Conflict of interest issues raised by subject's suicide
Conflict of interest issues raised by subject's suicide
Subject's mother sued based on COI
When is the dual role of physician/investigator a conflict of interest? This is the question IRBs might consider in the aftermath of clinical trial participant Dan Markingson's suicide.
Conflicts of interest among physician investigators are on a lot of IRB members' minds as the U.S. Senate has held hearings on the matter, says Mark S. Schreiner, MD, an associate professor of anesthesia in pediatrics at the University of Pennsylvania in Philadelphia, PA. Schreiner also is the chair of the Committees for the Protection of Human Subjects at The Children's Hospital of Philadelphia.
Earlier this year, Sen. Chuck Grassley (R-Iowa) and his staff investigated payments made by drug companies to three psychiatrists/researchers, employed at Massachusetts General Hospital in Boston, MA. Grassley then called for a national reporting system that would track payments made by the drug industry to researchers.
Both the Markingson case and Grassley's investigations highlight how important it is for IRBs to be aware of any perceived or actual conflicts of interest among investigators.
Perhaps in response to both instances, AstraZeneca of Wilmington, DE, announced in May, 2008, that the company supports the revised Physician Payment Sunshine Act that Grassley and Sen. Herb Kohl (D-Wisconsin) sponsored. The act would create a national registry of payments made to health care providers and medical organizations by biopharmaceutical companies, medical supply companies, and device manufacturers.
Mary Weiss, Markingson's mother, claimed in a lawsuit that the investigator of her son's trial had a conflict of interest because of his dual role as her son's primary physician and an investigator in the study. The same person who diagnosed her son with schizophrenia also determined that he met the enrollment criteria and that he had the decisional capacity to understand that he could receive treatment whether or not he participated in the clinical trial. Weiss also claimed that the investigator's five-figure payment for each subject's enrollment created a conflict of interest.1
While it is debatable whether any particular payment per enrolled subject is considered excessive enough to be a conflict of interest, in general these payments are considered acceptable, Schreiner notes.
"Clinical trials are a huge amount of work," he says. "If you only paid people what they'd receive in clinical care then they'd never do research."
Also, there are many studies in which the primary physician is also the person who is conducting the clinical trial, Schreiner says.
"Parents of children in pediatric studies often agree to participate because the investigator is their physician, and they have trust in him," he says. "This is not a straight-forward issue."
The tradition of having physicians enroll patients in research protocols is a long and time-honored tradition that is done in a variety of medical fields, including oncology, says John Csernansky, MD, Gilman professor and chairman in the department of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine in Chicago, IL.
"When I chaired an IRB it was commonplace to see protocols where physicians enrolled their own patients in research," Csernansky says. "HIPAA regulations somewhat encourage this because these are patients who you can approach about research since they're your own patients."
If the question is whether a primary care physician should also be the principal investigator, the answer is both 'Yes' and 'No,' says Don E. Workman, PhD, interim associate vice president for research operations at Northwestern University in Evanston, IL.
"The reason for saying 'Yes' is that the physician knows the patient already and has the context and history from which to continue to monitor what's in the patient's best interest," Workman explains. "The reason for saying 'No' is that he may now confuse the two roles, and the patient may confuse the researcher as caregiver, and the physician might switch roles and treat the patient only as a subject."
So whenever there is a dual role, the physician/investigator needs to be cognizant of the dual role and manage it adequately, always recognizing that the patient is a patient first, Workman says.
Another strategy, particularly when a clinical trial involves a vulnerable population, would be to involve an independent second doctor to review patient care decisions.
"It's well accepted for principal investigators to be a person's doctor," says Alan M. Sugar, MD, chairman, New England Institutional Review Board, and a professor of medicine, Boston University School of Medicine, Boston, MA.
"The problem is exacerbated when people are vulnerable, such as psychiatric patients," he says.
"It's not the IRB's position to resolve the problem, but it needs to be discussed and solutions suggested," Sugar says. "One solution is having an independent, second doctor verify what the principal investigator/primary doctor wants to do, but there are some issues with that, as well."
For instance, the second doctor likely would be someone who works with the primary doctor, so there'd be a question of whether the second doctor's opinion was truly autonomous, he adds.
"The best thing is for the principal investigator to be separate from the person's physician, who then can act as the patient's advocate," Sugar says. "If there's any question, err on the side of caution and have other people participate."
Reference
- Olson J, Tosto P. Dan Markingson had delusions. His mother feared that the worst would happen. Then it did. St. Paul Pioneer Press May 23, 2008. Available at: www.TwinCities.com.
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