What Are Clinical Research Trials?
Clinical research trials are the heart of medical breakthroughs. Research trials provide critical information about a medicine’s safety and effectiveness, and generate in-depth data that can even lead to the creation of other innovative treatments. Clinical trials are the heart of all medical advances; they look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
Why Should I Participate?
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies cannot be accomplished.
Are there risks in participating?
As in routine medical care and activities of daily living, there are risks are involved in clinical research. The specific risks associated with each research protocol are described in detail in the consent documents, and will be will be explained to you by a member of the research team. They will also answer any questions you might have about the study. Most clinical studies pose risks of minor discomfort, lasting only a short time.
Are there safeguards to protect participants?
There are several safeguards to protect the safety and rights of volunteer participants. Delta Waves takes every precaution to insure the safety of our volunteers. Including the following:
Protocol Review. Protocols for clinical trials must be approved by the institutional review board (IRB). The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, and acts as the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
Informed Consent. Your participation in clinical research is voluntary. For every study in which you intend to participate, you will receive and informed consent document that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of your primary doctor.