Play by the rules

New penalties give bite to rules requiring clinical trials results to be posted on federal website

 By Laura Mize

Heads up, clinical trial investigators: New penalties implemented in March by the U.S. Food and Drug Administration could mean big bucks for violating regulations on releasing results to the public.

Since 2007, federal regulations have been in place requiring researchers to post online the results of certain types of trials involving human subjects. Within one year of an applicable study’s completion, results must be posted on clinicaltrials.gov, a website run by the National Institutes of Health that houses the registry and database of all clinical trials conducted in the United States. The regulations also require timely corrections be made to the record and updates posted every six months with new or changed information.

Trials that fall under the purview of these regulations include studies on drugs or devices approved by the FDA. Under current law, Phase 1 and observational studies are excluded from the requirements. But the International Committee of Medical Journal Editors requires researchers to follow the federal guidelines in order for their work to be published in journals represented by the ICMJE, even if the studies don’t fall into the applicable categories.

Many researchers have not been complying, however, moving regulators to up the ante. Now scientists who don’t follow the rules may face fines and the withholding of NIH funding.

“It has gotten everyone’s attention,” said Anthe Hoffman, assistant director of sponsored research in the College of Medicine. “There may be fines up to $10,000 a day, per occurrence, which could be a huge fiscal responsibility.”

The UF Division of Sponsored Research is responsible for assisting UF researchers with registering their trials and ensuring study results are posted properly on the website. Jon Shuster, Ph.D., a statistician and director of the CTSI Research Design and Analysis Program, has been helping researchers who need assistance organizing data properly for posting.

Helping investigators become or remain compliant with the requirements has been “an enhanced collaborative effort between the Division of Sponsored Research, the College of Medicine’s Research Administration and Compliance Office, the Clinical and Translational Science Institute and the Institutional Review Board,” said Yvonne Brinson, R.N., M.H.Sc., assistant dean of research administration and compliance in the College of Medicine.

Gathering and organizing data properly can be difficult, if not impossible, if researchers aren’t aware of requirements for posting before they begin a new clinical trial.

“It’s really important that upon registration (of the study with clinicaltrials.gov) they really learn what the system will require of them,” Brinson said. “It could be five years later before they complete the study. What’s been difficult is when no one looks at (the requirements) until it’s time to post the results, and then it’s often asking for data elements that might be a lot more difficult to find.”

A memo sent in March by David P. Norton, Ph.D., UF’s vice president for research, states that principal investigators ultimately are responsible for fulfilling the requirements for their studies. The investigators, their departments or their colleges must pay any fines accrued for non-compliance.

UF researchers have not incurred any fines for violating the rules, Hoffman said.

For more information on managing clinical trials at UF, visit research.ufl.edu/research/clinicaltrial.

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