How Do Review Groups Protect
Participants?
Clinical trials have several
procedures to protect the safety of the people who join the
study. Several groups have to approve the protocol for every
study. Two of those groups are the sponsor of the study (for
example, the National Cancer Institute) and the Institutional
Review Board (IRB).
Every study center has an
IRB, which includes doctors, other health care providers, consumers,
and sometimes members of the clergy who do not have any personal
interest in the results of the study which would bias them.
They serve as neutral reviewers and ensure that the study is
managed fairly and that no one is likely to be harmed who may
decide to join. Each Phase III cancer prevention study also
has a special group called a Data Safety and Monitoring Committee
that looks at the test results and monitors the safety of the
participants, and decides whether the study should go forward
as originally planned.
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National Cancer Institute
April 1999
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