James M. DuBois, DSC, PhD, Director, PI Program and Bioethics Research Center, Washington University School of Medicine
Abstract: Many factors increase the risk of research integrity violations or serious non-compliance. This article explores these factors, highlighting wrongdoing and “right-doing” in research, using data from the first 68 participants in the Professionalism & Integrity in Research Program and the Bioethics Research Center at Washington University School of Medicine. The Professionalism & Integrity in Research Program serves investigators following professional lapses. The Bioethics Research Center studies the factors that contribute to violations of research integrity and also to exemplary research. The implications of these findings for remediation and prevention of research integrity violations are described.
Disclosures: The author has no financial conflicts of interest. He is the director of the Professionalism & Integrity in Research Program. Projects described in this article were funded by NIH CTSA, R01, K01, R21, ORI RRI Program, and CITI sponsorship from 2014-2016.
About the Professionalism & Integrity in Research Program
The Professionalism & Integrity in Research Program at Washington University School of Medicine was the first program developed to offer remediation following a professional lapse in research (Table 1). It was started in 2013 with a $500,000 grant from the National Institutes of Health (NIH) to develop a training program for researchers who had serious or severe compliance violations.
Program staff spent a year developing the program. They worked with an interdisciplinary team comprised of clinical, organizational, and social psychologists; ethicists; and regulators, including a staff member from the Office of Research Integrity. The program team wanted to determine the root causes of these violations and which interventions were likely to address those root causes. In doing so, they would be filling a gap, since most research ethics training does not address the root causes of violations.
The program team developed a three-day face-to-face workshop in St. Louis, which was somewhat modeled on programs for physicians who have been accused of different kinds of wrongdoing. The program begins by promising confidentiality. All participants sign a confidentiality agreement before arriving for the workshop so that they can speak freely. Participants complete a variety of measures to assess their decision-making, attitudes, knowledge of responsible conduct of research, and professional strengths before the workshop. Psychologists who have received NIH funding and have served on institutional review boards serve as program faculty.
On the third day, participants write a professional development plan. Faculty make a series of follow-up coaching calls to help participants implement their professional development plan and troubleshoot problems. The program also includes post-assessments a year after participants complete the workshop. Thus far, the program has trained 81 researchers from 48 institutions (as of September 2018).
About the Bioethics Research Center
Social scientists trained in ethics focus on helping researchers do good work through the Bioethics Research Center at Washington University School of Medicine (Table 2). Much of the work has focused on trying to understand the factors that contribute to violations of research integrity and also to exemplary research. Researchers also study issues such as informed consent and how clinical research coordinators learn good clinical research practices.
Recent responsible conduct of research projects of the Bioethics Research Center were:
- Validation of new measures for professional decision-making in research, which are necessary in order to assess researchers
- Researchers’ attitudes towards compliance and values in research
- Testing predictors of good decision-making
- The influence of nation of origin on factors related to the responsible conduct of research
- Outcomes assessment for the Professionalism & Integrity in Research Program.
The Bioethics Research Center has worked with five study populations. The largest research sample was 903 NIH-funded researchers who provided baseline data about professional decision-making. The second study population is 267 of those researchers who were born outside the United States or for whom English is a second language. Other study populations are the 68 participants in the Professionalism & Integrity in Research Program; 112 research integrity officers; and 40 published cases of falsification, fabrication, and plagiarism.
Researchers at the Bioethics Research Center have also studied research exemplars as part of Alison Antes’ NIH career development award. One recent study involved interviews with 52 researchers who were nominated by their institutions for conducting high-impact federally-funded research while having a reputation for research integrity.
When researchers at the Bioethics Research Center started their work, they thought that they would be able to identify a few silver bullets that could lead to the responsible conduct of research. They found, however, that the root causes of wrongdoing in research are almost as unique as every individual. No single factor is applicable to most cases of wrongdoing in research.
Table 3 highlights results from Bioethics Research Center research. In the 40 cases of serious misconduct by researchers studied by the Center’s researchers, personality disorders are extremely prevalent. In certain cases, evidence of personality disorders was seen in about 50% of the sample. Among participants in the Professionalism & Integrity in Research Program, personality disorders are not common; however, they can play a role. Faculty in the Professionalism & Integrity in Research Program generally find it is easy to deal with narcissism in participants because it is not difficult to convince them that ongoing violations are bad for their reputation.
The vast literature about conflicts of interest and unconscious and self-serving bias has shown that self-serving bias is not just for narcissists. It is a human trait. Center researchers have found that people who score much higher on self-serving bias do worse on the professional decision-making test.
In terms of knowledge, physician investigators often lack systematic training in clinical research. In the basic sciences, researchers are well trained in research; however, they do not know how to manage people and budgets or how to lead and inspire people.
Stress is an important factor. On an objective measure of stress, participants in the Professionalism & Integrity in Research Program tend to report fairly modest levels of stress. However, their careers are in distress and most have just undergone a year or more of being investigated. Most people have no insight about their own stress.
Stress is associated with poor decision-making, including ethical decision-making, and increased bias. People will say more racist and biased things when they are under more stress or are tired.
Researchers at the Bioethics Research Center have found that the researchers’ nation of origin or culture is the single largest predictor of lower scores on decision-making scales. They are not sure why this is true. A little more than half of the participants in the Professionalism & Integrity in Research Program were born outside of the United States. The effects of being born outside of the United States are not mitigated by earning a doctoral degree in the United States. Part of this is probably due to the fact that people from the same culture congregate within labs. Values within the household may also contribute to this finding.
The first exercise in the Professionalism & Integrity in Research Program asks participants why or whether they chose to become researchers. For some participants, their families always assumed that they would become researchers.
Professional decision-making strategies in the Professionalism & Integrity in Research Program are taught using the SMART acronym:
- Seeking help
- Managing emotions
- Anticipating consequences
- Recognizing rules
- Testing one’s assumptions.
Some of the problems seen among researchers who participate in the Professionalism & Integrity in Research Program are violations of these good strategies for making decisions.
Low scores on the professional decision-making measure are very concerning. Cynicism is more strongly negatively correlated with bad decision-making than narcissism. Assuming the worst is a form of self-serving bias. The negative correlation is even stronger for moral disengagement and compliance disengagement. Participants who know more about the responsible conduct of research tend to have higher scores on the professional decision-making measure. The more that a researcher is exposed to unprofessional data practices, the worse is the outcome of the professional decision-making score.
To measure rule discrimination, Center researchers provided a list of rules in three categories:
- Federal regulations (laws)
- Well-entrenched scientific norms (e.g., about authorship)
- Ideals (e.g., mentoring others).
Research involving research integrity officers compared their attitudes and perceptions about violations to those of researchers. Among research integrity officers, the results showed a hierarchy where it was more serious to violate federal regulations than well-entrenched scientific norms or ideals. Researchers who were born in the United States were better at predicting the views of research integrity officers and evaluating the severity of the violations than internationally-born researchers. Internationally-born researchers often rated ideals nearly as highly as federal regulations and well-entrenched scientific norms.
Work Habits of Research Exemplars
After completing the Professionalism & Integrity in Research Program, participants hold more meetings and use more standard operating procedures. Program faculty believe that these work habits often have a significant impact on some of the problems.
Table 4 highlights common habits of research exemplars based on the study of 52 research exemplars. The research exemplars work an average of 60 hours a week. This was less than the working hours of the average participant in the Professionalism & Integrity in Research Program. The research exemplars are very productive in terms of grant dollars and publications. They are far more productive than program participants.
The research exemplars tend to have many staff, they work in the office, and they are accessible most days when they are in town. They hold regular meetings and unscheduled meetings as needed. The research exemplars look at the raw data and store all of the data in one place so that they can access it, which is crucial.
Using standard operating procedures (SOPs) for science and compliance is another work habit of the research exemplars. When working with industry, institutions often worry about conflicts of interest; however, industry generally provides good SOPs for compliance. Violations often occur when people move into new unfamiliar territory. For example, researchers may be at risk when conducting their first investigator-initiated trial.
Opportunity to Prevent and Fix Wrongdoing
The right environment is necessary in order to prevent and fix wrongdoing in research. In the more serious cases, there was often lax oversight. Principal investigators are held responsible for wrongdoing in research. This is why the Professionalism & Integrity in Research Program teaches participants leadership skills. The program also emphasizes ensuring that everyone on the research team is well trained and that data are kept in one place. Data sharing and collaborative research are also important. Transparency in general is key. Most serious wrongdoing occurs when there is a lack of transparency.
The Professionalism & Integrity in Research Program works with small groups comprised of researchers who have had a career crisis and are motivated to learn. Faculty remediate the causes of wrongdoing through intensive small group work and activities with worksheets. The activities include examining self-serving bias and compliance. Individualization is provided through worksheets for every activity. The program also includes stress assessments, techniques for stress management and research management, and role playing on effective communication. On the third day, participants write a professional development plan, which usually includes work habits. After the workshop, faculty use coaching calls to provide continued support and guidance to participants.
Professionalism & Integrity in Research Program Outcomes and Limitations
Researchers in the Bioethics Research Center published a paper in Academic Medicine (“The Professionalism and Integrity in Research Program: Description and Preliminary Outcomes,” April 2018) showing that the Professionalism & Integrity in Research Program resulted in:
- Significantly decreased compliance disengagement
- Improved professional decision-making
- Increased use of good work habits.
These results cover the first three years of the program (2013–2015) and are based on self-report from 39 researchers from 24 institutions. One of the things that participants do not mention changing is communication, which is often a challenge for them.
Limitations of the Professionalism & Integrity in Research Program include that the researchers are not in control of the research environment. Program faculty must repeatedly tell the participants that they need to focus on the things that they can change.
Communication with the participants’ institutions depends upon each participant and institution. Sometimes faculty have a great deal of communication with the institution and sometimes they do not. The only information that faculty share with the institution, with the participant’s permission, is completion of the certificate, which is itemized, and the professional development plan. Faculty will listen to background information from staff at the institution, which is helpful.
Another limitation is that the Professionalism & Integrity in Research Program cannot change a researcher’s personality. Researchers with big egos tend not to be a major problem for the program. It is quite serious, however, if researchers have attention deficit disorder. Faculty encourage these participants to partner with someone who can assist with compliance and data quality. Also, participants must have decent English proficiency in order to participate in the program.
Professionalism & Integrity in Research Program Outcomes and Limitations
Requiring training in the responsible conduct of research is typical, and this is a federal mandate for researchers who receive funding from the National Institutes of Health or the National Science Foundation. Most training in the responsible conduct of research, however, is not associated with any outcomes. Studies conducted in the Bioethics Research Center have examined researchers with training in the responsible conduct of research ranging from zero to more than 300 hours. The training is not correlated with a single variable that Center researchers study.
Providing training in the responsible conduct of research is important; however, the training must use evidence-based teaching to foster knowledge. The training should also teach researchers skills and compensating strategies such as professional decision-making skills, foster the good work habits that will help researchers manage a clinical trial or laboratory successfully, and be sensitive to cultural differences.