News and Announcements

FDA Adds to Informed Consent Form

FDA has added to its regulations 21 CFR 50.25 (c) a new required element in the informed consent form. Beginning March 7, 2012, informed consents for all FDA regulated studies must incorporate the following statement verbatim:

“A description of this clinical trial will be available on http://www.clinicaltrials.gov/ as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

For your convenience, Spanish translation of this statement is as follows:

“Según lo exigen las leyes estadounidenses, una descripción de este ensayo clínico se encontrará disponible en http://www.clinicaltrials.gov/ Este sitio Web no incluye información que lo pueda identificar a usted. A lo sumo, el sitio Web incluirá un resumen de los resultados. Usted puede buscar en este sitio Web en cualquier momento”.