Research participants come from all walks of life. Each individual who volunteers has their reason for doing so. Reasons include helping others, wanting to learn more about their condition, obtaining investigational treatments, or just wanting to help advance science. Washington University is grateful to the many individuals who have agreed to participate in its studies.
If you have questions about a research study that you are currently in at Washington University, please contact us at 314-747-6800 or 1-800-438-0445.
Research is defined as “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d)) Institutional Review Boards review research that involves living persons or their private identifiable information.
Research with humans is governed by a set of regulations put forth by the federal government. The two most common regulations used are those from the Department of Health and Human Resources (DHHS) and the Food and Drug Administration (FDA). These regulations provide the parameters under which a study must be designed, reviewed, and approved before any person may be enrolled or any information may be accessed.
Research that uses, accesses, creates, or stores private identifiable information is further governed under the Health Information Privacy and Portability Act (HIPAA).
Individuals who agree to participate in a research study are known as research participants or participants.
Clinical trials are governed by the Food and Drug Administration regulations and may involve drugs, devices, food substances, or a medicinal preparation created by a biological process.
A clinical investigation defined as any experiment that involves a test article (i.e., drug, device, food substance, or biologic) and one or more human participants that either is subject to requirements for prior submission to the FDA (IND, IDE requirements), or not subject to these requirements, but the results will be submitted later to the FDA or held for inspection by the FDA as part of an application for research or marketing permit. (21 CFR 50.3(c), 21 CFR 56.102(c))
Clinical trials can occur in a variety of settings such as a medical office, a community clinic, or a hospital. Clinical trials must be approved by an Institutional Review Board before they can begin.
There are two types of clinical trials:
- Therapeutic: These studies will provide a direct medical benefit to the research participants.
- Non-therapeutic: These studies provide no direct medical benefit to the research participants but help the researchers learn more so that future generations may benefit.
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
An Institutional Review Board (IRB) is a committee made up of individuals who have training in scientific areas, individuals who have expertise or training in non-scientific areas, and members of the community who represent people who would volunteer to participate in research studies. An IRB provides an independent review of research studies that propose to use human subjects. The IRB is concerned with the research being conducted in an ethical manner, with protecting the rights and welfare of the human subjects, and with adherence to federal regulations, state laws, or other requirements that may govern how research is conducted.
History of Institutional Review Board
Institutional Review Boards (IRB) began in 1974 when the National Research Act was signed into law, the Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with identifying the basic ethical principles that underlie the conduct of Biomedical and Behavioral research and to develop guidelines for research involving human subjects.
Washington University Institutional Review Board
The WU Institutional Review Board (IRB) is made up of individuals who are committed to protecting the rights, safety and welfare of research participants. Our committee members include physicians, non-physician scientists, researchers, clinicians, nurses, pharmacists, occupational therapists, physical therapists (among other members of the medical community), lawyers, clergy, and lay people from the St. Louis community and surrounding region.
Instructions on how to withdraw from a research study.
The Radiation Fact Sheet provides information that may help you to decide whether or not you wish to participate in a research study that involves radiation exposure.
Content current as of 10/5/2022