Consent Requirements: FAQs
The final rule revises the current informed consent regulations to require a new element for informed consent documents and processes that will inform potential participants that information about the research has been, or will be, entered into a databank that is publicly accessible at http://www.ClinicalTrials.gov. The statement is as follows:
“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 citation for the new regulation is: 21 CFR 50.25(c).
The final rule was published on Tuesday, January 4, 2011. The effective date is March 7, 2011 and the compliance date is one year from that date: March 7, 2012. Quorum updated its related procedures by the effective date, March 7, 2011.
This requirement only applies to studies that are required to be listed on the website http://www.ClinicalTrials.gov. The sponsor will make the determination as to whether a particular research study must be listed on the website.
No, the new statement will only be applied to consent forms for studies that must be listed on the website http://www.ClinicalTrials.gov. The statement will be included verbatim in new consent forms that are developed after Quorum’s procedures changed by March 7, 2011. Older consent forms can be revised to include this statement verbatim if the sponsor would like to revise them, but Quorum will not proactively revise existing consent forms as this is not required.