Normalization of deviance can lead to problems

Education is key to ensuring ethics compliance

In order to protect human subjects and the integrity of research, everyone involved should adhere to ethics guidelines and must adhere to ethics and compliance standards. IRB members, investigators, lab workers, and others involved in trials have a large number of compliance rules to follow. But compliance can be a burdensome thing, and researchers who are under significant pressure can feel the strain and might let rule-following slide.

John Banja, PhD, a professor and medical ethicist at Emory University in Atlanta, refers to the “normalization of deviance” — a behavior he says is found in virtually every profession that requires adherence to rules and procedures. Employees will occasionally take shortcuts or not completely adhere to a policy or procedure. “It’s not because they’re bad people. But often they don’t know what the rule is, or they feel enormous pressure to take shortcuts or do workarounds. They might feel that strict compliance with every policy, procedure, rule and regulation compromises their productivity, which they don’t want to sacrifice at any cost.”

“What we know from the published literature is that violations can range from mild to outrageous,” says Banja. Violations might consist of reports not filed on time or informed consent not being signed or recorded appropriately, or they might involve falsifying reports or failing to report serious adverse events. “Oftentimes, too, investigators don’t know what the appropriate regulation is and they’ll think they’re doing nothing wrong. Sometimes, you’ll have research protocol going on for a few years, and people will leave and new investigators come on board who aren’t entirely familiar with the protocol, and do things their way without checking the original protocol.”

“We always will get a certain amount of reported events from unanticipated problems related to new drugs and devices, or new treatments where something different happens than before,” says Carlton Dampier, MD, professor of pediatrics at Emory University School of Medicine. “We get a modest number of reports where the protocol wasn’t completely followed, and we work with investigators to make sure they can develop a plan to do it better. If the protocol isn’t feasible in the current structure, then we work with them to make sure they can be appropriately compliant.”

Dampier and Banja sit on the Q, or Quality, committee of the IRB at Emory, which hears protocol deviations when they come to light. Investigators are expected to have a corrective action plan (CAP) in place to handle the issue, and usually that’s all that’s needed, Banja says. For instance, if an investigator discovers some sensitive files that have been misplaced in a non-secured storage area — which would be a HIPAA violation — the violation would be properly reported and the files would be removed to a secure, HIPAA-compliant area. “On the other hand, if it’s a very serious deviation, like falsifying documents or failing to report a serious conflict of interest, the transgression would have to be reported to various offices like our office of research integrity or the conflict of interest committee and probably reported to the sponsor,” Banja says. “The ones that cause leadership at elite research institutions to lose sleep are when rule or regulation deviations endanger the welfare of research participants, corrupt research data, or flagrantly violate conflict of interest rules.”

Institutions are continuously challenged to ensure that their conflict of interest cases are carefully managed. It is almost inevitable, Banja says, that the more successful you are as a researcher, the more likely you will have financial ties to the drug or device industries. “The more prestigious you are, the more likely you are to have a conflict. It’s not necessarily wrong, but you have to take appropriate management steps. Conflict of interest committees and IRBs increasingly are getting more and more cautious and demanding with their researchers, and sometimes even forbid their getting involved with certain aspects of the research — like recruiting participants or interpreting data.”

Compliance through education

With a multimillion dollar grant from the NIH’s National Center for Advancing Translational Science, Emory University, Georgia Institute of Technology, and Morehouse School of Medicine have formed the Atlanta Clinical and Translational Science Institute (ACTSI). ACTSI launched six years ago, and the ethics program developed a website (http://www.actsi.org/ethics) containing dozens of ethical dilemmas in research including informed consent and privacy issues, data interpretation, drug trials, intellectual property, mentoring, and other issues. Dilemma submissions primarily come from graduate and post-doctoral students. Each dilemma is then followed by an expert opinion, in which the experts recommend a course of action. “[The site] gets hundreds of hits every month,” Banja says. “It’s a wonderful storehouse of ethical expertise. That’s why we put it there — for professors and students to have some teaching materials featuring expert opinion.”

Emory University’s Office of Research Compliance conducts lectures and educational activities throughout the year, while graduate students at Emory University’s Laney Graduate School are required to take an ethics course that consists of coursework and additional training from the students’ departments. Post-doctoral students take a course on ethical issues as well that features discussions and case studies.

“This is part and parcel of creating a culture of research ethics and compliance. I think that we are doing a fabulous job in terms of teaching grads and post-docs on ethics and compliance. But I don’t know if we are doing all that good a job with engaging our senior researchers with issues about compliance and ethics,” Banja says. “There are some people who have been in the field 20 or 30 years and who may have developed bad habits, or feel the rules don’t apply to them and think they haven’t gotten to where they are by following rules.”

Ensuring compliance probably works best as a top-down approach, Banja says, starting with leadership: administrators, supervisors, lab directors, principal investigators. “They are the people who really need to be impressed with ethics and compliance because they are the role models,” he says. “The people who are in the trenches look to them for guidance and leadership.”

A case can also be made, he says, for positive deviance — in other words, if there is a more efficient way of doing things, or if a rule actually gets in the way of patient safety. “We need to do a better job of changing rules and regulations that are truly inefficient and largely worthless to make life for researchers easier,” Banja says. “I will tell you that rule following is one of the most burdensome kinds of chores they [researchers] have to do. Just staying abreast of new rules and regulations can be daunting, not to mention complying with them to the letter.”

“You have this very interesting tension between innovation and vigilance and carefulness,” he says. “Innovators are oftentimes risk-takers and sometimes push their creativity to limits. So, if a rule gets in the way they might look for way around it or simply ignore it. On the other hand, you have to protect patients and the quality of data. So, the tension between innovation and exquisite carefulness likely won’t disappear any time soon.”