Informed consent is the process by which patients agree to undergo a specific medical treatment after the study details are communicated to them by the physician.
Legally (and ethically), patients must be given enough information to be fully informed before deciding to consent, which must be documented in writing. For more reading on Informed Consent, visit www.centerwatch.com for further details.
Individuals who participate in clinical trials are protected by an Institute Review Board (IRB). The IRB is set in place to protect the rights, safety, and wellbeing of human clinical research participants.
It is the duty of the IRB to approve, monitor, and review all aspects of clinical research being conducted at healthcare facilities.