When a researcher recruits volunteers for a clinical trial, there is often an elephant in the room. The volunteers may not see it, but the researcher may wonder if it’s necessary to point it out – and how to do so without scaring the people off.
The elephant is the researcher’s financial tie to the company that’s funding the study.
About one-third of academic investigators have personal financial relationships with industry sponsors. Though researchers must disclose some of these relationships to the federal government, they are under no obligation to tell the research subjects. However, there is a growing consensus they have an ethical obligation to do so – that this information is crucial for informed consent.
Indeed, after the deaths of two young volunteers in clinical trials – Jesse Gelsinger in 1999 and Jolie Mohr in 2007 – an inevitable question was whether they would have given consent had they known that the investigators had financial interests. A new study in the Journal of General Internal Medicine hints at some answers.
A computer survey asked 3,623 adults whether they would participate in a hypothetical clinical trial if one of five financial interests were disclosed. The disclosures ranged from a generic statement that the lead researcher might benefit financially to specific financial arrangements, such as that the lead researcher holds equity in the sponsoring company.
All of the disclosures said that an institutional review board and another committee had determined that the financial interest “is not likely to affect your safety or the scientific quality of the study.”
Anyone who assumes that revealing financial ties is like dropping a bomb is in for a surprise. The financial disclosures were more like a whimper than a bang.
Most of the financial interests were unlikely to affect the potential subjects’ willingness to participate in a clinical trial. The exception was the lead researcher holding equity in the sponsor: only 45 percent of respondents said that they would consent under that circumstance. In contrast, 59 percent said that they would participate if the lead researcher received per capita payments for recruiting volunteers.
But there was another, perhaps more revealing, message from this survey. Only 36 percent of respondents said that their trust in the researchers and their institutions diminished because of their financial ties. The disclosure of equity holdings was most likely to reduce trust.
This significant minority has reason to lose trust. There are ominous signs that industry-sponsored research often is untrustworthy – that it tends to draw pro-industry conclusions and that researchers who hold equity stakes are inclined to withhold unfavorable data.
It is this minority voice that deserves attention. “Policy makers should consider the relative sense of unease we observed about researchers owning equity as they determine what types of financial interests to permit in clinical research,” conclude the researchers, adding that “it would be inappropriate not to disclose such information when recruiting research participants.”