FAQs About Clinical Studies

Clinical studies are medical research studies in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of improving our understanding of disease or developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by NIH and the US Food and Drug Administration. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.

More information is available at the NIH’s Educational Resources web page.

A database of clinical studies being conducted by the NIH at the Clinical Center in Bethesda, MD, is accessible at Search the Studies. If you have any questions about participating in a clinical study here, please contact the Office of Patient Recruitment at: 1-800-411-1222, TTY 1-866-411-1010.

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. Learn more about Healthy Volunteers.

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

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.

Patients who participate in clinical studies are helping others with the same disease, both today and in the future. 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.

Without your help, the research studies at the Clinical Center cannot be accomplished.

Patients taking part in NIH Clinical Center studies are seen by a team of expert doctors, dentists, nurses, technicians, and support staff. Our patients often are the first to receive promising new treatments before they become available in the community.

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.

A volunteer subject with no known significant health problems who participates in research to test a new drug, device, or intervention is known as a "healthy volunteer" or "Clinical Research Volunteer."

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'.)

The clinical research volunteer may be a member of the community, an NIH investigator or other employee, or family members of a patient volunteer. Research procedures with these volunteers are designed to develop new knowledge, not to provide direct benefit to study participants.

Clinical research volunteers have always played a vital role in medical research.

When developing a new technique such as a blood test or imaging device, we need healthy clinical research volunteers to help us define the limits of "normal." These volunteers are recruited to serve as controls for patient groups. They are often matched to patients on such characteristics as age, sex, or family relationship. They are then given the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.

Learn more about Healthy Volunteers.

One way to become a healthy 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.

Visit the Healthy Volunteers web page to join the registry.

The NIH 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. NIH reports compensation of $600 or more to the Internal Revenue Service and sends a "Form 1099-Other Income" to the participant at the end of the year.

Please be aware that, under US law, some or all of that compensation may be garnished by the US Treasury if the participant has outstanding debts to the federal or state government. The NIH does not have any way of knowing if a volunteer has an outstanding debt to the government and is not told when the US Treasury garnishes compensation. The US Treasury will notify the payee directly in this circumstance.

NIH may also compensate healthy 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.

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.

• Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
• Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
• Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
• Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

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.

Placebos are harmless, 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.

Medical research is dogged by the placebo effect - the real or apparent improvement in a patient's condition due to wishful thinking by the investigator or the patient. Medical techniques use three ways to rid clinical trials of this problem. These methods have helped discredit some previously accepted treatments and validate new ones. Methods used are the following: randomization, single-blind or double-blind studies, and the use of a placebo.

Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. In this way, the fewest number of patients receive the less beneficial treatment.

In single- or double-blind studies, the participants don't know which medicine is being used, and they can describe what happens without bias. Blind studies are designed to prevent anyone (doctors, nurses, or patients) from influencing the results. This allows scientifically accurate conclusions. In single-blind ("single-masked") studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the doctors, nurses, patients, and other health care staff are not informed. If medically necessary, however, it is always possible to find out what the patient is taking.

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.

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?

Before deciding to participate, you should carefully weigh these risks against possible benefits. Although you may not receive any direct benefit for yourself and your condition as a result of participating in research, you will know that the knowledge developed may help others.

To take part in studies at the Clinical Center, referral by a medical practitioner is preferable. However, in certain instances, self-referral may be appropriate.

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.

Many protections and safeguards for that protect the safety and rights of volunteer patients are built into the Clinical Research process. These safeguards include:

Protocol Review Process
As in any medical research facility, all new protocols produced at NIH 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 Procedures
Your participation in any Clinical Center research protocol is voluntary. Before entering a Clinical Center study, it is important that you as the patient fully understand the study and what your involvement would mean.

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. 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.

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 the doctor who referred you to NIH.

Patient Representative
The Patient Representative acts as a link between the patient and the hospital. 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.

Patient Bill of Rights
Finally, whether you are a clinical research or a patient volunteer subject, you are protected by the Clinical Center Patient Bill of Rights. This document is adapted from the one made by the American Hospital Association for use in all hospitals in the country. The bill of rights concerns the care you receive, privacy, confidentiality, and access to medical records.

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.