When we conduct a clinical trial at Overlake Medical Center protecting the well being of our patients is our first concern. Our patients are always our top priority.
Clinical trials follow strict scientific guidelines and ethical principles. A researcher must prepare a written document called a “protocol.” This explains and details the treatment plan, rationale, the number of patients who will be enrolled in the study, as well as the examinations and tests the patient will receive, and how often. The sponsoring institution or clinical cooperative group that coordinates the study, along with a review board and ethics committee, must approve protocols. This Institutional Review Board (IRB) includes both national and local experts. In addition to clinicians, the IRB may consist of medical consumers, other health care professionals, clergy and lay people to ensure that the research will not expose patients to extreme or unethical risks. Once a protocol has been approved, the committee must be informed of any new findings or any modifications, which also must be approved.
Today, federal regulations help ensure that clinical trials are run in an ethical manner. Participant rights and safety are protected through:
- Informed Consent: A process through which potential participants learn the purpose, risks and benefits of a clinical trial before deciding whether to participate. This process continues throughout the study.
- Confidentiality: No one should be allowed to identify you as a research volunteer unless you give permission to use your name.
- Two Review Panels: Which approve a clinical trial protocol before it begins:
– A scientific review panel.
– The IRB that oversees clinical research at the local participating institution. A federally mandated watchdog committee that oversees research facilities using human subjects.
- Monitoring: Which continues during the trial, by:
– IRBs, which monitor participant safety.
– Data and Safety Monitoring Boards for phase III trials, which perform periodic reviews of the conduct of the clinical trials and participant safety.
– Required reports to federal agencies—which oversee the conduct of the trial.