In February 2012, the FDA released a Guidance document to assist IRBs, Investigators, and Sponsors with understanding and implementing the informed consent requirement found at 21 CFR 50.25(c), which states the following language must be included in consent documents for applicable studies initiated on or after March 7, 2012:
“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.”
This Guidance provides further explanation of the final regulation which was published by the FDA on January 4, 2011. The Guidance is intended to assist small businesses to better understand the consent requirements.
The required compliance date for this regulation is March 7, 2012. Last year, Quorum Review implemented these changes prior to the effective date of March 7, 2011. The guidance is available on the FDA’s website at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf.
Additional questions and responses regarding the regulatory change and Quorum Review’s processes are provided below:
Q: What is required by this regulatory change?
A: The final rule revises the current informed consent regulations to require a new element for informed consent documents and processes. This language informs potential participants that information about the research has been, or will be, entered into a publicly accessible databank 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.”
Q: When did this change happen and how does it impact Quorum’s procedures?
A: The final rule was published on January 4, 2011. The effective date was March 7, 2011 and the compliance date is one year from that date, March 7, 2012. Quorum Review updated its procedures last year before the effective date, March 7, 2011.
Q: What studies will this change apply to?
A: This requirement only applies to studies required to be listed on the website http://www.ClinicalTrials.gov. These are considered “applicable clinical trials”. As indicated in the Guidance, “’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 United States, involved a drug, biologic or device that is manufactured in the U.S….or is conducted under an…IND or…IDE.” It is important to note that trial sponsors and investigators have the responsibility of determining whether a trial is an “applicable clinical trial.” Quorum Review will rely on the assessment of the sponsor as to whether a particular study is an “applicable clinical trial” and requires the above-referenced language in its consent documents.
Q: Will this be applied to all consent forms?
A: No, the new statement will only be applied to consent forms for “applicable clinical trials”. The statement has been included in new consent forms developed after Quorum Review’s procedures were changed before the effective date of March 7, 2011. Older consent forms can be revised to include this statement if the sponsor would like to revise them; however, Quorum Review will not retroactively revise existing consent forms, as this is not required.
