Clinical Trial Risks and Safety Measures: What is Involved?

Clinical trials are an important (and sometimes the only) way to test a new
medication or treatment. However, participants must be aware of the risks and
safety measures steps during a clinical trial.
Possible risks include:

• Participants may experience unpleasant, serious, or even life-threatening
  side effects of the drug or treatment being studied.
  
• The treatment may not work.
  
• The requirements of the study may be more than the participant thought. Every
  clinical trial has a protocol, which is the plan on which the entire study is
  based. The protocol describes exactly what the participants must do during the
  trial such as how often they need to see the research staff, how much of the
  drug they need to take, what other procedures they must follow, and how long
  the trial will last. Sometimes, particularly for participants who are not in
  good health, these activities take up a good deal of time and attention.

• All clinical trials that involve human participants in the United States are
  approved and monitored by an Institutional Review Board (IRB). This is a group
  of doctors, researchers, community advocates, and others who ensure the ethical
  nature of the trial and make sure that the rights of the study participants
  are protected.
  
• The IRB reviews all study-related documents such as the protocol, participant
  recruitment announcements, and consent forms.