In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review boards (IRBs) better understand and comply with the new 21 CFR § 50.25(c) informed consent requirement, which calls for the inclusion of “a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.”
Sponsors and investigators must determine whether or not a trial is applicable, which FDA describes as including “controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).”
For applicable trials initiated on or after March 7th, 2012 informed consents (ICs) must now include the following statement: “A description of this clinical trial will be available on 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 more information about clinical trial compliance or for help with consent forms, protocol review, or any other IRB services, contact PearlIRB.