Human Research Protections Office (HRPO)

What is a Research Study?

Healthcare professionals who are committed to finding better ways of doing things and more effective forms of treatment collect information through research studies (also called clinical trials, research projects, or experiments) to find answers to specific questions that could improve the current standard of medical care. Research contributes to the development of new medicines, new techniques, new procedures, and new ways of identifying and treating medical conditions. These discoveries often change educational programs, social policies, professional standards, and technologies.

Patients who receive standard care are sometimes asked to be a research study volunteer (also called a subject or participant). Most research studies have certain criteria you have to meet in order to participate. These criteria are designed to protect the safety of the subjects and to strengthen the research results. For example, a study may require subjects to be at least 18 years of age, to have a certain kind of disease, to be taking a specific type of medicine, or to have a certain set of symptoms.

Research studies usually involve some procedures or tests that are not a part of standard care and are done in addition to the normal course of treatment to gather scientific information. Some studies are designed to simply gather scientific information without providing standard care to the subjects at all. Once a person agrees to be a research subject, they agree to participate in all of the study activities. Study activities could last only a few minutes or a few years depending on the kind of research. Some studies involve answering questions or filling out surveys while other studies require taking experimental medicines or using experimental devices. Depending on the type of research, study subjects may receive payment for their participation or reimbursement for expenses related to the research activities.

Participation in research is voluntary. This means that subjects have the right to refuse participation or to withdraw from a study, at any time, if they change their mind about their initial agreement to participate.