Research Compliance Topics in the News
A message from EVPR G. Michael Purdy
It is always wonderful when we see the results of our important research in the media and on the daily news. It brings much deserved attention to the importance of our work and awareness of the positive impacts it has on health and security of humankind.
So, when a news story focuses upon failures to meet regulatory requirements or ethical standards it is disappointing and painful and damaging to the credibility of our research enterprise and our university.
The Office of the Executive Vice President for research is dedicated to the support of Columbia researchers in the fulfillment of research compliance regulations and policies. As government oversight increases and the regulatory burden grows, we rededicate ourselves to help researchers avoid potential problems and reduce risk. It is to emphasize the seriousness of this task that we have added this section to our web page.
In the sections below you will see a collection of news stories about significant research violations. The function here is not a ‘scare’ tactic, but simply an attempt to increase awareness of the gravity of many of the decisions that researchers have to make on a daily basis.
I hope you find this helpful and informative.
A conflict of interest (COI) exists where a researcher’s outside interests or activities could improperly affect, or give the appearance of affecting, the researcher’s activities at Columbia. Problems can arise from the failure of researchers to adequately disclose potential conflicts. Visit Office of Research Compliance and Training's website on COI for more information.
Conflict of Interest Cases
2018: José Baselga | Memorial Sloan Kettering Cancer Center
"Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles."
2008: Joseph Biederman, Thomas Spencer, and Timothy Wilens | Harvard Medical School
"Three US psychiatrists, responsible for trailblazing the use of antipsychotic drugs in children, are facing sanctions for their failure to declare their acceptance of millions of dollars from pharmaceutical companies between 2000 and 2007."
2008: Charles B. Nemeroff | Emory University
"One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules."
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. As cases of research misconduct show, misconduct is carried out by individuals at all levels and in many fields of research. For more information on Research Misconduct, visit the Office of Research Compliance and Training website.
Research Misconduct Cases
2020: Purdue University
"The charging documents to which the defendants pled guilty allege that Dr. Han devised a scheme to defraud NSF into giving Hans Tech over $1.3 million in research grants through its SBIR and Small Business Technology Transfer (“STTR”) programs by making materially false and fraudulent pretenses, representations, promises and material omissions."
2019: Duke University
"Duke University has agreed to pay $112.5 million to the U.S. government to settle a lawsuit alleging that a research technician falsified data for several years to obtain federal grants, university officials announced Monday."
2011: Marc Hauser | Harvard University
"Harvard University said Friday that it had found a prominent researcher, Marc Hauser, “solely responsible” for eight instances of scientific misconduct."
2010 Anil Potti | Duke University
"In 2006 Potti’s team published several papers in high-profile journals reporting that certain gene expression signatures predicted a patient’s response to chemotherapy. Two outside biostatisticians soon raised concerns about the studies. In 2010, Duke put Potti on administrative leave and suspended three clinical trials based on his work after The Cancer Letter, a newsletter in Washington, D.C., reported that Potti had padded his resume."
2006: Eric Poehlman | University of Vermont
"Experts say the case marks the first time a U.S. scientist will serve jail time for research misconduct not linked to fatalities."
2005: Hwang Woo-suk | South Korea
"A scientist today issued an apology as he resigned from South Korea's top university after the school announced he had fabricated results in stem cell research that had raised hopes of new cures for hard-to-treat diseases."
“Export controls” refer to U.S. laws and regulations that control the conditions under which certain technology, commodities and software can be transmitted overseas to individuals, including U.S. citizens, or to a foreign national on U.S. soil. Consequences for violating export control laws and regulations are severe, and may include criminal penalties for the individuals who violate them. For more information on Export Controls, visit the Office of Research Compliance and Training website.
Export Control Cases
2009: Georgia Institute of Technology
"The disclosure came from a Georgia Institute of Technology course for federal employees and contractors on infrared technology used in weapons-aiming systems for aircraft, ships and tanks. Asked by instructor David Schmieder to copy the course onto a DVD, Georgia Tech’s media staff instead uploaded it to servers."
2008: J. Reece Roth | University of Tennessee
"A federal jury in Knoxville, Tenn., convicted a retired university professor on conspiracy, wire fraud and export control charges yesterday for improperly sharing sensitive technology with students from China and Iran."
Some research data are highly sensitive, such as Protected Health Information, including names or addresses associated with clinical information, or Personally Identifiable Information such as Social Security numbers, credit card numbers, or personal financial data. The release of such data can lead to harm such as privacy violations or identify theft. For more information on Data Management and Security, visit Research Data at Columbia website.
Data Security Cases
2011: Bonnie C. Yankaskas | University of North Carolina
"A prominent cancer researcher at the University of North Carolina at Chapel Hill is fighting the university's decision to demote her and cut her pay in half after a security breach in a medical study she directs was discovered. The breach could have revealed medical records of of more than 100,000 women whose data were studied."
Data Management Cases
2014: Oklahoma State University
The senior author of “Relation of Parenting Styles, Feeding Styles and Feeding Practices to Child Overweight and Obesity: Direct and Moderated Effects” requested a retraction of the paper due to the discovery of "an error in the data for the manuscript and had tracked down the source of the error to a column switching mistake in copying data from one spreadsheet to another by a research assistant."
2013: All India Institute of Medical Sciences
"There were multiple errors in the table on pages 18 and 19 of the Supplementary Appendix...These errors, in turn, changed some values in Table 4 of the article. Although these changes do not alter the conclusions of the article, the primary data could not be located to verify corrections made from secondary tables. Accordingly, we have no way of confirming the correct data and, with regret, wish to retract the article."
One of the most potentially problematic funding issues is Scientific Overlap, which occurs when a research proposal is identical to or substantially the same as another proposal the researcher may have submitted or plan to submit to a different funding agency.
2012: Craig Grimes | Pennsylvania State University
"The recent charges were brought against Craig Grimes, who until 2010 was a professor of electrical engineering at Pennsylvania State University. Last month, he pleaded guilty to charges that included accepting grants from the Department of Energy (DOE) and the US National Science Foundation (NSF) to fund the same research on solar conversion of carbon dioxide into hydrocarbons."
2011: Guifang Li | University of Central Florida
"During our joint investigation with the Air Force into the plagiarism allegations, we learned the subject proposed the same research to the Air Force, NSF, and DARPA and was funded by each agency."
Laboratory-based research often involves materials that are or can be dangerous when not properly handled. Protecting the health and safety of research personnel and the environment of the surrounding community is a fundamental responsibility of any university. As recent lab safety cases demonstrate, if researchers are not properly trained, compliance measure are not maintained, and proper safety procedures are not followed, accidents, sometimes fatal, can occur. For more information on Laboratory Safety, visit Environmental Health and Safety.
Laboratory Safety Cases
2010: Texas Tech
"The accident occurred during the handling of explosive compounds and resulted in serious injuries to a graduate student. The case study...identifies systemic deficiencies in safety accountability and oversight by the principal investigators, the chemistry department, and the university administration at Texas Tech."
"Unprecedented criminal charges against U. of California regents and UCLA professor, stemming from a death, highlight importance of proper safety training."