Whenever allegations of research falsification, fabrication, or plagiarism arise at the University of Virginia (UVA) in Charlottesville, David Hudson is the university’s first responder. Most universities and research institutions have someone like Hudson: a single, designated person who is charged with overseeing these delicate undertakings, dubbed the research integrity officer (RIO). An institution’s RIO may be a faculty member or an administrator. Their backgrounds are often in science, but RIOs may also be career administrators or attorneys. Whatever their backgrounds, the RIO’s central responsibility is to empanel and lead an investigative committee whenever an allegation of misconduct arises.
It sounds exciting, and it can be: The RIO role offers plenty of opportunity for intrigue. But, because compliance with standards is crucial in any misconduct investigation, the job also calls for facility working with (and enforcing) bureaucracy. And because false misconduct allegations can damage the reputations of innocent scientists, the job requires a dispassionate and meticulous approach. In a typical investigation, the RIO-led committee—made up mostly of faculty with relevant expertise—reconstructs the research behind a scientific result from its documentation (which may be sparse, cryptic, or fabricated)—so the RIO job requires deep insight into how scientists work. That is why many (and perhaps most) RIOs are scientists or former scientists.
Law and order on campus
Hudson, who is also the university’s associate vice president for research, says he entered the ethics field “almost by accident.” He earned a neurochemistry Ph.D. at the University of Oregon (UO) and then did two postdocs studying circadian rhythms, the first at the University of Texas, Austin, and the second at the Institute of Neuroscience at UO.
At the end of his second postdoc, Hudson encountered a tough job market and decided to seek positions outside the lab. He accepted a post as assistant department chair for neurobiology and sociology at Northwestern University, a nontenure-track junior faculty post. The department needed someone with a research background to handle various administrative tasks, including faculty recruiting. “We were the muscle power, the doers in the front office,” Hudson says. “Though it meant not doing science as actively as before, it didn’t mean leaving science altogether,” he reasoned.
In 1987, Hudson moved to UVA, taking a similar position. Rising through the administrative ranks, he was soon working in the Office of the Vice President for Research, then called the Office of the Vice Provost for Research. That was where his first brush with research misconduct cases occurred. After that, the field of research integrity never lost its appeal.
Under federal regulations, universities and research institutions are required to look into every misconduct allegation that comes to them, regardless of how substantial (or insubstantial) it seems at first glance and regardless of where the allegation comes from. Hudson once received misconduct allegations in the mail, unsigned and with no return address.
Federal regulations script the approach institutions must take in handling allegations. Hudson’s job is to make sure that script is followed. Serving as a coordinator, he assembles a group of university faculty members with expertise in the fields most relevant to the case. Because they are familiar with the field’s techniques and procedures, these experts are positioned well to determine whether the work was done correctly. As the investigation progresses, Hudson serves as a liaison to the federal oversight agencies: the Office of Research Integrity (ORI) for work funded by the National Institutes of Health, or the Office of Inspector General for work funded by the National Science Foundation. Hudson also conducts investigative interviews and forensic analysis of data.
“There’s an element of research in all of this, which one finds quite captivating,” he says. “Some of doing an inquiry is the thrill of using the research tools to figure out whether a figure has been falsified or if the numbers have been manipulated.”
The challenge, he says, is to maintain a sense of balance in order to dig out the truth. Instead of going for the jugular, you’re often working to exonerate an innocent scientist. “You have to approach it with the same sort of earnestness and same sort of care that you approach questions in science,” Hudson says.
Clearing a path to research integrity
Some people, including Hudson, move directly from junior faculty into administrative work, bypassing those painstaking steps up the faculty ranks. Others enter the field from the outside. Robert Nobles, assistant vice chancellor at the University of Tennessee (UT), Knoxville, transitioned from a state government agency into university administration while maintaining a role in research.
Nobles, an epidemiologist, completed a bachelor’s degree in molecular biology in 1998 and a master’s degree in epidemiology in 2000, all at Florida A&M University. While completing his master’s degree, Nobles served as program manager and environmental specialist at Florida’s Department of Health. There, he oversaw a program to monitor water quality at beaches frequented by vacationers and report beach closures and advisories. Lifeguards, park personnel, and beach monitors carried out the assessments, and Nobles monitored compliance. Nobles says the program “set the stage” for his work as an administrator.
After he completed his master’s degree, Nobles became a public-health prevention specialist at the Centers for Disease Control and Prevention. There, he developed plans to prepare for bioterrorism attacks and conducted investigations into infectious diseases and environmental threats, collaborating with university-based investigators. In the course of those collaborations, he began to notice that researchers often face challenges monitoring and regulating their own research activities.
Federal regulations on working with human subjects, for example, require filling out detailed applications on study design and subsequent reporting. Each phase generates an extensive paper trail, which can be difficult to track, organize, and store. Guidelines for training lab personnel (i.e., for working with hazardous materials) are often vague, leaving investigators with little more to go on than a gut feeling. “I noticed how unclear the guidelines were and how unknowledgeable the administrators were,” Nobles says. “From that point forward, I angled my career path to become a hybrid administrator and faculty researcher.”
In 2004, Nobles joined the University of Texas Health Science Center at Houston as director of research compliance, education, and integrity. Over 7 years, he directed programs tied to compliance, managing initiatives and disseminating regulations . A few years later he resumed his studies, and in 2009 received a doctoral degree in health policy management and epidemiology.
In 2011, Nobles became executive director for the Office of Research Compliance and Biosafety at Texas A&M University. Working under the vice president for research, he oversaw programs for the responsible conduct of research and assisted with misconduct investigations. Then, early this year, he joined UT, as its RIO. There, in addition to his core RIO duties, he teaches classes on responsible conduct of research and oversees efforts to ensure that research undertakings meet regulatory requirements. Since arriving at UT, he has streamlined record-keeping and reporting requirements on campus, aiming to help investigators carry out their studies with optimal compliance but minimal interference.
His own research—analyzing data on public health issues—has covered a wide range of topics. A current project focuses on evaluating programs that aim to change behaviors that lead to teen pregnancy and sexually transmitted infections; the goal of the research is to see which programs work and assess their cost-effectiveness. “I’ve intentionally not allowed myself to be pigeon-holed in one area,” he says.
But Nobles’ driving desire is to help other researchers succeed. “If I can make the infrastructures easier for everybody else to be successful in their research endeavors, then in my mind, I’ve had a greater impact than if I was doing one project at a time,” he says.
Hooking into compliance structures
Career opportunities in regulatory compliance—a field closely tied to research integrity and a possible point of entry for those aiming to enter research-integrity work—are rapidly growing, and universities frequently seek qualified compliance professionals, Nobles says. Though qualifications vary from institution to institution, leaders typically need an advanced degree—a master’s degree or doctorate—and experience with the activities they are regulating. Compliance units for radiation safety, for example, are likely to seek candidates with a background in health physics, while biosafety units look for skills in areas such as microbiology or infectious diseases. “The hands-on experience is important to me,” Nobles says.
When candidates don’t come in with all of the qualifications, universities may be willing to train them. Nobles urges those interested in research-integrity work to look for opportunities to get involved with their institution’s compliance structure. That way, they can learn how the structure is set up and decide whether the work meets their expectations.
In contrast to much academic work, the need for research integrity professionals is especially high when federal grant money is tightest. Compliance staff not only put the proper support systems in place; they also provide reassurance—to both the outside and inside worlds—that research is being done as proposed, Nobles says. “Millions upon millions of dollars are going out to these institutions, and we need to show that they are good stewards of those dollars.”
Top Image: David Hudson. Courtesy of David Hudson.