Thank you for your interest in clinical studies at Washington University School of Medicine and ICTS Affiliated Institutions. Participating in a clinical study is a rare opportunity to make a great contribution to humanity. Information scientists gain through medical research helps to improve medical care for everyone.
What is a clinical study?
A clinical study, also called a clinical trial, is an organized experiment performed on human participants to answer a specific scientific question. Clinical studies are conducted to determine the best way to treat, diagnose or prevent a disease. A clinical study could test the effectiveness of a new drug or medical device such as an artificial hip, see how well a new medical test or surgical technique works, study feelings or behaviors, or simply gather other types of information.
The purpose of a clinical study is to answer questions about safety and effectiveness. They help scientists determine whether we are using the best treatments or to help the U.S. Food and Drug Administration (FDA) determine whether or not to approve a treatment for general use. The information scientists learn from clinical studies helps to improve the medical care for future patients.
All medical advances come about through research. By participating in a clinical study, study participants make a great contribution to humanity by helping researchers understand how to improve the diagnosis, treatment or prevention of medical conditions.
Besides making a difference in the future of medical care, research participants may benefit in other ways:
- They may receive experimental drugs or devices not widely available
- They may be compensated for time and effort
- They may receive research related medical care at no cost
- They may be able to take a more active role in their own health care
Many people volunteer for participation in clinical studies because they are survivors of a disease such as cancer, and want to do all they can to prevent other people from getting the same disease. Others simply want to contribute to research efforts that may help others in the future.
How to Register
The first step to becoming a study participant is to become a member of the Research Participant Registry (RPR). Click the Register Now on this page to complete the 10-minute online registration process, which includes:
1) Registration (name, email, date of birth)
2) General Health Questionnaire (link via email)
Before you begin, we will ask you to provide your consent for the RPR to store your personal information and for it to be used by various study staff. RPR staff members check the RPR regularly to look for potential matches — participants who fit the needs of a particular study. You will receive emails with study information. Please note that it may be someone from WU or someone from one of the ICTS Institutions that contacts you.
We may forward your contact information to the study coordinator. The coordinator is the person who handles participant recruitment and other administrative aspects of running a clinical study. The coordinator reviews your information and, depending on many factors, may or may not contact you to talk about your interest and eligibility.
Membership in the RPR does not obligate you to participate in any study; you can always say no. You may contact us to remove or modify your RPR information at any time. All of the information you provide in the RPR will be kept completely confidential, in compliance with federal law and Washington University policies. Any contact information shared with an ICTS Institution will be provided in a password-protected document.
Clinical studies are carefully and ethically designed to protect participants from unnecessary side effects and other risks.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participant’s names will remain secret and will not be mentioned in these reports.
The participant’s rights and safety are protected in two important ways. First, any physician awarded a research grant by a private company or the National Institutes of Health must obtain approval from an Institutional Review Board (IRB) before conducting the study. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensure that a clinical trial is ethical, protects participant’s rights and does not present undue or unnecessary risk to the participant. Consequently, every clinical trial at Washington University must be approved and monitored by the Washington University IRB. Each ICTS Institution must also receive approval and be monitored by their IRB of record.
Second, anyone participating in a clinical trial in the United States is required to sign an “informed consent” form. This form details the nature of the study, the risks involved, and what may happen to a participant in the study. The informed consent tells participants that they have a right to leave the study at any time.
Your personal health information is kept in the strictest confidence. It will only be seen by Research Participant Registry (RPR) staff and relevant study staff. All of the individuals who have access to your personal health information will be fully trained to comply with federal health privacy laws — namely, the Health Insurance Portability and Accountability Act (HIPAA) — and in human subjects protection practices. They will maintain the utmost protection, security and confidentiality. Your personal health information will be shared with no one else.