What Are Clinical Studies?
Clinical studies are medical research studies in which people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.

Our database of clinical studies being conducted by the National Institutes of Health at the Clinical Center in Bethesda, Maryland is accessible at Search the Studies. If you have any questions about participating in a clinical study here, please contact the Patient Recruitment and Public Liaison Office at: 1-800-411-1222, TTY 1-866-411-1010.

What Are the Costs?
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.

Why Participate?

• 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, periodically reviews the Clinical Center hospital to see if stringent standards, leading to Joint Commission 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.

Who Participates?
People who take part in Clinical Center studies include:

Children and adults wishing to improve their own health. They may be patients with newly diagnosed medical problems. They may have had the problems over a period of time, or they may have a family history of a certain disease.

Healthy volunteers who seek to advance knowledge about causes, progress, and treatment of disease also can participate in clinical research. They provide important medical information to researchers by helping them compare how healthy people differ medically from those who have a specific disease.

To participate, patients and healthy volunteers must meet certain requirements, which are different for each study.

Information for Healthy Volunteers
There are about 300 studies available to healthy volunteers. You can find information on these studies at Search the Studies. (To search for studies accepting healthy volunteers, type in the keywords: 'healthy' and 'normal'.)

Will I be compensated as a healthy volunteer? Yes. NIH compensates volunteers for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the volunteer's time; the study's principal investigator determines inconvenience rates.

How can I volunteer? One way to volunteer is to join the registry for the Clinical Research Volunteer Program (CRVP). The CRVP, created in 1995, is a resource that helps match potential research volunteers to clinical research studies at the NIH Clinical Center. To participate in the registry, we'll ask you to provide some basic information and give us permission to share that information with the research teams. If you are a potential match to a study's requirements, the study team will contact you.

How do I enroll myself or my child? You can contact us at 301-496-4763. Parents or guardians must call to register anyone under 18 years of age.

What Are the Main Types of Studies?
There are four types of drug studies:

Phase 1 studies test a potential new drug with a small number of volunteers for best dosage and potential side effects.

Phase 2 studies test a drug with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body uses the drug, and how the drug helps the condition.

Phase 3 and 4 studies compare the new drug with a commonly used drug.

Other research may provide only indirect benefit to the patient by giving researchers information that may be an important first step toward developing a treatment. For example, research may show how a disease progresses or how it affects others systems in the body.

Patients can take part in clinical studies covering a wide range of medical diseases, conditions, and rare disorders affecting both children and adults, including those relating to AIDS, aging, alcohol abuse and alcoholism, allergy, cancer, digestive and kidney problems, diabetes, eye disorders, infectious diseases, genetics, mental health, neurological disorders, stroke, and others. There is an online database of current studies.

Making the Decision
It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Clinical Center staff. Be sure you know the answers to the following questions before you make your decision:

• What is the purpose of the study?
• What is required of me?
• What is my role in the study -- am I a healthy volunteer or a patient volunteer?
• Will the study directly benefit me?
• Will the study benefit others?
• Are there risks? If so, what are they and what are the chances that they will occur?
• What discomforts are involved?
• What is the total time involved?
• Are there other inconveniences?
• Have I discussed participation in the study with those who are important to me, such as family and friends?
• Do I wish to participate in this study?

Patients and volunteers become partners in a special relationship with members of the research team who are searching for better ways to understand and treat disease. Their participation is critical for improving health today and in future generations. Please call us at 1-800-411-1222, or e-mail us at prpl@mail.cc.nih.gov with any questions about how you or someone you know might participate.