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.
Conflicts of Interest and Research
A conflict of interest 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. For more information on Conflict of Interest and Research, visit the Office of Research Compliance and Training website, or review the Rascal COI training course here. Here are a few recent cases of conflicts of interest and research:
Conflict of Interest Cases
Joseph Biederman – In 2008, Harvard psychiatrist Joseph Biederman was sanctioned by Harvard Medical School and Massachusetts General Hospital for failing to disclose over $1 million in consulting fees from the pharmaceutical industry. Read the New York Times article.
Charles B. Nemeroff – In 2008, Emory University professor Charles Nemeroff stepped down as the chair of psychiatry, and was later barred by Emory from acting as an investigator or co-investigator on National Institutes of Health grants for at least two years, following the revelation by U.S. Senator Charles Grassley that Nemeroff had failed to disclose more than $1.2 million in income from drug companies while conducting federally-funded research involving those companies’ products. Read the New York Times article.
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. Here are a few recent cases of research misconduct:
Research Misconduct Cases
Marc Hauser – In 2011, Harvard found that evolutionary biologist Marc Hauser was guilty of research misconduct in his research into primate cognition. He resigned from Harvard in 2011. Read the New York Times article.
Eric Poehlman – In 2006, University of Vermont professor Eric Poehlman became the first researcher to be jailed for research misconduct not linked to fatalities for knowingly using falsified data in a federal grant application. Poehlman spent one year in federal prison. Read the Science Magazine article.
Hwang Woo-suk – In 2005, Korean Researcher Hwang Woo-suk was found to have fabricated research that purported to show that he had successfully created human embryonic stem cells by cloning. Read the New York Times article.
“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. Here are a few recent cases of export control issues:
Export Control Cases
Georgia Institute of Technology – In 2009, Georgia Tech allowed Internet users in 36 countries, including China, Russia, Iran and Pakistan, to view sensitive information on infrared technology used in weapons-aiming systems that was intended only for federal employees and contractors. The State Department stated that it had determined that violations had occurred. Read the Bloomberg article.
J. Reece Roth – In 2008, retired University of Tennessee professor J. Reece Roth was found guilty of violations of the Arms Export Control Act, including passing sensitive information from a U.S Air Force contract to research assistants from China and Iran, and of taking sensitive documents to China on his laptop. In January 2012, he began serving a four-year sentence in federal prison. Read the Washington Post article.
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 the Office of Research Compliance and Training website. Here is a recent case of data-related issues:
Data Security Cases
Bonnie C. Yankaskas – In 2011, University of North Carolina professor Bonnie Yankaskas was forced into early retirement following the discovery that computers containing data from a large mammography study on which she was principal investigator had been hacked, resulting in the potential release of the personal information of over 100,000 women, including names, addresses, birthdates, and Social Security numbers. Read the Chronicle of Higher Education 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. Here are a few recent cases of funding-related issues:
Craig Grimes – In 2012, Pennsylvania State University professor Craig Grimes pleaded guilty to charges that included accepting grants from both the Department of Energy and the National Science Foundation to fund the same research on solar conversion of carbon dioxide into hydrocarbons. Read the Nature Magazine article.
Guifang Li – In 2011, University of Central Florida professor Guifang Li was barred from applying for federal funding for two years for applying for and accepting grants for the same research from the Air Force, National Science Foundation, and the Department of Defense. Read the NSF’s Notice of Debarment.
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 the Office of Research Compliance and Training website. Here are a few recent laboratory safety cases:
Laboratory Safety Cases
Texas Tech – A 2010 chemistry lab explosion at Texas Tech University in Lubbock, Texas, resulted in serious injuries to one graduate student. The U.S. Chemical Safety Board (CSB) identified “systemic deficiencies in safety accountability and oversight by the principal investigators, the chemistry department, and the university administration.” Read the details of the CSB investigation.
UCLA - In 2009, a UCLA research assistant died days after air-sensitive chemicals she was working with burst into flames and ignited her clothing. The university was cited and fined for failing to properly train the assistant, allowing her to work without protective clothing at the time of the fire, and for not correcting safety deficiencies that had been previously identified. In 2012, felony charges were filed against the university and the PI for willfully violating occupational health and safety standards, resulting in the death. Read the article from Inside Higher Ed.