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Promoting an ethical culture might succeed where rules fail
Compliance requires understanding
Research organizational leaders sometimes forget that it takes more than firm written rules and guidelines to create an ethical and compliant clinical research atmosphere.
Clinical research leaders need only to look at media attention paid to research problems and noncompliance over the past decade to realize that good intentions do not always lead to good results.
"In some respects, compliance challenges have been made easier by the fact that we've had a lot of attention paid to a lot of important compliance areas over the last couple of years," says Kristin West, JD, an associate vice president for research administration and the director of the office of research compliance at Emory University in Atlanta, GA. West spoke about the elements of a strong compliance program at the 2009 Advancing Ethical Research Conference, held by PRIM&R [Public Responsibility in Medicine & Research], Nov. 14-16, 2009, in Nashville, TN.
Academic and medical research organizations now can see the value that's added to having strong compliance programs: institutional reputations are at stake, West notes.
Examples of ethical breaches have made headlines in medical research, as well as in government, corporate business, and Wall Street investments in recent decades.
"There's a fabulous code of business ethics from 1990, describing a company that you'd want to work for just because of all the thinking that went into this code. But this was Enron's code of ethics," says Elizabeth Heitman, PhD, an associate professor in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center in Nashville, TN. Heitman spoke about creating a culture of compliance at the recent PRIM&R conference.
The Enron Corp., whose very name is synonymous with pervasive corporate fraud, had the right kinds of compliance rules, but lacked a culture of conscience and integrity among its leadership, Heitman says.
"They'd done all of the work that lays out what the code of conduct should be, and they had an internal component of ethics for employees to follow, but the company was rotten at the top," she explains. "And being rotten at the top meant the body couldn't survive."
Enron ended up with a reputation not for excellence, but as a punch line to a joke, Heitman adds.
Institutions that have strong compliance programs with safeguards in place are less likely to be the subject of long-term public interest even when something goes wrong, West suggests.
"It loses a lot of sex appeal as far as the media is concerned, and the same goes for audits and investigations," West adds.
"No audit or investigation by a regulatory agency is ever going to be perfect," West explains. "But if you can show you have tried to predict and put in place processes to eliminate those findings, then you're going to get a lot of credit for that if you have an FDA inspector monitor show up."
Research organizations likewise need a strong sense of leadership about how to do excellent work with integrity, Heitman says.
"Everyone needs to be working for a common goal, and there needs to be compliance policies that work, not policies that drive people crazy," she adds.
For example, if a research institution requires detailed documentation and justification of every travel expense and expects staff to complete these items on paper, as well as electronically, then the institution may be inviting noncompliance.
"An onerous method of completing required paperwork discourages people from doing it right," Heitman says.
Another self-defeating practice is to have administrators treat employees like they're untrustworthy and arbitrarily restricting their activities regardless of its correlation to actual compliance goals.
This creates an atmosphere in which employees feel the institution is unfair, and this feeling of unfairness can lead to noncompliance, Heitman notes.
"A study by Brian Martinson, Melissa Anderson, Lauren Crain, and Raymond de Vries found one of the most important predictors of misbehavior by researchers was the sense that the environment they worked in was not fair," she says.1
Institutions that too rigidly or too inconsistently enforce compliance rules run this risk.
"People might feel the rules are unfairly imposed on them or that the administrative structures of their institutions don't really fit their work, or that other people are allowed to get away with things and they are not," Heitman explains. "This is the kind of culture in which people may begin to cheat or maybe just begin to interpret the rules in their favor in order to level the playing field."
For example, researchers already spend a big portion of their time attending to documentation and administrative duties, so institutional leaders should be sensitive to this and not impose unnecessary additional documentation requirements.
It's a fine line between paying careful attention to the good stewardship of resources, which is what compliance offices are about, and creating burdensome documentation demands, Heitman says.
When compliance policies are burdensome then employees will seek shortcuts or will procrastinate, both of which could lead to noncompliance, she adds.
Another counterproductive strategy institutions sometimes take is to create policies that reflect all regulatory rules and organizational guidelines and then have employees sign copies to show they have read them, only to drop the subject after that, Heitman says.
University officials might think the institution is off the hook once it has employees sign the rules document, but what it might be doing is creating an atmosphere in which people believe compliance is a signature and not a process.
This type of hands-off approach might send the message of "We need to get this done, and we don't care how you do it," Heitman explains.
The key to avoiding these types of institutional dangers is to create a culture of compliance through words, action, and deeds.
"The idea of making it easy to do the right thing is also to make it easy for people to want to do the right thing," Heitman says. "Employees should want to make their institution proud, to work at a place they're proud of, and to have the rest of the world know they do good work here."
These feelings of pride come not just from high publication rates or obtaining grant money, but from a collegial atmosphere in which no one wants to find a different job, and everyone else wants to work there too, she adds.