The United States Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the U.S. Department of Health and Human Services (HHS). The PHS consists of a number of offices and agencies, among them NIH, CDC, FDA, SAMHSA, HRSA and IHS.

ORI fulfills its oversight responsibility in part by reviewing and monitoring research misconduct investigations conducted by the HHS Office of Inspector General (OIG) as well as those conducted by extramural institutions themselves. Occasionally, an ORI probe can lead to enforcement action under the federal civil False Claims Act, 31 U.S.C. § 3729 et seq.

That’s precisely what happened in November 2023, when Purdue University agreed to pay $737,391 to resolve allegations that an associate professor falsified documentation not only in published papers, but across 17 grant applications.

In December 2022, ORI concluded that Alice C. Chang—an associate professor of Cancer Biology and Pharmacology in Purdue’s College of Veterinary Medicine—knowingly falsified and fabricated data by reusing data to represent unrelated experiments from different mouse models or cell lines with different treatments in 384 figure panels. ORI also found that Chang falsified or fabricated data included in two PHS-supported published papers. As a result of the findings, Dr. Chang voluntarily excluded herself from all federal contracting (including grant funding) for 10 years and requested corrections to the two published papers.

Because Dr. Chang included falsified or fabricated data in 17 applications for federal grant funding—with that funding secured for Purdue University—the University itself faced False Claims Act liability. The National Cancer Institute (a division of the NIH) and the Department of the Army funded two of Dr. Chang’s grant applications. Beginning in 2018, when it received notice calling into question the authenticity of Dr. Chang’s research results, Purdue cooperated and investigated the alleged misconduct.  It determined that was not deserved and agreed to pay the federal government a total of $737,391 in restitution.

Without Purdue’s cooperation, its liability for the professor’s false claims could have totaled a considerably higher amount. The False Claims Act allows the government to pursue treble damages, which can lead to a recovery of up to three times the amount of actual damage to the government. Disclosure and cooperation can significantly reduce False Claims Act settlements.

The U.S. Department of Justice’s press release on the pre-suit settlement is available here.