What is your protection of a research subject?
How are clinical research trial participants/volunteers protected?
There are several procedures in place, as part of the protocols, to protect
the safety of the people who participate. Two groups that oversee the safety
- The organization sponsoring a trial also monitors the safety of
volunteers. Depending on the type of sponsor, there may be a monitoring board
or a monitor that reviews all study records.
- The MetroHealth System's Institutional Review Board (IRB). The IRB includes
physicians, other health care providers, consumers, and community members who
do not have any personal interest in the results of the trial. As neutral
reviewers, they try to ensure that the trial is conducted fairly and that
participants are not likely to be harmed. All clinical trials require approval
from the IRB before the trial may begin. The IRB reviews clinical trials on no
less than an annual basis and conducts thorough, random audits to insure that
patient's rights are being protected.