Clinical Research Frequently Asked Questions

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 involved in participating in a clinical trial?

Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks  research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.

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.

Will I be Compensated?

Often, study participants are compensated for their time and, in some instances, for the inconvenience of a procedure. Compensation rates are calculated by the review board and take into consideration such things as time spent, inconvenience, transportation, etc. Compensation for participation will commensurate with the time and intensity of the procedures that the participant is asked to commit. When assessing the risk-benefit ratio, the review board does not consider payment a benefit to offset the research risk. This is because payment is not to be considered a benefit but rather a recruitment incentive. If there is a completion bonus for participation, it will be reasonable and not set to coerce participants to stay in the study when they would otherwise have withdrawn. Compensation varies from trial to trial and is outlined in the informed consent. Compensation occurs once the informed consent is signed.

Participate in a Clinical Research Trial

The success of clinical trials rests in part on finding the right people to participate in them. Every study has different eligibility requirements, which could include age, gender, treatment history, and stage of disease. If you are interested in enrolling or learning more about participating in a clinical trial please contact Delta Waves at 719-262-9283 or complete the form below and the research team at Delta Waves will contact you.

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5835 Lehman Drive Colorado Springs, CO 80918 719-262-9283