The rule—21 C.F.R. § 50.25 in Section 801 of the FDA Amendments Act of 2007 (FDAAA)—was effective March 7, but the compliance date is exactly one year later for trials initiated on or after the compliance date. That means the FDA intends to enforce the rule only for informed consent documents and processes for clinical investigations begun on or after March 7, 2012. Trials begun prior to that date will not be required to modify their consent process or to re-consent subjects.
“The reference to the databank web site allows participants to ascertain the nature, scope and progress of a registered applicable clinical trial, thus reassuring the participant that participation in a trial contributes to the advancement of medical knowledge, an important benefit in the full disclosure of risks and benefits,” the FDA wrote in its final regulation.
The new rule requires sponsors to include this exact wording in their consent paperwork: “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.”
It amends 21 C.F.R. § 50.25 and the requirements for informed consent documentation and process in FDA-regulated clinical trials of drugs, biological products and medical devices, in an effort to increase transparency.
The regulation states, “Alerting potential clinical trial participants to the existence of a publicly accessible databank, whether in the informed consent or during the process, can reassure them that a transparent system exists to help ensure greater accountability and responsibility of investigators.”
What will this mean for sponsors, CROs and sites? Liz Wool, president and CEO of QD-Quality and Training Solutions and a board of trustees member of the Association of Clinical Research Professionals, said the new regulation will require initial training and reaching out to sites.
“Sponsors and CROs immediately need to modify their informed consent templates and their informed consent review check lists, train study managers and CRAs to the new requirements and implement a plan of communication with the sites to ensure compliance, connecting with them on how they will revise their informed-consent process,” said Wool. “Then follow up with central IRBs—if they use them—to see what they’re doing to update the standard language in their template.”
But beyond that, Wool said the change is not a big deal, nor is it controversial, and the industry has known it was coming since last year. Mark Lacy, founder and CEO of Austin, Texas-based site group Benchmark Research, agreed.
“Many IRBs already include a similar statement in their ICF’s, and I believe this has already been a requirement for federally-funded research,” he said. “The only additional training coordinators might need is to familiarize themselves with the web site. It’s really that simple.”
Though many sponsors and IRBs already include a reference to ClinicalTrials.gov in their informed consent forms, now everyone will be required to. Wool said potential subjects may find it comforting.
“It’s very compelling to the consumer,” she said, “that a summary of the trial’s results will eventually be available.”