Protecting Patients In Clinical Trials
November 19, 2008 by Jack
Obviously, participating in a clinical trial involves some degree of risk. The risk cannot be eliminated entirely—even taking well-studied medications involves a risk—but the medical community has developed several practices that are designed to protect the participants in clinical trials as much as possible.
One of these practices is informed consent. In the United States and many other countries, no one may participate in a clinical trial unless he or she is informed about it in writing. This means that doctors cannot give people experimental treatments without their knowledge or without informing them that they are participating in an experiment. The doctors must also provide as much detail as possible about the methods they will use, how long the study will last, and any risks and side effects the experimental treatment might have. The volunteers must sign documents stating that they received and understand all the relevant information.
Informed consent does not allow volunteers to know ahead of time whether they will be assigned to an experimental or control group. However, volunteers do have the right to find out which treatment they received after their part of the study is over.
Other guidelines protect volunteers from problems that might arise during the experiment.
Volunteers almost always receive all medical care relating to the study for free. This includes anything that might be required to counteract the side effects of the treatment. If a volunteer’s health becomes seriously threatened because the experimental treatment is either dangerous or ineffective, the researchers must stop the experiment and switch the affected person over to an established treatment. If a patient’s life is in danger, and the danger can be removed by a known treatment, doctors cannot substitute an experimental treatment just for the sake of a study. If, however, a new treatment proves to be far superior to existing treatments during the course of a study, the experiment may be stopped so that all the
patients can be switched over to the new treatment.
To make sure these standards are met, every clinical trial is supervised by an institutional review board (IRB). This is a
council of doctors, nurses, social workers, ethical experts, and other consultants, hired by whatever institution is running the study (usually a hospital, clinic, university, research center, or government agency). The researchers who are conducting
the study report regularly to the IRB and keep its members informed about the methods used in the study, the progress of
the experiment, the number of volunteers involved, and any problems that arise during the study. The researchers also provide statistical information about the volunteers. On the basis of the reports and the statistical information, the IRB continues an existing study, advances a study to the next phase, or stops a study at any time. The IRB also has the authority to pprove or reject a new study.
