James DuBois believes in second chances.
DuBois, DSc, PhD, the Steven J. Bander Professor of Medical Ethics and Professionalism at Washington University School of Medicine in St. Louis, founded the first national training program for researchers who have had lapses in laboratory compliance or research ethics, providing strategies and resources to help them get back on track.
“I grew up in a household where everyone was quite passionate — quick to yell perhaps but quick to forgive,” DuBois said. “And I think that element of my upbringing might come through in this training program. People make mistakes. Let’s help them do a better job.”
Finding a remedy
The Professionalism and Integrity in Research Program is funded by the National Institutes of Health (NIH) and provides intensive training in the responsible conduct of research. Since its inception in 2013, nearly 90 researchers from over 60 institutions across the country have been through the three-day workshop. Scientists’ participation typically is required by the institutions where they work.
“Most of the scientists who come to our program are good researchers,” said DuBois, also a professor of psychology and of medicine. “But maybe they’re not prioritizing research compliance, or they’ve got so many projects, they can’t provide adequate oversight. These aren’t people who have deliberately fabricated data — that’s a more egregious offense that would be handled differently. But even if it’s not deliberate, poor data management practices can create false data, and the scientific community needs a way to address these kinds of problems.”
The Professionalism and Integrity in Research Program is unique across the country, according to DuBois. Before it began, he said, institutions seemed to have only two options for addressing lapses in research compliance or integrity: Fire the researcher, which might end a career; or write a stern letter and perhaps require an online training module, which does little to elicit true change.
Frustrated by these limited extremes, DuBois sought a middle ground.
“Our program is focused on teaching good decision-making skills, stress management, people management, leadership skills and providing a lot of practical tools so that when the researchers return to their labs, they have concrete strategies they can apply to make everything run more smoothly,” said DuBois, who also directs the Bioethics Research Center, which is part of the university’s Institute of Clinical and Translational Sciences. “Being investigated for wrongdoing is traumatic, and we have found that our program really does help scientists get their careers going again.”
It also helps researchers identify where their own lapses in research ethics might have originated, or how they fell short in complying with any relevant regulations — whether, for example, in making missteps to getting informed consent for research involving people; in research protocols involving animals; in managing data storage; or in providing oversight of data analysis by trainees. After examining how the problems came to be, the workshop provides strategies to remedy them.
The human side of science, medicine
To help inform the program, DuBois and his colleague Alison Antes, PhD, an assistant professor of medicine, also study researchers who embody model qualities. The two interviewed 52 investigators nationwide whom they dubbed research exemplars, or researchers who conduct consistently high-quality research while exemplifying integrity and professionalism. Fellow scientists nominated the researchers.
In a recent publication about these standout investigators, Antes and DuBois wrote, “According to the exemplars, research requires attending to matters of heart as much as mind. The human dimension in research was the common thread in their advice for a successful career.”
Indeed, the single most important quality for career success — cited by more than half of the exemplars — might come as a surprise. It was not skill or intelligence. Likewise, passion, resilience and leadership were high on the list, but not at the top.
The most important key: good relationships.
“Having good working relationships is an ethical issue that is often ignored,” DuBois said.
And when viewed broadly, fostering good relationships can encompass issues of diversity, equity and inclusion in scientific research, areas that DuBois and his colleagues have begun to explore in a unique journal he founded and edits, called Narrative Inquiry in Bioethics.
The journal is unusual in that it publishes first-person accounts from individuals — health-care providers, patients and their family members — who have had some encounter with ethical questions in medicine or health care.
“What I love about this journal is there is no filter; these are people sharing their own stories in their own words about their lived experiences,” DuBois said.
Past issues have explored the stories of patients who experienced stigmatization from a health-care provider, perhaps due to obesity or autism. One dealt with stories of moral distress among health-care providers — for example, cases in which Medicare rules or insurance companies blocked care the providers felt was best. The most recent issue focused on the #MeToo movement and published female surgeons’ stories of sexual harassment. DuBois emphasized that the stories are not all negative. In one issue on living organ donors, for example, some called the experience of donating an organ among the most rewarding of their lives.
“We try to publish the broadest range of experiences to introduce people to the issues and explore ethical questions,” DuBois said. “And then we have commentary articles from different experts such as health-care ethicists or medical anthropologists, who try to pull out major themes and draw lessons to inform policy or practice.
“In general, we approach these issues as social scientists of ethics, rather than ethicists,” he added. “In other words, we’re studying the issues and posing questions that are important for people to consider, rather than trying to give people answers.”
Posing questions, seeking answers
Another component of DuBois’ work is serving as an adviser to a national study called APOLLO, which is an effort to improve outcomes for African American patients who receive kidney transplants. Among people of West African ancestry, there are relatively common genetic variants in a gene called APOL1 that increase the risk of kidney disease. People of other ancestries have never been found to have these high-risk variants. As part of the study, researchers would like to perform DNA sequencing of this gene in living and deceased kidney donors and the recipients, and then track how well recipients do, knowing which donors and recipients have the high-risk genetic variants.
“This raises obvious ethical issues,” DuBois said. “One racial group is being singled out for genetic testing. How do you identify who should be tested? The black community is extremely diverse — not everyone is of West African descent. Should testing be mandatory? Should you tell the recipients that their kidney donor has one or both high-risk variants? There are so many ethical and social issues here. We are excited to launch a project that will study these issues, and we look forward to working with the communities and patients involved with this trial to foster a consensus on acceptable clinical policies.”
DuBois described some of what he has already learned in serving on the community advisory board for the APOLLO study.
“Members of the board discussed how unfortunate it was to call it the APOLLO study,” DuBois said. “For many people, the word ‘study’ to describe research involving solely people of color is reminiscent of the extremely unethical Tuskegee study, in which African American men with syphilis were deliberately not treated in order to study the disease. Calling APOLLO a research project or an investigation might have been more sensitive to that history.”
But members of the advisory board also pointed out the importance of not assuming that any potential mistrust African Americans might feel toward medical research is only due to historic wrongdoing.
“It’s also the everyday racism that is present and ongoing in many health-care encounters,” DuBois said, recalling the board’s discussion. “That systemic racism is evident in the massive differences in health and wellness that we see between African Americans and white populations in this country.”
With that in mind, DuBois said the staff of the bioethics journal is planning an issue that will explore first-person accounts of racism in health care, along with possible constructive responses to such occurrences.
“The scope of the problem of racism in St. Louis and throughout the whole nation can be overwhelming,” DuBois said. “But we’re trying to find small ways to take a stand and do something to address some of these issues.”
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