Program helps “RePAIR” noncompliance issues
Remediation instead of punishment
A new research ethics program seeks to repair problems when investigators misbehave or are in noncompliance.
The RePAIRprogram.org (Restoring Professionalism & Integrity in Research) was created with a $500,000 grant from the National Institutes of Health (NIH) to train investigators who have engaged in wrongdoing or unprofessional behavior, says James DuBois, PhD, DSc, director of the Bander Center for Medical Business Ethics and a professor of health care ethics at Saint Louis University in MO.
“We had a year to piece together a curriculum that would address someone engaged in some sort of wrongdoing in research or chronic noncompliance,” DuBois says. “These could range from data integrity to IRB issues, including people recruiting inappropriate patients into clinical trials.”
RePAIR is a three-day seminar program in which participants are coached through an action plan. They attend in small groups, and the remediation is similar to what has been available in the field of medicine for years, DuBois says.
The NIH-funded program focused on both human subjects research and animal research, he notes.
RePAIR has received national publicity recently with a January article in the journal Nature.
“A lot of people are spinning it as a program focused on research misconduct, but we want to provide services to a much bigger group of people, including human subject researchers whose IRBs told them they are in noncompliance,” DuBois says. “We’re trying to get to the root causes and address the way they think about research to address biases.”
DuBois conducted a survey last year that looked at how common wrongdoing is in research. It found that 96% of institutions surveyed had investigated a case within the previous two years. The problems investigated ranged from procedural — the most common — to consent issues, oversight, conflict of interest, privacy, recruitment, and fraud problems.
“We surveyed 194 research-intensive schools in the nation, including medical schools, and we found that over the past two years nearly every institution had investigated someone formally,” DuBois says.
Stress is a contributor to wrongdoing, he notes.
“If you have a stressful life, like going through a divorce or bankruptcy, you can make worse decisions,” DuBois explains. “So one solution is to teach researchers stress reduction techniques.”
Also, there are certain personality patterns that can lead to transgressions. For instance, some people who engage in unethical behavior have self-serving biases, which include self-centered thinking, assuming the worst, blaming others, and minimizing or mislabeling problems.
Cynicism a problem
“Some people have a strong sense of entitlement or cynicism,” DuBois says. “People who habitually assume the worst or think badly of their colleagues or institutions are more likely to make bad ethical decisions, and environmental factors can play a role.”
In DuBois’ research, he has also observed that in the human subjects protection field, wrongdoing can be a result of rules and regulations that are fairly ambiguous.
“You see some really scandalous cases where they had IRB approval,” he says. “One example is the Kennedy Krieger [Institute] case — a lead abatement study that was controversial and was IRB approved.”
The Kennedy Krieger Institute is a children’s health and research facility that is part of Johns Hopkins University in Baltimore. The institute conducted research about low-cost partial lead abatement procedures in public housing in Baltimore between 1993 and 1995. The goal was to prevent lead poisoning in children. Two families sued the institute, saying they were not fully informed of the risks. A court of appeals issued a ruling that compared this study to the Tuskegee syphilis study and Nazi research on prisoners, calling the experiment callous for using children as measuring tools. The court focused on informed consent and said that parents could not give consent for their children to enroll in non-therapeutic research.1
The point is that the way IRBs interpret minimal risk has been very inconsistent, DuBois says.
“If you ask 10 IRBs if an MRI is risky or not, you get 10 different answers,” he says. “So we try to identify where investigators are on the ambiguous rules and how they can gain clarity, what processes they can follow, and who can they call to get answers to questions to ensure they are proceeding in a way that would be compliant.”
The goal of RePAIR is remediation, changing behavior through confronting, educating, and monitoring professionals engaged in inappropriate behavior.
What IRBs can do
IRBs can be part of the solution if they focus on how they respond to investigators’ phone calls and requests, Dubois notes.
“One challenge investigators face is when they call the IRB office for guidance, the IRB staff can advise, but they’re not decision makers,” DuBois says. “It’s really the IRB members, and sometimes researchers hear contradictory answers, and that contributes to ambiguity.”
If researchers know more about a particular topic than the IRB members reviewing the study, they need to share their information with the IRB, he says.
It’s helpful to enhance and foster communication between the IRB and researchers, he adds.
“Also, earlier intervention with researchers can be helpful,” DuBois advises. “Ask yourself whether the behavior problem is due to a lack of knowledge or due to something else.”
If the problem is knowledge-based, the solution could include sending the researcher to a human subjects protection course or workshop through CITI or PRIM&R, he suggests.
This strategy won’t work if the investigator knows the rules but just chooses not to follow them, he adds.
“What I hear about a lot from colleagues in the field is, ‘We have an investigator and this problem has been festering for three years; we’ve had to intervene four or five times,’” DuBois says. “That problem is unlikely to change abruptly without some sort of effective intervention.”
In DuBois’ recent study of 100 published cases of wrongdoing in research and medicine, he found that 81% involved repeated wrongdoing.
Research institutions should look for alternative interventions when their usual measures, such as a letter of reprimand or sending an investigator for more education, fail, DuBois says.
“When you’ve written the letter and reminded them of the rules and still are seeing repeat offenses, that’s the scenario that the RePAIR program has in mind,” he adds.
When DuBois watched a RePAIR session, he observed how investigators would arrive with a chip on their shoulders, feeling punished by having been sent to the seminar.
“Within an hour they were fully participating and left, saying, ‘Thank you,’” he says.
The program is expensive to run. It includes coordinators who conduct interviews with institutional officials and two faculty members who devote a week to the program, including preparation work and follow-up calls.
The RePAIR program runs three times a year with the next session in May 2013. It costs $3,000 for the course, but through partnerships with institutions there is a 50% discount, DuBois says.
“We ask them to use us for remediation training for $1,500 a year, and we give them access to a webinar each year to deal with wrongdoing,” he says.
Research institutions can show their commitment to remediation by covering part of the cost when investigators are required to participate in this type of intervention, he notes.
“It sends a message to the investigator that this is not about punishment, but investing in you as a researcher,” DuBois says. “They’ve made a decision to not fire this person.”
While it may be easier for institutions to simply fire investigators who have engaged in misconduct, this is shortsighted, he adds.
“You might have someone who is not intentionally running afoul of the rules, but still is noncompliant,” he explains. “In cases that turn out tragically bad and the school deals with bad press, sometimes the actual compliance failure is unintentional and not all that egregious despite its horrible consequences.”
There are a lot of different reasons why someone is not in compliance, DuBois says.
“Still this is a situation that has to change, and we’re in the business of helping them change and be more effective as researchers,” he adds.
Reference
- Buchanan DR, Miller FG. Justice and fairness in the Kennedy Krieger Institute Lead Paint Study: the ethics of public health research on less expensive, less effective interventions. Am J Pub Health. 2006;96(5):781-787.
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