What Should Physician-Researchers Tell Patient-Subjects About Their Relationships With Industry?
Year: 2021
Type: article
Abstract: An investigator's personal financial interest in technology under investigation or in the company sponsoring the research is a clear conflict of interest (COI).Such financial relationships are common, and ethical questions rightly emerge about COIs' capacity to compromise an investigator's approaches to research.This commentary on a case suggests that COI disclosure is appropriate during the process of facilitating patient-subjects' informed consent because it promotes informed decision making and motivates transparency.But COI disclosures are not always efficacious, nor are they sufficient to address the problem of research bias.This commentary argues that mitigation or elimination of COIs is a more effective strategy than disclosure.Case Dr M is a senior resident physician conducting research on a vagal nerve stimulator (VNS) with supervision from the attending physician and principal investigator, Dr A. The VNS was initially approved as a device for a specific indication and application by the US Food and Drug Administration (FDA) following clinical trials.Anecdotal reports from subjects in those clinical trials suggest that VNS might also be helpful for another indication, so the device's manufacturer, Company K, suggested that a novel off-label application of the VNS be investigated by Drs M and A. This new clinical trial is federally funded and also supported financially by Company K. Dr A has received numerous research grants, dinners, and speakers' fees from Company K. Dr M asks Dr A about the nature and scope of what they need to disclose to subjects during informed consent in order to comply with the Physician Payments Sunshine Act.This law requires manufacturers to report all payments to physicians and for physicians to either confirm or dispute and correct the data within 60 days of it being posted. 1 "Nothing," responds Dr A to Dr M. "That law applies to manufacturers, not to physicians and patients.""Well, that's true, but if you were going to enroll in our study, wouldn't you want to know?" Dr M continues.
Source: The AMA Journal of Ethic
Author: Jeffrey R. Botkin
Institution: University of Utah
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W3203801993