Informed Consent (cont.)
Clinical Trials and Research
Clinical research trials, or studies, are an important part of health care research. They are one of the most important means available to advance the quality of medical care. Clinical studies are often used to determine whether new drugs, procedures, or treatments are safer or more effective than drugs or treatments currently being used.
- Enrollment in a clinical study often gives you the opportunity to receive a new drug or treatment before it is widely available. The trade-off is that you may be exposed to risks of the drug or treatment that are not known at the time of the study.
- In most studies, there is a control group that receives what is considered the current standard of care or best treatment available. One or more experimental groups receive the new treatment.
- There is usually no cost associated with participation in a study. In some cases participants may receive payment, medications, tests, or follow-up care at no cost.
- Informed consent is needed before you may be enrolled in clinical research trials. The purpose of informed consent in this setting is to allow you to learn enough about the study to decide whether or not to participate. Informed consent for a research study (clinical trial) should include the following information:
- Why the research is being done
- What the researchers hope to accomplish
- A description of what will be done during the study and how long you are expected to participate
- The risks to you from participation in the study
- The benefits that you can expect from participation in the study
- Other treatments that are available if you decide not to participate in the study
- Verification that you have the right to leave the study at any time, and that standard medical care will be provided without penalty if you choose to withdraw from the study
- Although an informed consent document must be signed before enrollment in a study, it is important to remember that informed consent is a process that continues throughout the study. You may ask questions of the health care providers at any time before, during, or after the study. Because deciding whether to participate in a clinical study is an important decision, it is often helpful to discuss the study and the informed consent documents with family members or friends before deciding whether to participate.
Richard A Wagner, MD, PhD
Francisco Talavera, PharmD, PhD
Jeter (Jay) Pritchard Taylor III, MD
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