In the context of clinical trials, what is informed consent and why is it important?
Researchers obtain informed consent by telling prospective research participants about the nature of a particular clinical trial. This typically involves one or more conversations between the research participant (the patient) and the principal investigator (the leader of the research team), research nurses or assistants, and the patient’s doctor. It also includes a review of the written consent form with the patient. This communication is essential to protect the rights and ensure the safety and privacy of potential research participants. Q: What information does the patient receive before giving informed consent? A: The information includes a clear statement that the intervention being tested is for research purposes and an explanation of the type of treatment, potential risks and benefits (if any), available treatment alternatives, and the right to withdraw from participation in the study at any time without penalty. Other topics include potential costs, protection of privacy, and w