Who is involved in a research study?

People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.

The doctor or healthcare professional who conducts the clinical research study may be called a clinical investigator, principal investigator, or study doctor. It is important to remember that the role of a clinical investigator is very different from the role of the health care provider. While your health care provider is responsible for making health care decisions for you based upon your medical condition, a clinical investigator is conducting a research study and is responsible for carrying out the study as described in the study protocol or study plan. This means that while the clinical investigator is responsible for carrying out the study in a way that minimizes research participant risks and maximizes the study benefits, the clinical investigator is limited by the requirements of the study with regard to the treatment options that can be provided to you, the research participant. Therefore, if you volunteer to participate in a research study, it is important that you maintain contact with your primary health care provider (your regular doctor) and other specialists before, during, and after your participation in the study to make sure that you have the best information about your health care decisions and to make sure that other treatments or medications you are taking do not interfere with your ability to participate in the study.

The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other healthcare professionals.

Studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.

Finally, studies that involve human subjects generally must be conducted under the oversight of an institutional review board (IRB) or research ethics board (REB) to confirm that the health, safety and welfare of the participants are adequately protected. See below for more information about IRBs and REBs.