The explosion of biotech research has brought billions of dollars to academe, not the least of which was windfall funding from the National Institutes of Health. But the accompanying surge in industry funding also brought a slew of ethical questions that many academic researchers and institutions found themselves unprepared to address.
Do industry ties always have to be disclosed to peer-reviewed journals? What stipulations should researchers put up with in return for money from the private sector?
These are just a few of the questions that the Federation of American Societies for Experimental Biology wants institutions and researchers to consider.
The federation released a report, "Shared Responsibility, Individual Integrity: Scientists Addressing Conflicts of Interest in Biomedical Research," which offers some ethical guidelines that FASEB hopes will spur widespread discussion and that might eventually lead to consensus on some ethical issues.
“This will be an unending issue for us,” said Leo Furcht, president of FASEB, who has been both a researcher, a physician, and an entrepreneur, and is head of the department of laboratory medicine and pathology at the University of Minnesota Medical School. “The vast majority of researchers want to do the right thing, if they know what the right thing is but … some of the conflicts are not obvious.”
Though FASEB officials acknowledged the impossibility of rooting out all improprieties in biological research, they said that more clearly stated principles could go a long way in strengthening public trust in medical research, even as researchers embrace and often seek funding or consulting work with companies.
Among the 19 “guiding principles” in the FASEB report are: “Investigators shall not use federal funds to the benefit of a company, unless this is the explicit purpose of the mechanism used to fund the research,” and “Mentors and institutions should make trainees aware of their rights and responsibilities in industry relationships.”
Guiding principle number nine -- “Investigators shall be aware of and adhere to individual journal policies on disclosure of industry relationships” -- is particularly timely.
Last week, the Journal of the American Medical Association printed a note telling readers that many of the 13 authors of a study published in February, which showed that pregnant women who go off antidepressants can slip back into depression, have ties to drug companies, including antidepressant manufacturers, which they did not disclose. It’s the second time in two months that JAMA has had such an experience with unreported conflicts.
In a letter to JAMA, the researchers defended their work, saying that industry interests did not influence the work, and that because it was funded by the government, they did not think they had overlooked relevant disclosures.
A study by Harvard Medical School researchers, which was published in JAMA in May, found that about half of medical studies are now funded entirely by for-profit entities, and that such clinical trials are more likely to find a positive benefit from whatever drug or treatment is being tested.
Furcht said that many conflict of interest questions remain in a gray area, like how much equity, if any, a researcher should take in a company that funds research at their institution. “We think there needs to be a greater consensus,” Furcht said. He added that the attitude often taken is that “ laissez faire is fine as long as it works out,” but that it is not fine right now. “We have fallen short of where we need to be.”
Robert Palazzo, president-elect of FASEB and director of the Center for Biotechnology and Interdisciplinary Studies at Rensselaer Polytechnic Institute, said that the medical research community is “relatively naïve about this terrain.”
Last August, some researchers showed their apparent naïveté in a Seattle Times investigation. Some researchers told the paper that they didn’t see a problem with sharing their impressions of a clinical trial -- for which they had signed a confidentiality agreement -- with select clients from investment firms prior to the completion and public dissemination of the study. The Securities and Exchange Commission and at least one of the institutions home to one of the researchers named began investigations immediately after the article appeared.
Furcht, who said he holds 30-40 patents, said that researchers also need to learn the ins and outs of the patent process so they don’t hurriedly make public results that could be patented and used to bring money to a university. Furcht recalled an assistant professor who published, without a patent, the discovery of a new signaling pathway in detecting whether prostate tumor cells are metastatic.
Palazzo echoed one of the guiding principles in the report when he emphasized the need for student protection. Confidentiality and pre-publication review stipulations made by corporate funders can delay or restrict a graduate student’s ability to publish, and hence to complete their degree. “There has to be clarity that the student needs to be protected,” Palazzo said. “It’s not something that pops into a junior professor’s mind when there’s a chance for funding.”
Some institutions have been proactive in outlining principles for years. Harvard’s Medical School has a comprehensive set of guidelines originally drafted in the 1980s, and reviewed every 8-10 years. A Harvard spokesman said that all researchers have to fill out a formal conflict of interest form every 12-18 months, and that if the forms show a conflict, Harvard insists that the researcher divest.
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