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FDA's New Rule on Clinical Trial Consent to Take Effect in March

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration will require that informed consent documents used in clinical trials of drugs, biologics, and medical devices include a statement letting participants know that information from the trials will be entered into a databank.

The new rule, which will take effect in March, will mean that those conducting applicable clinical trials must include a section in their consent forms that explains that de-identified data from the trials will be included in the National Library of Medicine's clinical trial registry databank.

FDA drafted the rule — after it had engaged in a public comment phase and tweaking the final language — to comply with the Food and Drug Administration Amendments Act of 2007 (FDAAA), which created the NLM registry.

After a number of comments suggested that FDA's language in the proposed rule was complex, ambiguous, and too difficult for some people to understand, the agency worked to simplify it and to use common terms, such as using "Web site" instead of "databank."

The rule that will go into effect in two months will read: "A description of this clinical trial will be available on, 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 broad aim of this amendment to the FDAAA was to "promote transparency of clinical research to participants and patients," FDA said today in a notice in the Federal Register.

FDA claims that the rule will enhance transparency in clinical trials by increasing participants' awareness of the clinical trials databank and the kind of information that it contains. The clinical trials bank is supposed to "create a system of checks and balances" for patients, participants, and physicians to use to find out information about a trial, FDA said. The bank also is supposed to provide more accountability regarding "outcomes and adverse events, thereby raising confidence in the validity of the research process," the agency said in the notice.

"Last of all, [the databank] would encourage physicians and patients to obtain more information in order to make more educated treatment decisions," FDA continued.

The American Clinical Research Organization's Executive Director Douglas Peddicord said in public comments that the rule will serve to "educate prospective research participants about and help ensure that investigators and sponsors submit the required information to the clinical trial registry databank."

Peddicord suggested that ACRO doubts whether the rule will raise the public's confidence in "the validity of the research process," but said the group supports the inclusion of the statement in the informed consent document.

John Lewis, ACRO's VP of public affairs, told GenomeWeb Daily News on Tuesday that all of the issues ACRO posed to FDA about the rule were addressed and that the organization was "pretty pleased with the final rule."

"There's a need to simplify informed consent to the extent you can and still provide useful information, and I think they did a good job in this case," Lewis said.

But he also said that ACRO does not view this facet of consent development as "a major issue" and that they are not certain that participant distrust in the research community and the government is as much of an impediment as the FDA may think.

"There is always a concern or at least an awareness about protecting privacy and protecting your own health information and clinical trial participation information. On the other hand, there's a lot of data out there that shows that people who participate in clinical trials are very willing to share information and are doing it for the betterment of science and for the betterment of the people who will eventually use the treatments," he said.

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