Clinical Trials Basics
What Are the Costs?
Adapted from the National Institutes of Health Clinical Center.
The Clinical Center does not charge patients for participation and treatment in clinical studies at NIH. In addition, in certain emergency circumstances, you may qualify for help with travel and other expenses.
- Patients taking part in NIH Clinical Center studies are seen by a team of expert doctors, dentists, nurses, technicians, and support staff.
- Clinical Center patients often are first to receive promising new treatments before they become available in the community.
- Patients are helping others with the same disease, both today and in the future.
Risks and Benefits
It is important to understand that some risks are involved in clinical research, just 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 against possible benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge developed may help others.
Dealing with Fears
Many protections and safeguards for volunteer patients are built into the Clinical Research process. It may help alleviate some of your fears about participating in a clinical study to know what some of these are:
The Patient Bill of Rights. All patients who take part in studies at the Clinical Center are protected by the Patient Bill of Rights, developed by the American Hospital Association for use in hospitals across the country. The Patients' Bill of Rights contains guidelines to ensure privacy and confidentiality of patients and their medical records.
Hospital Accreditation. As in any medical research facility, an institutional review board (IRB) must review and approve every new study at NIH before the study can begin. The IRB is made up of medical specialists, statisticians, nurses, social workers, medical ethicists, and members of the community. The IRB reviews protocols to ensure patient safety. In addition, The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), periodically reviews the Clinical Center hospital to see if stringent standards, leading to JCAHO accreditation, have been met.
Informed Consent. Before entering a Clinical Center study, it is important that you as the patient fully understand the study and what your involvement would mean. Clinical Center staff members will help by providing you with an informed consent statement, which has detailed information about the study, including the length of the study, the number of visits required, and medical procedures and medications included. It also provides expected outcomes, potential benefits, and possible risks.
Clinical Center staff will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement and talking with staff and family members, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to participate voluntarily.
Reviewed by Francine Kaufman, MD. 4/08