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Protecting Participants in Clinical Trials
A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.
Monitoring NCI-Sponsored Clinical Trials
Protections for patients in cancer studies come into play at various times before and during a clinical trial. Before a trial can start enrolling patients, for example, it must be approved by an Institutional Review Board (IRB), located at the hospital or other site where the study will be conducted.
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What Are IRBs?
An Institutional Review Board functions as both a clinical trials clearinghouse and monitor -- in other words, it must give approval before any clinical trial can begin, and then keep close tabs on the progress of the research. Most institutions that carry out clinical trials have their own IRBs; in fact, there are roughly 3,000 of them in the U.S. In selected cases, a small research institution might arrange for their research to be reviewed by another IRB, rather than setting up their own.
While the specific make-up of an IRB varies from place to place, it always includes people who are qualified to evaluate new and ongoing clinical trials on the basis of scientific, legal, and ethical merit. Federal regulations require that an IRB include at least five people of diverse occupations and backgrounds; for instance, an IRB could not be made up of five physicians or five nurses. At least one member must have primarily scientific interests, and another member must have primarily non-scientific interests.
In addition, one member must be an institution outsider, not connected by a job or relatives to the institution. To meet these requirements, IRBs usually are made up of a mix of medical specialists, ethicists, and patient advocates.
If the trial you are considering is federally funded or is evaluating a new drug or medical device regulated by the FDA, then it is definitely subject to review by an IRB. However, many institutions also require that all clinical trials conducted there be approved and reviewed by the IRB.
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