Trying to reign in a few difficult PIs?
Trying to reign in a few difficult PIs?
Here are tips for dealing with them
Every compliance department has encountered the occasional investigator who causes staff to pop antacid pills the minute he or she walks into the room. And such personalities may have been tolerated in the past, with today’s tighter focus on research compliance and ethical concerns, such personalities now can be a real problem.
There are several common personality and behavior problems that clinical trial staff might encounter among investigators, including the following:
• "Rules don’t apply to me."
"One of the biggest concerns is a scientist who feels the rules don’t apply to him," says Cindy Kiel, JD, CRA, director of sponsored projects at the University of Nevada, Reno.
"A lot of times these are brilliant people," she explains. "When dealing with cutting-edge research, what most researchers are doing is pushing what is known, disproving what people thought they knew."
Because of the maverick personality needed to succeed in this type of research, often the successful investigators also are people who are more creative than bound to rules and conventions, Kiel explains.
"Sometimes that can flow over into the compliance world where an institution might end up with legal and liability concerns if the individual feels the rules don’t apply to him or that they were made to be broken," she says. "There are times when you need to think outside the box and times when you need to play inside it."
The solution to dealing with an investigator who refuses to follow rules and regulations could be terminating the person’s position or contract; although with university tenure tradition, that is extremely difficult to do, Kiel notes.
"If the person causes extreme liability then you need to go down that road, but if the person will listen to reason, then the team approach sometimes will work," she suggests.
By this, Kiel means that research administrators assemble a group of people at the institution to sit down with the investigator, explain what the problem is and why it’s a problem, and let the person know that if things don’t change there will be severe repercussion, such as a job dismissal, she notes.
"Hearing stories about extreme examples of what happens with noncompliance does help," Kiel says.
For instance, when federal officials brought criminal charges against faculty at another institution because of their inaccurate effort reporting, that got the attention of researchers, she notes.
"When our faculty saw their colleagues facing criminal sanctions they started calling our office to say, Tell us what the rules are because we want to follow whatever the rules are, and we don’t want to get close to the edge,’" Kiel recalls. "It has much more of an impact when it’s someone they know who gets into trouble."
• "Don’t bother me with details."
"A second variety of difficult scientists is the individual who feels like, I’m only here to do my science, and don’t bother me with the business details — that’s not why I was hired,’" Kiel says.
The most effective way to cope with these types of personalities is through proper training of the roles and responsibilities, especially when the person is first hired or learning to become a researcher, she says.
• "It’s not my world, and I don’t want to have to do it."
Then there’s the type of investigator who simply refuses to follow some rules and obligations, such as taking time for mandatory training courses, Kiel says.
"A lot of institutions have made training mandatory, and those sometimes are the ones who have been hit with legal or audit findings," she notes. "That gives them the clout on campus to say, We will make this training mandatory.’"
Still, there always are the scientists who will say the rule shouldn’t apply to them because they haven’t gotten into trouble or because they are so low on the federal radar screen that no one will be looking over their shoulders, Kiel says.
One solution is to make the training as pertinent and valuable as possible for investigators, so they cannot use the argument that they wouldn’t learn anything from it.
Every compliance department has encountered the occasional investigator who causes staff to pop antacid pills the minute he or she walks into the room. And such personalities may have been tolerated in the past, with todays tighter focus on research compliance and ethical concerns, such personalities now can be a real problem.Subscribe Now for Access
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