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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 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.
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.
We may compensate study participants for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant’s time. The study’s principal investigator determines inconvenience rates.
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 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.
The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
- The Protocol Review Process
- Informed Consent Procedures
- The Patient Representative
- The Patient Bill of Rights
Protocol review: As in any medical research facility, all new protocols produced 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. 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 your doctor.
Patient representative: The Patient Representative acts as a link between the patient and the clinic. The Patient Representative makes every effort to assure that patients are informed of their rights and responsibilities, and that they understand what the Clinical Center is, what it can offer, and how it operates. We realize that this setting is unique and may generate questions about the patient’s role in the research process. As in any large and complex system, communication can be a problem and misunderstandings can occur. If any patient has an unanswered question or feels there is a problem they would like to discuss, they can call the Patient Representative.
Bill of Rights: Finally, whether you are a clinical research or a patient volunteer subject, you are protected by the Clinical Center Patients’ Bill of Rights. The bill of rights concerns the care you receive, privacy, confidentiality, and access to medical records.