Is a Research Study for You?
A Guide to Understanding Your Rights and Responsibilities as a Participant in a Research Study

Research & the Research Team

In this section you will read about the:

• Nature of Research
• Principal Investigator (PI) and the Research Team
• Difference between a Principal Investigator and a Primary Physician (Doctor)

Nature of Research
There are different kinds of research. A research study may be looking at:

• a new drug or procedure
• an existing drug or procedure
• behaviors
• attitudes
• learning styles
• cultural practices

Volunteering for a research study:

• is not the same as receiving a cure
• is not the same as receiving standard treatment for a disease or condition
• is not a guarantee that you will be getting a new, more effective drug or procedure
• is not offering you better or more frequent health care

Principal Investigator & Research Team
The research team includes a Principal Investigator and the research staff. The Principal Investigator (PI) is the person in charge of a research study. Part of being in charge is to determine who will be asked to participate.

Depending on the research study, possible participants can be chosen based on age, gender, type and stage of the disease or condition, previous treatment history, and other medical or behavioral conditions. The Principal Investigator is also responsible for the informed consent process.

He or she determines where and how the informed consent process will occur. It is common for the informed consent process to be conducted by a trained member of the research staff and not always by the Principal Investigator. The research staff is composed of people trained and supervised by the Principal Investigator to help conduct the research study. As an example, research staff might help with informed consent, drawing blood or keeping study records.

Difference between a Principal Investigator and your Doctor
It is possible that your doctor is also the Principal Investigator in charge of the research study you have been asked to join.

There is a difference between a doctor's role and a Principal Investigator's role:

Role: Doctor
Goal: To treat a condition or illness
Responsibility: to treat you with already approved drugs, devices, procedures or behavioral interventions

Role: Principal Investigator
Goal: To conduct a research study that is testing whether a drug, device, procedure, or behavioral change is safe and effective
Responsibility : To conduct the research study according to ethical standards, regulations, and IRB approval

A Principal Investigator is responsible for the conduct of a research study. A doctor is responsible for providing you with health care. These roles support the difference between research and standard treatments.