Whistleblower accuses researchers of misusing NIH funds.

Cornell University has settled a lawsuit charging its researchers with false claims for payment.

Researchers at Cornell University in New York are under investigation for allegedly enrolling inappropriate participants in research studies and filing false information on protocols with the US National Institutes of Health (NIH) to maintain government funding for a university research center.

A former researcher at the now-closed pediatric center accused the center's director of using the clinic to treat her adult patients and alleged that clinic staff double-billed the NIH and Medicaid for some patients, among other charges.

The case is being reviewed by the appropriate authorities and appropriate action will be taken. Don Ralbovsky, NIH

In response, the US Department of Justice and the NIH both launched investigations into research activities at the university's Children's Clinical Research Center. After a two-year inquiry, Cornell's Weill Medical College in July agreed to pay the federal government $4.4 million to settle the charges levied by the US Attorney, the Justice Department's litigation arm, in New York City. As part of the settlement, Weill also agreed to cooperate in any subsequent investigations involving research center staff. Cornell did not admit to liability or wrongdoing in the settlement and, in its statement, noted that the case didn't involve “the quality or integrity of the research” and that none of the researchers was the subject of sanctions.

Kyriakie Sarafoglou, then a researcher at the center, first notified the NIH about problems at the center in 2003. Sarafoglou, now an assistant professor at the University of Minnesota, also filed a complaint with the Justice Department. The law allows whistleblowers like Sarafoglou to bring claims on behalf of the government and to share in any financial settlements.

In her complaint, Sarafoglou named Weill dean Antonio Gotto, and three administrators and seven physicians at the research center, including former director Maria New, a prominent pediatric endocrinologist. New has since left Cornell and works at the Mount Sinai School of Medicine in New York. Both Cornell and New say her departure was voluntary and New maintains that it was unrelated to the case.

After investigating Sarafoglou's complaint, the US Attorney in July added fraud and other charges, alleging that the center's staff made false statements in grant renewals and annual progress reports and included minimally active or defunct protocols in grant renewal applications. Doctors at the center performed procedures on staff, never enrolled them in protocols and then charged the NIH for the services, according to the charges.

The complaint also says Weill allowed New to “dominate” use of NIH funds for her patients and protocols in violation of NIH guidelines. The NIH, which sponsors about 80 such research sites, limits individual researchers to using no more than 33% of a center's resources.

But when the US Attorney reviewed Weill's database on actual use, it found, for instance, that in 2003 the program director used 80% of inpatient resources and 67% of outpatient resources. “The case is being reviewed by the appropriate authorities and appropriate action will be taken,” says NIH spokesperson Don Ralbovsky.

New declined to comment on the case details, citing the possibility of additional legal action. However, she noted that it is not unusual for a single researcher to exceed the guidelines barring them from using more than 33% of a center's resources. But NIH staff say the guidelines are taken “very seriously” and researchers may only exceed them with permission from the agency.

New remains in good standing at the NIH, retaining several grants. In 2003, she was one of eight scientists to be funded through a new Rare Diseases Clinical Research Network. “I have no explanation for this,” says Sarafoglou. “It is perplexing.”