Has FDP really improved research bureaucracy? 

There have been benefits and losses

The Federal Demonstration Partnership’s (FDP) latest incarnation in its nearly 20 years has the goal of reducing administrative burden in research and reducing bureaucracy, lofty objectives that clinical trial administrators and others could be forgiven for greeting with skepticism.

After all, the successes the FDP has had thus far in reducing unnecessary paperwork have been offset by the increase in new documentation requirements under the U.S. Patriot Act, including the unfunded mandates regarding the handling of biohazardous materials, exporting materials to foreign countries, and recruiting foreign scientists and students, some FDP members say.

However, the research administrators, faculty, and investigators who participate in phase IV of the FDP say they are enthusiastic that some of the new goals will be achieved and that others at least will be discussed with federal officials for the first time.

"FDP is one of the few, if not the only forum that serves the purpose of getting groups together to talk about burdens that some federal regulations may have created either inadvertently or knowingly," says Thomas Higerd, PhD, professor of microbiology and associate provost of institutional research and assessment at the Medical University of South Carolina (MUSC) in Charleston.

"The main success in this latest phase is what we’re trying to do is work with federal officials to either eliminate or streamline or simplify nonvalue-added research compliance requirements, such as payroll certification or subrecipient monitoring," says Elizabeth Mora, associate vice president for research administration department at Harvard University in Cambridge, MA.

The FDP is a faster way to bring researchers’ and research administrators’ ideas to the attention of federal regulatory officials, notes John Bain, associate director of cost analysis and compliance department at Harvard University.

"Federal agency representatives also are a part of FDP so there is a joint working arrangement for understanding the areas of regulations that need changing," he says. "This was a very constructive approach; rather than just writing letters or using lobbyists — we can meet with the federal agencies directly."

One of the bigger successes has been the expanded authority, which allows successful initiatives that are piloted by FDP institutions to be rolled out for all institutions, Bain says.

"That was one of the early big wins that allows much more streamlined changes and modifications of grants, which federal authorities have agreed to," he adds.

There have been numerous successes since the project began in the mid-1980s as the Florida Demonstration Project, says Dillard Marshall, director of the Office of Research and Sponsored Programs at MUSC.

"One of the cornerstones of FDP is the intent to reduce administrative burden of conducting research while sustaining or promoting public accountability for research funds," Marshall says. "So there has been extensive work where we’ve been able to reduce a lot of bureaucracy."

For example, some of the changes promulgated by FDP has eased the burdens of faculty and staff who handle grants, including the use of expanded authorities, says Marvin Paule, PhD, professor and interim chair of biochemistry and molecular biology at Colorado State University in Fort Collins.

"It eliminated a lot of silly paperwork that we needed to do to administer our grants," he says.

Also, current members of FDP are working potential solutions to some major sources of regulatory burden to research institutions, including changing the way effort reporting occurs, improving the process for recruiting foreign scientists/students, and improving space surveys.

Where FDP has worked

Paule and some of the other current members of FDP provide these examples of some of the research burdens that have been improved:

  • Reducing paperwork for subrecipient monitoring: "What we’ve done on subrecipient monitoring has been the most successful of all of the efforts," Mora says.

"We as prime recipients of federal funds are responsible for compliance requirements of all of our subrecipients," Mora explains. "If we contract with Brown University, and they have a problem on our award, then we’re responsible to make sure they pay back any money owed or we need to increase oversight in that area."

The old and time-consuming way of providing this oversight was for the main grant recipient to write letters requesting updates from the subrecipient, Mora says.

This took time away from other research administrative duties and resulted in extra loads of paperwork, and it added no value to compliance goals, she adds.

So thanks to FDP, this process has been simplified: Rather than write letters to subrecipients, the main grant recipient can check the Federal Clearinghouse web site and use that site’s information as the monitoring tool. If the subrecipient has any problems to report, they will be posted on the Clearinghouse web site, Mora says.

"The Clearinghouse uploads the detailed results of all of our audits into one place so that any sponsor or member of the public can look and see how we’re all doing," she says.

If a subrecipient has a problem, then the main grant recipient can follow up, and if there are no problems, then no additional action needs to be taken, Mora adds.

This change along has saved Harvard one-half a full-time equivalent position, Mora says.

  • Permitting no-cost extensions: Budget revisions were a costly part of the process for institutions before the FDP paved the way for easy no-cost extensions, Marshall says.

Previously, it might take institutions weeks to receive word on no-cost extensions even though 99.9% of them were approved, he adds.

Now, institutions can make the decision locally, giving a study a one-time no-cost extension for up to 12 months and reporting this extension to federal officials prior to the grant’s expiration date, he says.

"There’s no additional cost to the government," Marshall adds.

For example, if an investigator is collecting data from 1,200 patients and the region is hit with bad weather, resulting in many no-shows to the clinic that cause the work to be delayed, then the research institution can provide a no-cost extension so the investigator can complete the work, he explains.