sound. The IRB looks at every protocol or research study before it is conducted. 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 researcher and their team follows all the rules the federal government has set up to protect human subjects who volunteer to participate in a research study.

A Principal Investigator, or PI, is the main person responsible for the conduct of the research study. 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 with the study.

Subject pools are typically comprised of adult undergraduate students enrolled in a department course or courses offering course credit for participation in one or more research projects. The USF IRB reviews all research subject pools to ensure participation is voluntary and reviews all research which will recruit participants from the subject pool. Alternative assignments must be provided to students who decline from participating in the subject pool.

USF faculty and students conduct research involving children. Research can occur in schools or in a clinical setting if your child is sick or has a certain disease. These studies have special ethical and regulatory considerations the IRB must take into account in order to protect the rights of the child. As a parent, it is important for you to know what is being asked of your child, if there are risks and/or benefits to their participation in the research, if sensitive data is being collected, how much time is required, and how information will be protected. You may be asked to sign a parental permission form to allow your child to participate in the research. In addition, your child may be asked to sign a document called an assent form.

If you have concerns or complaints about the research you are participating in, or wish to discuss your rights as a research participant, you should contact the USF IRB Office at (813) 974-5638.