Informed Consent In Clinical Trials

Informed consent is the process of a prospective participant learning the details of a clinical trial when deciding whether to participate. The process begins when the prospective participant first learns of the study, and continues throughout the study so that participants can determine if they wish to continue. Typically, the process takes the form of researchers explaining the study's details in a way that the participant can understand. Researchers are also obligated to inform prospective participants of their rights and options in regard to the study. Researchers must explain alternative options to participating to the study, and they must give potential subjects information on alternative therapies and medication (1, 2).

A key component of informed consent in clinical trials is the informed consent document, which must be signed by the participant before he or she can participate in the study. This document includes such information as the study's purpose, duration, possible risks and benefits, procedures, information on compensation, and key contacts (3). This document does not constitute a contract, and the participant may still leave the trial at any time (1). Participants have the opportunity to ask questions and raise concerns before, during, and after the trial. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session (2).

  1. "A Guide to Understanding Informed Consent." From ClinicalTrials.gov, by the U.S. National Institute of Health. Available: http://clinicaltrials.gov/ct/info/whatis (Accessed July 16, 2007).
  2. A Guide to Understanding Informed Consent. From the National Cancer Institute. Available: http://www.cancer.gov/ClinicalTrials/AGuidetoUnderstandingInformedConsent/page2 (Accessed July 16, 2007).

 

 

 

 

 
- A - B - C - D - E - F - G - H - I - L - M - N - O - P - Q - R - S - T - V - W - X