Patient Safety
Patient Safety
In clinical trials, patient safety is of the utmost importance. There are several ways that patient safety is enforced in clinical trials:
Institutional Review Board (IRB)
Before a clinical trial can begin, it must be reviewed and approved by an independent committee that is responsible for ensuring the rights and welfare of study participants. The IRB reviews the study protocol and informed consent documents to ensure that the risks to participants are minimized and that the potential benefits outweigh the risks.
Informed Consent
Informed consent is a process in which researchers explain the details, in a private setting, the clinical trial to potential participants, including any potential risks and benefits. Participants are then given the opportunity to ask questions and decide whether or not they want to participate in the trial.
Data and Safety Monitoring Board (DSMB)
A DSMB is an independent group of experts that reviews the data from a clinical trial on an ongoing basis to ensure the safety of the participants. The DSMB has the authority to stop the trial if they find that it is no longer ethical to continue.
Adverse Event Reporting
Researchers are required to report any adverse events that occur during a clinical trial to the IRB and the DSMB. Adverse events are any negative or unintended effects that occur as a result of the study treatment. Adverse event reporting can help participants make informed decisions about whether or not to continue participating in the study.
