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Your safety

Clinical studies are carefully and ethically designed to protect participants from unnecessary side effects and other risks.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants.

The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

The participant's rights and safety are protected in two important ways. First, any physician awarded a research grant by a private company or the National Institutes of Health must obtain approval from an Institutional Review Board (IRB) before conducting the study. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical, protects participants’ rights and does not present undue or unnecessary risk to the participant. Consequently, every clinical trial at Washington University must be approved and monitored by the Washington University IRB. Each ICTS Institution must also receive approval and be monitored by their IRB of record.

Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a participant in the study. The informed consent tells participants that they have a right to leave the study at any time.

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