Cast of actors in The Lab, a teaching tool developed
by the federal Office for Research Integrity.
April 2014--To paraphrase Antony Rosen, the Johns Hopkins University vice dean for research: If science is the pursuit of truth about the material world around us, the most serious crime a scientist can commit is the deliberate falsification of that body of truth.
Here at the school of medicine, misconduct allegations involving the faculty, staff and trainees jumped from two to an average of 16 per year from 2000 to 2012. Johns Hopkins isn’t alone: An international survey of 742 English-language papers retracted between 2000 and 2009 found that the number of papers retracted for issues of fraud jumped from two to 51. While the author of the survey is careful to note that retractions due to mistakes also increased at a similar rate, suggesting that there is something more going on than a simple increase in scientific fraud, the sheer number of allegations and retractions is enough to create public mistrust. Even worse, fraudulent results can influence clinical trials, putting subjects at risk, a recent study found. At a minimum, leading other researchers astray results in the wasting of untold time and funds.
In light of these high stakes, Johns Hopkins has developed robust processes for handling allegations and heading off misconduct before it happens, while helping to shape the emerging field of research integrity management.
Creating a Culture of Integrity
Around 2005, the National Institutes of Health and the National Science Foundation began talking about requiring all researchers funded on certain types of training grants to be trained in the responsible conduct of research. Chi Dang, then vice dean of research for the Johns Hopkins University School of Medicine, decided that the training was important not just for trainees, but for all faculty and trainees conducting research. Together, Dang and Sheila Garrity, the director of the Division of Research Integrity, developed a three-pronged approach for fostering a culture of integrity.
The first prong is requiring completion of an online course on the principles and rules governing research integrity. The second requires each department, division and laboratory to focus on a research integrity-related topic during at least one meeting each year.
The third is unique to Johns Hopkins and may well be the most important and influential in shaping the academic culture. Eight times each year, a senior faculty member gives a presentation to his or her peers about one of four topics related to research integrity: the importance of collaborative research, the scientist as a responsible member of society, the importance of mentor/mentee relationships, and data acquisition and management. These Dean’s Research Integrity Lectures are followed by a panel discussion moderated by Garrity.
“The response to these lectures has been really positive,” she says. “It means so much for these ideas to come not from a ‘compliance officer’—who may have never experienced the pressures of academic research—but from a respected peer.”
In one recent lecture, on January 8, 2014, Rosen used Nelson Mandela’s commitment to fairness as his theme for speaking about scientists as responsible members of society. He reminded his audience that the people of the U.S. invest public funds in science, because they believe that it will benefit them in the long run. They therefore expect it to be conducted in a rigorous way, because each piece of the scientific edifice depends on the stability of what is below.
It is crucial, Rosen said, to “establish a culture of integrity within the institution—to make it clear that our goal is not publications, but the truth.” Suggesting that dedication to the truth, like dedication to liberty, has to be inspired and constantly nurtured, he quoted Justice Learned Hand: “Liberty lies in the hearts of men and women; when it dies there, no constitution, no law, no court can save it; no constitution, no law, no court can even do much to help it.”
Justice Learned Hand, Wikimedia
Part of creating that culture of truth is acknowledging that we aren’t perfect and learning from our mistakes. For this reason, Rosen and Landon King, the executive vice dean, plan to break with precedent on May 2 and discuss all of the research misconduct cases that resulted in findings at Johns Hopkins last year … anonymously, of course.
Garrity expects this discussion to help dispel the notion that it’s only “grossly unethical people” that fail in the responsible conduct of research. “Oftentimes, these issues come up because of a lack of appropriate mentorship, because a lab has gotten too big,” she says. “That’s important for our faculty to realize.”
Faculty members can also head off issues of misconduct by reinforcing the thorough and orderly collection and storage of data, making sure that the data produced are accurately and completely represented in the experimental results and avoiding the creation of high-pressure, competitive atmospheres. Garrity also emphasizes that it is critical for faculty members review the primary data of their trainees on a regular basis.
Responding to Allegations
Accusations of scientific fraud have been around forever and, historically, the institution has used different avenues to respond. In the past, the responsibility of addressing fraud accusations rested with an individual department; later, they were handled by different institutional offices. Eventually, all misconduct cases were handed over to Sheila Garrity in the Office of Policy Coordination under the direction of Julie Gottlieb. Garrity assumed this responsibility around the same time the term “Research Integrity Officer” came into use. (The term is abbreviated RIO and is pronounced like the city in Brazil.) She has held the position for nearly 10 years now.
She says that one of the reasons there are more allegations of misconduct is that it is so much easier to make them these days, thanks to email and the ability to view publication images online. Allegations can be made by research collaborators, journal editors, reviewers and readers, but the number of readers has increased exponentially, thanks again to the Internet.
“If an allegation is made against someone at Johns Hopkins, our first step is an assessment, an initial ‘smell test,’” says Garrity. She conducts that assessment together with Rosen or another subject matter expert. If the “test” comes back positive, an inquiry is launched.
The most important part of an inquiry is the initial sequestration of evidence, which involves everything from collecting laboratory notebooks to imaging hard drives—Garrity has a forensics IT firm on speed dial. No notice is given to the accused, because it is important for everyone to be able to trust the integrity of the data gathered. But the data gathering is usually done when the lab is empty, since any allegation of misconduct, whether merited or not, has the potential to negatively impact one’s reputation, which is of great concern to Garrity as she staffs the process.
Usually during collection of the evidence, a “charge letter” is delivered to the accused with a concrete description of the allegations. The accused is given an opportunity to respond to the allegations within 14 days. During this time, an initial review of the evidence is made, followed by a decision about whether to go forward with a full investigation. It is at this point that Johns Hopkins must alert the federal Office of Research Integrity if the allegation involves federally funded research.
The third stage of the process is an investigation conducted by senior faculty members, which is managed by Garrity. Ralph Hruban, professor of pathology, has the distinction of being the only person to have been asked by Garrity to serve on two of these committees, because she tries to never ask the same person twice, knowing the demands of serving.
Hruban says, “It’s very difficult to interview and judge a colleague, someone you probably know somewhat and will have to work with afterward. What helps is the belief that you are doing good, that you are being fair and proceeding as if you were the one accused—and the knowledge that ‘There, but for the grace of God, go I.’” He remembers being struck by a palpable sense of responsibility among the other faculty members serving on the committee. “It was clear that everyone recognized the importance of what they were doing, both for the institution and for the integrity of science itself,” he says.
Garrity says that the institution owes a huge debt of gratitude to professors like Hruban. “They put a lot of time into a thankless task,” she says. “The investigation process is only supposed to take 60 days, but it has sometimes dragged on for four years.”
At the end of an investigation, a detailed report is prepared, which includes all of the evidence and a review of the allegations. Findings of misconduct may or may not be made based on the committee’s review. The report, which can often exceed 1,000 pages, is given to the accused, who is given 30 days to respond. If the committee makes findings of misconduct, the proceedings move on to the adjudication phase, which involves a review by the Standing Committee on Discipline. This is a group of 14 to 18 senior faculty members who make sure the investigation is complete and review any mitigating and aggravating circumstances. They may then recommend that no actions be taken, or they may recommend sanctions, which could include letters of reprimand, retraction of papers, periods of oversight, termination of employment and prohibition against rehire.
Finally, the advisory board of the medical faculty—the governing body of the school of medicine—reviews the case, upholds or overturns the findings and modifies or upholds the recommended sanctions.
Shaping the Research Integrity Field
Garrity is proud of the proactive approach that Johns Hopkins has taken toward dealing with issues of research misconduct. “As a top recipient of federal grant money in this country, we have a responsibility to lead in this field,” she says.
In addition to developing robust educational programs to help inform a culture of integrity, Johns Hopkins has also been instrumental in creating a network of RIOs across the country so that resources and experiences can be shared and a set of best practices can be developed in this poorly charted territory. In support of this goal, Johns Hopkins hosted the second-ever RIO Boot Camp in 2007, a training program developed by the federal Office of Research Integrity for RIOs and their general counsel.
The RIO network was formalized last year with the creation of ARIO, the Association of Research Integrity Officers. Its first meeting was hosted by Johns Hopkins last fall. The 80 participants at the three-day conference discussed everything from staffing to forensic tools to funding for the unpredictable detective work with which RIOs are tasked.
A few months later, in March 2014, a smaller group of RIOs from the mid-Atlantic region gathered at Memorial Sloan Kettering Cancer Center in New York City to continue the discussions and to share new challenges and solutions.
“The RIO boot camps provide some solid training—and there is discussion of transitioning responsibility for them to ARIO—but regularly scheduled meetings are also needed since the boot camps can’t address the potentially conflicting and overlapping interests present in each case,” says Garrity. “One of our primary goals in creating ARIO is the development of standards to ease the navigation of these complex cases. These standards are becoming increasingly important as research is performed more collaboratively between departments, institutions and even countries.”
If a RIO is working on a case of misconduct that involves a published paper, should he or she “warn” the journal before the case is decided, or would that be breaching confidentiality and maybe needlessly marring someone’s reputation? Does the answer to this question change if there is an ongoing clinical trial based on the potentially faulty results?
What, exactly, are RIOs charged with protecting? The integrity of scientific data? Their institution and its researchers? Garrity says her job is protecting the integrity of the process. “I want to be the person who anyone can call,” she says. “I am not a prosecutor.”
While being a RIO may sometimes be a thankless task, Garrity finds that most faculty members are quite grateful for her participation in the process and comforted that an institutional process is in place. One former professor, who was ultimately found responsible for research misconduct, even sent her a box of chocolates when it was all said and done. “She knew that it had been a fair process,” Garrity says. “And she was grateful.”
For videos that are used as research integrity teaching tools, visit The Lab for scientists or The Research Clinic for clinicians.
Sheila Garrity on safeguarding research integrity