How are the rights and safety of research participants protected?
There are ethical and legal standards that apply to clinical research, just as there are in other aspects of healthcare. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is the Institutional Review Board (IRB). Every clinical trial in the U.S. 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 that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, ensure that an IRB initially approves and periodically reviews the research.
