Clinical research is medical research that involves people like you. When you volunteer to participate in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future. Clinical research includes all research that involves people. Clinical trials look at new ways to prevent, detect, or treat disease. Clinical trials can study:

- New drugs or new drug combinations

- New ways of doing surgery

- New medical devices

- New ways to use existing treatments

- New ways to change behaviors to improve health

- New ways to improve the quality of life of people with acute or chronic diseases.

The goal of clinical trials is to determine whether these treatment, prevention, and behavioral approaches are safe and effective. People participate in clinical trials for many reasons.

Healthy volunteers say they participate to help others and to help advance science. People with illnesses or diseases also participate to help others, but also to possibly receive the latest treatment and to receive extra care and attention from clinical trial staff. Clinical trials offer hope to many people and a chance to help researchers find better treatments for others in the future.

It is only through clinical research that we can gain information and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and past have only been possible through the participation of volunteers, both healthy and sick, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities affected by disease. As research opens new doors to find ways to diagnose, prevent, treat, or cure diseases and disabilities, participation in clinical trials is essential to help us find the answers.

Many types of people participate in clinical trials. Some are healthy, while others may have diseases. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to participants. Healthy volunteers have always played an important role in research.

Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or an imaging device, healthy volunteers help define the limits of “normal.” These volunteers provide the baseline against which groups of patients are compared and are often matched to patients based on factors such as age, sex, or family relationships. They receive the same tests, procedures, or medications that the patient group receives. Researchers learn about the disease process by comparing the patient group to the healthy volunteers.

Factors such as the time required, the discomfort you may experience, or the risk involved depend on the trial. While some studies require minimal time and effort, others may require a significant commitment of your time and effort, and may involve some discomfort. The research procedure(s) may also involve some risks. The informed consent process for healthy volunteers includes a detailed discussion of the study procedures and tests and their risks.

A patient volunteer has a known health problem and participates in research to better understand, diagnose, or treat that disease or condition. Research with a patient volunteer helps develop new knowledge. Depending on how well-known the disease or condition is, these procedures may or may not benefit study participants.

Patients may volunteer for studies similar to those involving healthy volunteers. These studies involve drugs, devices, or treatments designed to prevent or treat disease. Although these studies may provide direct benefit to the patient volunteers, the primary goal is to prove, by scientific means, the effects and limitations of the experimental treatment. Therefore, some groups of patients may serve as a reference for comparison by not taking the test drug or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the disease.

Researchers follow clinical trial guidelines when deciding who can participate in a study. These guidelines are called inclusion/exclusion criteria. Factors that allow you to participate in a clinical trial are called “inclusion criteria.” Factors that exclude or prevent participation are called “exclusion criteria.” These criteria are based on factors such as age, gender, type and stage of a disease, treatment history, and other medical conditions. Before you participate in a clinical trial, you must provide information that helps the research team determine whether or not you can safely participate in the study. Some research studies look for participants with diseases or conditions to be studied in the clinical trial, while others need healthy volunteers. Inclusion and exclusion criteria are not used to reject people personally.

Clinical trials are approved and monitored by an institutional review board (IRB) to ensure that risks are minimized and outweighed by potential benefits. IRBs are committees that review research to protect the rights and safety of people participating in the research, both before the research begins and as it is conducted.

Clinical trials are approved and monitored by an ethics committee to ensure that risks are minimized and outweighed by potential benefits. An ethics committee is responsible for reviewing research to protect the rights and safety of people participating in the research, both before the research begins and as it is conducted.