The U.S. Food and Drug Administration (FDA) has amended the regulatory requirements for obtaining informed consent for FDA-regulated products. The changes require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials must include a specific statement that clinical trial information will be entered into the ClinicalTrials databank. This databank is the clinical trial registry databank maintained by the National Library of Medicine.
Does this apply to my study?
To determine if your trial must include the statement, you must consider if it is an “applicable clinical trial” and when the trial was “initiated”. If an IRB has approved any informed consent documents for the applicable clinical trial before March 7, 2012, then the trial will be considered “initiated” prior to the compliance date. “Applicable clinical trials” generally include 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 U.S., involves a drug, biologic, or device that is manufactured in the U.S. (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE). Trial sponsors and investigators have the responsibility of determining whether or not a trial is an “applicable clinical trial.” Definitions vary for applicable device and drug trials including biologics. For help determining if your study is covered, please contact OCTRI investigator support and integration services.
These requirements also apply to applicable trials conducted outside of the U.S. and the statement must be included in any oral consent process with a waiver of the requirement to document consent. Finally, the FDA has indicated in their guidance that if an informed consent document fails to properly include the statement, then the IRB should be notified and a revised consent form containing the statement should be provided to the IRB for review and approval.
When does it go into effect?
For applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.
The required statement is that “[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.”
The OHSU consent templates are being changed to include this language. For all studies submitted on or after March 7, 2012, the new template must be used. Any study that is not considered an “applicable clinical trial” by FDA terms, but is still registering with www.ClinicalTrials.gov should include the language as well at either continuing review or by modification.
If you have any questions, please contact the IRB at 503-494-7887, option 1.