The Association of American Medical Colleges recently announced new conflict-of-interest guidelines for medical researchers involved in experiments with human subjects.
The guidelines -- developed by an AAMC task force comprised of various stakeholders in human testing, and endorsed by 26 of the 28 task force members -- prevent researchers at the AAMC's member schools who have a "significant" financial interest in the outcome of experiments from conducting them, unless "compelling circumstances" arise.
They were designed as a basic standard for AAMC's 125 member medical schools, which include Penn's School of Medicine. The AAMC is a non-profit association that works for reform in medical education.
The issue had arisen at Penn, as well, when a lawsuit was filed against the University, its Institute of Human Gene Therapy head James Wilson, and several other researchers and institutions after the death of 18-year-old Jesse Gelsinger, Wilson's genetic research patient.
Had this criteria existed in 1999 when the experiment that resulted in Gelsinger's death was conducted, more questions may have been asked as to whether or not Wilson should have been barred from personally conducting tests on Gelsinger and other patients due to a conflict of interest.
Wilson was the founder of Genovo, Inc., which held patents for any therapies that resulted from the trial that Gelsinger was involved in.
The University itself also had a claim at that time to any profits that may have been generated by the experiment involving Gelsinger.
"The Gelsinger Case was highly publicized and drew attention to concern about financial relationships," said Jennifer Kulynych, the director of the division of biomedical and health sciences research at AAMC. "With the Gelsinger case there has been more attention to conflict of interest as a human protection issue."
Kulynych added that the AAMC task force was created to reevaluate the role of financial interest in human testing because of numerous cases, including Gelsinger's, discussed at a conference at the National Institute of Health concerning the subject.
While the guidelines bar researchers with a "significant financial interest," defined by the National Institute of Health as $10,000 or five percent ownership of a company, they allow individual institutions to decide whether extenuating circumstances should allow the researcher to participate -- though even if allowed to participate, the researcher's influence is greatly diminished.
The guidelines also require medical schools to disclose all conflicts before and during the research to the institutional review board of the school -- which approves all experiments involving human research -- and other outside parties. As stated in the report, "transparency must be the watchword for the oversight of financial interests."
The Director for Penn's Center of Bioethics Arthur Caplan said he is in favor of the AAMC's new guidelines. "I absolutely support it," he said, adding, "If you have a conflict of interest, don't study the drug or treatment yourself."
However, Caplan also said that these guidelines would not have made a big difference in the case of Wilson and Gelsinger.
Had Wilson not been involved, "the [Gelsinger] study would have changed slightly," Caplan said. Many aspects of the trial, however, would have remained the same. For example, Caplan noted, Mark Batshaw and Steven Raper -- the two main researchers working with Wilson in the Gelsinger case and involved in the lawsuit -- did not have a financial conflict of interest in the experiment.
Caplan said he believes that Wilson did not stand to gain a significant financial reward in the Gelsinger case.
Even so, Caplan adds, "the school did talk about this" beforehand, setting up a "firewall" that was similar, but less rigid than AAMC's guidelines.
The Gelsinger study was "driven [more] by the desire to do good than anything else," Caplan added. "It was not a lucrative study for Wilson."
Gelsinger was enrolled in Wilson's study because he had a mild form of a liver disease that is normally fatal to infant boys.
Wilson and his staff were hoping to find genetic therapies for the disease. However, after receiving a high dose of treatment, Gelsinger became ill, went into a coma, and died shortly thereafter.
