Clinical trials for healthy volunteers

A healthy volunteer is someone who does not have the disease or condition being studied but chooses to take part in a clinical trial.

Healthy volunteers help researchers understand how an investigational treatment may work in people without the medical condition being studied. This helps researchers compare results between people with and without a disease.

Not always. Each clinical trial has its own eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria. The research team will review your health history to see if a trial may be a good fit for you.

That depends on the trial. Activities may include, but are not limited to:

• Health screenings or physical exams
• Blood or urine tests
• Taking a study medicine
• Follow-up visits or questionnaires

The research team will explain all requirements before you decide to join.

Before a clinical trial can start, it must be approved by an Independent Ethics Committee (IEC) to make sure the risks are as low as possible and are worth any possible benefits. An IEC is a committee of doctors, data experts, community advocates, and others who help ensure that a trial is done in an ethical way and the rights of participants are protected.

Each trial follows a carefully controlled plan (protocol) that explains what researchers will do during the trial. During the trial, researchers report the results to the trial’s IEC, to medical journals, and to government agencies. If problems such as severe side effects happen during a trial, it may be stopped or paused to protect participants.

Some clinical trials offer reimbursement for travel expenses. Details vary by trial and are explained during the informed consentInformed Consent ProcessThe process of discussing and learning about the details of a study [clinical trial] before deciding whether to participate; a process in which people (participants) are given important information, including possible risks and benefits, about a study (clinical trial) to help them decide if they want to participate in the trial; People are also given any new information that might affect their decision to continue process.

Yes. You can leave a clinical trial at any time. If you decide to leave a trial, talk to the trial team first. The trial team may also ask about your reasons for leaving the trial.

You can:

• Talk with the research team
• Discuss participation with your doctor, family, or friends
• Call the Clinical Trial Information Center at 1-888-577-8839