Being a Clinical Research Participant

Working Together to make a Difference.

Learn how you can take part in the future of healthcare by being a clinical research volunteer.

Medical Exams

Most studies provide physician examinations, evaluations, and lab work at no cost. Research can also offer patients early access to new investigational treatments.

No Insurance Required

Most research studies do not require insurance. In fact, many studies offer a per-visit stipend for travel reimbursements and reasonable expenses.

Research Hero

As a participant, you provide scientists with important data used to improve treatment options and expand our knowledge of human health and wellbeing.

Frequently Asked Questions

What are clinical research trials?

Clinical studies are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases and conditions, such as clinical trials, which are evaluating the effects of a biomedical or behavioral intervention on health outcomes. There are strict rules for clinical trials, which are monitored by the National Institutes of Health for the trials it funds, and the U.S. Food and Drug Administration more broadly. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.

Will I be compensated?

STAT Research may compensate study participants for their time, travel, and, in some instances, for the inconvenience of a procedure. Study compensation is by study and set for each completed visit in the informed consent file. Payment is typically done at the completion of the visit, or in some cases such as direct deposit, in two-three banking days.

What is a Placebo?

Placebos are inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.

Are there risks involved in participating in clinical research?

Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in the research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.

Why should I participate?

The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.

What are Phase I, Phase II, Phase III, and IV studies?

Phase 1 – The phase 1 study is used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. STAT Research does not currently conduct any Phase 1 trials.

Phase 2 – The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.

Phase 3 – The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.

Phase 4 – A phase 4 study is often called a post-marketing study. This means the study drug is already FDA approved and marketed, but the sponsor is looking into additional aspects of the drug, such as use in other indications, dosages, routes, or to build a long-term safety profile.

What safeguards are there to protect participants in clinical research?

The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:

» The Independent Review Process

» Informed Consent Procedures

» Withdrawing Consent

Independent Review – All research conducted by STAT Research must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.

Informed Consent – Your participation in any Clinical Center research protocol is voluntary. For every study in which you intend to participate, you will receive a document called “Consent to Participate in a Clinical Research Study” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment.

Withdrawing Consent – At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor or specialist.