What are the risks of participating in a clinical trial?
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment • The experimental treatment may not be effective for you • The protocol may require more of your time and attention than would a non-protocol treatment, including trips to the trial site, more treatments, hospital stays or complex dosage requirements 12. How is my safety protected? The same ethical and legal codes that apply to doctors also apply to clinical trials. In addition, most clinical research is regulated by governments, with built in safeguards to protect the participants. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures a clinical trial is ethical and the rights of participants are protected. Many countries have similar revie
