Key potential conflicts of interest
Institutional and individual conflicts of interest perhaps always will plague human subjects research. Until there are uniform rules that all institutions must follow, it will be up to conflict of interest committees and IRBs to make certain that ethical abuses do not result from conflicts of interest that are both unacceptable and preventable.
It’s a good idea for an institution to have a conflict of interest subcommittee and also to have rules that describe how an IRB would handle a discovered conflict of interest, says Jesse Goldner, JD, professor of law and IRB chairman at Saint Louis (MO) University.
However, IRBs and others who are scrutinizing the connections between researchers, institutions, and research sponsors should keep in mind that there are many gray areas that should be decided on a case-by-case basis, he says.
Goldner offers these examples of subtle as well as more blatant conflicts of interest circumstances that could be encountered by an IRB:
• Individual financial conflict: An investigator owns 100 shares of a drug company’s stock, and this drug company will sponsor one of the investigator’s clinical trials. "At the theoretical level, you have attenuated interest," Goldner says. "But if the 100 shares are in a mutual fund that owns the stock, then no subject will be concerned about that."
• Institutional financial conflict: The research institution has a substantial financial stake in a company that is sponsoring research at its site. "That research should absolutely be prohibited," he says.
• Lecture fees: A pharmaceutical company is sponsoring lectures and paying an investigator a large fee to speak. Since academic salaries typically are far less than what an investigator would be paid by industry, these fees could be considered potential conflicts of interest and should at least be disclosed to potential subjects of a trial that this investigator is conducting through the same company’s sponsorship, Goldner says.
• Tenure pressure: Among the most subtle forms of conflict of interest involve the process by which researchers at an academic institution earn tenure. "Part of the process is being successful at the research game and part of being successful is having sponsors come to you because they think you will be good at recruiting subjects in a short period of time," he explains.
"I’ve encountered a situation where a researcher arguably enrolled subjects who fell outside the inclusion criteria because there was pressure to enroll subjects within the research deadline," Goldner says.
This type of conflict of interest is very difficult for an IRB to detect without a whistle-blower or careful monitoring of an ongoing study, he adds.
Institutional and individual conflicts of interest perhaps always will plague human subjects research. Until there are uniform rules that all institutions must follow, it will be up to conflict of interest committees and IRBs to make certain that ethical abuses do not result from conflicts of interest that are both unacceptable and preventable.
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