Following a string of high-profile scandals, the US government is pushing for stricter oversight of grants given by the National Institutes of Health (NIH). The trend has many researchers worried that they might have to start accounting for their time and money or face being investigated.

Much of the scientists' concern centers on detailed new guidelines from the US Department of Health and Human Services (HHS), which oversees the NIH, but other auditing and investigative efforts could also cause trouble for some institutions. The guidelines dictate specifics on research oversight and might require scientists to track time spent on teaching, patient care or research. Meanwhile, Congress is also prodding the HHS to investigate graduate student stipends.

You take things quite seriously when they're issued by the inspector general. Susan Ehringhaus, Association of American Medical Colleges

The Office of Inspector General, the HHS' enforcement arm, released the draft guidelines on 28 November and is soliciting comments until the end of January. Agency officials declined to comment on any aspect of the guidelines.

The rules are technically voluntary, but research advocates predict they will have the effect of laws. “You take these things quite seriously when they're issued by the inspector general,” says Susan Ehringhaus, general counsel of regulatory affairs at the Association of American Medical Colleges, a research lobby group. “This is somebody that you pay attention to, because that's an office that will set up audits,” she says.

The draft says that, in certain circumstances, the failure to accurately account for time and effort “could subject an institution to civil or criminal fraud investigations.” An HHS official close to the issue, speaking on condition of anonymity, agreed that institutions that follow the guidelines would be likely to fare better in a fraud investigation or audit.

The government has already scrutinized several NIH grant recipients in the past few years, often leading to large out-of-court settlements (see table). Prompted by a Wall Street Journal report on the investigation of Cornell's Weill Medical College, also covered in Nature Medicine (11, 810; 2005), the US House of Representatives in October asked the HHS to step up its grant oversight. Audits may become more common in response to the new congressional pressure.

Table 1 Settlements in Recent Investigations of NIH Grant Recipients.

In their letters to the department, Republican Congressmen Joe Barton and Ed Whitfield called for both a general increase in audits and a specific investigation of graduate student stipends (Nature 437, 601; 2005). The HHS had cracked down on creative stipend accounting at several institutions in 1994, but the Congressmen contend that some universities may still be overbilling the NIH for graduate students' pay. The HHS official declined to discuss specific investigations, but said the agency is likely to comply with Congress' request.

At the NIH, officials declined to comment on any grant oversight issues except the new draft guidelines. In an official statement on the guidelines, Norka Ruiz Bravo, NIH deputy director for extramural research, said, “The NIH is pleased to see these principles issued as guidance for comment.”