What is a Clinical Study and Why Should I Participate?
Clinical trials are voluntary research studies conducted in people. Patient participation helps researchers to find better ways to treat, prevent and/or detect disease. The aim is to answer specific questions about the safety or effectiveness of drugs, vaccines, medical devices, surgical procedures or new ways of using existing treatments.
Every study has a protocol, or action plan, for the trial. It describes how the study will be conducted, what will be done, and why each part of the study is needed. Each study has its own rules about who can take part. Some studies need participants with a specific medical condition. Some need healthy volunteers. Others want just men or just women, or people in a certain age range.
All clinical trials done at RUHS are reviewed, approved and monitored by an Institutional Review Board (IRB). It is an independent committee whose members include physicians and community representatives. The IRB:
- Ensures the study is ethical
- Protects the rights, welfare and safety of the participants
- Makes sure the study’s risks are reasonable compared to the potential benefits
In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or if it is funded or carried out by the federal government.
The FDA provides oversight for clinical trials that use FDA regulated products, such as drugs and medical devices.
For more information about clinical studies at RUHS, please contact us CECORC@ruhealth.org.
Research Resources for Patients
Recursos de Investigación para Pacientes