I still remember my time as a university graduate student involved with research.
One day, in conversation with my mentor, she questioned the accuracy of the data collection for the first handful of pilot subjects. I showed her the raw data files and she confirmed that the results were accurate.
I only realized the true importance of this conversation years later as a clinical research coordinator when I recently came across a newspaper article about research misconduct where a prestigious university child psychiatrist (and recently named ‘top doctor’ by a survey) knowingly tested lithium on children under the age of 13, failed to disclose the risks, misused the 3.1 million dollars received from the National Institutes of Health for the study, and falsified data to cover up the misconduct. What was the most devastating result of this misconduct? Several parents reported serious psychological and behavioral changes in their children and some even had to be hospitalized due to the effects. The university finally shut down the study and the Institute received the money owed. However the consequences of research misconduct by someone who was fully aware was ultimately paid by the children.
One of the main criticisms is that the university panel and IRB should have been more thorough regarding evaluations and audit from the beginning of the study. By the time the internal investigation was conducted and subsequent termination of the study, many families were already affected by the misconduct. However the fact is that this well-known psychiatrist and ‘top doctor’ deliberately misused her privileges and through misconduct, compromised the safety of her subjects, all in the name of ‘cutting-edge research.’
Falsification of research data is more prevalent than one might assume. According to the Federal Office of Integrity (ORI) in 2006, 111 institutions reported a total of 151 allegations of misconduct. From these allegations, 69 allegations comprised of falsification, 53 of fabrication, and 29 of plagiarism. Similarly in 2007, the ORI found verified cases of misconduct in 33% of reported cases. In 2008, out of the 2, 212 responses by researchers to Nature, 60% reported fabrication/falsification and 36% reported plagiarism.
Falsification refers to manipulating, changing, or omitting data while fabrication refers to concocting false data or results. Plagiarism refers to the use of another individual’s ideas or results without giving due credit.
The most common actions were debarment from federal funding for at least a period of 3 years. According to the ORI, a finding of research misconduct requires that the allegation is proven by a preponderance of the evidence.
The ORI updates verified evidence of research misconduct on a frequent basis. All details of each finding can be found on their website.
Although before this article, the university has not had any previous cases of research misconduct; the events involved in this case, as well as the other reports mentioned, bring to light the serious issue of ethics and integrity in research and medicine as well as the importance of training and responsibility to ensure research integrity whenever any research is conducted.
As a word of caution, readers should be aware about falsification of data in literature and critically examine the accuracy of the data and results presented. In addition, as it pertains to physicians and hospitals, research misconduct can result in catastrophic consequences, such as when inaccurate data is used to generate guidelines that direct treatment, which and affect the quality of patient care and even compromise patient health and safety.
Daya Devanathan MS
Daya Devanathan, MS is currently a clinical research coordinator at the Department of Orthopedics at Weiss Memorial Hospital. She obtained her MS in Rehabilitation Sciences from the University of Illinois at Chicago. Her previous published research related to using noninvasive brain stimulation to improve motor reaction time in individuals recovering from stroke. Her additional areas of interest include rehabilitation or functional outcomes, health professions training, and clinical performance.
Allan Tachauer, MD, FACP
Dr. Allan Tachauer is currently the Associate Director of the Internal Medicine Residency Program at Weiss Memorial Hospital. In addition he also serves as the medical ethicist for the hospital as well as on the physician peer review committee. He received his medical degree from Carol Davila University of Medicine and Pharmacy and has been in practice for more than 20 years. He completed fellowship training from the University of Chicago. He has published several articles in peer-reviewed journals including Journal of Critical Care and Annals of Internal Medicine.