When Good Intentions Hurt

Only 8% to 10% of the world has ever been approached about doing a study.

Among them: Kaye Spector. It was a close doctor, a surgeon, who first approached her about one. Since then, the Ohio-based health/medical writer has said yes to two more. A desire to give back to the doctors who saved her life convicted Spector. “I wanted to help them as well,” she says.     

Such good intentions, however, can raise eyebrows. “Some people criticize that,” says Jonathan Seltzer, MD, director of clinical research at the Main Line Health Heart Center and president and CEO of ACI Consulting Group. Those who criticize fear patient exploitation at the hands of an investigator, the trusted doctor.

“But,” says Seltzer, “it’s the doctor’s job to be so clear it’s ultimately okay for them to do it. It’s like your house builder saying, ‘I think we should try to do that.’ If you trust the person, yes, you’ll do it.”                

If you don’t trust them? Then they shouldn’t be a doctor or a house builder. Unfortunately, that fact doesn’t stop nontrustworthy people from joining either professions. That’s where the law comes in.         

Or at least tries to sometimes. But laws or regulations cannot be enacted to create a system of honesty. If that were true, the jails would be empty. 

In the case of clinical trials, regulations are deemed necessary to prevent misconduct or tragedy from striking twice. But these good intentions can birth negative consequences for investigators.

“It’s always the high-profile cases that engender some kind of response,” says Seltzer, “so instead of a sort of systematic examination of [if] this is a one time thing, there’s always a new law or new regulation.”

The result: Seasoned investigators must sit through a three-hour course once a year to prove they’re trustworthy. Frustrating? Imaginable. It’s for a good cause of course. Problem is, it’s also demeaning to some investigators, says Seltzer.

So, they opt out of research. It’s like the straw that breaks the camel’s back, which is already laden with heavy clinical administrative burdens and patient loads.

And we lose another good investigator.